TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE

K965154 · Albert Browne , Ltd. · LRT · Sep 19, 1997 · General Hospital

Device Facts

• Record ID: K965154
• Device Name: TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
• Applicant: Albert Browne , Ltd.
• Product Code: LRT · General Hospital
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2
• Attributes: Expedited Review

Intended Use

The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator designed to indicate, through a yellow to blue color change, when a combination of parameters necessary for sterilization (270°F for 3 minutes) have been achieved.

Device Story

Device is a chemical sterilization process indicator; consists of paper strip with pH-sensitive chemical ink. Used in steam autoclaves to monitor sterilization cycles. Input: exposure to saturated steam at 270°F for 3 minutes. Transformation: chemical reaction triggered by time, temperature, and steam presence; ink changes color from yellow to blue when parameters are met. Output: visual color change on strip. Used by healthcare personnel to verify sterilization conditions. Benefits patient by providing confirmation that sterilization parameters were achieved, ensuring instruments are safe for use.

Clinical Evidence

Bench testing only. Performance evaluated in BIER/Steam vessels per ANSI/AAMI ST45-1992. Testing confirmed color change occurs only upon exposure to saturated steam at 270°F for 3 minutes. Side-by-side testing with biological indicators demonstrated a safety margin for spore kill. Stability testing confirmed color change remains stable for at least 5 years; shelf-life validated at 3 years.

Technological Characteristics

Paper strip with pH-based chemical indicator ink. Color change mechanism is pH-dependent. Dimensions/form factor not specified. Standalone device. No energy source required. Sterilization method: steam autoclave.

Indications for Use

Indicated for use as a steam sterilization process indicator to confirm that sterilization parameters (270°F for 3 minutes) have been achieved in steam autoclaves.

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

• TST Control Integrator for Steam Autoclave (K902958)

Submission Summary (Full Text)

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K965154
Sept. 19, 1997

510(k) SUMMARY
Albert Browne Ltd.
TST Control Integrator for Steam Autoclave

1. SUBMITTED BY
Albert Browne Ltd.
Chancery House
Rosebery Road
Anstey
Leicester LE7 7EL
United Kingdom

CONTACT PERSON
Alan Charlton
Chancery House
Rosebery Road
Anstey
Leicester LE7 7EL
United Kingdom

DATE PREPARED
April 24, 1997

2. DEVICE NAME
TST Control Integrator for Steam Autoclave

CLASSIFICATION NAME
Physical/chemical sterilization process indicator

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# CLASSIFICATION STATUS

Physical/chemical process indicator is classified as class II under Sterilization process indicator in 21 CFR 880.2800 by the General Hospital and Personal Use Devices Panel.

## 3. PREDICATE DEVICES

TST Control Integrator for Steam Autoclave, Albert Browne Ltd.

## 4. INTENDED USE

The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator designed to indicate, through a yellow to blue color change, when a combination of parameters necessary for sterilization (270°F for 3 minutes) have been achieved.

## 5. DEVICE DESCRIPTION

Albert Browne Ltd. received clearance for a TST Control Integrator for Steam Autoclave, K902958, which monitored sterilization cycles with a holding temperature/time combinations of 250°F (121°C)/15 min. The purpose of this submission is to expand the process parameter combinations to include a cycle of 270°F/3 min.

Like the integrator described in K902958, the TST steam integrator discussed in this amendment changes color from yellow to blue when a specific set of process parameters required for steam sterilization to occur have been met. The parameters of the sterilization cycle monitored by the proposed integrator - time, temperature and the presence of steam - are equivalent to those monitored by the integrators described in K902958. Albert Browne Ltd. is amending K902958 in order to increase the combinations of parameters which produce a color change to include additional temperatures. The time-temperature combinations in sterilization cycles which will induce TST Control Integrators to change color from yellow to blue are presented in Table 1.

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Table 1. Performance Characteristics for the TST Control Integrator for Steam Autoclave

| Temperature | Time (minutes) | Presence of Steam | Regulatory Status |
| --- | --- | --- | --- |
| 250°F | 15 | yes | K902958 |
| 270°F | 3 | yes | proposed |

## 6. TECHNOLOGICAL CHARACTERISTICS

The TST steam integrator consists of a paper strip with the chemical indicator ink located on one end. The color change is pH based. The time and temperature required for the color change to occur is precisely controlled through manipulation of the chemical composition of the ink.

## 7. PERFORMANCE TESTING

All performance testing was conducted in a BIER vessel/prototype which conforms to the performance requirements for BIER/Steam vessels described in ANSI/AAMI ST45-1992.

Testing was conducted to evaluate the performance of the strips in partial and full cycles. The data showed that the strips changed color only when exposed to saturated steam for 3 minutes at 270°F, confirming that the integrators will accurately report exposure to those conditions.

Side by side testing was performed with biological indicators. The results showed that the temperature/time required for color change to occur provides wide safety margin over that necessary to kill the spores on a biological indicator, indicating that the conditions required for a color change to occur are sufficient for sterilization.

Additional testing was performed which demonstrated that the color change was stable at least 5 years after exposure. All strips used for testing were all ≥3 years from the date of manufacture, demonstrating that the 3 year expiration date is adequate to ensure accurate, reproducible performance.

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

SEP 19 1997

Cynthia J. M. Nolte, Ph.D.
Associate Consultant
Albert Browne Ltd.
C/O Medical Device Consultants
49 Plain Street
North Attleboro, Massachusetts 02760

Re: K965154
Trade Name: TST Control Integrator For Steam Autoclave
Regulatory Class: II
Product Code: JOJ
Dated: June 25, 1997
Received: June 26, 1997

Dear Dr. Nolte:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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

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Page 2 - Dr. Nolte

through 542 of 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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510(k) Number (if known): K965154

Device Name: TST Control Integrator for Steam Autoclave

Indications For Use:

The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator designed to indicate, through a yellow to blue color change, when a combination of parameters (270°F, 3 min.) necessary for sterilization have been achieved.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chris S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Review
510(k) Number K965154

Prescription Use ☐
(Per 21 CFR 801.109)

OR Over-The-Counter Use ☑

(Optional Format 1-2-96)

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