# K233065: V-PRO maX 2 Low Temperature Sterilization System

- Pathway: 510(k) (Special)
- Applicant: Steris
- Decided: Oct 20, 2023 after 24 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K190103 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223476: V-PRO maX 2 Low Temperature Sterilization System, STERIS Corporation (2023) Summary page 7.

## Indications for use
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. 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 load 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 single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 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), endoscope accessories, mat, and additional instruments. †† The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length • Additional instruments may include non-lumened or lumened medical devices with the following configurations: o Single, dual or triple channel stainless steel lumen that is • ≥ 0.48 mm ID and ≤ 100 mm in length †† The validation studies were conducted with a flexible endoscope in a tray with endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg). The Lumen Cycle can sterilize: † Medical devices with the following configurations: • Single, dual or triple channeled stainless steel lumen that are: • ≥ 0.77 mm ID and ≤ 527 mm in length • ≥ 0.8 mm ID and ≤ 542 mm in length • ≥ 0.48 mm ID and ≤ 100 mm in length • Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length • Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: • ≥ 3 mm ID and ≤ 298 mm in length • ≥ 4 mm ID and ≤ 424 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 Specialty Cycle can sterilize: Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures.* or Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.** 3D Printed Devices constructed of the following materials, and lumen if present, must be sterilized in the Specialty Cycle identified Material Manufacturer Specialty Cycle Lumens Surgical Guide Resin Formlabs F ≥3 mm ID x ≤30 mm L BioMed Amber Resin Formlabs F ≥3 mm ID x ≤30 mm L Dental LT Clear V2 Resin Formlabs D ≥3 mm ID x ≤30 mm L BioMed Clear Resin Formlabs D ≥3 mm ID x ≤30 mm L MED615RGD Stratasys E ≥3 mm ID x ≤20 mm L MED620 Stratasys E ≥3 mm ID x ≤20 mm L MED610 Stratasys E ≥3 mm ID x ≤20 mm L * The validation studies were conducted using a validation load consisting of single-pouched guide(s)/model(s) (with or without tray) with a total weight of 5 lbs. (2.3 kg) of 3D printed material. ** The validation studies were conducted using a validation load consisting of pouched devices (with or without tray) for a total weight of 11 lbs. (5 kg).

Source page: https://510kreport.com/device/K233065
Methodology: https://510kreport.com/methodology