The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer and can be used in conjunction with a integrator test pack.

Device Description

The SPSmedical SporView® Steam Bl Test Pack consists of a SporView® steam biological indicator placed inside a package of porous and non-porous material. The SPSmedical SporVlew® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the SPSmedical SporView® Steam BI Test Pack:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly linked to the performance of the predicate device, the AAMI biological indicator test pack. The study aims to demonstrate equivalence, meaning the new device should perform similarly.

Acceptance Criterion (Implicit)	Reported Device Performance (SPSmedical SporView® Steam BI Test Pack)
Equivalence to AAMI biological indicator test pack for:
* Routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time.	The SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack for both pass and failure sterilization testing. The device provides a sufficient load challenge to monitor these cycles.
* Prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.	The SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack for both pass and failure sterilization testing. The device provides a sufficient load challenge to monitor these cycles.
Ability to create a significant challenge to air removal and steam penetration.	The SPSmedical SporView® Steam BI Test Pack is designed to create a significant challenge to air removal and steam penetration. It adds resistance and impedes steam penetration to the SporView® steam biological indicator located within the pack. This provides a significant challenge to the steam sterilization process.
Effective and reliable, single use device.	The study concludes that the SPSmedical SporView® Steam BI Pack is an effective and reliable, single use device.

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

Sample Size: 210 sterilization tests were conducted.
- 60 comparison tests for failures were orchestrated.
- 90 comparison tests for pass/failures were orchestrated (this phrasing is ambiguous, likely meaning situations where both pass and failure results were anticipated/orchestrated for comparison).
- 60 tests for passing results were orchestrated.
Data Provenance: The document does not explicitly state the country of origin. Given the submitter (SPSmedical Supply Corp.) is located in the U.S.A. (Rush, NY), it's highly probable the testing was conducted in the United States. The study appears to be a prospective comparison study designed to test the new device against a known standard.

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

This information is not provided in the document. The "ground truth" here is the biological indicator's response (growth or no growth) to sterilization processes, and the performance of the predicate device (AAMI biological indicator test pack). The text doesn't mention expert review for establishing this ground truth, as it's typically based on established protocols for biological indicator performance.

4. Adjudication Method for the Test Set

This information is not provided and is likely not applicable in the context of biological indicator testing. The "truth" of a pass or fail is determined by the growth/no growth of the biological indicator, not by expert consensus or adjudication.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with medical imaging or diagnostic devices where human interpretation plays a significant role. This study focuses on the objective performance of a physical test pack.

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

Yes, in essence, this was a standalone performance study. The device (SPSmedical SporView® Steam BI Test Pack) was tested in a standalone manner against the predicate device (AAMI biological indicator test pack) within sterilization cycles. There is no human-in-the-loop component for the device's function or interpretation beyond reading the biological indicator's result (which is a standard practice).

7. The Type of Ground Truth Used

The ground truth used was the performance of a legally marketed predicate device (AAMI biological indicator test pack) and the biological response (growth/no growth of Geobacillus stearothermophilus spores) to varying sterilization conditions. This is essentially a reference standard comparison.

8. The Sample Size for the Training Set

This information is not applicable as this device is a physical biological indicator test pack, not an AI/machine learning algorithm that requires a training set. The study describes comparison testing, not a model training process.

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

This information is not applicable for the reasons stated in point 8.

Summary

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OCT 2 5 2002

K022706

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 October 21, 2002 .
Gary J. Socola . Printed name of person submitting for 510(k) seen in
- Signature of person submitting for 510(k)
Director of Quality Assurance . Title of person submitting for 510(k)

Device Name and Classification

Trade Name:	SPSmedical SporView® Steam Bl Test Pack
Classification Name:	Biological Indicator
Common Name:	Biological Test Pack
Device Classification:	Class II, Regulation Number 880.2800
Product Code:	80FRC
Predicate Device:	StenTec Biological Indicator Test Pack (K001444)

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Device Description:

Intended Use:

Technical Characteristics:

The SPSmedical SporView® Steam Bl 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 SporView® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration. The SPSmedical SporView® Steam Bl Test Pack adds resistance and impedes steam penetration to the SporViews steam biological indicator located within the pack. This provides a significant challenge to the steam sterilization process.

Non-Clinical Testing:

Two hundred ten (210) sterilization tests were nun to compare performance standards/results of the SPSmedical SportView® Steam Bl Test Pack to the AAMI biological indicator test pack. A SporView® self-contained biological indicator containing Geobacillus stearothermophilus spores was used within the AAMI biological indicator test. Of the two hundred and ten stedlization tasts that were run: 60 comparison tests for failures were orchestrated, 90 comparison tests for passifallures were orchestrated and 60 tests for passing results were orchestrated. The pass and failure stenilization testing of SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack.

Conclusion:

Supportive data has demonstrated that the SPSmedical SporView® Steam Bl Pack is equivalent to the predicate device. Results of performance testing indicate that the SPSmedical SporView @ Steam Bl Pack provides a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer. The SPSmedical SporViews Steam Bl Pack is an effective and reliable, single use device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

od and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2002

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

Re: K022706

Trade/Device Name: Sporview® Steam BI Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: August 6, 2002 Received: August 14, 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. Ulbrich

Timothy A. Ulatowski 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 STATEME

SPSmedical Supply Corp. Applicant:

510(k) Number (if known): _ K022706

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Ure:

The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and provacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.

(Pl.Ease 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)

Qitin S-Lin

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K022706

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).