STERITEC DISPOSABLE BIOLOGICAL TEST PACK

K961721 · Steritec Products Mfg Co, Inc. · FRC · Aug 23, 1996 · General Hospital

Device Facts

• Record ID: K961721
• Device Name: STERITEC DISPOSABLE BIOLOGICAL TEST PACK
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The SteriTec Disposable Biological Test Pack is a steam sterilization monitor designed specifically for biological testing of 121°C (250°F) gravity or 132°C (270°F) pre-vacuum steam sterilizers. The pack consists of a self-contained biological indicator containing B. stearothermophilus spores inside a small package of porous and nonporous materials.

Device Story

Device is a disposable biological test pack for steam sterilizers; contains B. stearothermophilus spores within porous/nonporous materials. Used in hospital settings to verify sterilization cycle efficacy. Operates as a challenge test; mimics performance of standard AAMI 16-towel test pack. Healthcare providers place pack in sterilizer; after cycle, biological indicator is processed to determine if spores were killed. Results confirm whether sterilization conditions were met, ensuring instrument sterility and patient safety.

Clinical Evidence

Bench testing only. Comparative study against AAMI standard test pack in gravity (121°C) and pre-vacuum (132°C) sterilizers. Gravity testing (10-20 min) showed identical survival/kill results at 10, 12, 15, and 20 minutes. Pre-vacuum testing (1-3 min) showed identical survival/kill results at 1, 2, and 3 minutes. No clinical data.

Technological Characteristics

Disposable test pack containing B. stearothermophilus spores; constructed of porous and nonporous materials. Designed to simulate AAMI standard 16-towel pack challenge. No electronic components, software, or external energy source.

Indications for Use

Indicated for biological testing of steam sterilizers, specifically 121°C (250°F) gravity and 132°C (270°F) pre-vacuum cycles, to monitor sterilization 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

• AAMI standard biological test pack (16 surgical towels)

Reference Devices

• AMSCO Model 57CR Type QDS-1024 gravity steam sterilizer
• Amsco Eagle Series pre-vacuum steam sterilizer

Submission Summary (Full Text)

{0}

FROM : SteriTec Prod.
PHONE NO. : 303 660 4213
P03
K961721
3 pages
AUG 23 1996

Steritec Products Mfg. Co., Inc.
Steritec Disposable Biological Test Pack
FDA 510(k) Application

Page 30

# 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 _August 20, 1996 (Revised)_

- **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
Common/Usual Name: Biological Test Pack
Classification Name: Biological
Classification: The SteriTec Disposable Biological Test Pack is a disposable biological test pack for testing steam sterilizers. It falls under the FDA classification of *Indicator, Biological Sterilization Process* in Class II under Classification Number 80FRC, Regulation Number 880.2800.

{1}

FROM : SteriTec Prod.
PHONE NO. : 303 660 4213
P04

Steritec Products Mfg. Co., Inc.
Steritec Disposable Biological Test Pack
FDA 510(k) Application

Page 31

## 510(k) Summary - continued

### Identification of Predicate device:

The SteriTec disposable biological test pack is equivalent in function and operation to the standard AAMI biological test pack which consists of 16 surgical towels measuring 16" x 26" which when folded according to AAMI directions form a 9" x 9" x 6" test pack. A biological indicator is placed in the middle of the AAMI pack which is considered the "Standard" for conducting a biological test in steam sterilizers. The AAMI standard test pack is the predicate device used in this submission.

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

Intended use:

The SteriTec Disposable Biological Test Pack is a steam sterilization monitor designed specifically for biological testing of 121°C (250°F) gravity or 132°C (270°F) pre-vacuum steam sterilizers. The pack consists of a self-contained biological indicator containing *B. stearothermophilus* spores inside a small package of porous and nonporous materials.

Comparison to Predicate devices:

Laboratory testing
Laboratory tests were performed to substantiate and verify that the performance of the submitted SteriTec product performed as described and is equivalent in function to the predicate device.

Two series of tests were performed to show that the SteriTec Disposable Biological Test Pack performed equivalently to the standard AAMI Biological Challenge Test packs.

### Series 1

Gravity Sterilizer 121°C

Sterilization runs were also conducted in a typical hospital gravity sterilizer. The sterilizer used was a AMSCO, Model 57CR, Type QDS-1024 gravity steam sterilizer. Tests were conducted at 10 minutes, 12 minutes, 15 minutes and 20 minutes exposures.

{2}

FROM : SteriTec Prod.
PHONE NO. : 303 660 4213
P05

Steritec Products Mfg. Co., Inc.
Steritec Disposable Biological Test Pack
FDA 510(k) Application

Page 32

## Series 2

### Prevacuum sterilizer at 132 C

Sterilization runs were also conducted in a pre-vacuum sterilizer run at 132 C (270 F). The sterilizer used for this series was a specially constructed laboratory prevacuum steam sterilizer built around an Amsco 20" x 20" x 40" chamber. All runs were done using a typical Amsco Eagle Series cycle consisting of a one minute purge and four prevacuum pulses. Tests were run at one (1) minute, two (2) minutes and three (3) minutes at 132 C.

## Results

### Gravity Sterilizer 121 °C

After 10 minutes exposure, all the biologicals survived both in the AAMI standard pack and the Steritec Disposable Biological test packs. After 12 minutes exposure, both packs experienced partial survivors. After 15 minutes and 20 minutes exposures, all the biologicals were killed in both the AAMI and Steritec test packs.

### Prevacuum Sterilizer 132 °C

After 1 minute and 2 minute exposures, both packs experienced partial survivors. After 3 minute exposure, all the biologicals were killed in both the AAMI and Steritec test packs.

## Conclusion:

The results of this testing show that the SteriTec Disposable Biological Test Packs paralleled the results of the AAMI standard cloth biological test pack.