MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS

K032914 · Raven Biological Laboratories, Inc. · FRC · May 25, 2004 · General Hospital

Device Facts

• Record ID: K032914
• Device Name: MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
• Applicant: Raven Biological Laboratories, Inc.
• Product Code: FRC · General Hospital
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple (single species G. stearothermophilus ATCC #7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135°C. A reduced incubation time of 24 hours at 60°C ± 2°C has been validated for steam sterilization when the spore strip (either the single species G. stearothermophilus or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple

Device Story

Device consists of biological spore strips containing G. stearothermophilus (ATCC #7953) or dual species (G. stearothermophilus and B. atrophaeus ATCC #9372) paired with Modified Tryptic Soy Broth with Bromocresol Purple. Used to monitor steam sterilization efficacy. Spore strips are placed in sterilization cycles; subsequently incubated in broth at 60°C ± 2°C for 24 hours. Growth of spores indicates sterilization failure; color change in broth (due to Bromocresol Purple) provides visual readout. Used by clinical staff to verify equipment sterility; ensures patient safety by confirming sterilization process effectiveness.

Clinical Evidence

Bench testing only. Validation performed for a reduced incubation time of 24 hours at 60°C ± 2°C for steam sterilization efficacy monitoring.

Technological Characteristics

Biological indicator consisting of spore strips (G. stearothermophilus ATCC #7953 or dual species with B. atrophaeus ATCC #9372) and Modified Tryptic Soy Broth with Bromocresol Purple. Principle of operation: biological challenge test with visual colorimetric readout. Form factor: strip and liquid media. No electronic components or software.

Indications for Use

Indicated for testing the efficacy of steam sterilization cycles at 121°C - 135°C. Intended for use by healthcare facilities or other settings performing steam sterilization.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2004

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

Re: K032914

Trade/Device Name: Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: March 12, 2004 Received: March 15, 2004

Dear Ms. 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 cquivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the cnactment 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general appto var upprisation (The Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

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 Nr.), it has ob of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register.

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Page 2 - Ms. 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 and instile (2) - as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicaller 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 Icgally 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.

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

510(k) Number (if known) __ K032914

Device Name: __Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple

Indications For Use:

The Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple (single species G. stearothermophilus ATCC #7953 or dual species G. r urple (Single openor of Stan53 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135°C. A reduced in counting the of 24 hours at 60°C ± 2°C has been validated for steam sterilization inoubation time of 2 more Strip (either the single species G. stearothermophilus whon the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple

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

Over-The-Counter Use x (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Moley

Division of Anesthesiology. General Ho Infection Control, Dental D

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510(k) Number. K032914