PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
Device Facts
| Record ID | K160595 |
|---|---|
| Device Name | PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator |
| Applicant | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti |
| Product Code | FRG · General Hospital |
| Decision Date | Nov 18, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
PMS Steripack Tyvek Sterilization Pouches (TP) 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) 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.
Device Story
Sterilization packaging system consisting of Tyvek and laminated PET/PE film pouches/rolls; used by healthcare providers to enclose medical devices for VHP sterilization. Devices are inserted into pouches/rolls and heat-sealed. Pouches are processed in Steris V-PRO 1 PLUS Lumen Cycle; sterilant penetrates Tyvek to destroy microorganisms. Integrated Class 1 chemical indicator ink on exterior changes from red to blue/lighter upon VHP exposure, allowing visual distinction between processed and unprocessed units. Maintains sterility for 30 days post-sterilization. Output is a sterile-packaged medical device; assists clinical decision-making by confirming sterilization cycle exposure.
Clinical Evidence
Bench testing only. Validated to a sterility assurance level (SAL) of 10^-6. Performance testing confirmed microbial barrier properties, material compatibility with V-PRO 1 PLUS Lumen Cycle, and package integrity. Chemical indicators validated per ISO 11140-1. No clinical data.
Technological Characteristics
Materials: Tyvek and laminated PET/PE film. Construction: Heat-sealed pouches/rolls with triple band seal. Chemical indicator: Class 1 process indicator (ISO 11140-1) printed on exterior. Sterilization: VHP (Vaporized Hydrogen Peroxide). Standards: ISO 11140-1:2005, ISO 11607-1:2006/(R)2010. Dimensions: Various sizes provided. Connectivity: None.
Indications for Use
Indicated for healthcare workers to enclose medical devices for sterilization via vaporized hydrogen peroxide (VHP) in the Steris V-PRO 1 PLUS Lumen Cycle. Compatible with stainless steel lumens (min 1.5mm ID, max 50mm length; or min 3mm ID, max 400mm length).
Regulatory Classification
Identification
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Predicate Devices
- STERIS Vis-U-All Low Temperature Sterilization Pouch/Tubing (K140487)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
PMS TIBBI CIHAZLAR TEKNOLOJISI SANA YI VE TICARET ANONIM ŞIRKETI Derya Dikici, Ph.D. Business Development Manager Karaduvar Mahallesi, Serbest Bolge 11. Cadde No:46 Mersin Serbest Bolgesi, 33020, Akdeniz/MERSIN/TURKEY
Re: K160595
Trade/Device Name: PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: October 10, 2016 Received: October 19, 2016
Dear Derya Dikici:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
#### 510(k) Number (if known) K160595
Device Name
## PMSSteripack Tyvek Sterilization Pouch(TP) and Roll(TY) with Chemical Indicator
Indications for Use (Describe)
PMS Steripack Tyvek Sterilization Pouches (TP) 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) 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).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Devices with stainless steel lumens with the following internal diameter (ID) and maximum length can be processed in V-PRO 1 Plus, Lumen Cycle.
| Pouch Size | Max. lumen length | Min. internal diameter | Max # Lumens | | | | | | |
|----------------|-------------------|------------------------|--------------|--|--|--|--|--|--|
| 50 x<br>200mm | 50 mm | 1.5 mm | 1 | | | | | | |
| 150 x<br>300mm | 3 mm | 200 mm | 1 | | | | | | |
| 350 x<br>600mm | 3 mm | 400 mm | 1 | | | | | | |
# Table 1. Lumen Claims
# 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.
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Image /page/4/Picture/0 description: The image shows the logo for PMS. The logo consists of a red and gray graphic on the left, followed by the letters "PMS" in gray. The graphic is a stylized shape with a red upper portion and a gray lower portion.
# K160595
# 510 (k) Summary For PMSSteripack Tyvek Sterilization Pouch(TP) and Roll (TY) with Chemical Indicator
### 1.0. Name. address and contact
PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM ŞIRKETI Karaduvar Mahallesi, Serbest Bolge 11. Cadde No:46 Mersin Serbest Bolgesi, 33020, Akdeniz/MERSIN/TURKEY
| Phone | 90 324 2387042 – 90 542 648 6312 |
|----------------|--------------------------------------------------|
| Fax | 90 324 2386549 |
| Prepared by : | Taner Ersen<br>Quality Management Representative |
| Contact : | Derya Dikici<br>Business Development Manager |
| Phone : | 90 324 2387042- 90 542 648 6312 |
| Fax : | 90 324 2386549 |
| E-mail : | derya.dikici@pmsmedikal.com |
| Date Prepared: | November 17, 2016 |
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#### 2. Device Name
Trade Name: PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
Common/Usual Name: Tyvek Sterilization Pouch and Roll
Device Classification Name: Wrap, Sterilization - Indicator, Physical/Chemical Sterilization Process
Product Code: FRG
Product Classification: Class II, 21 CFR 880.6850, General Hospital (FRG)
#### 3. Predicate Device
#### K140487, STERIS Vis-U-All Low Temperature Sterilization Pouch/Tubing
#### 4.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 cvcle 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.
