TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS

K103210 · Advanced Sterilization Products · FRG · Jun 6, 2011 · General Hospital

Device Facts

• Record ID: K103210
• Device Name: TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
• Applicant: Advanced Sterilization Products
• Product Code: FRG · General Hospital
• Decision Date: Jun 6, 2011
• 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® 100NX™ Sterilizer 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 seal of the pouch/roll is opened.

Device Story

Device consists of Tyvek®/plastic film pouches and rolls used to contain medical devices for terminal sterilization in STERRAD® hydrogen peroxide vapor systems. Pouches feature integrated chemical indicator bar printed on Tyvek® film; indicator changes color from red to yellow (or lighter) upon exposure to hydrogen peroxide vapor. Device serves as physical barrier to maintain sterility post-processing until seal is opened. Used by healthcare personnel in clinical environments to package instruments; provides visual confirmation of exposure to sterilization process. Does not signify sterility; serves as process indicator only. Benefits include simplified packaging workflow via self-seal options and visual verification of processing.

Clinical Evidence

Bench testing only. Studies included sterilant penetration, package integrity, material compatibility, chemical indicator functionality, post-processing color stability, shelf life, and biocompatibility. All tests passed.

Technological Characteristics

Materials: Tyvek® and transparent plastic film. Sensing: Chemical indicator bar (ISO 11140-1:2005) reacting to hydrogen peroxide vapor. Form factor: Pouch or roll, heat-sealable or self-seal. Connectivity: None. Sterilization: Hydrogen peroxide vapor. Software: None.

Indications for Use

Indicated for use as a sterilization packaging system for medical devices undergoing terminal sterilization in STERRAD® Sterilization Systems. Suitable for use in clinical settings where medical devices require sterilization. No specific patient population or contraindications defined.

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

• STERRAD® Sterilization Pouch (K951295)
• STERRAD® Chemical Indicator Strip (K921910)

Submission Summary (Full Text)

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K103210
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### 510(k) Summary

Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products, 33 Technology Drive Irvine, CA 92618

JUN - 6 2011

Establishment Registration Number: 2084725

### Contact Person

Nancy Chu Manager, Regulatory Affairs Email: [e-mail] [phone] (Telephone) [phone] (Fax)

Date: May 27, 2011

| 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 |
| Proprietary Name: | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator |

### 2. PREDICATE DEVICES

STERRAD® Sterilization Pouch, which is currently manufactured and distributed by Advanced Sterilization Products [510(k) Notification K951295, cleared May 19, 1995].

STERRAD® Chemical Indicator Strip, which is currently manufactured and distributed by Advanced Sterilization Products [510(k) Notification K921910, cleared October 4, 1993].

### 3. INDICATIONS FOR 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® 100NX™ Sterilizer 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 seal of the pouch/roll is opened.

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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.

### 4. DESCRIPTION OF DEVICE

The Tyvek® Pouch/Roll with STERRAD® Chemical Indicator is intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD® Sterilization System. After completion and the sterilization process, the pouch/roll maintains sterility of the enclosed medical devices until the seal is opened. The pouch/roll is printed with a chemical indicator bar that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during the sterilization process in the STERRAD® Sterillization Systems.

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 smot in place of, the biological indicator. STERRAD® Chemical Indicators no 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.

### 5. SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator maintains sterility until the seal of the pouch/roll is opened, after completion of the sterilization process, and that the STERRAD® Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen peroxide.

| Study | Results |
|---------------------------------------------|---------|
| Sterilant Penetration | Passed |
| Package Integrity | Passed |
| Maintenance of Package Integrity | Passed |
| Material Compatibility | Passed |
| Chemical Indicator Functionality | Passed |
| End Point / Post Processing Color Stability | Passed |
| Shelf Life | Passed |
| Biocompatibility | Passed |

## Table 1: Pouch/Roll with Chemical Indicator Performance Tests

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### 6. COMPARISON OF TECHNICAL CHARACTERISTICS

| Characteristics | Proposed<br>Pouch/Roll with<br>Chemical Indicator | Predicate Pouch<br>(K951295) | Predicate Chemical<br>Indicator<br>(K921910) |
|----------------------------------------------------|---------------------------------------------------|------------------------------|----------------------------------------------|
| Pouch Construction:<br>Tyvek® and transparent film | Yes | Yes | N/A |
| Siliconized Tyvek® | No | Yes | N/A |
| User heat seal | Yes | Yes | N/A |
| User self-seal | Yes | No | N/A |
| Chemical Indicator (CI) | Yes | No | Yes |
| CI substrate | Tyvek® | N/A | Styrene |
| Chemical reaction | Hydrogen peroxide | N/A | Hydrogen peroxide |
| Distinct color change | Red to yellow | N/A | Red to yellow |
| Single use device | Yes | Yes | Yes |
| Shelf life | 24 months | N/A | 12 months |

### Table 2: Summary of Comparison between Proposed Device and Predicate Devices

## 7. 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 devices and are substantially equivalent.

Tyvek® is a registered trademark of Du Pont.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a low-resolution image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

JUN - 6 2011

Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

Re: K103210

Trade/Device Name: Tvvek® Pouch/Roll with STERRAD® Chemical Indicator Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: May 6, 2011 Received: May 9, 2011

Dear Ms. Chu:

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.

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Page 2- Ms. Chu

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 device-related adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony D. Owen

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K103210

# Device Name: Tyvek Pouch/Roll with STERRAD® Chemical Indicator

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® 100NX" Sterilizer 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 seal of the pouch/roll is opened.

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 expossed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clavins-Williams

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K103210

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(Posted November 13, 2003)