RAVEN PROTEST - STEAM

K041386 · Raven Biological Laboratories, Inc. · FRC · Aug 9, 2004 · General Hospital

Device Facts

• Record ID: K041386
• Device Name: RAVEN PROTEST - STEAM
• Applicant: Raven Biological Laboratories, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.

Device Story

Self-contained biological indicator for steam sterilization monitoring; consists of Geobacillus stearothermophilus spores on paper carrier and glass ampoule of modified Tryptic Soy Broth with Bromocresol Purple pH indicator inside plastic vial. Placed in sterilization chamber with load; subjected to steam cycle; activated by crushing internal ampoule; incubated at 55-60°C for 24 hours. Growth of viable spores consumes media, producing waste products that lower pH, causing color change from purple to yellow. Healthcare providers observe color change/turbidity to confirm sterilization efficacy. Benefits include verification of sterilization process performance.

Clinical Evidence

Bench testing only. Testing performed per AAMI ST59:1999 on three lots to validate resistance, spore population, and recovery of injured spores. Results demonstrate efficacy for monitoring routine steam sterilization cycles with a 24-hour incubation period.

Technological Characteristics

Self-contained biological indicator. Materials: Geobacillus stearothermophilus ATCC #7953 spores, paper filter carrier, glass ampoule, plastic vial. Sensing principle: pH-sensitive colorimetric change (Bromocresol Purple) in Tryptic Soy Broth. Energy source: None (passive). Sterilization: Not applicable (device is a monitor).

Indications for Use

Indicated for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles) using Geobacillus stearothermophilus spores.

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

• SGM EZTest® - Steam (K963841)

Submission Summary (Full Text)

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K041386

## 510(k) Summary

#### 510(k) Notification ProTest - Steam Biological Indicator

| Submitted by: | Raven Biological Laboratories<br>8607 Park Drive<br>Omaha, NE 68127 |
|-------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact: | Wendy Royalty-Hann<br>Quality Assurance/Regulatory Affairs Manager |
| | Or |
| | Robert V. Dwyer, Jr.<br>President |
| | Phone: [phone]<br>Fax: [phone] |
| Prepared on: | May 19, 2004 |
| Device: | Trade name: ProTest - Steam<br>Biological Indicator<br>Common name: Self-contained Biological<br>Indicator for Steam |
| Classification: | Class II |
| Predicate Device: | SGM EZTest® - Steam (K963841) |

#### DESCRIPTION

The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

#### OPERATIONAL PRINCIPALS

The ProTest - Steam Biological Indicator is placed with a load in the sterilization chamber and subjected to a normal steam sterilization cycle. The unit is then removed and activated by crushing the glass media ampoule inside. The processed unit and an unprocessed (control) unit are incubated at 55-60℃ for 24 hours.

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- During incubation, the available food supply (Tryptic Soy Broth) and temperature During incubation, the available lood Supply (Trypts es germinate and consume the media promote grown of any viable spores. TAS viable speres sing the acidity of the media
provided nutrients waste products are released, increasing the acidity of the media provided nuthents waste products are reterange from purple to yellow.
Evidence of growth by color change and/or turbidity within 24 hours should be Evidence of growth by color onango undrer takensy for sterilizations, provided signs of growth are present in the control unit.

# STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE

ProTest – Steam is similar in composition and function to the legally marketed predicate device EZTest - Steam.

- o Both are intended for use in monitoring steam sterilization cycles from 121℃ to 135°C.
- Utilize the same strain of bacterial spores.
- ם Utilize the same carrier material.
- o Virtually the same size and shape.
- a Activated in the same manner.

#### DESCRIPTION OF TESTING

Testing was performed in accordance with AAMI ST59:1999 to validate the labeled claims and performance characteristics of ProTest - Steam.

Three separate lots of product manufactured from three different primary spore crops I hree separate foto of production, recovery of low numbers of injured spores, were tested for resistante, opors population, For all lots tested, the above parameters and a readood moubation penonitoring routine steam sterilization cycles has been demonstrated.

## STATEMENT OF SAFETY AND EFFECTIVENESS

Based on the similar claims, design and results from the above mentioned testing, the Dasod on the entillar of indicator has been demonstrated to be substantially r rollest - Gtoum Blerogical masafe and effect as, the legally marketed device EZTest -Steam.

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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 features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG - 9 2004

Ms. Wendy Royalty-Hann Quality Assurance, Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127

Re: K041386

R041500
Trade/Device Name: Raven ProTest Self-Contained Biological Indicator for Steam Regulation Number: 880.2800 Regulation Name: Sterilization Process Indication Regulatory Class: II Product Code: FRC Dated: May 20, 2004 Received: May 25, 2004

Dear Ms. Royalty-Hann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in the device is substantially equivalent (for the referenced above and have decemblied and to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisece prior to frid, 20, 10, 10, 10, 10, 10, 20, 10, 2011, 10, 2011, 10, 2019, 10, 10, 2019, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Amendinents, or to devroos and navic Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosmen's , therefore, market the device, subject to the general approval application (1 MIT). 1 Car een controls provisions of the Act include Controls provisions of the Fea. "The girling 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 If your device is classified (see as 10) inn a controls. Existing major regulations affecting (PMA), It may be subject to such adaltions, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

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Page 2 - Ms. Royalty-Hann

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

| 510(k)<br>Number | K041386 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Raven ProTest - Steam |
| Indications for<br>Use | Raven ProTest - Steam is a self-contained Biological Indicator<br>inoculated with viable Geobacillus stearothermophilus bacterial<br>spores and is intended for monitoring the efficacy of steam<br>sterilization cycles (121°C gravity displacement and 121°C - 135°C<br>prevacuum cycles). Raven ProTest - Steam has a validated<br>reduced incubation time of 24 hours. |

Prescription Use (Part 21 CFR 801 Subpart D)

...

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Mulvey

(Division Sign-Off) (UNIsion of Anesthesiology, General Hospital, Infection Control, Dental Devi

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510(k) Number: K041386