| Pouch<br>Size | Max.<br>lumen<br>length | Min.<br>Internal<br>diameter | Max #<br>Lumens |
|----------------|-------------------------|------------------------------|-----------------|
| 50 x<br>200mm | 50 mm | 1.5 mm | 1 |
| 150 x<br>300mm | 3 mm | 200 mm | 1 |
| 350 x<br>600mm | 3 mm | 400 mm | 1 |
#### Table 1. Lumen Claims
#### 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.
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#### 5. Device Description
PMSSteriback Tvvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are manufactured from tyvek material/laminated PET/PE film that are heat sealed on sides. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear.
PMSSteripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are divided into 2 main configuration groups as below.
#### Sterilization Pouches, Flat:
These pouches are manufactured from twek material/ laminated PET/PE plastic film that are heat sealed on 3 sides, the remaining open side is heat sealed by the end user.
#### Sterilization Rolls, Flat:
These rolls are manufactured from tyvek material and laminated PET/PE plastic film that are heat sealed on opposite two sides. The required size is cut from the roll and the remaining open sides are heat sealed by the end user.
#### Available Sizes /Configurations for TP&TY:
#### Table 2. Product List of "PMSSteripack Tyvek Sterilization Pouch (TP) with Chemical Indicator "
| PRODUCT LIST | | | | | | | | | |
|--------------|-------|--------|-------|--------|-------|---------------|-----------------|---------------|----------|
| | (A) | (B) | (A) | (B) | (L) | (V)<br>Single | (P)<br>Distance | (S) | (T) |
| Product | Total | Total | Total | Total | Seal | | | | Thicknes |
| Name | Width | Height | Width | Height | Width | Seal | Between | Diameter (µm) | |
| | (mm) | (mm) | (in.) | (in.) | (mm) | Width | 2 Seals | (mm) | |
| | | | | | | (mm) | (mm) | | |
| TP0520 | 50 | 200 | 2 | 8 | 10 | 2 | 2 | 10 | 223±18 |
| TP0525 | 50 | 250 | 2 | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP0530 | 50 | 300 | 2 | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP0532 | 50 | 320 | 2 | 12¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP0535 | 50 | 350 | 2 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP7515 | 75 | 150 | 3 | 6 | 10 | 2 | 2 | 10 | 223±18 |
| TP7518 | 75 | 180 | 3 | 7 | 10 | 2 | 2 | 10 | 223±18 |
| TP7520 | 75 | 200 | 3 | 8 | 10 | 2 | 2 | 10 | 223±18 |
| TP7523 | 75 | 230 | 3 | 9 | 10 | 2 | 2 | 10 | 223±18 |
| TP7525 | 75 | 250 | 3 | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP7528 | 75 | 280 | 3 | 11 | 10 | 2 | 2 | 10 | 223±18 |
| TP7530 | 75 | 300 | 3 | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP7535 | 75 | 350 | 3 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP7540 | 75 | 400 | 3 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP7545 | 75 | 450 | 3 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP0815 | 80 | 150 | 3¼ | 6 | 10 | 2 | 2 | 10 | 223±18 |
| TP0817 | 80 | 170 | 3¼ | 6¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP0818 | 80 | 180 | 3¼ | 7 | 10 | 2 | 2 | 10 | 223±18 |
| TP0820 | 80 | 200 | 3¼ | 8 | 10 | 2 | 2 | 10 | 223±18 |
| TP0827 | 80 | 270 | 3¼ | 10¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP0860 | 80 | 600 | 3¼ | 24 | 10 | 2 | 2 | 10 | 223±18 |
| TP0956 | 90 | 560 | 3½ | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP0960 | 90 | 600 | 3½ | 24 | 10 | 2 | 2 | 10 | 223±18 |
| TP0961 | 90 | 610 | 3½ | 24 | 10 | 2 | 2 | 10 | 223±18 |
| TP1015 | 100 | 150 | 4 | 6 | 10 | 2 | 2 | 10 | 223±18 |
| TP1018 | 100 | 180 | 4 | 7 | 10 | 2 | 2 | 10 | 223±18 |
| TP1019 | 100 | 190 | 4 | 7½ | 10 | 2 | 2 | 10 | 223±18 |
| TP1020 | 100 | 200 | 4 | 8 | 10 | 2 | 2 | 10 | 223±18 |
| TP1023 | 100 | 230 | 4 | 9 | 10 | 2 | 2 | 10 | 223±18 |
