Sterilization Pouch/Roll Made with Tyvek
Device Facts
| Record ID | K180672 |
|---|---|
| Device Name | Sterilization Pouch/Roll Made with Tyvek |
| Applicant | Sigma Medical Supplies Corporation |
| Product Code | FRG · General Hospital |
| Decision Date | Jun 6, 2018 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilizer.
Device Story
Sterilization pouches/rolls contain medical devices for terminal sterilization in STERRAD® 100S Sterilizer (50°C, 6-minute cycle). Constructed from Tyvek® and plastic film; includes integrated chemical indicator bar (red-to-blue color change) to verify exposure to hydrogen peroxide vapor. Used by healthcare workers in clinical settings. Devices inserted, sealed (self-sealing or heat-sealed), and processed. Output is a sterile-barrier-protected device. Chemical indicator serves as process verification only; not a sterility indicator. Benefits include maintenance of device sterility for up to 3 years post-processing.
Clinical Evidence
Bench testing only. Validated per AAMI/ANSI/ISO 14937, 11607-1, and 11140-1. Testing included 6-log reduction of Geobacillus stearothermophilus, package integrity (tensile, tear, burst, seal peel, dye penetration), microbial barrier testing, biocompatibility (ISO 10993-10), and 3-year accelerated aging.
Technological Characteristics
Materials: Tyvek®, PET, PE, n-Heptane adhesive. Chemical indicator: Hydrogen peroxide vapor-sensitive ink. Form factor: Self-sealing pouches, flat/gusseted pouches, flat/gusseted rolls. Sterilization: Gas plasma (STERRAD® 100S). Standards: ASTM D882, D5035, D1922, F1140, F88, F1929, F1980, F2251; ISO 11607-1, 11140-1, 10993-10; DIN 58953-6.
Indications for Use
Indicated for healthcare workers to enclose medical devices for sterilization in STERRAD® 100S Sterilizers and maintain sterility for up to 3 years post-sterilization.
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
- Sterilization Pouch/Roll Made with Tyvek® (K133838)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 6, 2018
Sigma Medical Supplies Corporation % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. 15F .- 2, No.1, Lane 26, Mincyuan 1st Rd., Lingya District Kaohsiung City, 802 Taiwan
Re: K180672
Trade/Device Name: Sterilization Pouch/Roll Made with Tyvek Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: February 27, 2018 Received: March 14, 2018
Dear Uta Shih:
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
## Geeta K. Pamidimukkala -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
#### K180672
Device Name Sterilization Pouch/Roll Made with Tyvek®
#### Indications for Use (Describe)
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilizer.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- · Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
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# K180672 510(K) Summary
## 5.1 Submitter's Information
| Name: | SIGMA Medical Supplies Corp. |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui<br>Fang Dist., New Taipei City 224, Taiwan (R.O.C.) |
| Establishment<br>Registration Number: | 3004970050 |
| Contact: | Mason Huang<br>Regulatory Affair Specialist<br>886-4-24366111 ext. 127<br>E-mail: mason@sigma-medical.com.tw<br>Or<br>Jack Wang<br>President /C.E.O |
| Date Prepared: | May 23, 2018 |
| 5.2 Device Trade Name: | |
| Trade Name: | Sterilization Pouch/Roll Made with Tyvek® |
| Common/usual Name: | Sterilization Pouch/Roll Made with Tyvek® |
| Device Classification Names: | 1) Wrap, Sterilization.<br>2) Indicator, Physical/Chemical Sterilization Pro-<br>cess |
| Panel: | General Hospital |
| Classification Product Code:<br>Subsequent Product Code: | 1) FRG<br>2) JOJ |
| Device Classification: | Class II |
| Regulation Number: | 1) 21 CFR 880.6850<br>2) 21 CFR 880.2800 |
#### 5.3 Predicate Devices:
The predicate device [510(k) Notification K133838, cleared March 11, 2015] is the Sterilization Pouch/Roll Made with Tyvek®
Manufacturer: SIGMA Medical Supplies Corp. Product Code:1) FRG 2) JOJ 510(k) number:K133838
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## 5.4 Intended Use
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STER-RAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
## 5.5 Device Description
Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® 100S Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 100S Sterilization System (The recommended cycle parameter is 6 minutes (Injection volume: 2880µL) at 50°C.). After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilization System.
