PROSPORE II

K960790 · Raven Biological Laboratories, Inc. · FRC · Aug 16, 1996 · General Hospital

Device Facts

• Record ID: K960790
• Device Name: PROSPORE II
• Applicant: Raven Biological Laboratories, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Aug 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

ProSporeII® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle.

Device Story

Self-contained biological indicator for steam sterilization monitoring. Device consists of plastic tube housing, plastic cap with tines for steam passage, paper spore disc with 10⁵ Bacillus stearothermophilus spores (ATCC #7953), and 1 ml glass ampule of Tryptic Soy Broth with phenol red pH indicator. Placed in sterilizer with load; steam exposure deactivates spores if cycle parameters met. Post-cycle, user presses cap to seal and squeezes tube to crush glass ampule, bringing media into contact with spore disc. Incubated at 55-60°C for 7 days. If sterilization fails, spores germinate, lowering media pH and changing color from red to yellow. External label includes chemical indicator to distinguish processed from unprocessed vials. Provides visual confirmation of sterilization cycle efficacy.

Clinical Evidence

Bench testing only. Evaluated 18-month shelf-life stability across three product lots. Metrics included D-value stability, spore population stability, and recovery media performance (ability to recover low numbers of injured spores and color change reliability). Results demonstrated consistent resistance characteristics and effectiveness in monitoring steam sterilization cycles.

Technological Characteristics

Plastic tube/cap housing; 1 ml glass ampule containing Tryptic Soy Broth and phenol red; paper spore disc with 10⁵ B. stearothermophilus (ATCC #7953). Steam sterilization monitoring via biological growth/pH-mediated color change. External chemical indicator on label. No software or electronic components.

Indications for Use

Indicated for monitoring the efficiency of 121°C steam sterilization cycles in general hospital settings.

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™ (AMSCO) (K915275)

Submission Summary (Full Text)

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AUG 16 1996

X960790

# Summary of "ProSpore II Self-contained Biological Indicator" for steam sterilization at 121°C

| Submitter: | Raven Biological Laboratories, Inc. |
| --- | --- |
| | 5017 Leavenworth Street
Omaha, Nebraska 68106 |
| | [phone]
[phone] FAX |
| Contact: | Russ Nyberg
Production Microbiologist |
| Prepared on: | 29 May 1996 |
| Device name: | ProSpore II® self-contained biological indicator |
| Classification: | Class II medical device, General hospital |
| Predicate Devices (legally marketed): | ProofPlus™ (AMSCO) |
| Predicate Device 510 (k) number: | K915275 |

# DESCRIPTION:

ProSporeII® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle. ProSpore II is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1 ml glass ampule of growth media consisting of Tryptic Soy Broth and a pH indicator of phenol red. 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 ProSpore II vial has short 'tines' along it's 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 reach the spore disc. A ProSpore II 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 ProSpore II capsule will be sufficient to deactivate or kill the spores on the paper disc. Once the cycle is finished, the ProSpore II vial is removed from the sterilizer and the cap is pressed down with ones thumb. This seals the vial. After allowing the unit to cool for 10 to 15

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minutes, the sides of the plastic tubes are squeezed which will result in crushing the glass of the media ampule. With this done, the spore disc is now in contact with the recovery media and the ProSpore II unit can be placed in an incubator and incubated at 55 to 60°C for a 7 day period of time. If the spores were killed in the sterilization cycle, the color of the recovery media will not change. If the cycle was 'failed cycle' and failed to kill the spores, the recovery media will change color from red 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 of nitrogen waste products which lower the pH of the media and increases the acidity which causes the color to change from red to yellow. Detection of failed steam sterilization cycles is facilitated by the use of ProSpore II. The outer label of the ProSpore II plastic tube body has a chemical indicator on the label which changes color when exposed to saturated steam at 121°C thus making it easy to distinguish processed from unprocessed vials.

# STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE

ProSpore II 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 it's 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 capsule.
- both devices contain a sealed recovery media ampule made of glass.
- both devices use a pH indicator in the recovery media which turns from red to yellow in color when growth is present.
- both devices require that the recovery media ampule be activated after sterilization by breaking the glass ampule 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 ampules or vials can be distinguished from unprocessed vials.

# DESCRIPTION OF TESTING:

ProSpore II has been tested for Population Stability over an 18 month self-life. This testing included both D-value stability and Population stability with three separate lots of finished product ProSpore II ampules. 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 stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness in monitoring routine steam sterilization cycles that has been demonstrated.

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# CONCLUSION:

Raven's ProSpore II 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 self-life stability data.