ProSporeII® is a biological sterilization 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

ProSpore2 is a self-contained biological indicator used for determining the efficacy of a 121°C steam sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside the tube is a 1ml glass ampoule of growth media consisting of Tryptic Sov Broth and a pH indicator of Bromocresol Purple. Also inside of the tube housing is a paper spore disc impregnated with a population of 105 Bacillus stearothermophilus spores (ATCC #7953).

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the ProSpore2 Self-contained Biological Indicator:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a formal table with pass/fail thresholds. However, based on the description of the testing and the conclusion of substantial equivalence, the implicit acceptance criteria relate to the stability and effectiveness of the device compared to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance
Population Stability over 18-month shelf life	Demonstrated.
D-value stability over 18-month shelf life	Demonstrated (tested with three separate lots).
Reduced incubation time validation (48-hour)	Validated (based on testing results).
Recovery media stability in recovering low numbers of injured spores over 18-month shelf life	Demonstrated.
Stability of color change when growth occurred over 18-month shelf life	Demonstrated.
Overall effectiveness in monitoring routine steam sterilization cycles	Demonstrated.
Substantial equivalence in composition and function to predicate device (ProofPlus™)	Concluded. The devices are similar in: - Intended use (monitoring 121°C steam sterilization)- Bacterial spore strain (B. stearothermophilus)- Spore carrier (paper disc)- Housing (plastic vial and cap)- Recovery media ampoule (sealed glass)- pH indicator for growth detection (purple to yellow)- Activation method (crushing glass ampoule)- Chemical indicator on label for processed/unprocessed distinction.

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

Sample Size for Test Set: The document states "three separate lots of finished product Prospore2 units" were tested for Population Stability and D-value stability. It doesn't specify the exact number of units per lot, but implies multiple units within each lot would have been tested across the 18-month shelf life.
Data Provenance: The data is presented as originating from Raven Biological Laboratories, Inc., the manufacturer of the device. It is prospective data, generated from testing the ProSpore2 device specifically for its shelf-life and performance characteristics. The country of origin is not explicitly stated for the testing location, but the company is based in Omaha, Nebraska, USA.

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

There is no mention of experts being used to establish ground truth in the traditional sense (e.g., review of medical images). Instead, the "ground truth" for a biological indicator is the objective outcome of a controlled sterilization process and the subsequent growth or non-growth of the bacterial spores. The testing itself, conducted by the manufacturer's microbiologist and likely other qualified personnel within the company, serves as the establishment of this "truth" based on microbiological principles and FDA guidelines.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" in this context is the objective observation of bacterial growth (color change) or lack thereof after a defined sterilization and incubation period. It's a binary outcome based on scientific observation, not a subjective interpretation requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation heavily influences the outcome. For a biological indicator, the performance is a direct result of the biological response to the sterilization process and the growth media.

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

Yes, the testing described is effectively standalone performance, as it evaluates the device's intrinsic biological and chemical function without human-in-the-loop diagnostic interpretations. The device's color change is an automated visual indicator of growth, not requiring complex human judgment for its primary function.

7. The Type of Ground Truth Used

The ground truth used is based on microbiological principles and observable outcomes:

For resistance characteristics (D-value), the ground truth is established by exposing the spores to controlled sterilization conditions and observing the kill rate.
For population stability, the ground truth is the actual count of viable spores.
For recovery media performance, the ground truth is the successful cultivation of viable spores, especially injured ones.
For the overall effectiveness, the ground truth is the unambiguous indication of successful or failed sterilization based on spore viability (no growth vs. growth).

