STERITEC DRY HEAT INDICATOR LABEL

K953122 · Steritec Products Mfg Co, Inc. · JOJ · Apr 2, 1997 · General Hospital

Device Facts

• Record ID: K953122
• Device Name: STERITEC DRY HEAT INDICATOR LABEL
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

SteriTec Dry Heat Indicator Labels are designed to be utilized in dry heat (hot air) sterilizers operating at 160 C. The label provides clear identification of processed versus unprocessed items.

Device Story

Chemical process indicator label; monitors dry heat sterilization cycles. Input: exposure to 160 C dry heat environment. Transformation: chemical color change from green to dark brown/black. Output: visual indicator on label surface. Used in clinical/hospital settings; operated by sterilization technicians. Provides immediate visual confirmation of cycle exposure; assists in inventory management of sterile goods; prevents use of non-processed items.

Clinical Evidence

Bench testing only. Performance testing confirmed color change from green to dark brown/black in less than 10 minutes at 160 C.

Technological Characteristics

Chemical process indicator label; color-changing ink formulation; designed for 160 C dry heat sterilization; standalone physical indicator.

Indications for Use

Indicated for use in dry heat (hot air) sterilizers operating at 160 C to distinguish between processed and unprocessed items.

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 Dry Heat Indicator Labels (ATI Division of PyMah Corporation)

Submission Summary (Full Text)

{0}

APR - 2 1997
K953122
SteriTec Products Mfg. Co., Inc.
SteriTec Dry Heat Indicator Label

# 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

- Original Date Summary was Prepared May 15, 1995
Date of this submission February 12, 1997

- **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 Dry Heat Indicator Label
Common/Usual Name: Dry Heat Sterilization Process Indicator
Classification Name: Process Indicator
Classification:

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

{1}

SteriTec Products Mfg. Co., Inc.
SteriTec Dry Heat Indicator Label

# 510(k) Summary - continued

## Identification of Predicate device:

The SteriTec Dry Heat Indicator Label is a sterilization process indicator label product and is similar in design, composition and function to the:

ATI Dry Heat Indicator Labels
ATI Division of PyMah Corporation
89 Rt. 206, P.O. Box 1114
Somerville, NJ 08876
[phone] [phone]

## Description of Steritec Dry Heat Indicator Label:

SteriTec Dry Heat Indicator Labels are process indicators that turn color from green to dark brown/black during dry heat processing at 160 C. The labels will usually complete their color change in less than 10 minutes at this temperature.

### Intended use:

SteriTec Dry Heat Indicator Labels are designed to be utilized in dry heat (hot air) sterilizers operating at 160 C. The label provides clear identification of processed versus unprocessed items.

### Comparison to Predicate devices:

Tests substantiated that the Steritec Dry Heat Indicator Label performed safely and effectively as described and is equivalent to the predicate device.