STERRAD CHEMICAL INDICATOR STRIP

K103218 · Advanced Sterilization Products · JOJ · Apr 1, 2011 · General Hospital

Device Facts

• Record ID: K103218
• Device Name: STERRAD CHEMICAL INDICATOR STRIP
• Applicant: Advanced Sterilization Products
• Product Code: JOJ · General Hospital
• Decision Date: Apr 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® Chemical Indicator Strip is a Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems: MODEL CYCLE STERRAD® 100S Standard STERRAD® 50. Standard STERRAD® 200 Standard STERRAD® NX™ Standard STERRAD® NX™ Advanced STERRAD®100NX™ Standard STERRAD®100NX™ Flex STERRAD®100NX™ EXPRESS

Device Story

STERRAD® Chemical Indicator Strip is a through-put process indicator used to verify exposure to hydrogen peroxide gas plasma in STERRAD® sterilization systems. The strip functions via a chemical reaction; exposure to the sterilization cycle triggers a color change from red to yellow. The resulting yellow or lighter bar confirms the package has been exposed to the sterilant. Used in clinical settings by healthcare personnel to distinguish processed from unprocessed medical device packages. The device provides a visual confirmation of sterilization cycle exposure, aiding in the management of sterile inventory and ensuring that only processed items are used in clinical procedures.

Clinical Evidence

Bench testing only. Studies confirmed chemical indicator functionality, post-processing color stability, shelf life, and biocompatibility. Results demonstrated the strip responds as expected to hydrogen peroxide exposure in the STERRAD® 100NX™ EXPRESS cycle.

Technological Characteristics

Class 1 chemical process indicator per ISO 11140-1. Operates via chemical reaction resulting in a color change (red to yellow) upon exposure to hydrogen peroxide gas plasma. Standalone strip form factor.

Indications for Use

Indicated for use as a Class 1 process indicator to differentiate processed from unprocessed medical device packages sterilized in STERRAD® hydrogen peroxide gas plasma sterilization systems.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• STERRAD® Chemical Indicator Strip (K921910)

Submission Summary (Full Text)

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# 510(k) Summary

APR - 1 2011

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

# Contact Person

Nancy Chu Manager, Regulatory Affairs Tel: [phone] Fax: [phone]

Date: October 29, 2010

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

| Classification Name: | Indicator, Physical/Chemical Sterilization Process |
|-------------------------|----------------------------------------------------|
| Common/Usual Name: | Chemical Sterilization Process Indicator |
| Product Classification: | 2 |
| Proprietary Name: | STERRAD® Chemical Indicator Strip |

# 2. PREDICATE DEVICE

STERRAD® Chemical Indicator Strip (K921910)

### 3. INDICATIONS FOR USE

The STERRAD® Chemical Indicator Strip is a Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems:

| MODEL | CYCLE |
|----------------|----------|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| | Advanced |
| STERRAD®100NX™ | Flex |
| | EXPRESS |
| | |

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# 4. DESCRIPTION OF DEVICE

STERRAD® Chemical Indicator Strip is a through-put process indicator strip to be used with STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.

STERRAD® Chemical Indicator Strip functions by means of a chemical reaction. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow. The yellow (or lighter) chemical indicator bar indicates that the load has been exposed to hydrogen peroxide.

#### 5. SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to demonstrate the functionality of Chemical Indicator Strip in the STERRAD® 100NX™ EXPRESS Cycle and the results show that the Chemical Indicator Strip performs as a through-put process indicator by responding as expected to hydrogen peroxide exposure.

| Study | Result |
|---------------------------------------------|--------|
| Chemical Indicator Functionality | Passed |
| End Point / Post Processing Color Stability | Passed |
| Shelf life | Passed |
| Biocompatibility | Passed |

#### 6. OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the STERRAD® Chemical indicator Strip is as safe and as effective as the predicate for differentiating processed from unprocessed packages within the indications for use for the chemical indicator thus establishing that the modified STERRAD® Chemical Indicator Strip is substantially equivalent to the predicate device, the STERRAD® Chemical Indicator Strip (K921910).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

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

APR - 1 2011

Re: K103218

Trade Name: STERRAD® Chemical Indicator Strip Regulation Number: 21 CFR §880.2800 Regulation Name: Physical/chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: March 15, 2011 Received: March 16, 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 (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). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.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 yours.
James J. Robel
for Z

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): K103218

### Device Name: STERRAD® Chemical Indicator Strip

The STERRAD® Chemical Indicator Strip is a Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems:

| MODEL | CYCLE |
|----------------|----------|
| STERRAD® 100S | Standard |
| STERRAD® 50. | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| STERRAD® NX™ | Advanced |
| STERRAD®100NX™ | Standard |
| STERRAD®100NX™ | Flex |
| STERRAD®100NX™ | EXPRESS |

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)

Edith A. S. Clunie. Will

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

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(Posted November 13, 2003)

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