VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR

K051056 · Albert Browne , Ltd. · FRC · Oct 20, 2005 · General Hospital

Device Facts

• Record ID: K051056
• Device Name: VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
• Applicant: Albert Browne , Ltd.
• Product Code: FRC · General Hospital
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Verify® Self-Contained Biological Indicator described in this 510(k) premarket notification may be used for installation testing and routine monitoring of the following steam sterilization cycle: - 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle . for packaged items

Device Story

Verify® Self-Contained Biological Indicator (SCBI) monitors steam sterilization efficacy. Device consists of plastic vial containing disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and ampoule of culture media. Used by healthcare personnel in clinical settings to verify sterilization cycle performance. Following sterilization, SCBI is activated to release media; growth or lack thereof indicates sterilization success or failure. Provides objective confirmation of sterilization process for packaged items. Identical in design and materials to predicate; submission expands indications to include Express abbreviated prevacuum steam sterilization cycle.

Clinical Evidence

Bench testing only. Performance testing conducted to validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle. Results confirm the SCBI meets current FDA guidance and relevant industry standards for monitoring this specific cycle.

Technological Characteristics

Plastic vial containing disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and ampoule of culture media. Identical to predicate device (K855101).

Indications for Use

Indicated for installation testing and routine monitoring of 270°F (132°C), 4-minute Express abbreviated prevacuum steam sterilization cycles for packaged items.

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

• Verify® Self-Contained Biological Indicator (Assert™ Biological/Chemical Indicator) (K855101)

Submission Summary (Full Text)

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## OCT 2 0 2005

### 510(k) Summary

## for

## Verify® Self-Contained Biological Indicator

#### 1. SPONSOR

Albert Browne Ltd., subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

| Contact: | Richard Bancroft |
|------------|------------------|
| Telephone: | 0116 276 8636 |

Date Prepared: October 5, 2005

#### DEVICE NAME 2.

| Proprietary Name: | Verify® Self-Contained Biological Indicator |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Biological indicator |
| Classification Name: | Biological sterilization process indicators |

#### 3. PREDICATE DEVICE

- Verify® Self-Contained Biological Indicator (cleared as the Assert™ . Biological/Chemical Indicator, K855101)
#### DEVICE DESCRIPTION 4.

The proposed Verify® Self-Contained Biological Indicator (SCBI) is identical in components, design, materials, and manufacturing specifications to the predicate Verify® Self-Contained Biological Indicator (cleared in K855101 as the Assert™ Biological/Chemical Indicator). The SCBI consists of a plastic vial that contains a disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media.

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The predicate device was cleared for use in 250°F (121°C) gravity steam. 270°F (132°C) gravity flash steam, 270°F (132°C) prevacuum steam, and ethylene oxide sterilization cycles. This 510(k) premarket notification was submitted to expand the indications for use for the biological indicator to include the Express abbreviated prevacuum steam sterilization cycle (see Section 5).

#### న. INTENDED USE

The Verify® Self-Contained Biological Indicator described in this 510(k) premarket notification may be used for installation testing and routine monitoring of the following steam sterilization cycle:

- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle . for packaged items
#### 6. PERFORMANCE TESTING

Performance testing was conducted to validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle. The results support the use of the SCBI for monitoring this cycle and confirms that the SCBI meets the current requirements of FDA guidance and relevant industry standards.

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### Public Health Service

## OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Albert Brown Limited C/O Cynthia J. M. Nolte, Ph.D., RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K051056

R051050
Trade/Device Name: VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: October 5, 2005 Received: October 6, 2005

Dear Dr. Nolte:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because so 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 interstate comments, or to thay been reclassified in accordance with the provisions of Amendinents, or to de vices that nave oost (Act) that do not require approval of a premarket the rederal I vou, Drag, und Ocentraly, therefore, market the device, subject to the general approval application (1 Mill) - The general controls provisions of the Act include controls provisions of the Fiel. "Inter Jisting 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 II your device is classified (See ass 10) in a controls. Existing major regulations affecting (PMA), it may of subject to such adamar eral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Could of Pecesses on our device in the Federal Register.

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### Page 2 - Dr. Nolte

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 Incal that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal statute and such and limited to: registration r our must comply with and historial to revelong (21 CFR Part 801); good manufacturing practice alle listing (21 CF reful 077), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by occase (Sections 531-542 of the Act); applicable, the cloculonie precaswill allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence in 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), IT you desire specific ad not to read to your ce 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 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/industry/support/index.html.

Sincerely yours,

Sujata Y. Michael D.M.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): K051056

Device Name: Verify® Self-Contained Biological Indicator

Indications for Use:

The Verify® Self-Contained Biological Indicator may be used for installation testing The ventys och Song of the following steam sterilization cycle:

- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle • for packaged items
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (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)

Ruth L. Steel) kowitoy 10/19/05

19:301 Styl-Old
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: k051056