The pouches are constructed from Tyvek®/plastic films, with H2O2 Chemical Indicator printed onto the Tyvek® film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.
The H2O2 Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches
- · Sterilization pouches, Flat
- · Sterilization pouches, Gusseted
- · Sterilization rolls, Flat
- Sterilization rolls, Gusseted
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The defining characteristics of the 5 types as follows:
- · Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is Tyvek® and used to seal the pouch. Release Tyvek® used in the pouch is a laminated sheet with composing structure of Tyvek®, PET, PE. It is a strip to cover the adhesive area and is released before seal the pouch. The Tyvek® conforms to recognized material standards and can be sterilized by Gas plasma in the STER-RAD® 100S Sterilization System's standard cvcle. The Process Indicators Ink printed on the Tyvek® will exhibit a color change after the pouch is exposed to Gas plasma.
- . Sterilization pouches, Flat: These pouches have the same components with the Selfsealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when used.
- · Sterilization pouches, Gusseted: These pouches are the same as the Sterilization pouches, flat, except that the plastic film is folded on both long sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- · Sterilization rolls. Flat: These rolls are made from a Tyvek® and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the Tyvek® are the same with the self-sealing sterilization pouches.
- · Sterilization rolls. Gusseted: These rolls are the flat sterilization roll. except that the plastic film is folded on both long sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The following table (Table 5-1) lists the model numbers of the Sterilization Pouch/Roll Made with Tyvek® by type, model, dimensions, and max load (for pouches):
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| Type | Model | Dimensions (mm) | Content / Max Load (lbs) | | |
|---------------------------------------|------------|------------------|--------------------------|---------|------------------|
| | | | Metal | Plastic | Linens and Gauze |
| Self-sealing Sterilization<br>Pouches | TYSE057133 | 57mm×133mm | 0.0354 | 0.0327 | 0.0141 |
| | TYSE090162 | 90mm×162mm | 0.0534 | 0.0495 | 0.0214 |
| | TYSE090256 | 90 mm×256 mm | 0.1218 | 0.1129 | 0.0734 |
| | TYSE070257 | 70mm×257mm | 0.0807 | 0.0748 | 0.0323 |
| | TYSE090257 | 90mm×257mm | 0.1218 | 0.1129 | 0.0734 |
| | TYSE133282 | 133 mm×282 mm | 0.2424 | 0.4144 | 0.1940 |
| | TYSE135283 | 135mm×283mm | 0.2424 | 0.4144 | 0.1940 |
| | TYSE135335 | 135mm×335mm | 0.2986 | 0.5548 | 0.2502 |
| | TYSE190358 | 190mm×358mm | 0.4809 | 1.0107 | 0.4325 |
| | TYSE254408 | 254 mm ×408 mm | 0.7224 | 1.5303 | 0.6804 |
| | TYSE300380 | 300mm×380mm | 0.8488 | 1.9303 | 0.8004 |
| | TYSE300474 | 300mm×474mm | 1.0744 | 2.4943 | 1.0260 |
| | TYSE305485 | 305 mm × 485 mm | 1.0794 | 2.4995 | 1.0296 |