| TP1025 | 100 | 250 | 4 | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP1026 | 100 | 260 | 4 | 10¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP1027 | 100 | 270 | 4 | 10¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP1028 | 100 | 280 | 4 | 11 | 10 | 2 | 2 | 10 | 223±18 |
| TP1030 | 100 | 300 | 4 | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP1033 | 100 | 330 | 4 | 13 | 10 | 2 | 2 | 10 | 223±18 |
| TP1035 | 100 | 350 | 4 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP1036 | 100 | 360 | 4 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP1040 | 100 | 400 | 4 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP1045 | 100 | 450 | 4 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP1050 | 100 | 500 | 4 | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP1056 | 100 | 560 | 4 | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP1057 | 100 | 570 | 4 | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP1060 | 100 | 600 | 4 | 24 | 10 | 2 | 2 | 10 | 223±18 |
| TP1061 | 100 | 610 | 4 | 24 | 10 | 2 | 2 | 10 | 223±18 |
| TP1128 | 110 | 280 | 4¼ | 11 | 10 | 2 | 2 | 10 | 223±18 |
| TP1225 | 120 | 250 | 4¾ | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP1230 | 120 | 300 | 4¾ | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP1240 | 120 | 400 | 4¾ | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP1250 | 120 | 500 | 4¾ | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP1325 | 130 | 250 | 5 | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP1338 | 130 | 380 | 5 | 15 | 10 | 2 | 2 | 10 | 223±18 |
| TP1520 | 150 | 200 | 6 | 8 | 10 | 2 | 2 | 10 | 223±18 |
| TP1525 | 150 | 250 | 6 | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP1527 | 150 | 270 | 6 | 10% | 10 | 2 | 2 | 10 | 223±18 |
| TP1528 | 150 | 280 | 6 | 11 | 10 | 2 | 2 | 10 | 223±18 |
| TP1530 | 150 | 300 | 6 | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP1532 | 150 | 320 | 6 | 12½ | 10 | 2 | 2 | 10 | 223±18 |
| TP1535 | 150 | 350 | 6 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP1538 | 150 | 380 | 6 | 15 | 10 | 2 | 2 | 10 | 223±18 |
| TP1540 | 150 | 400 | 6 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP1543 | 150 | 430 | 6 | 17 | 10 | 2 | 2 | 10 | 223±18 |
| TP1545 | 150 | 450 | 6 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP1550 | 150 | 500 | 6 | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP1552 | 150 | 520 | 6 | 20% | 10 | 2 | 2 | 10 | 223±18 |
| TP1555 | 150 | 550 | 6 | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP1556 | 150 | 560 | 6 | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP1640 | 160 | 400 | 6¼ | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP1658 | 160 | 580 | 6¼ | 23 | 10 | 2 | 2 | 10 | 223±18 |
| TP1722 | 170 | 220 | 6¾ | 8¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP1735 | 170 | 350 | 6¾ | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP1830 | 180 | 300 | 7 | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP1832 | 180 | 320 | 7 | 12½ | 10 | 2 | 2 | 10 | 223±18 |
| TP1846 | 180 | 460 | 7 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP1933 | 190 | 330 | 7½ | 13 | 10 | 2 | 2 | 10 | 223±18 |
| TP2020 | 200 | 200 | 8 | 8 | 10 | 2 | 2 | 10 | 223±18 |
| TP2025 | 200 | 250 | 8 | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP2027 | 200 | 270 | 8 | 10¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP2030 | 200 | 300 | 8 | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP2033 | 200 | 330 | 8 | 13 | 10 | 2 | 2 | 10 | 223±18 |
| TP2035 | 200 | 350 | 8 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP2040 | 200 | 400 | 8 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP2041 | 200 | 410 | 8 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP2045 | 200 | 450 | 8 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP2050 | 200 | 500 | 8 | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP2060 | 200 | 600 | 8 | 24 | 10 | 2 | 2 | 10 | 223±18 |
