# K242208: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

- Pathway: 510(k) (Traditional)
- Applicant: Primed Medical Products, Inc.
- Decided: Oct 7, 2024 after 70 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K881471 (1988). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233777: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600), Primed Medical Products, Inc. (2024) Summary page 8.

## Indications for use
The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following: - Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600. - 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C. - Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems. - Advanced Sterilization Products STERRAD 100S system - Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle] - Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle] PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for a maximum of 180 days or until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below. PRIMED wraps are validated for Pre-Vacuum Steam and EO sterilization with two 3.0mm x 400 mm lumen devices as part of the load. PRIMED wraps are validated for ASP STERRAD 100 S sterilization with 10 stainless steel lumens (2mm ID x 250 mm length) as part of their load. PRIMED Sterilization wraps are validated for use with STERIS V-PRO cycles and intended load as listed below: V- PRO maX/maX2 Non-Lumen Cycle: • Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. • Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. V- PRO maX/maX2 Lumen Cycle: • Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. • Single, dual, or triple channeled stainless steel lumen that are: o ≥ 0.77 mm ID and ≤ 527 mm in length. o ≥ 0.8 mm ID and ≤ 542 mm in length. o ≥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 that are: o ≥ 3 mm ID and ≤ 298 mm in length. o ≥ 4 mm ID and ≤ 424 mm in length. V- PRO maX/maX2 Flexible Cycle: • Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. • 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: o 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 ID and ≤ 1050 mm in length o One flexible endoscope with a light cord (if not integral to the endoscope) and 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 load, up to 24 lbs (11 kg) can include lumened or non-lumened medical devices: - Single, dual, or triple channel stainless steel lumens ≥0.48 mm ID and ≤ 100 mm in length V-PRO 60/s2 Non-Lumen Cycle: • Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. • Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. V- PRO 60/s2 Lumen Cycle: • Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. • Medical devices (including single, dual, and triple channeled rigid and semi-rigid endoscopes) with the following configurations: o Single or dual channeled devices with stainless steel lumens that are: - ≥ 0.77 mm ID and ≤ 410 mm in length. - ≥ 1.8 mm ID and ≤ 542 mm in length. o Triple channeled devices with stainless steel 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 V-PRO 60/s2 Flexible Cycle: • Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. • One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to the endoscope), mat, and additional load. o The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length. o Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions: - ≥ 0.76 mm ID and ≤ 233 mm in length - ≥ 1.0 mm ID and ≤ 254 mm in length - ≥ 1.8 mm ID and ≤ 542 mm in length The PRIMED Sterilization wraps are validated with ASP STERRAD 100 NX and ASP STERRAD NX and ASP STERRAD 100s sterilization cycles and intended load detailed below: STERRAD 100NX Standard cycle: • Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. (A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle). STERRAD 100NX Flex Cycle: • Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Medical devices, including most flexible endoscopes, with the following materials and dimensions: o Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load) STERRAD 100NX Express Cycle: • Instruments surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Medical devices, including rigid or semi-rigid endoscopes without lumen. STERRAD 100NX DUO Cycle: • Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Medical devices, including most flexible endoscopes, with the following materials and dimensions: o Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter o Accessory devices that are normally connected to a flexible endoscope during use. o Flexible endoscopes without lumens STERRAD NX Standard cycle: • Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors and up to 10 lumens of followings. o Single channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 150 mm or shorter o Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter STERRAD NX Advanced Cycle: • Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Single channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 500 mm or shorter (up to 10 Lumen per load) • Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with an inside diameter of 1 mm or larger and length of 1065 mm or shorter (no additional load) STERRAD 100s: • Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Metal and nonmetal lumened instruments with inside diameter of 6 mm or larger and length of 310 mm or shorter. • A single stainless steel lumen with an inside diameter of 3 mm or larger and a length of 400 mm or shorter.

Source page: https://510kreport.com/device/K242208
Methodology: https://510kreport.com/methodology