The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60% Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60 minutes.

Device Description

SteriTec Disposable Biological Test Packs for EO Gas consist of a self-contained biological indicator containing B. Subtillis spores, placed inside a plastic canister and is covered with a closure cap containing a 5-100 micron porous plastic filter. This assembly is placed into a paper/plastic peel pouch along with a printed record card containing a chemical indicator.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for SteriTec Disposable Biological Test Pack for EO Gas

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Specification)	Reported Device Performance (SteriTec Test Packs)	Notes
All survivors at 15 minutes exposure to EO Gas at 600 mg/L, 50% RH, 130 F	100% survivors at 15 minutes exposure	This meets the criterion.
All killed at 60 minutes exposure to EO Gas at 600 mg/L, 50% RH, 130 F	Performance not explicitly stated for 60 minutes, but the study showed 12% survivors at 45 minutes, implying a full kill would occur between 45 and 60 minutes.	While not directly stated for 60 minutes, the trend suggests the "all killed" criterion would likely be met at 60 minutes or shortly thereafter. The submission implies substantial equivalence with a predicate that meets this.

Missing Information: The document provides performance data in a comparative context with the predicate device at 15, 25, 35, and 45 minutes, but does not explicitly state the SteriTec device's performance at the 60-minute mark, which is the "all killed" acceptance criterion. However, the FDA's clearance implies that this criterion was deemed acceptable.

2. Sample Size and Data Provenance

Sample Size for the Test Set: Not explicitly stated. The text mentions "all test packs" and then percentages for "ATI Test Packs" and "SteriTec Test Packs" at different time points, implying a set of multiple packs for each test, but the exact number is not provided.
Data Provenance: The performance tests were "conducted at NAMSA Laboratories," suggesting a third-party laboratory setting. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and NAMSA has labs globally, including in the US. The study appears to be prospective as it involves active testing of the device.

3. Number of Experts and their Qualifications for Ground Truth

This device is a biological indicator for sterilization. The ground truth (whether bacteria are killed or survive) is determined by microbiological culture methods, not human interpretation of images or other data. Therefore, the concept of "experts establishing ground truth" in the way it's used for AI/imaging devices does not directly apply here. Instead, laboratory technicians following established microbiological protocols would have been responsible for determining survival/kill rates. Their specific qualifications are not mentioned, but it's implied they adhere to standard laboratory practices.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The "ground truth" for a biological indicator is a binary outcome (growth/no growth) determined by scientific culture methods, not by human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI devices where human readers provide interpretations and the AI system assists them. This submission is for a medical device (biological indicator) that functions independently to assess sterilization. The study performed was a comparison to a predicate device to demonstrate substantial equivalence, focusing on the device's inherent performance rather than human-AI interaction.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Performance Testing" section directly reports the survival rates of the SteriTec Disposable Biological Test Pack for EO Gas at various exposure times (15, 25, 35, and 45 minutes) without human-in-the-loop. This is the core of demonstrating the device's effectiveness as a biological indicator.

7. Type of Ground Truth Used

The ground truth used is biological viability/non-viability (survival or kill) of B. Subtillis spores, determined through standard microbiological culture techniques. This is a form of direct, objective measurement of the intended biological outcome.

8. Sample Size for the Training Set

Not applicable. This device is a biological test pack, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development. The device itself is designed and manufactured based on scientific principles of microbial resistance and sterilization, not trained on data.

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

Not applicable. As stated above, there is no training set for this type of device. The understanding of the resistance of B. subtilis spores to EO gas has been established over many years through scientific research and is a fundamental principle in sterilization efficacy testing.

Summary

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Disposable Biological Test Pack for EO Gas 510(k) Premarket Notification SteriTec Products Mfg. Co., Inc.

K981497

OCT 29 1998

510(k) SUMMARY

SUBMITTER:

STERITEC PRODUCTS MFG. CO., INC. 680 Atchison Way - Suite 600 Castle Rock, CO. 80104 (303) 660-4201 (303) 660-4213 Fax

Establishment Registration Number: 2028456

Date Summary was Prepared April 23, 1998

Date Summary was Revised __ August 3, 1998

TOM ROLL
Printed name of person required to submit 510(k)

Signature of person required to submit 510(k)

PRESIDENT Title of person submitting 510(k)

Proprietary Name: Steritec Disposable Biological Test Pack for EO Gas

Common/ Usual Name: Biological Test Pack

Classification Name: Biological

Classification:

The Steritec Disposable Biological Test pack for EO Gas is a disposable biological test pack for testing ethylene oxide gas sterilizers. It falls under the FDA classification of Indicator, Biological Sterilization Process in Class II under Classification Number 80FRC, Regulation 880.2800.

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Disposable Biological Test Pack for EO Gas 510(k) Premarket Notification SteriTec Products Mfg. Co., Inc.

K98:497

510(k) Summary - continued

Identification of Predicate device:

The predicate device is the ATI Disposable Biological Test Pack for Ethylene Oxide, (510(k) # 895704) manufactured and distributed by ATI-PyMaH now owned by 3M Corporation.

Description of 510(k) submission device:

Product Description:

Intended use:

The intended use of this product is for biological testing of EO Gas sterilizers. The performance specification is 130 F, 45% to 60% Relative Humidity, 600 mg/L EO Gas with all survivors at 15 minutes and all killed at 60 minutes.

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Comparison to Predicate Device:

The SteriTec Biological Test Pack for EO Gas and the above named predicate device have the same intended use. Both products are test packs containing a self-contained biological. The predicate device uses the Attest biological made by 3M whereas the SteriTec Test uses the EZTest biological made by SGM Biotech. Both products are offered in a paper/plastic pouch. Both products offer resistance to EO gas through their design....the ATI pack uses a plastic syringe opened on one end to house the biological, the SteriTec Pack uses a plastic canister closed at one end completely and held at the other end by a stopper which contains a porous plastic plug. Both Test Packs are meant to extend the time it takes to kill B. Subtillis spores placed in a Ethylene oxide sterilization process.

Performance Testing:

The performance tests showed that at 15 minutes exposure to EO Gas at 600 mg/L with Relative Humidity at 50% and temperature at 130 F, all test packs had 100% survivors. At 25 minutes exposure, the ATI Test Packs had 86% survivors while the SteriTec Test Packs had 100% survivors. At 35 minutes exposure, the ATI Test Packs had 46% survivors while the SteriTec Test Packs had 96% survivors. At 45 minutes exposure the ATI Test packs had 0% survivors while the SteriTec test pack had 12% survivors. Based on these test results conducted at NAMSA Laboratories, The SteriTec Disposable Biological Test Pack for EO gas is substantially equivalent to the ATI Disposable Biological Test Pack for Ethylene Oxide, (FDA 510(k) 895704).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure with three lines representing the body, head, and hair. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1998

Mr. Tom Roll President SteriTec Products Mfg., Co., Incorporated 680 Atchison Way - Suite 600 Castle Rock, Colorado 80104

Re: K981497 SteriTec Disposable Biological Test Pack-EO Trade Name: Gas Requlatory Class: II Product Code: FRC Dated: August 3, 1998 Received: August 5, 1998

Dear Mr. Roll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Roll

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene organs or entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 11 of of 1 1

510(k) Number (if known): K981497

Device Name: SteriTec Disposable Biological Test Pack for Ethylene Oxide Sterilzation

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

counter ^

(Optional Format 1-2-96)

Qin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

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).