Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

K141693 · Advanced Sterilization Products · FRG · Dec 19, 2014 · General Hospital

Device Facts

• Record ID: K141693
• Device Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
• Applicant: Advanced Sterilization Products
• Product Code: FRG · General Hospital
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilization process, the pouch roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.

Device Story

Device consists of Tyvek® and plastic film pouches/rolls featuring printed chemical indicator (CI) bar. Used to enclose medical devices for terminal sterilization in STERRAD® hydrogen peroxide vapor systems. CI bar changes color from red to yellow (or lighter) upon exposure to hydrogen peroxide, providing visual confirmation of processing. Operated by healthcare personnel in clinical settings. Does not replace biological indicators; only confirms exposure to sterilant. Benefits include maintenance of device sterility for 30 days post-processing and clear visual differentiation between processed and unprocessed packages.

Clinical Evidence

Bench testing only. Studies included sterilant penetration (half-cycle efficacy), package integrity (seal strength, microbial barrier, burst, peel open), material compatibility, post-processing color stability, shelf-life verification, and biocompatibility (ISO 10993-10/11). All tests passed.

Technological Characteristics

Materials: Tyvek® and transparent plastic film. Chemical indicator: Hydrogen peroxide-sensitive ink (ISO 11140-1:2005). Form factor: Self-seal pouches, heat-seal pouches, and heat-seal rolls. Sterilization: Hydrogen peroxide vapor. Connectivity: None.

Indications for Use

Indicated for enclosing medical devices for terminal sterilization in STERRAD® systems/cycles. Used in single or double pouch configurations. Maintains sterility for 30 days post-processing. Includes chemical indicator for process verification.

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

• Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K112087)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three profiles facing to the right, resembling a bird or a symbol of human connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19,2014

Advanced Sterilization Products % Sun Choi Regulatory Affairs Specialist 33 Technology Dr. Irvine, California 92618

Re: K141693

> Trade/Device Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: November 20, 2014 Received: November 21, 2014

Dear Sun Choi,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin Keith, MS 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) K141693

### Device Name

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

Indications for Use (Describe) (Page 1 of 2)

Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilization process, the pouch roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.

The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.

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 yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.

| STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens | Load requirements |
|------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------|
| STERRAD® 100S | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm<br>long | ≤10 lumens per load |
| STERRAD® 50 | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm<br>long | ≤10 lumens per load |
| STERRAD® 200 | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Teflon® and<br>polyethylene<br>≥6 mm ID x ≤310 mm<br>long | ≤12 lumens per load<br>≤36.48 lbs |

# Table 1: Indications for Use

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)

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# Indications for Use

510(k) Number (if known) K141693

### Device Name

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

### Indications for Use (Describe) (Page 2 of 2)

## Table 1: Indications for Use (continued)

| | STERRAD® / Cycle | Single-channel stainless<br>steel lumens | Other lumens | Load requirements |
|--------------------|------------------|----------------------------------------------------|--------------|-----------------------------------------------------------------------------------|
| STERRAD®<br>NX® | Standard | ≥1 mm ID x ≤150 mm long<br>≥2 mm ID x ≤400 mm long | N/A | ≤10 lumens per load<br>≤10.7 lbs |
| | Advanced | ≥1 mm ID x ≤500 mm long | N/A | ≤10 lumens per load<br>≤10.7 lbs |
| STERRAD®<br>100NX® | Standard | ≥0.7 mm ID x ≤500 mm long | N/A | ≤10 lumens per load<br>≤21.4 lbs |
| | EXPRESS | N/A | N/A | ≤10.7 lbs on bottom<br>shelf only |
| | DUO | N/A | N/A | Accessory devices<br>(e.g., cameras and<br>light cords) only<br>2 cameras maximum |

