PROSPORE(STEARO FOR STEAM STERILIZER)

K962441 · Raven Biological Laboratories, Inc. · FRC · Sep 18, 1996 · General Hospital

Device Facts

• Record ID: K962441
• Device Name: PROSPORE(STEARO FOR STEAM STERILIZER)
• Applicant: Raven Biological Laboratories, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Sep 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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

Device Story

ProSpore is a self-contained biological indicator for steam sterilization validation. Device consists of Bacillus stearothermophilus spores (ATCC #7953) and Tryptic Soy Broth recovery medium with Bromocresol purple pH indicator in a flame-sealed glass ampule. User places ampule in sterilization chamber with load; subjects to steam cycle; removes and cools. Processed ampule and unprocessed control ampule incubated at 55°–60°C for 7 days. If spores survive, growth produces acidic waste, lowering pH and turning Bromocresol purple from purple to yellow; turbidity may also occur. Color change in test ampule (compared to control) indicates sterilization failure. Provides objective verification of sterilization cycle efficacy.

Clinical Evidence

No clinical data. Bench testing only. Validation studies confirmed labeled claims for incubation period, recovery of damaged spores, pH indicator effect on recovery, and one-year stability of spore population and D-value.

Technological Characteristics

USP type 1, 4-ml flame-seal flint glass ampule. Contains Bacillus stearothermophilus (ATCC #7953) spores (1.0-4.0 x 10^5 cfu/unit). Recovery medium: Trypticase Soy Broth, Bromocresol purple, Sodium Hydroxide, Hydrochloric Acid. Passive sensing via biological growth and pH-dependent colorimetric reaction. No energy source or software.

Indications for Use

Indicated for monitoring the efficacy of 121°C steam sterilization cycles in healthcare and industrial 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

• Kilit™ (BBL)
• SporView™ (SPSmedical) (K905425)

Submission Summary (Full Text)

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K962441

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

| Submitter: | Raven Biological Laboratories, Inc.
5017 Leavenworth Street
Omaha, NE 68106
[phone]
[phone] FAX |
| --- | --- |
| Contact: | Russ Nyberg
Production Microbiologist |
| Prepared on: | 20 June 1996 |
| Device name: | ProSpore® self-contained biological indicator |
| Classification: | Class II medical device, General Hospital |
| Predicate Devices (legally marketed) | Kilt™ (BBL)
SporView™ (SPSmedical) |
| Predicate Devices 510(k) number: | Kilit™(BBL) - Grandfather In*
SporView™ (SPSmedical) K905425 |

## Description

ProSpore® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle. The device is a *Bacillus* stearothermophilus in a recovery medium of Tryptic Soy Broth with Bromocresol purple, a pH indicator.

## Specifications

1) BI

Microorganism: *Bacillus stearothermophilus* (ATCC # 7953)

Population: 1.0 x 10⁵ - 4.0 x 10⁵ cfu/unit

Resistance Characteristics: (for saturated steam at 121°C)

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D-value: (determined using Spearman - Karber method on pages 43-50).

Survival time: (USP XXII, p. 204 - Attachment #9)
= [min] labeled D-value x (log₁₀ labeled spore count per carrier -2)

Kill time: (USP XXII, p 204 - Attachment #9))
= [max] labeled D-value x (log₁₀ labeled spore count per carrier +4)

Incubation period: 7 days

## 2) Components

Ampule: USP type 1, 4-ml flame-seal flint glass ampule

Culture/recovery medium: 10 ml of Bromocresol Purple (BCP) stock solution to each liter of Trypticase® Soy Broth (TSB), adjusted to a pH of 7.0 with Sodium Hydroxide (NaOH) and/or Hydrochloric Acid (HCL)

nutrient: Trypticase® Soy Broth powder (Becton Dickinson), as per manufacturer's instructions

neutralizers: Sodium Hydroxide (NaOH) and Hydrochloric Acid (HCL)

pH indicator: Bromocresol Purple (4 grams BCP powder to each liter of deionized distilled water)

## Operational Principles

The ProSpore® ampule is placed with a load in the sterilization chamber, and subjected to a normal steam sterilization cycle. The ampule is then removed and cooled to room temperature. Next, the processed ampule and an unprocessed (control) ampule are placed in incubation for a period of 7 days at a temperature favorable for growth (55° - 60° C. for B. stearothermophilus).

During incubation, the available food supply (TSB) and temperature promote growth of viable spore. The growth process may be accompanied by turbidity and/or a release of acidic waste by products which reduce the pH level of the surrounding medium. Bromocresol purple reacts to this reduction by changing in color to or toward yellow.

Within 7 days, growth will become evident by a change in color from purple to/toward yellow and/or turbidity in the test ampule. This may be interpreted as a failure to meet the conditions necessary for sterilization, provided these signs are present in the control ampule.

Statement of similarity to legally marketed (predicate) devices:

ProSpore® is similar in composition and function to Kilt™ and SporView™, as these devices, like ProSpore® combines Bacillus stearothermophilus spores and a recovery medium (combined

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with a pH indicator) in a flame-sealed glass ampule for use in determining the efficacy of steam sterilization cycles.

## Clinical Tests:

No clinical tests have been performed.

## Discussion of results from nonclinical tests:

Testing was performed to validate the labeled claims and performance characteristics for ProSpore®. These included studies on the labeled incubation period, recovery of damaged spores, the effect of the pH indicator on the recovery of injured spores, and the stability of population and D-value after a real time of one year. Test results confirmed that the tested samples conformed to the labeled claims.

## Statement of safety and effectiveness:

Based on similar claims and design, and results from the nonclinical studies mentioned above, the ProSpore® biological indicator has been determined to be substantially equivalent and, therefore, as safe and effective to the legally marketed devices Kilt™ 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 Trademarkscan 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 # is M452998.