The SPSmedical STEAMPlus™ Sterilizer Test Pack is indicated for use in routine and challenge testing of steam sterilization cycles in both gravity displacement and prevacuum steam sterilizers.

Device Description

The SPSmedical STEAMPlus™ Sterilizer Test Pack consists of a steam sterilization integrator placed inside a package of porous and non-porous material. The SPSmedical STEAMPlus TM Sterilizer Test Pack is designed to create a significant challenge to air removal and steam penetration.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "SPSmedical STEAMPlus™ Sterilizer Test Pack". The provided document describes the device, its intended use, and the non-clinical testing performed to establish its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner with specific thresholds. Instead, the performance is evaluated against the comparable performance of a predicate device and AAMI biological indicator test pack.

Acceptance Criteria (Implied)	Reported Device Performance
Performance comparable to the AAMI biological indicator test pack.	"The pass and failure sterilization testing of SPSmedical STEAMPlus™ Sterilizer Test Pack consistently showed results comparable to the AAMI biological indicator test pack."
Provide a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C.	"Results of performance testing indicate that the SPSmedical STEAMPlus™ Sterilizer Test Pack provides a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C."
Provide a sufficient load challenge to monitor prevacuum steam sterilization cycles at 132°C.	"Results of performance testing indicate that the SPSmedical STEAMPlus™ Sterilizer Test Pack provides a sufficient load challenge to monitor... prevacuum steam sterilization cycles at 132°C."

2. Sample size used for the test set and the data provenance:

Sample Size: 210 sterilization tests.
- 60 comparison tests for failures.
- 90 comparison tests for pass/failures.
- 60 tests for passing results.
Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study in the sense that the results are being presented after the tests were conducted, comparing the new device against existing standards/tests. It's a laboratory-based comparison rather than field data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of device (sterilization process indicator) does not involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" is established by the functional outcome of the sterilization process itself, specifically the viability of Bacillus stearothermophilus spores in a biological indicator. There are no human experts "adjudicating" the ground truth of the test set in this context.

4. Adjudication method for the test set:

Not applicable. As explained above, the "ground truth" is determined by the biological indicator's performance, not human adjudication of a diagnostic output.

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 is not an AI-powered diagnostic device that would involve human readers. It is a physical sterilization test pack.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable directly in the context of an "algorithm." However, the device itself functions in a standalone manner by indicating whether sterilization conditions were met. The comparison study acts as the "standalone" performance evaluation against a gold standard (AAMI biological indicator).

7. The type of ground truth used:

The ground truth was established using a biological indicator strip containing Bacillus stearothermophilus spores, which is considered the gold standard for verifying sterilization efficacy in steam sterilization processes (as per AAMI guidelines referenced). The biological indicator's viability (growth or no growth) after exposure to the sterilization cycle provides the definitive "ground truth" for whether the cycle was effective.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set." The 210 tests described are performance validation tests.

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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JUL 1 8 2002

K020409

510(k) Summary of Safety and Effectiveness

Submitter:

SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585)-359-0130 Fax: (585)-359-0167
Establishment FDA Registration No.: 1319130 ●
Date Summary was Prepared July 12, 2002 .
Gary J. Socola ● Printed name of person submitting for 510(k) 0)
der X lar ot . Signature of be son submitting for 510(k)
Director of Quality Assurance . Title of person submitting for 510(k)

Device Name and Classification

Trade Name:	SPSmedical STEAMPlus™ Sterilizer Test Pack
Classification Name:	Sterilization Process Indicator
Common Name:	Steam Challenge Test
Device Classification:	Class II, Regulation Number 880.2800
Product Code:	80JOJ
Predicate Device:	Propper Pass/Fail Steam Challenge Pack (K991276)

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Device Description:

Intended Use:

The SPSmedical STEAMPlus ™ Sterilizer Test Pack is designed to monitor sterilization cycles in gravity displacement steam sterilizers at 121°C and in prevacuum steam sterilizers at 132°C. It is to be used for routine monitoring and challenge testing of steam sterilizers and can be used in conjunction with a biological indicator test pack.

Technical Characteristics:

The SPSmedical STEAMPlus™ Sterilizer Test Pack has the same intended use and technological characteristics as the AAMI biological indicator test pack and other commercially available test packs. The SPSmedical STEAMPlus™ Sterilizer Test Pack is designed to create a significant challenge to air removal and steam penetration. The SPSmedical STEAMPlus™ Sterilizer Test Pack adds resistance and impedes steam penetration to the steam sterilization integrator located within the pack. This provides a significant challenge to the steam sterilization process.

Non-Clinical Testing:

Two hundred ten (210) sterllization tests were run to compare performance standards/results of the SPSmedical STEAMPlus™ Sterilizer Test Pack to the AAMI biological indicator test pack. A biological indicator strip containing Bacillus stearothermophilus spores was used within the AAM biological indicator test pack along with a STEAMPlus™ integrator. Of the two hundred and ten sterilization tests that were run; 60 comparison tests for failures were orchestrated, 90 comparison tests for passfiailures were orchestrated and 60 tests for passing results were orchestrated. The pass and failure sterilization testing of SPSmedical STEAMPlus™ Sterilizer Test Pack consistently showed results comparable to the AAMI biological indicator test pack.

Conclusion:

Supportive data has demonstrated that the SPSmedical STEAMPlus ™ Sterilizer Test Pack is equivalent to the predicate device. Results of performance testing indicate that the SPSmedical STEAMPlus™ Sterilizer Test Pack provides a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C and for prevacuum steam sterilization cycles at 132°C. The SPSmedical STEAMPlus ™ Sterilizer Test Pack is an effective and reliable, single use device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized profiles facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUL 1 8 2002

Mr. Gary J. Socola Director of Quality Assurance & Sterilization Projects SPS Medical Supply Corporation 6789 West Henrietta Road Rush, New York 14543

Re: K020409

Trade/Device Name: STEAMplus™ Sterilization Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: May 2, 2002 Received: May 3, 2002

Dear Mr. Socola:

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 (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Socola

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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INDICATIONS for USE STATEMENT

SPSmedical Supply Corp. Applicant:

510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The SPSmedical STEAMPlus™ Sterilizer Test Pack is indicated for use in routine and challenge testing of steam sterilization cycles in both gravity displacement and prevacuum steam sterilizers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Qùin Si him

(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).