### Table 2: Product Codes for Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator

| Product Type | Product Codes |
|----------------------------------------------------------------------|-----------------------------------------------------------|
| Tyvek® Self-Seal Pouches with<br>STERRAD® Chemical Indicator (123XX) | 12320, 12326, 12335, 12332, 12342, 12340,<br>12348, 12356 |
| Tyvek® Rolls with STERRAD® Chemical<br>Indicator (124XX) | 12407, 12410, 12415, 12420, 12425, 12435,<br>12442, 12450 |
| Tyvek® Heat-Seal Pouches with<br>STERRAD® Chemical Indicator (125XX) | 12521, 12526, 12532, 12541, 12548 |

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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

### Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618

Establishment Registration Number: 2084725

### Contact Person

Sun Choi Regulatory Affairs Specialist IV Email: [e-mail] [phone] (Telephone) [phone] (Fax)

Date: December 19, 2014

## 1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

| Classification Name: | Sterilization Wrap<br>Sterilization Process Indicator |
|----------------------------|-------------------------------------------------------|
| Common/Usual Name: | Sterilization Pouch / Roll with Chemical Indicator |
| Product Classification: | Class II |
| Product Code: | FRG / JOJ |
| Panel: | General Hospital |
| Classification Regulation: | 21 CFR 880.6850<br>21 CFR 880.2800 |
| Proprietary Name: | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator |

# 2. PREDICATE DEVICES

The predicate device [510(k) Notification K112087, cleared October 15, 2012] is the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, for use in the STERRAD® 100NX® Sterilizer.

### 3. INTENDED USE

Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.

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The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.

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 yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.

| | STERRAD® / Cycle | Single-channel stainless<br>steel lumens | Other lumens | Load requirements |
|--------------------|------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------|
| | STERRAD® 100S | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm<br>long | <10 lumens per load |
| | STERRAD® 50 | ≥1 mm ID x ≤125 mm long<br>>2 mm ID x <250 mm long<br>≥3 mm ID x <400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm<br>long | <10 lumens per load |
| | STERRAD® 200 | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Teflon® and<br>polyethylene<br>≥6 mm ID x ≤310 mm<br>long | <12 lumens per load<br><36.48 lbs |
| | Standard | ≥1 mm ID x ≤150 mm long<br>≥2 mm ID x ≤400 mm long | N/A | <10 lumens per load<br><10.7 lbs |
| STERRAD®<br>NX® | Advanced | ≥1 mm ID x ≤500 mm long | N/A | <10 lumens per load<br><10.7 lbs |
| | Standard | ≥0.7 mm ID x ≤500 mm long | N/A | <10 lumens per load<br><21.4 lbs |
| STERRAD®<br>100NX® | EXPRESS | N/A | N/A | <10.7 lbs on bottom<br>shelf only |
| | DUO | N/A | N/A | Accessory devices<br>(e.g., cameras and<br>light cords) only<br>2 cameras maximum |

Table 1: Indications for Use

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| Product Type | Product Codes |
|----------------------------------------------------------------------|-----------------------------------------------------------|
| Tyvek® Self-Seal Pouches with<br>STERRAD® Chemical Indicator (123XX) | 12320, 12326, 12335, 12332, 12342, 12340,<br>12348, 12356 |
| Tyvek® Rolls with STERRAD® Chemical<br>Indicator (124XX) | 12407, 12410, 12415, 12420, 12425, 12435,<br>12442, 12450 |
| Tyvek® Heat-Seal Pouches with<br>STERRAD® Chemical Indicator (125XX) | 12521, 12526, 12532, 12541, 12548 |

Table 2: Product Codes for Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator

# 4. DESCRIPTION OF DEVICE

The proposed pouches are constructed from Tyvek® / plastic films, with the STERRAD® 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 STERRAD® 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. STERRAD® 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 yellow (or lighter) when exposed to hydrogen peroxide. Refer to Table 3 for comparison between proposed and predicate devices.