| TP2128 | 210 | 280 | 8¼ | 11 | 10 | 2 | 2 | 10 | 223±18 |
| TP2135 | 210 | 350 | 8¼ | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP2140 | 210 | 400 | 8¼ | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP2142 | 210 | 420 | 8¼ | 16¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP2228 | 220 | 280 | 8¾ | 11 | 10 | 2 | 2 | 10 | 223±18 |
| TP2235 | 220 | 350 | 8¾ | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP2242 | 220 | 420 | 8¾ | 16¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP2525 | 250 | 250 | 10 | 10 | 10 | 2 | 2 | 10 | 223±18 |
| TP2530 | 250 | 300 | 10 | 12 | 10 | 2 | 2 | 10 | 223±18 |
| TP2535 | 250 | 350 | 10 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP2538 | 250 | 380 | 10 | 15 | 10 | 2 | 2 | 10 | 223±18 |
| TP2540 | 250 | 400 | 10 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP2545 | 250 | 450 | 10 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP2550 | 250 | 500 | 10 | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP2735 | 270 | 350 | 10¾ | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP2745 | 270 | 450 | 10¾ | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP2835 | 280 | 350 | 11 | 14 | 10 | 2 | 2 | 10 | 223±18 |
| TP2840 | 280 | 400 | 11 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP2845 | 280 | 450 | 11 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP2850 | 280 | 500 | 11 | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP2857 | 280 | 570 | 11 | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP3038 | 300 | 380 | 12 | 15 | 10 | 2 | 2 | 10 | 223±18 |
| TP3040 | 300 | 400 | 12 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP3042 | 300 | 420 | 12 | 16¾ | 10 | 2 | 2 | 10 | 223±18 |
| TP3045 | 300 | 450 | 12 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP3046 | 300 | 460 | 12 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP3050 | 300 | 500 | 12 | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP3055 | 300 | 550 | 12 | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP3060 | 300 | 600 | 12 | 24 | 10 | 2 | 2 | 10 | 223±18 |
| TP3245 | 320 | 450 | 12¾ | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP3250 | 320 | 500 | 12¾ | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP3255 | 320 | 550 | 12¾ | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP3346 | 330 | 460 | 13 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP3540 | 350 | 400 | 14 | 16 | 10 | 2 | 2 | 10 | 223±18 |
| TP3545 | 350 | 450 | 14 | 18 | 10 | 2 | 2 | 10 | 223±18 |
| TP3550 | 350 | 500 | 14 | 20 | 10 | 2 | 2 | 10 | 223±18 |
| TP3552 | 350 | 520 | 14 | 20% | 10 | 2 | 2 | 10 | 223±18 |
| TP3555 | 350 | 550 | 14 | 22 | 10 | 2 | 2 | 10 | 223±18 |
| TP3560 | 350 | 600 | 14 | 24 | 10 | 2 | 2 | 10 | 223±18 |
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# Table 3. Product List of "PMSSteripack Tyvek Sterilization Rolls (TY) with Chemical Indicator"
| PRODUCT LIST | | | | | | | | |
|--------------|-------|--------|-----------|-----------|----------|------------|--------------|-----------|
| | (A) | (B) | Total (A) | (B) Total | (L) Seal | (V) Single | (P) Distance | (T) |
| Product | Total | Length | Total | Length | Width | Seal | Between | Thickness |
| Name | Width | (m) | Width | (ft) | (mm) | Width | 2 Seals | (μm) |
| | (cm) | | (in) | | | | (mm) | |
| TY 0523 | 5 | 23 | 2 | 75 | 10 | 2 | 2 | 223±18 |
| TY 7523 | 7.5 | 23 | 3 | 75 | 10 | 2 | 2 | 223±18 |
| TY 1023 | 10 | 23 | 4 | 75 | 10 | 2 | 2 | 223±18 |
| TY 12523 | 12.5 | 23 | 5 | 75 | 10 | 2 | 2 | 223±18 |
| TY 1523 | 15 | 23 | 6 | 75 | 10 | 2 | 2 | 223±18 |
