SPSMEDICAL SPORVIEW PA CULTURE SET

K043135 · Spsmedical Supply Corp. · MRB · Jan 13, 2005 · General Hospital

Device Facts

• Record ID: K043135
• Device Name: SPSMEDICAL SPORVIEW PA CULTURE SET
• Applicant: Spsmedical Supply Corp.
• Product Code: MRB · General Hospital
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.

Device Story

Biological indicator for monitoring STERIS System 1 liquid chemical sterilization; utilizes paper strips inoculated with 10^5 G. stearothermophilus spores. Device processed in sterilizer via transfer clip; recovered in sterile modified soybean casein broth media containing color change indicator. Provides independent confirmation of sterilization conditions (1,000 ppm peracetic acid at 50°C). Survival/kill time parameters: survives 41 seconds, killed at 6 minutes. Used by healthcare staff to verify sterilization efficacy on exterior surface loads. Results interpreted via visual color change in media after 24-hour incubation; confirms whether sterilization cycle achieved required parameters.

Clinical Evidence

Bench testing only. Validation performed to confirm survival at 41 seconds and kill at 6 minutes in 1,000 ppm peracetic acid at 50°C. Reduced incubation time of 24 hours validated using SporView culture media.

Technological Characteristics

Biological indicator; paper carrier inoculated with 10^5 G. stearothermophilus spores. Includes modified soybean casein broth with color change indicator and transfer clip. Designed for 1,000 ppm peracetic acid at 50°C. No electronic components or software.

Indications for Use

Indicated for monitoring sterilization efficacy of the STERIS System 1 liquid chemical sterilization process using STERIS 20 sterilant. Intended for use by healthcare personnel to confirm sterilization conditions on exterior surface loads.

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

• Castle® SPOR-TEST PA Biological Indicator Kit (K020205)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary Statement (043135

| Date Prepared: | November 8, 2004 |
|---------------------------|-----------------------------------------------------------------------|
| Submitter's Name/Address: | SPSmedical Supply Corp.<br>6789 West Henrietta Road<br>Rush, NY 14543 |
| Contact Person: | Gary J. Socola, Vice President<br>Phone [phone] |
| Trade Name: | SporView® PA Culture Set |
| Classification: | Sterilization Process Indicator - 21 CFR 880.2800 (a) Class I |
| Predicate Device: | Castle® SPOR-TEST PA Biological Indicator Kit (K020205) |

#### Device Description:

Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.

### Intended Use:

The SporView® PA Culture Set is only intended to monitor the STERIS System 1® liquid chemical sterilization system using STERIS® 20 sterilant. The SporViews PA Culture Set was qualified using Spor View" Culture Media. The use of the product is restricted to the Sport Views biological indicator spore strip and media only. When tested at 1,000 ppm peracetic acid, 50 ℃ the Spor View PA Culture Set will survive at 41 seconds and will be killed at 6 aminutes.

## Comparison to the Predicate Device:

- Both devices are exclusively used to monitor the STERIS System 1® peracetic acid . process.
- Both devices are assessed in process conditions of 1000 parts per million peracetic . acid at 50°C.
- Both devices use a paper carrier inoculated with 105 spores of G. stearothermophilus .
- Both devices are processed in the sterilizer when held by a transfer clip. .
- Both devices are open-loop biological indicators that are recovered in tubes of sterile . growth media.
- Both use a growth medium that is modified with a color change indicator. .
- . Both devices may only monitor sterilization efficacy on exterior surfaces loads processed in the STERIS System 1 peracetic acid process.

### Conclusion:

The SporView PA Culture Set is substantially equivalent the Castle® SPOR-TEST PA Biological Indicator Kit for monitoring the STERIS System 19 peracetic acid process.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Public Health Service

JAN 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary J. Socola Vice President, Scientific Affairs SPSmedical Supply Corporation 6789 West Henrietta Road Rush, New York 14543

Re: K043135

Trade/Device Name: SporView® Peracetic Acid Culture Set Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: MRB Dated: December 29, 2004 Received: January 3, 2005

Dear Mr. Scola:

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 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 controls provisions of 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 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 - Mr. Scola

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 vours,

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

{3}------------------------------------------------

#### INDICATIONS for USE STATEMENT

Applicant: SPSmedical Supply Corp.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SporView® Peracetic Acid Culture Set Device Name:

Indications For Use:

The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.

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)

Syute Michie Omd.

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ 4043135

Page 1 of 1