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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

Acceptance Criteria and Study Details for STERRAD® Sterilizer CycleSure® Test Pack

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. Instead, it describes the performance criterion in qualitative terms, primarily focusing on the device's resistance compared to a biological model.

Acceptance Criterion	Reported Device Performance
Resistance to the Sterilization Process: The Test Pack must be more resistant to the sterilization process (hydrogen peroxide) in the STERRAD 50, STERRAD 100S, and STERRAD 200 Sterilizers than the biological model developed for each system.	"It was demonstrated that with all three STERRAD Sterilization systems, the Test Pack configuration [is] more resistant to the sterilization process than the biological model." (Page 2)
Indicative Functionality of the Chemical Indicator: The chemical indicator within the Test Pack must respond appropriately when in the Test Pack configuration using half-cycle parameters of the Standard Cycle.	"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." (Page 2)
Substantial Equivalence: The STERRAD Sterilizer CycleSure Test Pack must be substantially equivalent to the predicate devices (STERRAD NX Test Pack).	"The STERRAD Sterilizer CycleSure Test Pack is substantially equivalent to the predicate devices, the STERRAD NX Test Pack." (Page 2)

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

Sample Size: The document does not explicitly state the numerical sample size for the test set (e.g., number of test packs, number of sterilization cycles). It mentions "Test Packs containing CycleSure Biological Indictor were exposed to increasing doses of hydrogen peroxide in [each] of the STERRAD Sterilization systems." This implies multiple test packs and multiple exposures.
Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it's highly likely the data was generated in the US or in a manner compliant with US regulatory standards. The study appears to be prospective in nature, as it describes evaluations performed specifically to demonstrate the device's performance.

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

The document does not mention the use of human experts to establish ground truth for the test set. The ground truth in this context is based on biological and chemical indicators' response to controlled sterilization parameters and comparison to a "biological model," which is an objective, mechanistic standard.

4. Adjudication Method for the Test Set

Not applicable. The study relies on objective measurements of biological inactivation and chemical indicator response, not subjective expert assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human interpretation is a key component. The STERRAD® Sterilizer CycleSure® Test Pack is an indicator device for a sterilization process, not a diagnostic tool requiring human interpretation comparison.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Yes, the study describes the standalone performance of the device itself without human intervention during the "reading" of the sterilization outcome, in the sense that the biological indicator either grows or does not grow, and the chemical indicator either changes color or does not. The evaluation focuses on the inherent biological resistance and chemical reactivity of the test pack.

7. Type of Ground Truth Used

The ground truth used is based on:

Biological Inactivation/Survival Curves: Comparison of the Test Pack's resistance to a pre-established biological model for each STERRAD sterilizer system. This model represents a known, scientifically defined challenge to the sterilization process.
Chemical Indicator Response: The chemical indicator's color change (or lack thereof) in response to "half cycle parameters" where appropriate. This is an objective chemical reaction.

8. Sample Size for the Training Set

Not applicable. This device is a physical indicator, not an AI/machine learning algorithm, so there is no "training set" in the conventional sense. The "training" of the device is its manufacturing and calibration to respond predictably to hydrogen peroxide.

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

Not applicable, as there is no "training set" for this type of device. The scientific and engineering principles behind biological indicators (e.g., D-value determination for Geobacillus stearothermophilus) and chemical indicators are well-established for assessing sterilization efficacy. The "ground truth" for the performance of the components themselves would have been established through prior characterization and validation during their development.

Summary

{0}------------------------------------------------

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 (949) 453-6352 Fax (949) 789-3900

Or

Kevin Corrigan, RAC Director, Regulatory Affairs Telephone (949) 453-6410 Fax (949) 789-3900

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)

{1}------------------------------------------------

Description of Device

Indications for Use:

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (240) 276-0115. 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 (800) 638-2041 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

{5}------------------------------------------------

Indications for Use

510(k) Number: K051643

Device Name: STERRAD® Sterilizer CycleSure® Test Pack

Indications for Use:

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:

Page 1 of 1

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).