STERRAD NX CHALLENGE PACK

K042450 · Advanced Sterilization Products · FRC · May 12, 2005 · General Hospital

Device Facts

• Record ID: K042450
• Device Name: STERRAD NX CHALLENGE PACK
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: May 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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

Device Story

The STERRAD NX Test Pack is a biological indicator challenge device used to monitor the efficacy of STERRAD NX sterilization cycles. It consists of a CycleSure self-contained biological and chemical indicator, a vial with an orifice, and a holding pouch. The device is placed within the sterilizer to act as a challenge to the sterilization process. Healthcare personnel use the device to verify that the sterilization cycle has achieved the necessary conditions to kill biological indicators. The chemical indicator provides immediate feedback, while the biological indicator confirms the sterilization process. This monitoring ensures that medical instruments processed in the STERRAD NX system are properly sterilized, reducing the risk of infection for patients.

Clinical Evidence

Bench testing only. Resistance of the Test Pack was evaluated against biological models for both Standard and Advanced sterilization cycles using survival curves and fraction negative data. Results confirmed the Test Pack is at least as resistant as the biological models. Chemical indicator response was validated using half-cycle parameters.

Technological Characteristics

The device comprises a self-contained biological/chemical indicator, a vial with an orifice, and a pouch. It functions as a challenge device for hydrogen peroxide gas plasma sterilization. No specific materials or software algorithms are described.

Indications for Use

Indicated for routine monitoring of the STERRAD NX Sterilization cycle and periodic testing of the STERRAD NX System 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 CycleSure Biological Indicator
• STERRAD BI Test Pack

Submission Summary (Full Text)

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Advanced Sterilization Products May 9, 2005

STERRAD" NX Test Pack Confidential

# 510(k) Summary

MAY 1 2 2005

K042450

# 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 Sr. Manager, Regulatory Affairs Telephone [phone] Fax [phone]

#### Or

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

Summary Date May 9, 2005

#### Common Name

Biological Indicator (Test Pack)

#### Classification Name

ﻣﻦ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

Class II

### Officially Marketed Equivalent Device Name(s)

... ... .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

:

STERRAD® BI Test Pack STERRAD® CycleSure® Biological Indicator

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Advanced Sterilization Products May 9, 2005

STERRAD" NX Test Pack Confidential

#### Description of Device

The STERRAD® NX Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle.

#### Indications for Use

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

#### Summary of Non-clinical Tests

The STERRAD NX Test Pack has been evaluated for its resistance to both the Standard and Advanced sterilization cycles in the STERRAD NX Sterilizer.

A comparison of the Test Pack to the biological model developed for both the Standard and Advanced Cycles 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 both the Standard and Advanced Cycles. The survival curves for these were compared to the survival curves for the biological models developed for the

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Standard and Advanced Cycles. With both cycles the Test Pack configuration was at least as resistant as the biological model.

Additionally, fraction negative data collected using Test Pack containing three lots of CycleSure BI when exposed to increasing volumes of peroxide in both the Standard and Advanced Cycles 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 Standard Cycle and the response was determined to be appropriate for a chemical indicator.

# Overall Performance Conclusions

The STERRAD NX Test Pack has the necessary resistance relative to the biological model to be an appropriate challenge for testing both the Standard and Advanced Cycles of the STERRAD NX Sterilizer. The STERRAD NX Test Pack is substantially equivalent to the predicate devices STERRAD CycleSure Biological Indicator and STERRAD BI Test Pack

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in capital letters.

MAY 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Sterilization Products Dr. Joseph M. Ascenzi Senior Manager, Regulatory Affairs Benfor Manager, Isson Company/Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618

Re: K042450

Trade/Device Name: STERRAD® NX Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: April 1, 2005 Received: April 19, 2005

Dear Dr. Ascenzi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rother. The was your was a 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to actives 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 approval applied.ion (1 the Act. The general controls provisions of the Act include confors providens of an annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (been additional controls. Existing major regulations affecting (1 Mrx), it may of subject to tuat of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firster announcements concerning your device 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 Please be advisou that 1 DTC Issualites on that your device complies with other requirements Incall that I DA nas made a actess and regulations administered by other Federal agencies. of the Act of ally I edelar statules and squirements, including, but not limited to: registration You must comply with an the Fiel brog (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 607), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) Fills letter will anow you to begal mading of substantial equivalence of your device to a premiarket notification. The PDF results in a classification for your device and 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), II you desire specific advise to: Join are at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay obtain other general meetirs, International and Consumer Assistance at its toll-free Division of 01 01 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suita Y. Michio, m.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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# VANCED STERILIZATION PRODUCTS®

on company

Division of Ethicon, Inc.

# Indications for Use Form

510(k) Number: K042450

Device Name: STERRAD® NX Test Pack

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOPTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheila M Murphy, R

Civision of Anesthesiology, Ge a a loespital, Intection Control, Dental Devic

- 10(k) Number:

Appendix 1 - 2

Draft 7-2