STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS

K981497 · Steritec Products Mfg Co, Inc. · FRC · Oct 29, 1998 · General Hospital

Device Facts

• Record ID: K981497
• Device Name: STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Oct 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60% Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60 minutes.

Device Story

Device is a disposable biological test pack for monitoring ethylene oxide (EO) gas sterilizers. Input consists of exposure to EO gas sterilization cycle conditions (130°F, 45-60% RH, 600 mg/L EO). Device contains a self-contained biological indicator (B. Subtilis spores) housed in a plastic canister with a porous plastic filter cap, enclosed in a paper/plastic peel pouch with a chemical indicator record card. Principle of operation relies on the physical resistance provided by the canister/filter assembly to delay EO gas penetration to the spores, simulating a challenge to the sterilization process. Healthcare providers use the device to verify sterilization efficacy; survivors/death of spores after processing indicate cycle performance. Benefits include confirmation of sterilization process parameters to ensure patient safety from improperly sterilized instruments.

Clinical Evidence

Bench testing only. Performance testing conducted at NAMSA Laboratories compared the SteriTec pack to the predicate device under identical conditions (130°F, 50% RH, 600 mg/L EO). Results: at 15 minutes, 100% survivors for both; at 25 minutes, 100% survivors (SteriTec) vs 86% (predicate); at 35 minutes, 96% survivors (SteriTec) vs 46% (predicate); at 45 minutes, 12% survivors (SteriTec) vs 0% (predicate).

Technological Characteristics

Self-contained biological indicator containing B. Subtilis spores. Components: plastic canister, closure cap with 5-100 micron porous plastic filter, paper/plastic peel pouch, chemical indicator record card. Operates via passive gas diffusion resistance. No electronic components or software.

Indications for Use

Indicated for biological testing of ethylene oxide (EO) gas sterilizers to verify sterilization process efficacy.

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

• ATI Disposable Biological Test Pack for Ethylene Oxide (K895704)

Submission Summary (Full Text)

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Disposable Biological Test Pack for EO Gas 510(k) Premarket Notification SteriTec Products Mfg. Co., Inc.

K981497

OCT 29 1998

# 510(k) SUMMARY

SUBMITTER:

STERITEC PRODUCTS MFG. CO., INC. 680 Atchison Way - Suite 600 Castle Rock, CO. 80104 [phone] [phone] Fax

Establishment Registration Number: 2028456

Date Summary was Prepared April 23, 1998

Date Summary was Revised __ August 3, 1998

TOM ROLL
Printed name of person required to submit 510(k)

Signature of person required to submit 510(k)

PRESIDENT Title of person submitting 510(k)

Proprietary Name: Steritec Disposable Biological Test Pack for EO Gas

Common/ Usual Name: Biological Test Pack

Classification Name: Biological

Classification:

The Steritec Disposable Biological Test pack for EO Gas is a disposable biological test pack for testing ethylene oxide gas sterilizers. It falls under the FDA classification of Indicator, Biological Sterilization Process in Class II under Classification Number 80FRC, Regulation 880.2800.

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Disposable Biological Test Pack for EO Gas 510(k) Premarket Notification SteriTec Products Mfg. Co., Inc.

K98:497

#### 510(k) Summary - continued

#### Identification of Predicate device:

The predicate device is the ATI Disposable Biological Test Pack for Ethylene Oxide, (510(k) # 895704) manufactured and distributed by ATI-PyMaH now owned by 3M Corporation.

### Description of 510(k) submission device:

#### Product Description:

SteriTec Disposable Biological Test Packs for EO Gas consist of a self-contained biological indicator containing B. Subtillis spores, placed inside a plastic canister and is covered with a closure cap containing a 5-100 micron porous plastic filter. This assembly is placed into a paper/plastic peel pouch along with a printed record card containing a chemical indicator.

#### Intended use:

The intended use of this product is for biological testing of EO Gas sterilizers. The performance specification is 130 F, 45% to 60% Relative Humidity, 600 mg/L EO Gas with all survivors at 15 minutes and all killed at 60 minutes.

## -

## Comparison to Predicate Device:

The SteriTec Biological Test Pack for EO Gas and the above named predicate device have the same intended use. Both products are test packs containing a self-contained biological. The predicate device uses the Attest biological made by 3M whereas the SteriTec Test uses the EZTest biological made by SGM Biotech. Both products are offered in a paper/plastic pouch. Both products offer resistance to EO gas through their design....the ATI pack uses a plastic syringe opened on one end to house the biological, the SteriTec Pack uses a plastic canister closed at one end completely and held at the other end by a stopper which contains a porous plastic plug. Both Test Packs are meant to extend the time it takes to kill B. Subtillis spores placed in a Ethylene oxide sterilization process.

## Performance Testing:

The performance tests showed that at 15 minutes exposure to EO Gas at 600 mg/L with Relative Humidity at 50% and temperature at 130 F, all test packs had 100% survivors. At 25 minutes exposure, the ATI Test Packs had 86% survivors while the SteriTec Test Packs had 100% survivors. At 35 minutes exposure, the ATI Test Packs had 46% survivors while the SteriTec Test Packs had 96% survivors. At 45 minutes exposure the ATI Test packs had 0% survivors while the SteriTec test pack had 12% survivors. Based on these test results conducted at NAMSA Laboratories, The SteriTec Disposable Biological Test Pack for EO gas is substantially equivalent to the ATI Disposable Biological Test Pack for Ethylene Oxide, (FDA 510(k) 895704).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1998

Mr. Tom Roll President SteriTec Products Mfg., Co., Incorporated 680 Atchison Way - Suite 600 Castle Rock, Colorado 80104

Re: K981497 SteriTec Disposable Biological Test Pack-EO Trade Name: Gas Requlatory Class: II Product Code: FRC Dated: August 3, 1998 Received: August 5, 1998

Dear Mr. Roll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Roll

This letter will allow you to begin marketing your device as described in your 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 marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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 ene organs or entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K981497

Device Name: SteriTec Disposable Biological Test Pack for Ethylene Oxide Sterilzation

Indications For Use:

The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60% Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60 minutes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

counter ^

(Optional Format 1-2-96)

Qin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number