RAVEN PROTEST - EO

K041784 · Raven Biological Laboratories, Inc. · FRC · Sep 13, 2004 · General Hospital

Device Facts

• Record ID: K041784
• Device Name: RAVEN PROTEST - EO
• Applicant: Raven Biological Laboratories, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Sep 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Raven ProTest - EO is a self-contained Biological Indicator inoculated with viable Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization cycles. Raven ProTest - EO has a validated reduced incubation time of 48 hours.

Device Story

ProTest-EO is a self-contained biological indicator for monitoring ethylene oxide sterilization cycles. Device consists of a plastic vial containing a paper filter carrier inoculated with Bacillus atrophaeus spores and a glass ampoule of modified Tryptic Soy Broth with Bromothymol Blue pH indicator. User places device in sterilization chamber with load; after cycle, user crushes internal ampoule to release media. Device is incubated at 30-35°C for 48 hours. If spores survive, they consume nutrients, producing waste that lowers media pH; pH change triggers color shift from green to yellow. Growth (color change or turbidity) indicates sterilization failure. Used by healthcare personnel to verify sterilization efficacy.

Clinical Evidence

Bench testing only. Testing performed per AAMI ST59:1999 on three lots from different spore crops. Parameters validated include resistance, spore population, recovery of injured spores, and 48-hour incubation effectiveness.

Technological Characteristics

Self-contained biological indicator. Components: Bacillus atrophaeus spores on paper filter carrier, glass ampoule with Tryptic Soy Broth and Bromothymol Blue pH indicator, plastic vial. Principle: pH-dependent colorimetric change (green to yellow) indicating spore growth. Dimensions/form factor: self-contained vial. Standards: AAMI ST59:1999.

Indications for Use

Indicated for monitoring the efficacy of ethylene oxide sterilization cycles using Bacillus atrophaeus bacterial 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® - GAS (K930683)

Submission Summary (Full Text)

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K041784

SEP 1 3 2004

# 510(k) Summary

### 510(k) Notification ProTest - EO 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<br>Or<br>Robert V. Dwyer, Jr.<br>President<br>Phone: [phone]<br>Fax: [phone] |
| Prepared on: | |
| Device: | Trade name: ProTest – EO<br>Biological Indicator<br>Common name: Self-contained Biological<br>Indicator for Ethylene Oxide Sterilization |
| Classification: | Class II |
| Predicate Device: | SGM EZTest® - GAS (K930683) |

#### DESCRIPTION

The biological indicator consists of a self-contained unit that includes bacterial spores of The bloodioal manouler concluded onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromothymol Blue acting as a pH indicator encased in a plastic vial that serves as the culture tube.

### OPERATIONAL PRINCIPALS

The ProTest – EO Biological Indicator is placed with a load in the sterilization chamber rne i 10700 - LC Blorogical willing oxide 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 30-35℃ for 48 hours.

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During incubation, the available food supply (Tryptic Soy Broth) and temperature promote growth of any viable spores. As viable spores germinate and consume the provided nutrients waste products are released, increasing the acidity of the media which lowers the pH and causes a color change from green to yellow.

Evidence of growth by color change and/or turbidity within 48 hours should be interpreted as a failure to meet the conditions necessary for sterilization, provided signs of growth are present in the control unit.

# STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE

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

- Both are intended for use in monitoring ethylene oxide sterilization cycles. o
- Utilize the same strain of bacterial spores. ם
- a 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 - EO.

Three separate lots of product manufactured from three different primary spore crops were tested for resistance, spore population, recovery of low numbers of injured spores, and a reduced incubation period of 48 hours. For all lots tested, the above parameters and overall effectiveness in monitoring routine ethylene oxide sterilization cycles has been demonstrated.

#### STATEMENT OF SAFETY AND EFFECTIVENESS

Based on the similar claims, design and results from the above mentioned testing, the ProTest - EO Biological Indicator has been demonstrated to be substantially equivalent to and therefore, as safe and effect as, the legally marketed device EZTest - Gas.

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Public Health Service

SEP 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041784

Trade/Device Name: Raven ProTest-EO Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: June 28, 2004 Received: July 1, 2004

Dear Ms. Royalty-Hann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Federal F 6004). You may, therefore, market the device, subject to the general approvial applications of the Act. The general controls provisions of the Act include controls provided 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 NE), it nay obe address of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements 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 mean that I DTP nas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal barace and equirements, including, but not limited to: registration 1 od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 CF RT rat 807), and 1007), 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) This letter will and n your began finding of substantial equivalence of your device to a premarket notification. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at 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 maj obtain 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 | K041784 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Raven ProTest - EO |
| Indications for Use | Raven ProTest - EO is a self-contained Biological Indicator<br>inoculated with viable Bacillus atrophaeus bacterial spores and is<br>intended for monitoring the efficacy of ethylene oxide sterilization<br>cycles. Raven ProTest - EO has a validated reduced incubation<br>time of 48 hours. |

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

X ____________________________________________________________________________________________________________________________________________________________________________ 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)

Kein Mulay

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

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