| TY 2023 | 20 | 23 | 8 | 75 | 10 | 2 | 2 | 223±18 |
| TY 2323 | 23 | 23 | 9 | 75 | 10 | 2 | 2 | 223±18 |
| TY 2523 | 25 | 23 | 10 | 75 | 10 | 2 | 2 | 223±18 |
| TY 3023 | 30 | 23 | 12 | 75 | 10 | 2 | 2 | 223±18 |
| TY 3523 | 35 | 23 | 14 | 75 | 10 | 2 | 2 | 223±18 |
| TY 3823 | 38 | 23 | 15 | 75 | 10 | 2 | 2 | 223±18 |
| TY 4023 | 40 | 23 | 16 | 75 | 10 | 2 | 2 | 223±18 |
| TY 4523 | 45 | 23 | 18 | 75 | 10 | 2 | 2 | 223±18 |
| TY 5023 | 50 | 23 | 20 | 75 | 10 | 2 | 2 | 223±18 |
| TY 0530 | 5 | 30 | 2 | 100 | 10 | 2 | 2 | 223±18 |
| TY 7530 | 7.5 | 30 | 3 | 100 | 10 | 2 | 2 | 223±18 |
| TY 1030 | 10 | 30 | 4 | 100 | 10 | 2 | 2 | 223±18 |
| TY 12530 | 12.5 | 30 | 5 | 100 | 10 | 2 | 2 | 223±18 |
| TY 1530 | 15 | 30 | 6 | 100 | 10 | 2 | 2 | 223±18 |
| TY 2030 | 20 | 30 | 8 | 100 | 10 | 2 | 2 | 223±18 |
| TY 2330 | 23 | 30 | 9 | 100 | 10 | 2 | 2 | 223±18 |
| TY 2530 | 25 | 30 | 10 | 100 | 10 | 2 | 2 | 223±18 |
| TY 3030 | 30 | 30 | 12 | 100 | 10 | 2 | 2 | 223±18 |
| TY 3530 | 35 | 30 | 14 | 100 | 10 | 2 | 2 | 223±18 |
| TY 3830 | 38 | 30 | 15 | 100 | 10 | 2 | 2 | 223±18 |
| TY 4030 | 40 | 30 | 16 | 100 | 10 | 2 | 2 | 223±18 |
| TY 4530 | 45 | 30 | 18 | 100 | 10 | 2 | 2 | 223±18 |
| TY 5030 | 50 | 30 | 20 | 100 | 10 | 2 | 2 | 223±18 |
| TY 0570 | 5 | 70 | 2 | 230 | 10 | 2 | 2 | 223±18 |
| TY 7570 | 7.5 | 70 | 3 | 230 | 10 | 2 | 2 | 223±18 |
| TY 1070 | 10 | 70 | 4 | 230 | 10 | 2 | 2 | 223±18 |
| TY 1270 | 12 | 70 | 5 | 230 | 10 | 2 | 2 | 223±18 |
| TY 1570 | 15 | 70 | 6 | 230 | 10 | 2 | 2 | 223±18 |
| TY 2070 | 20 | 70 | 8 | 230 | 10 | 2 | 2 | 223±18 |
| TY 2570 | 25 | 70 | 10 | 230 | 10 | 2 | 2 | 223±18 |
| TY 3070 | 30 | 70 | 12 | 230 | 10 | 2 | 2 | 223±18 |
| TY 3570 | 35 | 70 | 14 | 230 | 10 | 2 | 2 | 223±18 |
| TY 4070 | 40 | 70 | 16 | 230 | 10 | 2 | 2 | 223±18 |
| TY 4570 | 45 | 70 | 18 | 230 | 10 | 2 | 2 | 223±18 |
| TY 5070 | 50 | 70 | 20 | 230 | 10 | 2 | 2 | 223±18 |
| TY 05100 | 5 | 100 | 2 | 330 | 10 | 2 | 2 | 223±18 |
| TY 75100 | 7.5 | 100 | 3 | 330 | 10 | 2 | 2 | 223±18 |
| TY 10100 | 10 | 100 | 4 | 330 | 10 | 2 | 2 | 223±18 |
| TY 125100 | 12.5 | 100 | 5 | 330 | 10 | 2 | 2 | 223±18 |
| TY 15100 | 15 | 100 | 6 | 330 | 10 | 2 | 2 | 223±18 |
| TY 20100 | 20 | 100 | 8 | 330 | 10 | 2 | 2 | 223±18 |
| TY 23100 | 23 | 100 | 9 | 330 | 10 | 2 | 2 | 223±18 |
| TY 25100 | 25 | 100 | 10 | 330 | 10 | 2 | 2 | 223±18 |
| TY 30100 | 30 | 100 | 12 | 330 | 10 | 2 | 2 | 223±18 |
| TY 35100 | 35 | 100 | 14 | 330 | 10 | 2 | 2 | 223±18 |
| TY 38100 | 38 | 100 | 15 | 330 | 10 | 2 | 2 | 223±18 |
| TY 40100 | 40 | 100 | 16 | 330 | 10 | 2 | 2 | 223±18 |
| TY 45100 | 45 | 100 | 18 | 330 | 10 | 2 | 2 | 223±18 |
| TY 50100 | 50 | 100 | 20 | 330 | 10 | 2 | 2 | 223±18 |
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5.1. Representative Engineering Drawing of "PMSSteripack Tyvek Sterilization Pouch (TP) with Chemical Indicator"
Image /page/12/Figure/1 description: The image shows a technical drawing of a part with several dimensions labeled. The dimension 'B' is shown vertically on the right side of the part. At the bottom, 'A' indicates the width, and there are also dimensions labeled 'P=2', 'V=2', and 'L=10' indicating other measurements of the part.
- A: Total width
- B: Total height
- L: Seal width
- V: Single seal width
- P: Distance between 2 seals
- S: diameter
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5.2. Representative Engineering Drawing of "PMSSteripack Tyvek Sterilization Roll (TY) with Chemical Indicator"
Image /page/13/Figure/1 description: The image shows a rectangular diagram with dimensions labeled. The length 'B' is along the horizontal axis, while the height 'A' is along the vertical axis. There are also labels indicating 'V=2', 'P=2', and 'L=10', which likely represent specific measurements or parameters within the diagram.