8. The Sample Size for the Training Set

There is no "training set" in the context of an AI/ML algorithm for this device. Biological indicators do not employ AI or machine learning. Their function is based on a direct biological response.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Summary of "ProSpore2 Self-contained Biological Indicator" for steam sterilization at 121°C 510(k) # K971430

Submitter:	Raven Biological Laboratories, Inc.5017 Leavenworth StreetOmaha, Nebraska 68106
	(402) 556-6690(402) 556-4722 FAX
Contact:	Russ NybergProduction Microbiologist
Prepared on:	3 April 1997
Device name:	ProSpore2 self-contained biological indicator
Classification:	Class II medical device, General hospital
Predicate Devices (legally marketed):	ProofPlus™ (AMSCO)
Predicate Device 510(k) number:	K915275

DESCRIPTION:

OPERATIONAL PRINCIPLES:

The plastic cap of the ProSpore2 vial has short "tines" along its lower edge. When placed on the plastic tube body, the space between the tines allows for the passage of steam into the tube and thus reaches the spore disc. A ProSpore2 unit is placed inside of the sterilizer along with a load to be sterilized. If all parameters are met for the cycle (exposure time and temperature), the steam entering the ProSpore2 capsule will be sufficient to deactivate or kill the spores on the paper disc. Onco the cycle is finished, the ProSpore2 vial is removed from the sterilizer and the cap is pressed down with one's thumb. This seals the vial. After allowing the unit to cool for 10 to 15 minutes, the sides of the plastic tubes are squeezed which will result in crushing the glass of the

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media ampoule. With this done, the spore disc is now in contact with the recovery media and the ProSpore2 unit can be placed in an incubator and incubated at 55 to 60°C for 48 hours. If the spores were killed in the sterilization cycle, the color of the recovery media will not change. If the cycle was a "failed cycle" and failed to kill the spores, the recovery media will change color from purple to yellow indicating growth.

The change in color is the result of viable spores germinating and consuming the nutrients provided in the growth media. This consumption process involves the release n first on waste products, which increases the acidity of the media, thus lowering the pH and causing the color to change from purple to yellow. Detection of failed steam sterilization cycles is facilitated by the use of ProSpore2. The outer label of the ProSpore2 plastic tube body has a chemical indicator on the label which changes color when exposed to saturated steam at 121°C, making it easy to distinguish processed from unprocessed vials.

STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE

ProSpore2 is similar in composition and function to the "Legally Marketed Predicate Device" ProofPlus.

both devices are intended for use in monitoring steam sterilization cycles at 121°C
· both devices utilize a USP recommended strain of B. stearothermophilus bacterial spore as its organism of choice for steam resistance characteristics
both devices use a paper disc as the spore carrier
both devices utilize a plastic vial and cap to house the spore disc and media 1 capsule
both devices contain a sealed recovery media ampoule made of glass 를
both devices use a pH indicator in the recovery media which turns to yellow when 199 arowth is present
both devices require that the recovery media ampoule be activated after sterilization by breaking the glass ampoule to release the media to come in contact with the spore disc
both devices incorporate a "chemical indicator" on the label which will change color when exposed to steam at 121°C so that exposed vials can easily be distinguished from unprocessed vials.

DESCRIPTION OF TESTING:

ProSpore2 has been tested for Population Stability over an 18-month shelf life. This testing included both D-value stability and Population stability with three separate lots of finished product Prospore2 units. Three lots were tested according to the FDA guidelines for validation of reduced incubation. A 48-hour reduced incubation was validated based on the testing results. The recovery media has been tested to show stability in the recovery of low numbers of injured spores over the 18-month shelf life and the stability of the color change when growth occurred. For all lots tested, the

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stability of the Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated.

CONCLUSION.

Raven's ProSpore2 is substantially equivalent in composition and function to the legally marketed predicate device, AMSCO's ProofPlus, for monitoring steam sterilization cycles at 121°C, based on the testing results and analysis of 18-month shelf life stability data.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 1997

Mr. Russ Nyberg Production Microbiologist Raven Biological Laboratories, Incorporated 5017 Leavenworth Street Omaha, Nevada 68106

K971430 Re : Prospore II Trade Name: II Requlatory Class: Product Code: FRC Dated: April 14, 1997 Received: April 17, 1997

Dear Mr. Nyberg:

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 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 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. Nyberg

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.goy/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timo hv A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical 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)

Ola S. Lim
(Division Sign-Off)

Division of Dental, Infection Control and General Hospital Device 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Formal 1-2-96)

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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).