STERRAD STERILIZER CYCLESURE TEST PACK

K051643 · Advanced Sterilization Products · FRC · Aug 19, 2005 · General Hospital

Device Facts

• Record ID: K051643
• Device Name: STERRAD STERILIZER CYCLESURE TEST PACK
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.

Device Story

The STERRAD Sterilizer CycleSure Test Pack is a biological indicator challenge device used to monitor hydrogen peroxide gas plasma sterilization cycles. It consists of a self-contained biological/chemical indicator, a vial with an orifice, a vial cap, and a pouch. Two silicon mats are included within the pouch to act as a hydrogen peroxide reservoir, increasing the challenge to the sterilization process. The device is placed in the sterilizer to simulate a worst-case load. Healthcare personnel use the device to verify that the sterilization process has achieved the required lethality. The chemical indicator provides immediate visual feedback, while the biological indicator confirms the destruction of microorganisms. This ensures the sterility of instruments, reducing the risk of infection for patients.

Clinical Evidence

Bench testing only. The device was evaluated for resistance in STERRAD 50, 100S, and 200 sterilizers. Survival curves for the Test Pack were compared against biological models for each system using half-cycle parameters. Results demonstrated the Test Pack is more resistant to the sterilization process than the biological models. Chemical indicator functionality was also verified using half-cycle parameters.

Technological Characteristics

Components include a self-contained biological/chemical indicator, vial with orifice, vial cap, and pouch. Two silicon mats are used as hydrogen peroxide reservoirs to increase resistance. Operates as a passive challenge device for hydrogen peroxide gas plasma sterilization. No electronic components or software.

Indications for Use

Indicated for routine monitoring and periodic testing of STERRAD 50, 100S, and 200 sterilization systems 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® NX Test Pack (K042450)

Submission Summary (Full Text)

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Advanced Sterilization Products June 9, 2005

510(k) Summary

STERRAD®SterilizerCycleSure® Test Pack Confidential

K051643

AUG 1 9 2005

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

Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

# Contact Person

Joseph M. Ascenzi, PhD, RAC Sr. Manager, Regulatory Affairs Telephone [phone] Fax [phone]

#### Or

Kevin Corrigan, RAC Director, Regulatory Affairs Telephone [phone] Fax [phone]

# Summary Date

June 16, 2005

## Common Name

Biological Indicator (Test Pack)

## Classification Name

Class II

## Officially Marketed Equivalent Device Name(s)

STERRAD® NX Test Pack (K042450)

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## Description of Device

The STERRAD® Sterilizer CycleSure® Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial (with an orifice) into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle. Two silicon mats are placed in the pouch during use to increase the resistance of the Test Pack, by acting as a reservoir for hydrogen peroxide.

#### Indications for Use:

The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.

#### Summary of Non-clinical Tests

The STERRAD Sterilizer Test Pack has been evaluated for its resistance in the STERRAD 50, STERRAD 100S, and STERRAD 200 Sterilizers.

A comparison of the Test Pack to the biological model developed for each of the STERRAD Sterilizers indicates that the Test Pack is more resistant to the sterilization process than the biological model.

Test Packs containing CycleSure Biological Indictor were exposed to increasing doses of hydrogen peroxide in cach of the STERRAD Sterilization systems using half cycle parameters. The survival curves for the Test Pack were compared to the survival curves

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for the biological models developed for each of the STERRAD Sterilization systems. It was demonstrated that with all three STERRAD Sterilization systems, the Test Pack configuration more resistant to the sterilization process than the biological model.

Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the Standard Cycle and the data indicate that the chemical indicator responds appropriately when in the Test Pack configuration.

## Overall Performance Conclusions

The STERRAD Sterilizer CycleSure Test Pack has the necessary resistance when compared to the biological model to be an appropriate challenge for testing of Sterilization processes in the STERRAD 50, STERRAD 100S, and STERRAD 200 Sterilizers. The STERRAD Sterilizer CycleSure Test Pack is substantially equivalent to the predicate devices, the STERRAD NX Test Pack.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three stylized lines.

AUG 1 9 2005

Dr. Joseph M. Ascenzi Sr. Manager, Regulatory Affairs_. . . . . Advanced Sterilization Products 33 Technology Dr. Irvine, California 92618

Re: K051643

R0510+5
Trade/Device Name: Sterrad Sterilizer Cyclesure Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: FRC Dated: August 2, 2005 Received: August 3, 2005

Dear Dr. Ascenzi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premainted is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard manating to the Medical Device Amendments, or to commerce prior to May 26, 1776, the enaonance with the provisions of the Federal Food, Drug, devices that have been recatismed in accessfied of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Costlience Act (Act) that to not requent of the general controls provisions of the Act. The You may, merclore, manot the device, beginements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contributio may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Court of Fourther in the Federal Register.

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Page 2 - Dr. Ascenzi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issumted on a cademically with other requirements of the Act that FDA has made a decicinnation that Jour Several agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, news, and manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons of Device as described in your Section 510(K)
This letter will allow you to begin marketing your device as described in your Sec I his letter will anow you to begin manceing your and equivalence of your device to a legally premarket notification. The PDA miding of backandary of the said thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your de rice on our last note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note Y comact the Office of Comphalico at (210) 276 or Part 807.97). You may obtain "Misbranding by relevelec to promanteriouslities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Consultive www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chi-Lin, Ph.D.

Chiu Lin, Ph.D. -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: K051643

Device Name: STERRAD® Sterilizer CycleSure® Test Pack

Indications for Use:

The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

< Linda A. Mincher, MD 8/18/05

oneral Hospital, sthestology, G ntrol Dental Infection Co

510(k) Number:

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