| | Proposed Device:<br>Tyvek® Pouch/Roll with<br>STERRAD® Chemical<br>Indicator | Predicate Device: Tyvek®<br>Pouch/Roll with STERRAD®<br>Chemical Indicator<br>(K112087) | Comparison | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use | The Tyvek® Pouch/Roll with<br>STERRAD® Chemical<br>Indicator is intended to enclose<br>a medical device that is to be<br>sterilized in the STERRAD®<br>Sterilization System, and to<br>show that the pouch/roll has<br>been exposed to hydrogen<br>peroxide during the sterilization<br>process. | The Tyvek® Pouch/Roll with<br>STERRAD® Chemical<br>Indicator is intended to enclose<br>a medical device that is to be<br>sterilized in the STERRAD®<br>Sterilization System, and to<br>show that the pouch/roll has<br>been exposed to hydrogen<br>peroxide during the sterilization<br>process. | Same |
| | | Proposed Device:<br>Tyvek® Pouch/Roll with<br>STERRAD® Chemical<br>Indicator | Predicate Device: Tyvek®<br>Pouch/Roll with STERRAD®<br>Chemical Indicator<br>(K112087) | Comparison |
| | Indications<br>for Use | Tyvek® Pouches and Rolls with<br>STERRAD® Chemical<br>Indicator are intended to be<br>used to enclose medical devices<br>that are to be terminally<br>sterilized in the STERRAD®<br>Sterilization Systems and<br>Cycles, in a single or double<br>pouch configuration, and to<br>indicate, by color change, that<br>the pouch has been exposed to<br>sterilant. After completion of<br>the sterilization process, the<br>pouch/roll maintains sterility<br>until the pouch/roll is used; in<br>the United States, this is for a<br>period of 30 days.<br><br>The STERRAD® Sterilization<br>Systems and Cycles that can be<br>used are shown in Table 1. The<br>product codes for all Tyvek®<br>Pouches and Rolls with<br>STERRAD® Chemical<br>Indicator are listed in Table 2.<br><br>The pouches and rolls are<br>printed with a chemical<br>indicator bar which is a process<br>indicator (ISO 11140-1:2005)<br>that changes from red to yellow<br>(or lighter) when exposed to<br>hydrogen peroxide vapor<br>during processing in the<br>STERRAD® Sterilization<br>Systems. | Tyvek® Pouches and Rolls with<br>STERRAD® Chemical<br>Indicator are intended to be<br>used to enclose medical devices<br>that are to be terminally<br>sterilized in the STERRAD®<br>100NX® Sterilizer and to<br>indicate, by color change that<br>the pouch has been exposed to<br>sterilant. After completion of<br>the sterilization process, the<br>pouch/roll maintains sterility<br>until the seal of the pouch/roll<br>is opened; in the United States,<br>this is for a period of 30 days.<br><br>The pouches and rolls are<br>printed with a chemical<br>indicator bar which is a process<br>indicator (ISO 11140-1:2005)<br>that changes from red to yellow<br>(or lighter) when exposed to<br>hydrogen peroxide vapor<br>during processing in the<br>STERRAD® Sterilization<br>Systems. | Additional<br>indications<br>have been<br>included in<br>the<br>Indications<br>for Use for<br>the proposed<br>device.<br>Clarification<br>added for<br>packaging<br>configuration. |
| Materials of<br>Construction | Tyvek® and transparent plastic<br>film | Tyvek® and transparent plastic<br>film | Same | |
| | Proposed Device:<br>Tyvek® Pouch/Roll with<br>STERRAD® Chemical<br>Indicator | Predicate Device: Tyvek®<br>Pouch/Roll with STERRAD®<br>Chemical Indicator<br>(K112087) | Comparison | |
| Pouch Types | Self Seal Pouch (123XX),<br>Heat-Seal Pouch (125XX), and | Self Seal Pouch (123XX),<br>Heat-Seal Pouch (125XX), and | Same | |
| | Heat-Seal Roll (124XX) | Heat-Seal Roll (124XX) | | |
| Design<br>Features | Two films which are heat<br>sealed together on three sides | Two films which are heat sealed<br>together on three sides for | Same | |
| | for individual pouches and on<br>two sides for roll form pouches. | individual pouches and on two<br>sides for roll form pouches. | | |
| | A Chemical Indicator (CI) bar<br>is printed onto the Tyvek® side | A Chemical Indicator (CI) bar is<br>printed onto the Tyvek® side of | | |
| | of the pouch. For the self-seal<br>pouch, the CI is printed onto<br>back surface of the Tyvek®. For | the pouch. For the self-seal<br>pouch, the CI is printed onto<br>back surface of the Tyvek®. For | | |
| | the heat-seal pouch and roll, the<br>CI is printed onto the Tyvek®, | the heat-seal pouch and roll, the<br>CI is printed onto the Tyvek®, | | |
| | but is encased in the seam of<br>the pouch between the Tyvek®<br>and transparent film. | but is encased in the seam of the<br>pouch between the Tyvek® and<br>transparent film. | | |
| Chemical<br>Indicator | STERRAD® indicator ink | STERRAD® indicator ink | Same | |
| Chemical<br>Indicator<br>Device<br>Design: | Chemical Indicator bar changes<br>from red to yellow (or lighter)<br>upon exposure to the sterilant,<br>hydrogen peroxide | Chemical Indicator bar changes<br>from red to yellow (or lighter)<br>upon exposure to the sterilant,<br>hydrogen peroxide | Same | |

