Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.

Device Description

The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical integrator.

AI/ML Overview

The provided text describes the acceptance criteria and performance study for the SteriTec CROSS-CHECKS EO Gas Sterilization Integrator (K982547).

Here's an analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantified table. Instead, the "Intended Use" defines the expected performance, and the "Performance Testing" section describes how the device met or surpassed the performance of predicate devices and biological indicators.

Inferred Acceptance Criteria / Intended Performance:

Criteria	Reported Device Performance
Color Change for EO Gas Sterilization
1. Integrated Response	Designed to provide an integrated response to EO gas sterilization in hospital sterilizers.
2. Time to Complete Color Change	Color change occurs between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130°F, and Relative Humidity at 45%. (Indications For Use specifies "Color change to brown is complete between 30 and 45 minutes...")
Comparison to Predicate Device (SURGICOT 2 EO Gas Indicator Strip)	Substantially equivalent in construction and performance. Performance data shows the Cross-Checks EO to be substantially equivalent.
Performance against Biological Indicators (EZTEST, ATTEST, STS Spore Strips)	Surpassed the performance of biological indicators for each of the four parameters used in ethylene oxide sterilization process.
Performance against other EO Integrators (Predicate and Sterigage EO Integrator)	Surpassed the performance of the Surgicot 2 EO Integrator (predicate) as well as the Sterigage EO indicator when tested on a side-by-side basis by an independent laboratory.

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

The document does not specify the exact sample size (number of integrators/strips) used for the performance tests.

Data Provenance:

Country of Origin: Not explicitly stated, but the testing was conducted by an "independent laboratory." The manufacturer is based in Castle Rock, CO, USA.
Retrospective or Prospective: Not explicitly stated, but performance testing of a new device is typically prospective, involving controlled laboratory studies.

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

This type of device (chemical integrator) does not typically involve human expert interpretation for "ground truth" in the same way as an imaging AI. The "ground truth" is based on the physical and chemical response of the integrator to specific sterilization conditions. The assessment of whether it "surpassed the performance" of other indicators would be based on quantitative measurements of their responses under controlled conditions, not expert consensus on an image or clinical condition.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is determined by the physical/chemical response under controlled conditions, not by human interpretation requiring adjudication.

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

Not applicable. This is a standalone chemical indicator, not an AI device designed to assist human readers.

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

This is a standalone chemical integrator, meaning its performance is evaluated directly based on its color change response to sterilization conditions, independent of human interpretation for its primary function. Its performance is the "algorithm only" in the sense that it is a direct measurement of the device's output.

7. Type of Ground Truth Used

The ground truth is established by:

Physical/Chemical Response: The inherent and expected color change response of the integrator material to specific concentrations, temperatures, humidity, and exposure times of ethylene oxide gas.
Comparison to Established Biological Indicators: Biological indicators are the gold standard for sterilization efficacy, as they contain highly resistant bacterial spores. The performance of the chemical integrator is compared against these.
Comparison to Predicate Devices: Performance is also compared to a legally marketed equivalent device (Surgicot 2 EO Gas Indicator Strip) operating under the same principles.

8. Sample Size for the Training Set

Not applicable. This is a chemical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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OCT 8 1998

CROSS-CHECKS EO Gas Sterilization Integrator 510(k) Premarket Notification K982547 SteriTec Products Mfg. Co., Inc.

510(k) PREMARKET NOTIFICATION

SUMMARY

SUBMITTER:

Image /page/0/Picture/5 description: The image shows a handwritten string of characters and numbers. The string begins with the letter 'K', followed by the number '98'. After '98', the numbers '2547' are written. A line is drawn underneath the numbers, possibly indicating a signature or underlining.

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

November 19, 1996 Date Summary was Prepared Date of First Revison February 7, 1997 November 5, 1997 Date of Second Revision Date of Third Revision July 15, 1998

TOM ROLL

Printed name of person required to submit 510(k)

Tom Selleck

Signature of person required to submit 510(k)

PRESIDENT

Title of person submitting 510(k)

Proprietary Name:	SteriTec CROSS-CHECKS EO Gas Sterilization Integrator
Common/ Usual Name:	Ethylene Oxide Gas Sterilization Process Integrator
Classification Name:	Sterilization Chemical Integrator
Classification:	FDA has classified Physical/Chemical Indicators in Class IIunder Classification Number 80JOJ, Regulation 880.2800

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CROSS-CHECKS EO Gas Sterilization Integrator 510(k) Premarket Notification-K982547 SteriTec Products Mfg. Co., Inc.

510(k) Summary - continued

Identification of Predicate device:

The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical integrator equivalent in construction and performance to the predicate device. Since it is equivalent in construction and performance to the SURGICOT 2 EO Gas Indicator Strip, (FDA 510(k) # K800029 and K800029A) manufactured by SURGICOT of Research Triangle Park, North Carolina (Predicate device), it will perform in the same safe and effective manner as the predicate device as demonstrated in performance tests.

Description of 510(k) submission device:

Intended Use:

The Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers.Color change occurs between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.

Comparison to Predicate Device:

Compared to the predicate device our performance data shows the Cross-Checks EO to be substantially equivalent.

Performance Testing:

The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator performance was determined in parallel tests against several biological indicators, (EZTEST, ATTEST, and STS Spore Strips) and in a separate test against the predicate device as well as the Sterigage EO Integrator. The Cross-Checks EO Integrators surpassed the performance of the biologicals for each of the four parameters used in the ethylene oxide sterilization process. In addition, the Cross-Checks EO Integrators surpassed the performance of the Surgicot 2 EO Integrator (the predicate) as well as the Sterigage EO indicator when tested on a side by side basis by an independent laboratory. In both tests , each parameter for EO gas sterilzation was varied while holding the balance of parameters constant.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES - USA" on the right side.

OCT 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K982547 Trade Name: SteriTec CROSS-CHECKS EO Gas Sterilization Inteqrator Regulatory Class: II Product Code: JOJ Dated: July 16, 1998 Received: July 21, 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 qeneral controls provisions of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 the Federal Register. Please note: this response to your 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 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.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 _ 1 of _ 1 _ _ 1 _ _

510(k) Number (if known):_____K982547

Device Name:___Cross-Checks EO Integrator

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)

Over-The-Counter X

(Optional Format 1-2-96)

Clins S. Cin
(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).