SPSMEDICAL SPORVIEW STEAM BI TEST PACK

K022706 · Spsmedical Supply Corp. · FRC · Oct 25, 2002 · General Hospital

Device Facts

• Record ID: K022706
• Device Name: SPSMEDICAL SPORVIEW STEAM BI TEST PACK
• Applicant: Spsmedical Supply Corp.
• Product Code: FRC · General Hospital
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer and can be used in conjunction with a integrator test pack.

Device Story

SPSmedical SporView® Steam BI Test Pack consists of a self-contained biological indicator (containing Geobacillus stearothermophilus spores) enclosed within a package of porous and non-porous materials. Device functions as a challenge pack to monitor steam sterilization efficacy by creating resistance to air removal and steam penetration. Used in healthcare settings to verify sterilization cycle performance. Healthcare providers place the pack in the sterilizer load; after the cycle, the biological indicator is retrieved and processed to determine if sterilization conditions were met. Provides a significant challenge to the sterilization process, ensuring reliable monitoring of gravity displacement and prevacuum steam cycles.

Clinical Evidence

Bench testing only. 210 sterilization tests were conducted comparing the subject device to the AAMI biological indicator test pack. Testing included 60 failure comparison tests, 90 pass/failure comparison tests, and 60 passing result tests. Results showed the subject device consistently provided performance comparable to the AAMI biological indicator test pack.

Technological Characteristics

Biological indicator test pack containing Geobacillus stearothermophilus spores. Constructed of porous and non-porous materials designed to impede steam penetration and air removal. Single-use device. No electronic components or software.

Indications for Use

Indicated for routine and challenge testing of steam gravity displacement sterilization cycles (121°C/250°F for 30 min) and prevacuum steam sterilization cycles (132°C/270°F for 4 min or longer).

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

• StenTec Biological Indicator Test Pack (K001444)

Reference Devices

• AAMI biological indicator test pack

Submission Summary (Full Text)

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

# OCT 2 5 2002

K022706

## 510(k) Summary of Safety and Effectiveness

## Submitter:

- . SPSmedical Supply Corp. 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: [phone] Fax: [phone]
- Establishment FDA Registration No .: 1319130 .
- Date Summary was Prepared October 21, 2002 .
- Gary J. Socola . Printed name of person submitting for 510(k) seen in
- Signature of person submitting for 510(k)
- Director of Quality Assurance . Title of person submitting for 510(k)

### Device Name and Classification

| Trade Name: | SPSmedical SporView® Steam Bl Test Pack |
|------------------------|--------------------------------------------------|
| Classification Name: | Biological Indicator |
| Common Name: | Biological Test Pack |
| Device Classification: | Class II, Regulation Number 880.2800 |
| Product Code: | 80FRC |
| Predicate Device: | StenTec Biological Indicator Test Pack (K001444) |

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

#### Device Description:

The SPSmedical SporView® Steam Bl Test Pack consists of a SporView® steam biological indicator placed inside a package of porous and non-porous material. The SPSmedical SporVlew® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration.

#### Intended Use:

The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer and can be used in conjunction with a integrator test pack.

#### Technical Characteristics:

The SPSmedical SporView® Steam Bl Test Pack has the same intended use and technological characteristics as the AAMI biological indicator test pack and other commercially available test packs. The SPSmedical SporView® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration. The SPSmedical SporView® Steam Bl Test Pack adds resistance and impedes steam penetration to the SporViews steam biological indicator located within the pack. This provides a significant challenge to the steam sterilization process.

#### Non-Clinical Testing:

Two hundred ten (210) sterilization tests were nun to compare performance standards/results of the SPSmedical SportView® Steam Bl Test Pack to the AAMI biological indicator test pack. A SporView® self-contained biological indicator containing Geobacillus stearothermophilus spores was used within the AAMI biological indicator test. Of the two hundred and ten stedlization tasts that were run: 60 comparison tests for failures were orchestrated, 90 comparison tests for passifallures were orchestrated and 60 tests for passing results were orchestrated. The pass and failure stenilization testing of SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack.

#### Conclusion:

Supportive data has demonstrated that the SPSmedical SporView® Steam Bl Pack is equivalent to the predicate device. Results of performance testing indicate that the SPSmedical SporView @ Steam Bl Pack provides a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer. The SPSmedical SporViews Steam Bl Pack is an effective and reliable, single use device.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

od and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 5 2002

Mr. Gary J. Socola Director of QA & Sterilization Projects SPS Medical Supply Corporation 6789 West Henrietta Road Rush. New York 14543

Re: K022706

Trade/Device Name: Sporview® Steam BI Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: August 6, 2002 Received: August 14, 2002

Dear Mr. Socola:

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.

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.

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

Page 2 .- Mr. Socola

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulbrich

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## INDICATIONS for USE STATEME

SPSmedical Supply Corp. Applicant:

510(k) Number (if known): _ K022706

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Ure:

The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and provacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.

(Pl.Ease DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Qitin S-Lin

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

510(k) Number. K022706