| Sterilization Pouches,<br>Flat | TYFP075200 | 75mm×200mm | 0.0826 | 0.0347 | 0.017 |
| | TYFP075300 | 75mm×300mm | 0.1576 | 0.0662 | 0.032 |
| | TYFP100200 | 100mm×200mm | 0.1326 | 0.0557 | 0.027 |
| | TYFP100300 | 100mm×300mm | 0.2326 | 0.0977 | 0.0474 |
| | TYFP150255 | 150 mm × 255 mm | 0.2326 | 0.0977 | 0.0474 |
| | TYFP150300 | 150mm×300mm | 0.3826 | 0.3977 | 0.1974 |
| | TYFP190330 | 190 mm×330 mm | 0.5836 | 0.9407 | 0.3654 |
| | TYFP200400 | 200mm×400mm | 0.7326 | 1.0977 | 0.5474 |
| | TYFP250450 | 250mm×450mm | 1.0576 | 1.7477 | 0.8724 |
| | TYFP300500 | 300mm×500mm | 1.4326 | 2.4977 | 1.2474 |
| Sterilization Pouches,<br>Gusseted | TYGP100300 | 100mm×40mm300mm | 0.2592 | 0.0488 | 0.0146 |
| | TYGP150400 | 150mm×50mmx400mm | 0.5592 | 0.9488 | 0.2842 |
| | TYGP200400 | 200mm×50mmx400mm | 0.7592 | 1.5488 | 0.4842 |
| | TYGP250480 | 250mm×60mmx480mm | 1.1592 | 2.7488 | 0.8842 |
| | TYGP300500 | 300mm×70mmx500mm | 1.4592 | 3.6488 | 1.1842 |
| Type | Model | Dimensions (mm) | Content / Max Load (lbs) | | |
| | | | Metal | Plastic | Linens and Gauze |
| | TYFR050070 | 50mm×70M | 0.0354 | 0.0327 | 0.0141 |
| | TYFR022f | 50.8 mm × 61 M | 0.0354 | 0.0327 | 0.0141 |
| | TYFR075070 | 75mm×70M | 0.0811 | 0.0342 | 0.016 |
| | TYFR100070 | 100mm×70M | 0.1326 | 0.0557 | 0.027 |
| | TYFR042f | 101.6 mm ×61 M | 0.1326 | 0.0557 | 0.027 |
| | TYFR150070 | 150mm×70M | 0.2326 | 0.0977 | 0.0474 |
| | TYFR062f | 152.4 mm×61 M | 0.2326 | 0.0977 | 0.0474 |
| | TYFR200070 | 200mm×70M | 0.7326 | 1.0977 | 0.5474 |
| | TYFR082f | 203.2 mm× 61 M | 0.7326 | 1.0977 | 0.5474 |
| | TYFR250070 | 250mm×70M | 1.0576 | 1.7477 | 0.8724 |
| | TYFR102f | 254 mm ×61 M | 1.0576 | 1.7477 | 0.8724 |
| | TYFR300070 | 300mm×70M | 1.4326 | 2.4977 | 1.2474 |
| | TYFR350070 | 350mm×70M | 1.6326 | 2.7977 | 1.4474 |
| | TYFR400070 | 400mm×70M | 1.8306 | 3.2931 | 1.6422 |
| | TYFR450070 | 450mm×70M | 2.664 | 4.3655 | 2.1795 |
| | TYFR500070 | 500mm×70M | 3.559 | 6.2162 | 3.0885 |
| | TYFR050100 | 50mm×100M | 0.0354 | 0.0327 | 0.0141 |
| Sterilization Rolls,<br>Flat | TYFR075100 | 75mm×100M | 0.0811 | 0.0342 | 0.016 |
| | TYFR100100 | 100mm×100M | 0.1326 | 0.0557 | 0.027 |
| | TYFR150100 | 150mm×100M | 0.2326 | 0.0977 | 0.0474 |
| | TYFR200100 | 200mm×100M | 0.7326 | 1.0977 | 0.5474 |
| | TYFR250100 | 250mm×100M | 1.0576 | 1.7477 | 0.8724 |
| | TYFR300100 | 300mm×100M | 1.4326 | 2.4977 | 1.2474 |
| | TYFR350100 | 350mm×100M | 1.6326 | 2.7977 | 1.4474 |
| | TYFR400100 | 400mm×100M | 1.8306 | 3.2931 | 1.6422 |
| | TYFR450100 | 450mm×100M | 2.664 | 4.3655 | 2.1795 |
| | TYFR500100 | 500mm×100M | 3.559 | 6.2162 | 3.0885 |
| | TYFR050200 | 50mm×200M | 0.0354 | 0.0327 | 0.0141 |
| | TYFR075200 | 75mm×200M | 0.0811 | 0.0342 | 0.016 |
| | TYFR100200 | 100mm×200M | 0.1326 | 0.0557 | 0.027 |
| | TYFR150200 | 150mm×200M | 0.2326 | 0.0977 | 0.0474 |
| | TYFR200200 | 200mm×200M | 0.7326 | 1.0977 | 0.5474 |
| | TYFR250200 | 250mm×200M | 1.0576 | 1.7477 | 0.8724 |
| | TYFR300200 | 300mm×200M | 1.4326 | 2.4977 | 1.2474 |