- A: Total width
- B: Total length
- L: Seal width
- V: Single seal width
- P: Distance between 2 seals
#### 6. Description of the Principle of Operation
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.
Medical device to be sterilized is put into pouch or roll and the open parts of the packages are closed by the end user with heat sealing. Sterilization Pouches then are subjected to sterilization operation in recommended (validated) VHP (Vaporized Hydrogen Peroxide) sterilization devices and cycle as V-PRO 1 PLUS, Lumen Cycle.
Sterilant penetration occurs through the tyvek material into the packages and microorganisms on the surfaces of the enclosed medical devices are destroyed via of the sterilant.
The process indicator on "PMSSteripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator" is intended to be used by a health care provider to distinquish between processed and unprocessed units by changing color. Chemical process indicators
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on the pouch and/or roll indicate that the pouch or roll has been exposed to sterilization process by changing color.
Chemical process indicators are printed on the pouch and roll exterior (printed on tyvek material component) change color when exposed to sterilant vapor during processing. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 30 days. Chemical indicator bars printed on to the medical grade paper component of the pouches are 100 mm² size, having dimensions of 5 mmx20 mm.
The indicators used on the pouches are classified as Class 1 type process indicator according to the ISO 11140-1 standard.
#### 7. Comparison of Submission Device and Predicate Device and Substantial Equivalence
Technological characteristics of the submission device and the comparison with predicate device are given in Table 7.1 as a summary. Performance comparison of submission device and predicate device is presented in Table 7.2.
| DEVICE NAME | SUBMISSION DEVICE | PREDICATE<br>DEVICE | SUBSTANTIALLY<br>EQUIVALENCE |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| CHARACTERISTICS | PMSSteripack Tyvek Sterilization<br>Pouch (TP) and Roll (TY) with<br>Chemical Indicator | STERIS Vis-U-All<br>Low Temperature<br>Sterilization<br>Pouch/Tubing<br>(K140487) | YES |
| DESIGN AND<br>CONSTRUCTION&<br>MATERIAL<br>COMPOSITION | Tyvek material and heat sealed<br>laminated PET/PE plastic film<br>Externally printed H2O2 chemica<br>process indicator ink. Pouches are<br>manufactured from tyvek material<br>/plastic film that are heat sealed on 3<br>sides. The remaining side is lef<br>opened and heat sealed by the end<br>user. Rolls are manufactured from<br>tyvek material/plastic film that are hea<br>sealed on opposite two sides. The<br>required size is cut from the roll and<br>the remaining open two sides are hea<br>sealed by the end user. | Pouches are<br>constructed fron<br>Tyvek and plastic<br>films, with the<br>Ethylene Oxide<br>Process Chemica<br>Indicator Printed on<br>both sides of Tyvek | YES |
| INDICATIONS FOR<br>USE | PMS Steripack Tyvek Sterilization<br>Pouches (TP) and Rolls (TY) with<br>Chemical Indicator; are intended to<br>provide healthcare workers with an<br>effective method to enclose medical<br>devices intended for sterilization in<br>vaporized hydrogen peroxide (VHP)<br>sterilization method.<br><br>PMS Steripack Tyvek Sterilization<br>Pouches (TP) and Rolls (TY) with<br>Chemical Indicator is a device intended<br>to be used to enclose another medical<br>device that is to be sterilized by a<br>healthcare provider. It is intended to<br>allow sterilization of the enclosed<br>medical devices and also maintain<br>sterility of the enclosed devices until<br>used. | The Vis-U-All Low<br>Temperature<br>Sterilization<br>Pouches/Tubing is<br>a sterilization<br>containment pouch<br>for use by health<br>care providers to<br>enclose medical<br>devices to be<br>sterilized in Lumen<br>and Non Lumen<br>Cycles in V-PRO<br>60 Low<br>Temperature<br>Sterilization<br>System.<br><br>The Pouch<br>maintains the<br>sterility of the<br>enclosed devices<br>until used. | YES |
