The SPSmedical SporView®Plus Steam B1 Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at indication for ace in rouintes exposure time or longer and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.

Device Description

The SPSmedical modified SporView Plus Steam BI Test pack is a single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles.

AI/ML Overview

The provided document describes the K051173 submission for the SPSmedical SporView® Plus BI Test Pack. This is a biological indicator (BI) to monitor steam sterilization cycles. It is not an AI/ML powered device, so many of the requested fields (such as MRMC studies, training/test sets, expert adjudication, etc.) are not applicable.

Here's an analysis of the provided information, framed by your request, and addressing the relevance of each point:

Acceptance Criteria and Device Performance Study for SPSmedical SporView® Plus BI Test Pack

The acceptance criteria for this device, as implied by the non-clinical testing section, is equivalence in performance to both the established AAMI (Association for the Advancement of Medical Instrumentation) biological indicator test packs and the predicate device (SPSmedical SporView® BI Test Pack, K022706). Performance is measured by the ability of the biological indicators within the test packs to accurately reflect complete survival, partial survival, and complete kill cycles under specified sterilization conditions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence to AAMI biological indicator test packs in detecting complete survival, partial survival, and complete kill cycles in gravity displacement steam sterilizers at 121°C.	The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the AAMI biological indicator test packs during complete survival, partial survival, and complete kill cycles run in a gravity displacement steam sterilizer at 121°C (250°F).
Equivalence to AAMI biological indicator test packs in detecting complete survival, partial survival, and complete kill cycles in pre-vacuum steam sterilizers at 132°C.	The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the AAMI biological indicator test packs during complete survival, partial survival, and complete kill cycles run in a pre-vacuum steam sterilizer operating at 132°C (270°F).
Equivalence to the predicate device (SPSmedical SporView® BI Test Pack) in detecting complete survival, partial survival, and complete kill cycles in gravity displacement steam sterilizers at 121°C.	The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the predicate test pack during complete survival, partial survival, and complete kill cycles run in a gravity displacement steam sterilizer at 121°C (250°F).
Equivalence to the predicate device (SPSmedical SporView® BI Test Pack) in detecting complete survival, partial survival, and complete kill cycles in pre-vacuum steam sterilizers at 132°C.	The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the predicate test pack during complete survival, partial survival, and complete kill cycles run in a pre-vacuum steam sterilizer operating at 132°C (270°F).

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

Sample Size: The document states that "Three separate lots of biological indicators containing G. stearothermophilus spores were used." This implies a sample size of at least three product lots. Within each lot, multiple biological indicators would have been tested. The specific number of individual BIs per lot or per test cycle is not explicitly stated.
Data Provenance: The testing was "performed in a 121°C (250°F) gravity displacement sterilizer and in a pre-vacuum steam sterilizer operating at 132°C (270°F)." This indicates a laboratory-based, prospective experimental study. The country of origin is implicitly the USA, given the submission to the FDA by a US-based company.

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

This is not applicable as this is a biological indicator, not an AI device relying on expert interpretation for ground truth. The "ground truth" for a biological indicator is the objective outcome of sterilization (i.e., whether the spores are killed or not), which is determined by culturing the BI.

4. Adjudication Method for the Test Set

Not applicable. The outcome of the biological indicator (survival/kill) is an objective biological determination, not subject to human adjudication in the traditional sense of clinical imaging or interpretation.

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

Not applicable. This is not an AI/ML device, and its performance is not evaluated in terms of improving human reader effectiveness.

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

Not applicable. This is not an AI algorithm. Its performance is inherently "standalone" in that it directly measures the effectiveness of sterilization. There is no human-in-the-loop component in its core function.

7. The Type of Ground Truth Used

The ground truth used is based on biological viability (spore killing). The AAMI standard ST-46:2002 prescribes how biological indicators (containing G. stearothermophilus spores) are used and evaluated to determine if a sterilization cycle achieved its intended purpose (i.e., killing the spores). The "complete survival, partial survival, and complete kill cycles" refer to carefully controlled conditions designed to elicit these specific outcomes from the biological indicators, which then serve as the ground truth for evaluating the test pack's performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the computational sense. The device's design is based on established biological and sterilization principles.

