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.

Device Description

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.

AI/ML Overview

This document is a 510(k) summary for the STERRAD® 100NX™ EXPRESS Cycle Test Pack, a biological indicator used to monitor sterilization cycles. It describes non-clinical tests performed to demonstrate the device's substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The Test Pack must be at least as resistant to the EXPRESS sterilization process as the biological model.	Survival curves for three lots of CycleSure Biological Indicator in the Test Pack configuration were compared to survival curves for the biological models. The Test Pack configuration was found to be at least as resistant as the biological model.
Fraction negative data for the Test Pack must indicate it is at least as resistant as the biological models.	Fraction negative data collected using three lots of CycleSure BI in the Test Pack configuration showed it to be at least as resistant as the biological models when exposed to increasing volumes of peroxide in the EXPRESS Cycle.
The chemical indicator in the Test Pack must demonstrate appropriate indicative functionality.	Indicative functionality of the chemical indicator was evaluated using half-cycle parameters of the EXPRESS Cycle, and the response was determined to be appropriate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The tests involved "three lots of CycleSure Biological Indictor" and "three lots of CycleSure BI." (Specific numerical sample sizes within each lot are not provided in the summary).
Data Provenance: The data is retrospective, as it was collected as part of a non-clinical test performed by the manufacturer to demonstrate substantial equivalence to existing predicate devices. The country of origin of the data is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This study did not involve human experts establishing ground truth in the typical sense of medical image analysis or diagnostic studies. The evaluation was based on direct measurements of biological indicator survival and chemical indicator functionality under defined sterilization conditions. Therefore, this section is not applicable in the context of expert review.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation was based on objective, quantitative measurements rather than subjective expert interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This device is a biological indicator for sterilization monitoring, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This study's primary focus was on the standalone performance of the biological indicator (Test Pack) itself. The "device" in question is the test pack, which functions autonomously to indicate sterilization effectiveness.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was the established "biological models developed for the EXPRESS Cycle." These models represent the expected resistance of biological organisms to the sterilization process. The Test Pack's performance was compared directly against these established biological models as the gold standard for effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is a non-clinical study for a physical device (biological indicator), not a machine learning model requiring a training set. The "models" referred to are biological models for sterilization efficacy, not AI training models.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no "training set" in the context of an AI/machine learning model. The "biological models" serving as ground truth were "developed for the EXPRESS Cycle," implying they were established through prior scientific validation and testing to characterize the resistance of microorganisms to the specific STERRAD sterilization process.

Summary

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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: nchu@its.jnj.com Telephone (949) 453-6435 Fax (949) 789-3900

Or

Kevin Corrigan Director, Regulatory Affairs Email: kcorriga@its.jnj.com Telephone (949) 453-6410 Fax (949) 789-3900

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

Indications for Use

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 (800) 638-2041 or (301) 796-7100 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.

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

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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Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).