STERRAAD 100NX EXPRESS CYCLE TEST PACK

K092755 · Advanced Sterilization Products · FRC · Feb 25, 2011 · General Hospital

Device Facts

• Record ID: K092755
• Device Name: STERRAAD 100NX EXPRESS CYCLE TEST PACK
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® 100NX™ EXPRESS Test Pack is used for routine monitoring of the STERRAD 100NX EXPRESS Sterilization cycle and is also used for the periodic testing of a STERRAD 100NX System using the hospital-defined loads in the EXPRESS cycle.

Device Story

The STERRAD® 100NX™ EXPRESS Test Pack is a biological indicator system used to monitor the efficacy of the STERRAD 100NX EXPRESS sterilization cycle. The device consists of a CycleSure® self-contained biological indicator (containing biological and chemical indicators) housed within a protective pouch. During the sterilization cycle, the test pack is exposed to hydrogen peroxide vapor. The device functions as a challenge to the sterilization process; its resistance is compared against a validated biological model for the EXPRESS cycle. Healthcare personnel use the test pack to verify that sterilization parameters are met. The chemical indicator provides immediate visual feedback, while the biological indicator confirms the destruction of microorganisms. This monitoring ensures that sterilized loads are safe for clinical use, reducing the risk of infection.

Clinical Evidence

No clinical data. Bench testing only. Resistance of the test pack to the EXPRESS sterilization cycle was validated by comparing survival curves and fraction negative data against the biological model developed for the EXPRESS cycle. Three lots of CycleSure biological indicators were tested across multiple peroxide doses to confirm the test pack is at least as resistant as the biological model. Chemical indicator response was evaluated using half-cycle parameters.

Technological Characteristics

The device is a self-contained biological indicator (BI) and chemical indicator (CI) housed in a pouch. It functions as a challenge pack for hydrogen peroxide gas plasma sterilization. The sensing principle relies on the biological inactivation of microorganisms and a chemical color change. It is a passive, non-electronic device. No software or energy source is required for operation.

Indications for Use

Indicated for routine monitoring and periodic testing of the STERRAD 100NX EXPRESS sterilization cycle using hospital-defined loads.

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® 100NX™ Test Pack
• STERRAD® CycleSure® Biological Indicator

Submission Summary (Full Text)

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# 510(k) Summary

# 11092755

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

Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618

## Contact Person

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

#### Or

Kevin Corrigan Director, Regulatory Affairs Email: [e-mail] Telephone [phone] Fax [phone]

### Summary Date

November 17, 2010

#### Common Name

Biological Indicator (Test Pack)

#### Classification Name

Class II

# Officially Marketed Equivalent Device Name(s)

STERRAD® 100NX™ Test Pack STERRAD® CycleSure® Biological Indicator FEB 2 5 2011

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### Description of Device

The STERRAD® 100NX™ EXPRESS Cycle Test Pack consists of the CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), and a pouch for holding the vial during the sterilization cycle.

## Indications for Use

The STERRAD® 100NX™ EXPRESS Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX™ EXPRESS Sterilization cycle and is also used for the periodic testing of a STERRAD® 100NXTM System EXPRESS Cycle using hospital-defined loads.

### Summary of Non-clinical Tests

The STERRAD® 100NX™ EXPRESS Cycle Test Pack has been evaluated for its resistance to the EXPRESS sterilization cycle in the STERRAD 100NX Sterilizer.

A comparison of the Test Pack to the biological model developed for the EXPRESS Cycle indicates that the Test Pack is at least as resistant to the sterilization process as the biological model. This is based on both survival curves and fraction negative data as a function of dose.

Test Packs containing three lots of CycleSure Biological Indictor were exposed to several doses of peroxide in EXPRESS Cycle. The survival curves for these were compared to the survival curves for the biological models developed for the EXPRESS Cycle. The Test Pack configuration was at least as resistant as the biological model.

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Additionally, fraction negative data collected using Test Pack containing three lots of CycleSure BI when exposed to increasing volumes of peroxide in the EXPRESS Cycle indicate that the Test Pack configuration is at least as resistant as the biological models.

Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the EXPRESS Cycle and the response was determined to be appropriate for a chemical indicator.

## Overall Performance Conclusions

The STERRAD® 100NX™ EXPRESS Test Pack has the necessary resistance relative to the biological model to be an appropriate challenge for testing the EXPRESS Cycle of the STERRAD 100NX Sterilizer. The STERRAD® 100NX™ EXPRESS Cycle Test Pack is substantially equivalent to the predicate devices, STERRAD® 100NX™ Test Pack and STERRAD® CycleSure® Biological Indicator.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

FEB 2 5 2011

Re: K092755

Trade/Device Name: STERRAD® 100NX EXPRESS Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator
Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: February 18, 2011 Received: February 22, 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 to market the indications for use stated in the enclosure) to legally market productions for the
indications for use stated in the enclosure) to legally marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices mark.
Amendments, or to devices that have been realersify, in Amendments, or to devices that have been reclassified in accordance of the Medical Devices
Amendments, or to devices that have been reclassified in accordance with the provis the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of any issues of
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a approval application (PMA). You may, therefore, market the device, subject to fa premarker
approval application (PMA). You may, therefore, market the device, subject to the controls provisions of the Act. The general controls provisions of the Act includes to the requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and manufacturing practice,
labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does the every stations against misoranding and adulteration. Please note: CDRH doss
not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mablity ware
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 firther 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 stantes and requiration that your device complies with othe of the Act or any Federal statutes and regulations administered by other requireme
You must comply with all the Act's requirements in the Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registrer.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device regist
(reporting of medical device-related advance (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse evens) (21 CFR 803); good manufacturing
practice requirements as set forth in the quolity consemn (21 CFR 803); good manufacturin practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820);
and if applicable, the electronic product radiation sectorial (21 CFR Part 820); and if a productions a set tour in the quality systems (QS) regulation (21 CFR Part 820)
and if applicable, the electronic product radiation control provisions (Sections 531the 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/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, him for the 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 Assist http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

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

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AST ADVANCED STERILIZATION PRODUCTS® a Johnson. Johnson company REGULATORY AFFAIRS DEPARTMENT

# 510(k) Number (if known): KD92755

#### STERRAD® 100NX EXPRESS Test Pack Device Name: Indications-For-Use:

The STERRAD® 100NX™ EXPRESS Test Pack is used for routine monitoring of the STERRAD 100NX EXPRESS Sterilization cycle and is also used for the periodic testing of a STERRAD 100NX System using the hospital-defined loads in the EXPRESS cycle.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (PER 21 CFR 801.109) | OR Over-The-Counter Use √ |
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Elizabeth B. Clamin-Will (Optional Format 1-2-96)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K 092755 |
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