PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA

K031114 · Raven Biological Laboratories, Inc. · MRB · Mar 3, 2004 · General Hospital

Device Facts

• Record ID: K031114
• Device Name: PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
• Applicant: Raven Biological Laboratories, Inc.
• Product Code: MRB · General Hospital
• Decision Date: Mar 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.

Device Story

Raven ProPACT Peracetic Acid Culture Test Kit serves as biological indicator for STERIS SYSTEM 1 liquid chemical sterilization system. Device provides independent confirmation of sterilization cycle efficacy. User processes kit within STERIS SYSTEM 1 cycle; subsequent incubation for 48 hours confirms sterilization conditions. Used in clinical or healthcare settings to verify equipment sterility; benefits patient by ensuring instruments are properly processed.

Clinical Evidence

Bench testing only; validation of 48-hour incubation time for biological indicator performance.

Technological Characteristics

Biological indicator for peracetic acid-based liquid chemical sterilization. Designed for use with STERIS SYSTEM 1. Validated for 48-hour incubation period.

Indications for Use

Indicated for use as a biological indicator to confirm sterilization conditions in the STERIS SYSTEM 1 liquid chemical sterilization system. Intended for over-the-counter use.

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.

Reference Devices

• STERIS SYSTEM 1

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

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

Re: K031114

Trade/Device Name: Raven ProPACT Peracetic acid Culture Test kit Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: MRB Dated: January 13, 2004 Received: January 14, 2004

Dear Ms. Royalty-Hann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yourse 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 mensiale conmistee procted fridge been reclassified in accordance with the provisions of Allendinents, or to dovrees that in to Act (Act) that do not require approval of a premarket the Federal I 000; Drag, Drag, therefore, market the device, subject to the general approval application (1 Mill). The general controls provisions of the Act include controls provisions of the ristration, 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 (FMA), it may oe subject to back adata actuations, 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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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 Incall that I DA nas made a deceminations administered by other Federal agencies. of the Act of ally i edelta batales and regirements, including, but not limited to: registration You must comply with an the Hee Process roq 21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 067), acciity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of other (Sections (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) I mis letter will anow you to organ 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), If you desire spooline ad 100 to 100 to 100 m 100 m 100 m me more 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 may 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,

Clair Liu, 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

510(k) Number (if known): K031114

Device Name: Raven ProPACT Peracetic Acid Culture Test Kit

Indications For Use: The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.

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)

Marshall D. Zone, Branch Chief

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(Division Sighton) Sign-Off, General Hosp Infection Control, Denta

510(k) Number: K031114