ProSpore® is a biological steritization process indicator for steam sterilization at 121°C is a device intended for use by a health care provider to accompany products being sterilized through a steam sterilization procedure and to monitor adequacy of sterilization.

Device Description

ProSpore is a self-contained biological indicator used for determining the efficacy of a 121°C sterilization cycle. The device is a hermetically sealed glass ampoule containing Bacillus stearothermophilus ATCC#7953 bacterial spores in a recovery medium of Tryptic Soy Broth with Bromocresol Purple pH indicator.

AI/ML Overview

The acceptance criteria and study proving the device meets these criteria for the ProSpore Self-contained Biological Indicator are detailed below, based on the provided text.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability of resistance characteristics and spore population (presumably over time)	Demonstrated for three separate lots.
Recovery of low numbers of injured spores	Demonstrated.
Effect of pH indicator on recovery of spores	Demonstrated (implying no detrimental effect or an acceptable interaction).
Reduced incubation period of 48 hours	The device demonstrates evidence of growth by color change and/or turbidity within 48 hours for effective monitoring of sterilization, provided signs of growth are present in the control ampoule. This implies the 48-hour period is sufficient for detection.
Overall effectiveness in monitoring routine steam sterilization cycles	Demonstrated.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The text states, "Testing was performed to validate the labeled claims and performance characteristics for Prospore. These included using three separate lots to show stability of resistance characteristics and spore population..." This indicates that a minimum of three production lots were used for testing, although the exact number of individual indicators within each lot or across all tests is not specified in the provided document.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Raven Biological Laboratories, Inc. The document does not specify country of origin or whether the study was retrospective or prospective, though it implicitly describes prospective testing for device validation.
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 nature of the device (biological indicator for sterilization) suggests that ground truth would be established by direct observation of bacterial growth and/or color change, rather than interpretation by human experts in the traditional sense of diagnostic imaging. The "growth by color change and/or turbidity" within 48 hours is the direct measure.
Adjudication Method for the Test Set:
- This information is not provided. Given the objective nature of detecting bacterial growth (color change/turbidity), a formal expert adjudication method (like 2+1, 3+1) is typically not applicable. The assessment would likely involve direct observation against a control.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The device is a biological indicator designed to provide a direct readout (color change/turbidity) of sterilization efficacy, not an imaging or diagnostic tool requiring human interpretation relative to AI. Therefore, the concept of human readers improving with AI assistance does not apply here.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in effect, a standalone performance was done. The ProSpore device is a standalone system. It functions as an "algorithm only" in the sense that its output (color change or turbidity) is an inherent, direct chemical/biological reaction of the indicator itself, without human interpretation as part of its core performance measurement. Its performance is measured directly by its ability to register growth if sterilization is incomplete.
The Type of Ground Truth Used:
- The ground truth used is biological activity/outcomes data. Specifically, it is the actual growth or non-growth of Bacillus stearothermophilus spores and the resulting color change (from purple to yellow) or turbidity in the recovery medium when subjected to specific sterilization conditions (or lack thereof for controls). This directly indicates the success or failure of sterilization.
The Sample Size for the Training Set:
- This information is not provided. The document describes validation testing, not a machine learning context. Therefore, the concept of a "training set" for an algorithm is not applicable to this biological indicator.
How the Ground Truth for the Training Set was Established:
- As the device is a biological indicator and not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it does not apply in the traditional sense. The device's "training" is its inherent biological and chemical design, optimized through laboratory development to respond to specific sterilization conditions.

Summary

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Summary of "ProSpore Self-contained Biological Indicator" for steam sterilization at 121°C 510(k) # K971432

Submitter:	Raven Biological Laboratories, Inc.
	5017 Leavenworth StreetOmaha, Nebraska 68106
	(402) 556-6690(402) 556-4722 FAX
Contact:	Russ NybergProduction Microbiologist
Prepared on:	2 April 1997
Device name:	ProSpore Self-contained Biological Indicator
Classification:	Class II medical device, General hospital
Predicate Devices (legally marketed):	Kilit™ (BBL)SporView™ (SPSmedical)
Predicate Devices 510(k) numbers:	Kilit™ (BBL) - Grandfather In*SporView™ (SPSmedical) - K905425

DESCRIPTION:

OPERATIONAL PRINCIPLES

The ProSpore ampoule is placed with a load in the sterilization chamber and subjected to a normal steam sterilization cycle. The ampoule is then removed and cooled to room temperature. The processed ampoule and an unprocessed (control) ampoule are incubated at 55-60°C for 48 hours.

During incubation, the available food supply (Tryptic Soy Broth) and temperature promote growth of any viable spores. As viable spores germinate and consume the nutrients provided nitrogen waste products are released, increasing the acidity of the media which lowers the pH and causes the color to change from purple to yellow.

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Evidence of growth by color change and/or turbidity within 48 hours may be interpreted Evidence of growth by Color change and on one of the sterilization, provided signs of growth are present in the control ampoule.

STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE

ProSpore is similar in composition and function to the "Legally Marketed Predicate Devices" Kilit™ and SporView™.

Intended for use in monitoring steam sterilization cycles at 121°C
Intended for use in montoning other of B. stearothermophilus bacterial spore as its organism of choice for steam resistance characteristics
Combine B. stearcthermophilus spores with a recovery media containing a pH indicator in a flame-sealed glass ampoule

DESCRIPTION OF TESTING

Testing was performed to validate the labeled claims and performance characteristics for Prospore. These included using three separate lots to show stability of resistance characteristics and spore population, recovery of low numbers of injured spores, the effect of the pH indicator on recovery of spores and a reduced incubation period of 48 hours. For all lots tested, the above parameters and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated.

STATEMENT OF SAFETY AND EFFECTIVENESS

Based on similar claims and design and the results from the above mentioned testing, the ProSpore Biological Indicator has been determined to be substantially equivalent to and therefore, as safe and effective as, the legally marketed devices Kilit™ and SporView™

*Kilit™ (BBL) does not have a 510(k) number. It was marketed under the grandfather clause, which exempts devices in commercial distribution prior to May 28, 1976. We have obtained the results of the Tradesmarkscan search of the U.S. Patent Office trademark filing showing that the product was introduced into commerce on June 8, 1955 (Attachment 10). The FDA number is M452998.

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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 stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1997

Mr. Kerrie Groff Quality Assurance Manager Raven Biological laboratories, Incorporated P.O. Box 6408 5017 Leavenworth Street Omaha, Nebraska 68106

K971432 Re : Prospore Trade Name: Requlatory Class: II Product Code: FRC Dated: April 15, 1997 April 17, 1997 Received:

Dear Mr. Groff:

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 requlation may result in requlatory 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

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Page 2 - Mr. Groff

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 i 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 requlation (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, uMisbranding 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,

L.J. Celtrist

hy 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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510(k) Number (if known):
Device Name:	ProSpore @

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number J 5

Prescription Use (Per 21 CFR 801.109)

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).