| | TYFR350200 | 350mm×200M | 1.6326 | 2.7977 | 1.4474 |
| | TYFR400200 | 400mm×200M | 1.8306 | 3.2931 | 1.6422 |
| | TYGR075100 | 75mm×35mm×100M | 0.1966 | 0.0434 | 0.012 |
| | TYGR100100 | 100mm×40mm×100M | 0.2592 | 0.0488 | 0.0146 |
| Sterilization Rolls,<br>Gusseted | TYGR150100 | 150mm×50mm×100M | 0.5592 | 0.9488 | 0.2842 |
| | TYGR200100 | 200mm×50mm×100M | 0.7592 | 1.5488 | 0.4842 |
| | TYGR250100 | 250mm×60mm×100M | 1.1592 | 2.7488 | 0.8842 |
| | TYGR300100 | 300mm×70mm×100M | 1.4592 | 3.6488 | 1.1842 |
| | TYGR350100 | 350mm×80mm×100M | 1.7959 | 4.1601 | 1.8547 |
| | TYGR400100 | 400mm×80mm×100M | 2.0685 | 4.5816 | 2.5917 |
## Table 5-1. The model numbers of Sterilization Pouch/Roll Made with Tyvek® (Type, Model, Dimension, Max Load)
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# K180672 510(K) SUMMARY
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#### 5.6 Comparison of Technological Characteristics
A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-2.
| Feature | Proposed device | Predicate device | Comparison | |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Device name | Sterilization Pouch/Roll Made<br>with Tyvek® (K180672) | Sterilization Pouch/Roll Made<br>with Tyvek® (K133838) | | |
| Material<br>Composition | Tyvek®, PET, PE, Water, CH3COOH,<br>Alcohol, n-Heptane adhesive, Hydrogen<br>peroxide vapor Process Indicator Print Ink | Tyvek®, PET, PE, Water, CH3COOH,<br>Alcohol, n-Heptane adhesive, Hydrogen<br>peroxide vapor Process Indicator Print Ink | Same | |
| Intended use | Sterilization Pouch/Roll Made with<br>Tyvek® are intended to provide health care<br>workers with an effective method to en-<br>close devices intended for sterilization in<br>the STERRAD® 100S Sterilizer. The de-<br>vice is intended to allow sterilization of<br>enclosed devices and also to maintain ste-<br>rility of the enclosed devices until used up<br>to 3 years post sterilization.<br>The pouches and rolls are printed with a<br>chemical indicator bar which is a process<br>indicator (ISO 11140-1:2005) that changes<br>from red to blue (or lighter) when exposed<br>to hydrogen peroxide vapor during pro-<br>cessing in the STERRAD® 100S Sterilizer. | Sterilization Pouch/Roll Made with<br>Tyvek® are intended to provide health care<br>workers with an effective method to en-<br>close devices intended for sterilization in<br>the STERRAD® 100S Sterilizer. The de-<br>vice is intended to allow sterilization of<br>enclosed devices and also to maintain ste-<br>rility of the enclosed devices until used up<br>to 3 years post sterilization.<br>The pouches and rolls are printed with a<br>chemical indicator bar which is a process<br>indicator (ISO 11140-1:2005) that changes<br>from red to blue (or lighter) when exposed<br>to hydrogen peroxide vapor during pro-<br>cessing in the STERRAD® Sterilization<br>System. | Same | |
