# K222849: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System,  RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector

- Pathway: 510(k) (Special)
- Applicant: Steris
- Decided: Sep 30, 2022 after 9 days
- Product code: NVE (Washer, Cleaner, Automated, Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K930667 (1994). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222543: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System,  V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector, Steris (2022) Summary page 13.
- K190917: V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems, STERIS Corporation (2019) Summary page 28.

## Indications for use
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1): The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader. The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and the Fast Non Lumen Cycle. The Non Lumen Cycle can sterilize: Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). The Fast Non Lumen Cycle can sterilize: Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg). The Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either: • A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length • Or two lumens with: ▪ One lumen that is ≥ 1 mm ID and ≤ 990 mm in length ▪ And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The flexible endoscope may contain either: • A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length • Or two lumens with: ▪ One lumen that is ≥ 1 mm ID and ≤ 990 mm in length ▪ And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). The Lumen Cycle can sterilize: Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: • Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length • Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length • Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length • Triple channeled devices with stainless lumens that are either: ≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). The V-PRO s2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg). The V-PRO s2 Sterilizer Fast Cycle can sterilize: Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: • Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (~16-9/64”) in length ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length • Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) in length ≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length or ≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg). The V-PRO s2 Sterilizer Flexible Cycle can sterilize: One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load. • The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length • Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length ≥ 1.8 mm (~5/64”) ID and ≤ 542 mm (~21-5/16”) in length The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing. The V-PRO s2 Sterilizer Lumen Cycle can sterilize: Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: • Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) ID and ≤ 410 mm (16-9/64”) in length ≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length • Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) in length ≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length or ≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). The V-PRO 60 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg). The V-PRO 60 Sterilizer Flexible Cycle can sterilize: One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load. • The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64”) internal diameter (ID) and ≤ 990 mm (38-63/64”) in length • Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9-11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (10”) in length ≥ 1.8mm (~5/64”) ID and ≤ 542 mm (~21-5/16”) in length The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing. The V-PRO 60 Sterilizer Lumen Cycle can sterilize: Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: • Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) ID and ≤ 410 mm (16-9/64”) in length ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") length • Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) in length ≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length or ≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). The RAS Racks are used in the RAS Cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO 7053HP Single-Chamber Washer/Disinfector for the effective cleaning, rinsing, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.

Source page: https://510kreport.com/device/K222849
Methodology: https://510kreport.com/methodology