STERITEC INTEGRAPH MODEL CI-101

K960441 · Steritec Products Mfg Co, Inc. · JOJ · May 8, 1997 · General Hospital

Device Facts

• Record ID: K960441
• Device Name: STERITEC INTEGRAPH MODEL CI-101
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: May 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Steritec Integraph is designed to provide an integrated response to steam sterilization at 132 C for sterilizers operating for 3 ½ minutes or longer.

Device Story

Chemical indicator/integrator for steam sterilization monitoring; used in sterilizer chambers. Device consists of indicator strip that changes color from purple to green upon exposure to specified steam sterilization conditions (132 C for ≥3.5 minutes). Provides integrated response to sterilization parameters; serves as visual confirmation of cycle completion. Used by healthcare personnel to verify sterilization efficacy; provides margin of safety by ensuring no 'PASS' result occurs if biological spore survivors are present. Validated against biological indicators.

Clinical Evidence

Bench testing only. Performance validated against biological spore strips across multiple sterilization temperatures and times. Stability testing conducted under high temperature, high humidity, and long-term storage (up to 2.5 years). Results showed no false 'PASS' indications; device consistently correlated with biological indicator results.

Technological Characteristics

Chemical sterilization indicator/integrator. Color-changing chemistry (purple to green) responsive to steam sterilization parameters (132 C, ≥3.5 minutes). Form factor: indicator strip. Stable under high heat and humidity.

Indications for Use

Indicated for use as a chemical sterilization indicator/integrator to monitor steam sterilization cycles at 132 C for 3.5 minutes 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

• ATI Steam Clox

Submission Summary (Full Text)

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K960441

SteriTec Products Mfg. Co., Inc.
Steritec Integraph Integrators
FDA 510(k) Application-K960441
Original Submission-January 24, 1996
Current Date-May 2, 1997

510(k) SUMMARY

MAY - 8 1997

# 510(k) PREMARKET NOTIFICATION SUMMARY

510(k) Premarket Notification Summary

## SUBMITTER:

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

- Establishment Registration Number: 2028456

- Date: May 2, 1997

- **TOM ROLL**
Printed name of person required to submit 510(k)
[Handwritten signature]

- Signature of person required to submit 510(k)

- **PRESIDENT**
Title of person submitting 510(k)

Proprietary Name: Integraph

Common/Usual Name: Steam Sterilization Indicator/Integrator

Classification Name: Sterilization Indicator

Classification:

FDA has classified Physical/Chemical Sterilization Indicators in Class II under Classification Number 80JOJ, Regulation Number 880.2800.

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FROM : SteriTec Prod.
PHONE NO. : 303 660 4213
P03

SteriTec Products Mfg. Co., Inc.
Steritec Integraph Integrators
FDA 510(k) Application-K960441
Original Submission-January 24, 1996
Current Date-May 2, 1997
510(k) SUMMARY

## Identification of Predicate devices

The Steritec Integraph CI 101 is a chemical indicator/integrator equivalent in construction and operation to the ATI Steam Clox (predicate device). Since the Steritec Integraph is equivalent in construction to the predicate device, it will perform equivalently.

## Description of 510(k) submission device:

### Intended use:

The Steritec Integraph is designed to provide an integrated response to steam sterilization at 132 C for sterilizers operating for 3 ½ minutes or longer.

### Comparison to Predicate device:

Compared to the predicate device our performance data shows the Integraph Integrator to be substantially equivalent.

## Performance Testing:

To demonstrate the performance of the SteriTec Integraph the product was tested:

1. At multiple sterilization temperatures and times against biological indicators.
2. For stability after storage in high temperature conditions.
3. For stability after storage in high humidity conditions.
4. For stability after storage for two and one half years.
5. For stability after being sterilized and then stored for two years.

## No false "PASS" Indications

In all cases they indicated properly whether the sterilization conditions had been met or not in the sterilizer chamber as verified by biological spore strips. There were NO instances in which the SteriTec strips indicated that sterilization conditions were met when they were not (NO FALSE PASS RESULTS).

## Margin of Safety

Test results show the SteriTec strips provide a "margin of safety". During these tests, No SteriTec strip tested provided a "PASS" test result in tests when there were any biological spore survivors.

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SteriTec Products Mfg. Co., Inc.
Steritec Integraph Integrators
FDA 510(k) Application-K960441
Original Submission-January 24, 1996
Current Date-May 2, 1997

510(k) SUMMARY

were any biological spore survivors.

## Stability Testing:

Independent laboratory testing showed the SteriTec Integraph is stable after being subjected to extremes of heat and high humidity. In addition, under room temperature storage of both exposed and unexposed strips for 2 years the strips also performed satisfactorily. All strips maintained their purple color after storage testing. After exposure to sterilization conditions, the indicators properly changed color from purple to green.