# Table 3: Comparison Table for Proposed Device vs. Predicate Device

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# 5. SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator perform as intended and, anter completion of the
sterilization process in the STERRAD® 100S, STERRAD®200, STERRAD®200, STERRAD® pouch/roll is used. The testing also showed that the STERRAD® Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen peroxide. Refer to Table 4 for the summary of performance testing.

Table 4: Pouch/Roll with Chemical Indicator Performance Tests

| Study Type | Description | Results |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Sterilant<br>Penetration | Half-Cycle Efficacy<br>The sterilant penetrated through the “double pouch” configuration under the worst case half-cycle conditions and the sterility | Passed |
| Study Type | Description | Results |
| Chemical Indicator (CI) Functionality and Endpoint | assurance level (SAL) of $10^{-6}$ was demonstrated. The sterilant penetrated through the “double pouch” configuration and affected the CI color change to the endpoint color (from red to yellow or lighter) under the suboptimal conditions. | Passed |
| Package Integrity | Seal Strength<br>Seal strength performance characteristics were maintained for the manufactured seal and user made seal after STERRAD® processing. | Passed |
| | Microbial Barrier<br>The contents of pouches were sterile when the processed pouches were subjected to the microbial aerosol challenge test. | Passed |
| | Burst<br>Ability to withstand the internal pressurization was maintained after STERRAD® processing. | Passed |
| | Peel Open<br>Peel open characteristics of the Tyvek® Pouch/Roll were maintained after STERRAD® processing. | Passed |
| Maintenance of Package Integrity | Sterility was maintained in the Tyvek® Pouches/Rolls for 30 days after STERRAD® processing. | Passed |
| Material Compatibility | Seal strength test, microbial barrier properties, burst test, and peel open test were studied to demonstrate material compatibility characteristics of the Tyvek® Pouches/Rolls after STERRAD® processing. | Passed |
| End Point / Post Processing Color Stability | Tyvek® Pouches/Rolls, after STERRAD® processing, maintained the endpoint CI color reaction. | Passed |
| Shelf Life | Chemical Indicator (CI) Functionality<br>CI functionality of the processed Tyvek® Pouches/Rolls (CI color change from red to yellow or lighter) was verified at the end of shelf life. | Passed |
| | Seal Strength<br>Seal strength of the processed Tyvek® Pouches/Rolls was verified at the end of shelf life. | Passed |
| Biocompatibility | <i>In vivo</i> testing showed that the pouch samples, after STERRAD® processing, met the acceptance criteria per ISO 10993-11 and 10993-10 | Passed |

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### 6. OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator performs as intended as a sterilization packaging system of medical devices that are being terminally sterilized in STERRAD® Sterilization Systems. The Chemical Indicator performs as intended for differentiating processed from unprocessed packages in the STERRAD® Sterilization Systems. These studies also show that the proposed pouches have the same intended use and met the same criteria as the predicate device (K112087) and are substantially equivalent.

Tyvek® is a registered trademark of DuPont