#### T ABLE-7.1: Comparison of Submission Device and Predicate Device (Characteristics)
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| | | The recommended (and validated)<br>sterilization cycle parameters are:<br>The Steris V-PRO 1 PLUS LUMEN<br>CYCLE is a single preprogramed standard<br>sterilization cycle with NO cycle parameter<br>variables allowed by the end user.<br>Chemical process indicator on the exterior<br>of the Tyvek pouches and rolls indicates<br>that the pouch has been exposed to V- | | Pouches<br>ar<br>intended to contain<br>devices in such<br>manner as to leave<br>a minimum of one<br>inch between<br>the<br>devices and seal or<br>all sides.<br>Devices<br>with<br>stainless<br>steel<br>lumens<br>and the | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| PRO 1 Plus, Lumen Cycle sterilization<br>process by changing color from red to blue<br>or (lighter).<br>Devices with stainless steel lumens with<br>the following internal diameter (ID) and<br>maximum length can be processed in<br>V-PRO 1 Plus, Lumen Cycle. | | | | following minimum<br>internal<br>diameter<br>(ID) and maximum<br>length<br>can<br>be<br>processed in Vis-U-<br>All<br>Low<br>Temperature<br>Sterilization Pouch<br>/Tubing using the | |
| | Worst Case Load: | The worst case load for the 50 mm x 200<br>mm pouch is 0.058 lbs. of instruments. | | lumen cycle.<br>Single or dual<br>lumen devices | |
| | | The worst case load for the 150 mm x 300<br>mm pouch is 0.630 lbs. of instruments. | | 0.77 mm<br>ID and 410 mm<br>in length | |
| | | The worst case load for the 350 mm x 600<br>mm pouch is 3.054 lbs. of instruments. | | Triple Lumen<br>Devices<br>1.2 mm<br>ID and 275 mm | |
| Table 1. Lumen Claims | | | | in length<br>1.8 mm<br>ID and 310 mm<br>in length<br>or<br>2.8 mm<br>ID and 317 mm<br>in length | |
| Pouch<br>Size | Max.<br>lumen<br>length | Min.<br>internal<br>diameter | Max #<br>Lumens | | |
| 50 x<br>200<br>mm | 50<br>mm | 1.5 mm | 1 | | |
| 150 x<br>300<br>mm | 3 mm | 200 mm | 1 | | |
| 350 x<br>600<br>mm | 3 mm | 400 mm | 1 | | |
| | | | | | |
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| STERILIZATION<br>PROPERTIES | V-PRO 1 Plus, Lumen Cycle | V-PRO 60 Low<br>Temperature<br>Sterilization System<br>Lumen and Non<br>Lumen Cycles | YES |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| PRINCIPLE OF<br>OPERATIONS | PMS Steripack Tyvek Sterilization<br>Pouches (TP) and Rolls (TY) with<br>Chemical Indicator; are intended to<br>provide healthcare workers with an<br>effective method to enclose medical<br>devices intended for sterilization in<br>vaporized hydrogen peroxide (VHP)<br>sterilization method.<br><br>Medical device to be sterilized is put<br>into pouch or roll and the open parts of<br>the packages are closed by the end<br>user with heat sealing. Sterilization<br>Pouches then are subjected to<br>sterilization operation in recommended<br>(validated) VHP (Vaporized Hydroger<br>Peroxide) sterilization devices and the<br>cycle as V-PRO 1 PLUS, Lumen<br>Cycle.<br><br>Sterilant penetration occurs through<br>the tyvek material into the packages<br>and microorganisms on the surfaces of<br>the enclosed medical devices are<br>destroyed via of the sterilant.<br><br>The process indicator or a<br>"PMSSteripack Tyvek Sterilization<br>Pouches (TP) and Rolls (TY) with<br>Chemical Indicator" is intended to be<br>used by a health care provider to<br>distinguish between processed and<br>unprocessed units by changing color.<br>Chemical process indicators on the<br>pouch and/or roll indicate that the<br>pouch or roll has been exposed to<br>sterilization process by changing color.<br><br>Chemical process indicators are<br>printed on the pouch and roll exterior<br>(printed on tyvek material component)<br>change color when exposed to<br>sterilant vapor during processing. After<br>the sterilization is completed, the<br>sterility of the enclosed medical device<br>is maintained for 30 days. Chemical<br>indicator bars printed on to the medical<br>grade paper component of the<br>pouches are 100 mm² size, having<br>dimensions of 5 mmx20 mm.<br><br>The indicators used on the pouches<br>are classified as Class 1 type process<br>indicator according to the ISO 11140-1<br>standard. | The Vis-U-All Low<br>Temperature<br>Sterilization<br>Pouches/Tubing is<br>a sterilization<br>containment pouch<br>for use by health<br>care providers to<br>enclose medical<br>devices to be<br>sterilized in Lumen<br>and Non Lumen<br>Cycles in V-PRO 60<br>Low Temperature<br>Sterilization System.<br><br>The Pouch<br>maintains the<br>sterility of the<br>enclosed devices<br>until used.<br><br>Pouches are<br>intended to contain<br>devices in such a<br>manner as to leave<br>a minimum of one<br>inch between the<br>devices and seal or<br>all sides.<br><br>Devices with<br>stainless steel<br>following minimum<br>internal diameter<br>(ID) and maximum<br>length can be<br>processed in Vis-U-All<br>Low Temperature<br>Sterilization Pouch<br>/Tubing using the<br>lumen cycle.<br><br>Single or dual<br>lumen devices 0.77 mm ID<br>and 410 mm in<br>length Triple Lumen<br>Devices 1.2 mm ID<br>and 275 mm in<br>length 1.8 mm ID<br>and 310 mm in<br>length<br>or 2.8 mm ID<br>and 317 mm in<br>length | YES |
