PROSPORE II

K971430 · Raven Biological Laboratories, Inc. · FRC · May 22, 1997 · General Hospital

Device Facts

• Record ID: K971430
• Device Name: PROSPORE II
• Applicant: Raven Biological Laboratories, Inc.
• Product Code: FRC · General Hospital
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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 Story

ProSpore2 is a self-contained biological indicator for monitoring 121°C steam sterilization efficacy. Device consists of a plastic tube housing a paper spore disc impregnated with 10^5 Bacillus stearothermophilus (ATCC #7953) spores and a 1ml glass ampoule of Tryptic Soy Broth with Bromocresol Purple pH indicator. During sterilization, steam enters the tube via cap tines. Post-cycle, the user manually crushes the internal glass ampoule to release media onto the spore disc. The unit is incubated at 55-60°C for 48 hours. If sterilization fails, viable spores germinate, metabolize nutrients, and produce acidic waste, shifting the pH indicator from purple to yellow. A chemical indicator on the label provides visual confirmation of steam exposure. The device allows healthcare providers to verify sterilization cycle success, ensuring patient safety by confirming the destruction of resistant microorganisms.

Clinical Evidence

Bench testing only. Testing included 18-month shelf-life stability for three product lots, validating D-value stability, spore population counts, and recovery media performance. Reduced incubation validation (48 hours) was performed per FDA guidelines. Effectiveness in monitoring routine steam sterilization cycles was demonstrated through successful recovery of injured spores and consistent color-change response.

Technological Characteristics

Self-contained biological indicator. Components: plastic tube/cap, glass ampoule, Tryptic Soy Broth, Bromocresol Purple pH indicator, paper spore disc with 10^5 B. stearothermophilus (ATCC #7953). Principle: biological spore death and metabolic color change. External chemical indicator on label for steam exposure. Dimensions: 1ml media volume. Sterilization: intended for 121°C steam cycles.

Indications for Use

Indicated for use by healthcare providers to monitor the adequacy of steam sterilization cycles at 121°C.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• ProofPlus (K915275)

Submission Summary (Full Text)

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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.<br>5017 Leavenworth Street<br>Omaha, Nebraska 68106 |
|---------------------------------------|-----------------------------------------------------------------------------------------|
| | [phone]<br>[phone] FAX |
| Contact: | Russ Nyberg<br>Production 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:

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).

## 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

(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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