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

Not applicable. As there's no training set for an AI/ML model, there's no ground truth established in this context. The underlying scientific principles for biological indicator performance (e.g., G. stearothermophilus resistance to steam) are well-established prior to the device's development.

Summary

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MAY 27 2005

K051173
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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 .
May 5th, 2005 Date Summary was Prepared .
Gary J. Socola . Printed name of person submitting for 510(k)
X Jan ાજીન . Signature of person submitting for 510(k)
- Vice President, Scientific Affairs . Title of person submitting for 510(k)

Device Name and Classification

Trade Name:	SPSmedical SporView® Plus BI Test Pack
Classification Name:	Biological Indicator
Common Name:	Biological Test Pack
Device Classification:	Class II, Regulation No. 880.2800
Product Code:	80FRC
Predicate Device:	SPSmedical SporView® BI Test Pack (K022706)

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K051173
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Device Description:

The SPSmedical modified SporView Plus Steam BI Test pack is a single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles.

Intended Use:

The SPSmedical SporView®Plus Steam Bl Test pack is designed to monitor sterilization cycles in both gravity displacement and pre-vacuum steam sterilizers. It is to be used for routine and challenge monitoring of steam sterilizers.

Statement of Similarity to the Legally Marketed Predicate Device:

Have the same indicated use .
Are run in the same sterilization cycles .
Incorporate the same materials .
Have the same shelf life .
Have the same storage conditions .
Packaged using the same materials and processes .

Non-Clinical Testing:

Testing was performed in a 121°C (250°F) gravity displacement sterilizer and in a pre-vacuum steam sterilizer operating at 132°C (270°F). Three separate lots of biological indicators containing G. stearothermophilus spores were used. The validation study involved preparing AAMI biological indicator test packs as indicated in AAMI standard ST-46:2002, section 7.5.2. A biological indicator and STEAMPlus Integrator were placed within the center of each AAMI biological indicator test pack and within the SporView Plus Steam Bl Test pack. Complete survival, partial survival and complete kill cycles were run in a gravity displacement steam sterilizer at 121°C (250°F) and in a prevacuum steam sterilizer operating at 132°C (270°F). The biological indicators in the SporView Plus Bl Test packs were found to be equivalent in performance to those located within the AAMI biological indicator test packs. In addition a biological indicator and STEAMPlus Integrator were placed within the center of the predicate test pack and within the SporView Plus Steam Bl Test pack. Complete survival, partial survival and complete kill cycles were run in a gravity displacement steam sterilizer at 121°C (250°F) and in a pre-vacuum steam sterilizer operating at 132°C (270°F). The biological indicators in the SporView®Plus Bl Test packs were found to be equivalent in performance to those located within the predicate test packs.

Conclusion:

SPSmedical Sporview Plus Steam Bl Test pack has undergone appropriate validation. For all the foregoing reasons, SPSmedical believes that the SporView Plus Steam BI Test pack is equivalent to the predicate SPSmedical pack when used for routine and challenge monitoring of steam sterilizers and can be safely marketed in the United States.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2005

Mr. Gary J. Socola Vice President, Scientific Affairs SPSmedical Supply Corporation 6789 West Henrietta Road Rush, New York 14543

Re: K051173

Trade/Device Name: SporView Plus Steam BI Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: May 5, 2005 Received: May 9, 2005

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 Amerade even ar 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 Eederal Register.

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Page 2 - Mr. Socola

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 12 a determination that your device complies with other requirements modifine act or any Federal statutes and regulations administered by other Federal agencies. of the Fet of all , I eachar the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (2) see t forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadis ion 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 premainer notaries 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), If you dealts the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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: ___________________________________________________________________________________________________________________________________________________________________

KOSI173 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SporView®Plus Steam Bl Test Pack Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy R.S./1/15

Alon Sinn-Off) ം പ nesthesiology, General Hospital, o betor Control. Dental Devices

Number. 1051173

Page 1 of 1

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).