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| PRINCIPLES OF<br>OPERATION FOR<br>CHEMICAL<br>INDICATORS | The Process Indicators Ink printed on<br>the tyvek material will exhibit a color<br>change after the pouch is exposed to<br>Hydrogen Peroxide (H2O2) gas.<br>Hydrogen Peroxide (H2O2) sterilization<br>printed indicator bar changes from red<br>to blue (or lighter) when exposed to<br>hydrogen peroxide vapor. | The Process<br>Indicator Ink printed<br>on the tyvek will<br>exhibit a color<br>change after the<br>pouch is exposed<br>to sterilization. | YES |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----|
| SHELF LIFE<br>(Prior to Sterilization) | 3 years | 2 years | YES |
| SHELF LIFE<br>(Post Sterilization) | 30 days | 1 year | YES |
| CONFIGURATIONS&<br>DIMENSIONS | Various sizes (width and height/length) | Various sizes<br>(width and<br>height/length) | YES |
#### TABLE-7.2: Comparison Nonclinical Tests of Submission Device and Predicate Device (Performance)
| DEVICE NAME | PROPOSED DEVICE | PREDICATE DEVICE | SUBSTANTIALLY<br>EQUIVALENCE |
|------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------|
| PERFROMANCE | "PMSSteripack Tyvek<br>Sterilization Pouch (TP) and<br>Roll (TY) with Chemical<br>Indicator" | STERIS Vis-U-All Low<br>Temperature Sterilization<br>Pouch/Tubing (K140487) | YES |
| Sterilant Penetration | The sterilization (VHP) was<br>validated to a sterility assurance<br>level (SAL) of 10-6 | Meets requirements | YES |
| Microbial Barrier<br>Properties | Sterility was maintained for at<br>least 30 days after processing in<br>V-PRO 1 Plus, Lumen Cycle | Meets requirements | YES |
| Material<br>Compatibility | Suitability for use in V-PRO 1<br>Plus, Lumen Cycle sterilization<br>process and cycle parameters. | Meets requirements | YES |
| Biocompatibility | Not direct patient-contacting<br>devices; Materials are non-toxic<br>and meet ISO 10993-1<br>requirements. | Meets requirements | YES |
| Shelf Life (post<br>sterilization) | Sterility was maintained for at<br>least 30 days after processing in<br>V-PRO 1 Plus, Lumen Cycle | Meets requirements | YES |
| Package Integrity | Porous material providing a<br>microbial barrier. | Meets requirements | YES |
#### 8. Conclusion
"PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator" and "Vis-U-All Low Temperature Sterilization Pouch/Tubing" (submission device) (predicate device) are both single use devices that are used to enclose another medical device to be sterilized in recommended (validated) sterilization cycles.
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator and predicate device have many similar technological characteristics. Vis-U-All Low Temperature
{18}------------------------------------------------
Sterilization Pouch/Tubing are made from tyvek material and plastic film by heat sealing. On the other hand, PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator and Vis-U-All Low Temperature Sterilization Pouch/Tubing have similar design features and they all have various sizes.
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator and predicate device have similar sterilization methods (VH2O2). Submission device sterilization system is; VPRO 1 PLUS, Lumen Cycle; Predicate device sterilization system is V-PRO 60 Low Temperature Sterilization System, Lumen and Non Lumen Cycles.
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator and device have identical performance characteristics considering predicate Sterilant Penetration, Package Integity, Sterility Maintenance, Biocompatibility and Chemical Indicator Efficiacy.
Both the subject device "PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator" and the predicate device "Vis-U-All Low Temperature Sterilization Pouch/Tubing" meet the requirements of ANSI/ AAMI/ ISO 11140-1:2005 at 50 ℃ only and 11607-1:2006/(R)2010.
As indicated in Table 7.2. based on the results of non-clinical performance tests summaries of the subject and predicate device; any differences between subject and predicate device do not impact safety and effectiveness.
In conclusion, the subject device "PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator" is substantially equivalent to predicate device K140487 STERIS Vis-U-All Low Temperature Sterilization Pouch/Tubing. Based on the intended use, technological characteristics, and performance data, the subject PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator, is substantially equivalent and is as safe and as effective as the legally marketed predicate device.
