The SteriTec Chemical Integrator Challenge Pack-Steam is designed to be used to monitor sterilization cycles in pre-vacuum steam sterilizers operating at 132 "C. for 3 minutes or longer. It is to be used as a supplementary test to biological pack testing, not as a substitute.

Device Description

The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for load testing of steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam consists of a chemical integrator test sheet placed inside a package of porous and non porous material. This pack provides resistance to the penetration of steam during the sterilization cycle.

AI/ML Overview

The provided document describes the SteriTec Chemical Integrator Challenge Pack-Steam, a device designed to monitor steam sterilization cycles. The performance testing section outlines its behavior under different temperature and exposure duration conditions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SteriTec Chemical Integrator Challenge Pack-Steam are implicitly defined by its intended use and the performance characteristics of the predicate device. The performance data is presented as the device's response to specific temperature and time exposures.

Acceptance Criteria (Implicit)	Reported Device Performance
Equivalent performance to predicate device (ATI Disposable Test Pack for Steam K952408)	The laboratory test data showed that the performance of the SteriTec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate. (Quantitative equivalence metrics are not provided in this summary).
Does not change color completely at insufficient sterilization conditions.	At 132 °C: Did not change color completely when exposed for 1, 2, and 3 minutes.
Changes color completely (PASS) at sufficient sterilization conditions for its intended use (132 °C for 3 minutes or longer).	At 132 °C: Did change color completely (PASS) between 3 and 4 minutes. (This indicates it would pass at 3 minutes or longer as intended).
Does not change color completely at insufficient sterilization conditions (lower temperatures/shorter times)	At 130 °C: Did not change when exposed for 1, 2, 3, or 4 minutes. At 128 °C: Did not change when exposed for 1, 2, 3, 4, and 5 minutes.
Changes color completely (PASS) at sufficient sterilization conditions (lower temperatures/longer times as expected).	At 130 °C: Did change between 4 and 5 minutes. At 128 °C: Did change between 5 and 6 minutes. (These demonstrate appropriate responsiveness to varying conditions and correlation with expected sterilization times at lower temperatures, further supporting the product's reliability).
Provides a sufficient load challenge to monitor steam sterilization cycles at 132 °C for 3 minutes or longer.	Results of performance testing indicate that the SteriTec Chemical Integrator Challenge Pack-Steam provides a sufficient load challenge to monitor steam sterilization cycles at 132 °C for 3 minutes or longer.

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

Sample Size for the Test Set: Not explicitly stated. The document refers to "laboratory test data" but does not specify the number of individual challenge packs tested under each condition.
Data Provenance: The study was conducted as "laboratory test data." The country of origin is implicitly the United States, given the submitter's address and the FDA submission. It is a retrospective study in the sense that the testing was performed to support a 510(k) submission for an already developed device.

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

Not applicable. This device is a chemical indicator where the "ground truth" is a physical chemical reaction (color change) to defined physical parameters (temperature and time of steam exposure). The ground truth is established by the known physics and chemistry of sterilization processes and the specific chemical formulation of the indicator, rather than by human expert consensus or clinical outcomes. The document does not mention any expert review of the color changes.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is a direct chemical reaction. The outcome (color change or no color change) is a physical property, not subject to human adjudication for its primary determination in this context. It would be observed directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a standalone chemical indicator; its effectiveness is measured by its chemical response to sterilization conditions, not by how it improves human reader performance or diagnostic accuracy.

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

Yes, a standalone performance study was done. The "performance testing" described is for the device itself, without human intervention in interpreting its primary function (color change at specific conditions). The statement "the performance of the SteriTec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate" and the detailed description of color change under various temperature/time combinations are direct measurements of the device's standalone performance.

7. The Type of Ground Truth Used

The ground truth used is based on defined physical parameters and chemical reactions.

Defined Physical Parameters: Specific temperature (132°C, 130°C, 128°C) and exposure durations (1, 2, 3, 4, 5, 6 minutes) for steam sterilization. These are objective and measurable.
Chemical Reactions: The color change of the chemical integrator is a direct, observable outcome of the chemical reaction within the device when exposed to these physical conditions. The expectation of "passing" or "failing" at certain conditions is derived from established sterilization cycle parameters.

8. The Sample Size for the Training Set

Not applicable. This device is a passive chemical indicator, not an AI/algorithm-based system. Therefore, there is no "training set" in the machine learning sense. The device's design and chemical composition are developed through chemical engineering and testing, not through training on data.

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 chemical formulation and physical design of the pack are developed based on established principles of chemical integration for sterilization monitoring, aiming to achieve the desired response profile.

Summary

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COSIVE

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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 Revised_ April 14, 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)
SteriTec Chemical Integrator Challenge Pack-Steam Proprietary Name:

Chemical Integrator Pack for Steam Sterilizers Common/Usual Name:

Chemical Integrator Pack Classification Name:

"Indicator, Chemical Integrator Sterilization Process" in Class II Classification: under Classification Number 80JOJ, Regulation Number 880.2800.

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510(k) Summary - continued

Identification of Predicate device:

The predicate device is ATI Disposable Test Pack for Steam K952408

Description of 510(k) submission device:

Intended use:

The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for the testing of 132 ℃. (270 °F) pre-vacuum steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam is used to supplement testing with biological packs. It gives the operator assurance of sterilizer performance between biological tests or while waiting for biological test results during the incubation period.

Performance Testing:

The laboratory test data showed that the performance of the Steritec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate. In addition, laboratory test data show that the chemical integrator sheet inside the test pack did not change color completely when the SteriTec Chemical Integrator Challenge Pack-Steam was exposed for 1, 2, and 3 minutes at 132 ℃. but did change color completely (PASS) between 3 and 4 minutes. At 130 ℃. it did not change when exposed for 1, 2, 3, or 4 minutes but did change between 4 and 5 minutes. At 128 °C. it did not change when exposed for 1, 2, 3, 4, and 5 minutes but did change between 5 and 6 minutes.

Conclusion:

Results of performance testing indicate that the SteriTec Chemical Integrator Challenge Pack-Steam, provides a sufficient load challenge to monitor steam sterilization cycles at 132 ℃ for 3 minutes or longer.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the eagle in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1998

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

K965212 Re : SteriTec Chemical Integrator Challenge Pack-Trade Name: Steam Requlatory Class: II Product Code: JOJ Dated: January 28, 1998 Received: January 29, 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, Earts 800 to 895 ... A ... ...... substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Roll

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 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 the regulation 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.fdaygov/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 _

510(k) Number (if known):_

K965212

Device Name:__________________________________________________________________________________________________________________________________________________________________

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Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (01)[1)

Qlin S. Lin
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109) ાર

Over The-Counter Use. X

(Optional Formal 1-2-96)

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).