# K160595: PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
- Decided: Nov 18, 2016 after 262 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: 4 generations back to K771032 (1977). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140487: Vis-U-All Low Temperature Sterilization Pouch/Tubing, STERIS Corporation (2014) Summary page 6.

## Indications for use
PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization in vaporized hydrogen peroxide (VHP) sterilization method. PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed devices until used. The recommended (and validated) sterilization cycle parameters are: The Steris V-PRO 1 PLUS LUMEN CYCLE is a single preprogramed standard sterilization cycle with NO cycle parameter variables allowed by the end user. Chemical process indicator on the exterior of the Tyvek pouches and rolls indicates that the pouch has been exposed to V-PRO 1 Plus, Lumen Cycle sterilization process by changing color from red to blue or (lighter). Devices with stainless steel lumens with the following internal diameter (ID) and maximum length can be processed in V-PRO 1 Plus, Lumen Cycle. Table 1. Lumen Claims Pouch Size: 50 x 200mm; Max. lumen length: 50 mm; Min. internal diameter: 1.5 mm; Max # Lumens: 1 Pouch Size: 150 x 300mm; Max. lumen length: 3 mm; Min. internal diameter: 200 mm; Max # Lumens: 1 Pouch Size: 350 x 600mm; Max. lumen length: 3 mm; Min. internal diameter: 400 mm; Max # Lumens: 1 Worst Case Load: The worst case load for the 50 mm x 200 mm pouch is 0.058 lbs. of instruments. The worst case load for the 150 mm x 300 mm pouch is 0.630 lbs. of instruments. The worst case load for the 350 mm x 600 mm pouch is 3.054 lbs. of instruments.

Source page: https://510kreport.com/device/K160595
Methodology: https://510kreport.com/methodology