| Pouch Types | · Self-sealing sterilization pouches<br>· Sterilization pouches, Flat<br>· Sterilization pouches, Gusseted<br>· Sterilization rolls, Flat<br>· Sterilization rolls, Gusseted | · Self-sealing sterilization pouches<br>· Sterilization pouches, Flat<br>· Sterilization pouches, Gusseted<br>· Sterilization rolls, Flat<br>· Sterilization rolls, Gusseted | Same | |
| Device models<br>(Configura-<br>tions/Dimensi<br>ons) | Self-sealing Sterilization Pouches<br>Model Dimensions (mm)<br>TYSE057133 57mm×133mm<br>TYSE090162 90mm×162mm<br>TYSE090256 90 mm×256 mm<br>TYSE070257 70mm×257mm<br>TYSE090257 90mm×257mm<br>TYSE133282 133 mm×282 mm<br>TYSE135283 135mm×283mm<br>TYSE135335 135mm×335mm<br>TYSE190358 190mm×358mm<br>TYSE254408 254 mm×408 mm<br>TYSE300380 300mm×380mm<br>TYSE300474 300mm×474mm<br>TYSE305485 305 mm × 485 mm | Self-sealing Sterilization Pouches<br>Model Dimensions (mm)<br>TYSE057133 57mm×133mm<br>TYSE090162 90mm×162mm<br>TYSE070257 70mm×257mm<br>TYSE090257 90mm×257mm<br>TYSE135283 135mm×283mm<br>TYSE135335 135mm×335mm<br>TYSE190358 190mm×358mm<br>TYSE300380 300mm×380mm<br>TYSE300474 300mm×474mm | The models<br>(dimensions)<br>of type "Self-<br>Sealing Steri-<br>lization<br>Pouches" are<br>different.<br>There are 4<br>additional<br>models in<br>Proposed de-<br>vice.<br>The additional<br>models (Type,<br>Model and<br>Dimension) of<br>Proposed de-<br>vice are shown<br>in Table 5-3. | |
| Feature | Proposed device: Sterilization<br>Pouch/Roll Made with Tyvek®<br>(K180672) | | Predicate devices: Sterilization<br>Pouch/Roll Made with Tyvek®<br>(K133838) | comparison |
| Device models<br>(Configurations/Dimensions) | Sterilization Pouches, Flat<br>Model | Dimensions (mm) | Sterilization Pouches, Flat<br>Model | Dimensions (mm) |
| | TYFP075200 | 75mm × 200mm | TYFP075200 | 75mm × 200mm |
| | TYFP075300 | 75mm × 300mm | TYFP075300 | 75mm × 300mm |
| | TYFP100200 | 100mm × 200mm | TYFP100200 | 100mm × 200mm |
| | TYFP100300 | 100mm × 300mm | TYFP100300 | 100mm × 300mm |
| | TYFP150255 | 150 mm × 255 mm | TYFP150300 | 150mm × 300mm |
| | TYFP150300 | 150mm × 300mm | TYFP200400 | 200mm × 400mm |
| | TYFP190330 | 190 mm × 330 mm | TYFP250450 | 250mm × 450mm |
| | TYFP200400 | 200mm × 400mm | TYFP300500 | 300mm × 500mm |
| | TYFP250450 | 250mm × 450mm | | |
| | TYFP300500 | 300mm × 500mm | | |
| | Sterilization Rolls, Flat<br>Model | Dimensions (mm) | Sterilization Rolls, Flat<br>Model | Dimensions (mm) |
| | TYFR050070 | 50mm × 70M | TYFR050070 | 50mm × 70M |
| | TYFR022f | 50.8 mm × 61 M | TYFR075070 | 75mm × 70M |
| | TYFR075070 | 75mm × 70M | TYFR100070 | 100mm × 70M |
| | TYFR100070 | 100mm × 70M | TYFR150070 | 150mm × 70M |
| | TYFR042f | 101.6 mm × 61 M | TYFR200070 | 200mm × 70M |
| | TYFR150070 | 150mm × 70M | TYFR250070 | 250mm × 70M |
| | TYFR062f | 152.4 mm × 61 M | TYFR300070 | 300mm × 70M |
| | TYFR200070 | 200mm × 70M | TYFR350070 | 350mm × 70M |
| | TYFR082f | 203.2 mm × 61 M | TYFR400070 | 400mm × 70M |
| | TYFR250070 | 250mm × 70M | TYFR450070 | 450mm × 70M |
| | TYFR102f | 254 mm × 61 M | TYFR500070 | 500mm × 70M |
| | TYFR300070 | 300mm × 70M | TYFR050100 | 50mm × 100M |
| | TYFR350070 | 350mm × 70M…
