STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM

K965212 · Steritec Products Mfg Co, Inc. · JOJ · Apr 23, 1998 · General Hospital

Device Facts

• Record ID: K965212
• Device Name: STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Apr 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for the testing of 132 °C. (270 °F) pre-vacuum steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam is used to supplement testing with biological packs. It gives the operator assurance of sterilizer performance between biological tests or while waiting for biological test results during the incubation period.

Device Story

Device is a chemical integrator challenge pack for steam sterilizers; consists of a chemical integrator test sheet enclosed within a package of porous and non-porous materials. Pack provides resistance to steam penetration, simulating a load challenge. Used by operators in clinical settings to monitor sterilizer performance between biological tests. Integrator sheet changes color upon reaching specific time/temperature parameters (e.g., 132 °C for 3-4 minutes). Provides immediate visual feedback to the operator regarding sterilization cycle efficacy; supplements biological indicators to provide interim assurance of sterilizer function.

Clinical Evidence

Bench testing only. Laboratory data confirmed the device provides a sufficient load challenge for 132 °C steam sterilization cycles. Testing evaluated color change endpoints at various temperatures (128 °C, 130 °C, 132 °C) and exposure times to verify performance equivalence to the predicate.

Technological Characteristics

Chemical integrator test sheet enclosed in porous and non-porous packaging materials. Designed to provide resistance to steam penetration. Operates via chemical color-change reaction triggered by specific time/temperature/steam exposure thresholds. Standalone device; no energy source, software, or connectivity.

Indications for Use

Indicated for monitoring sterilization cycles in pre-vacuum steam sterilizers operating at 132 °C for 3 minutes or longer. Used as a supplementary test to biological pack testing.

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 Test Pack for Steam (K952408)

Submission Summary (Full Text)

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K965212

# 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 Revised_ April 14, 1998

- **TOM ROLL**
Printed name of person required to submit 510(k)
*(Handwritten signature: "Tom Roll" with a circle around "510(k)" below it)*

- Signature of person required to submit 510(k)
*(Handwritten signature: "Signature" with a circle around "510(k)" below it)*

- **PRESIDENT**
Title of person submitting 510(k)
*(Handwritten: "President" with a circle around "510(k)" below it)*

---

**Proprietary Name:** SteriTec Chemical Integrator Challenge Pack-Steam
**Common/Usual Name:** Chemical Integrator Pack for Steam Sterilizers
**Classification Name:** Chemical Integrator Pack
**Classification:** “Indicator, Chemical Integrator Sterilization Process” in Class II under Classification Number 80JOJ, Regulation Number 880.2800.

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510(k) Summary - continued

## Identification of Predicate device:

The predicate device is ATI Disposable Test Pack for Steam K952408

## Description of 510(k) submission device:

The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for load testing of steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam consists of a chemical integrator test sheet placed inside a package of porous and non porous material. This pack provides resistance to the penetration of steam during the sterilization cycle.

## Intended use:

The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for the testing of 132 °C. (270 °F) pre-vacuum steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam is used to supplement testing with biological packs. It gives the operator assurance of sterilizer performance between biological tests or while waiting for biological test results during the incubation period.

## Performance Testing:

The laboratory test data showed that the performance of the Steritec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate. In addition, laboratory test data show that the chemical integrator sheet inside the test pack did not change color completely when the SteriTec Chemical Integrator Challenge Pack-Steam was exposed for 1, 2, and 3 minutes at 132 °C. but did change color completely (PASS) between 3 and 4 minutes. At 130 °C. it did not change when exposed for 1, 2, 3, or 4 minutes but did change between 4 and 5 minutes. At 128 °C. it did not change when exposed for 1, 2, 3, 4, and 5 minutes but did change between 5 and 6 minutes.

## Conclusion:

Results of performance testing indicate that the SteriTec Chemical Integrator Challenge Pack-Steam, provides a sufficient load challenge to monitor steam sterilization cycles at 132 °C for 3 minutes or longer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

APR 23 1998

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

Re: K965212
Trade Name: SteriTec Chemical Integrator Challenge Pack-Steam
Regulatory Class: II
Product Code: JOJ
Dated: January 28, 1998
Received: January 29, 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 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 (Premarket Approval), 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 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Roll

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 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" (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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FROM : SteriTec Prod.
PHONE NO. : 303 660 4213
P02

Page 1 of 1

510(k) Number (if known): K965212

Device Name: SteriTec Chemical Integrator Challenge Pack-Steam

Indications For Use:

The SteriTec Chemical Integrator Challenge Pack-Steam is designed to be used to monitor sterilization cycles in pre-vacuum steam sterilizers operating at 132 °C for 3 minutes or longer. It is to be used as a supplementary test to biological pack testing, not as a substitute.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K 965212

Prescription Use
(Per 21 CFR 801.109)

OR

Over The-Counter Use ☐
(Optional Format 1-2-96)