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 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 vellow to blue are presented in Table 1.

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.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The TST Control Integrator for Steam Autoclave is designed to indicate, through a yellow to blue color change, when a combination of parameters (270°F for 3 minutes and the presence of steam) necessary for sterilization have been achieved.",
    "Reported Device Performance": {
      "Exposure in partial cycles": "The strips did NOT change color.",
      "Exposure in full cycles (270°F for 3 minutes, saturated steam)": "The strips changed color (yellow to blue).",
      "Safety margin": "The temperature/time required for color change to occur provides a wide safety margin over that necessary to kill spores on a biological indicator.",
      "Color change stability": "Color change was stable for at least 5 years after exposure.",
      "Expiration date validity": "Testing with strips ≥3 years from manufacture date demonstrated accurate, reproducible performance, confirming the 3-year expiration date is adequate."
    },
    "Table 1: Performance Characteristics for the TST Control Integrator for Steam Autoclave": {
      "Temperature": ["250°F", "270°F"],
      "Time (minutes)": ["15", "3"],
      "Presence of Steam": ["yes", "yes"],
      "Regulatory Status": ["[K902958](https://510k.innolitics.com/search/K902958)", "proposed"]
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document does not explicitly state the sample size used for the test set (number of strips tested). It mentions \"All strips used for testing were all ≥3 years from the date of manufacture,\" implying a prospective-like evaluation of aged product. The country of origin for the data is not specified beyond Albert Browne Ltd. being a UK company and the testing being conducted to U.S. standards (ANSI/AAMI ST45-1992).",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. The ground truth for this device is based on physical/chemical properties and the efficacy of sterilization parameters against biological indicators, not on human expert interpretation of an image or signal. The performance is assessed against established sterilization standards (e.g., biological kill rates, specific temperature/time/steam combinations) rather than expert consensus.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The color change is a direct read-out of a chemical reaction, not subject to individual interpretation requiring adjudication.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is a physical/chemical sterilization process indicator, not an AI-based diagnostic or assistive device that would involve human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, this study is a standalone performance test of the device (integrator) itself. Its function is to perform a specific chemical reaction (color change) based on exposure to sterilization parameters, without human interpretation of complex outputs.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth is established by: \n- **Defined physical parameters:** Specific temperature (270°F), time (3 minutes), and presence of saturated steam, as required for sterilization. \n- **Biological kill rates:** Comparison to biological indicators (BIs) to ensure the conditions for color change provide a wide safety margin beyond what is necessary to kill spores.",
  "8. The sample size for the training set": "Not applicable. This is a physical/chemical device, not an AI/machine learning model that requires a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a physical/chemical device, not an AI/machine learning model that requires a training set."
}

Summary

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K965154
Sept. 19, 1997

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

SUBMITTED BY 1.

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.

INTENDED USE 4.

DEVICE DESCRIPTION న.

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Temperature	Time(minutes)	Presence ofSteam	RegulatoryStatus
250°F	15	yes	K902958
270°F	3	yes	proposed

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

TECHNOLOGICAL CHARACTERISTICS 6.

PERFORMANCE TESTING 7.

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 The data showed that the strips changed color only when exposed to cvcles. 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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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular fashion around the eagle symbol. The logo is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 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 TST Control Integrator For Steam Autoclave Trade Name: Regulatory Class: II JOJ Product Code: 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 use Stated in the enorebars, or as 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ಗಳ 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 In addition, FDA may publish further announcements action. 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 requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Qhin S. Lin

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

(Optional Format 1-2-96)

TST Control Integrator Additional Information - K965154

4/24/97

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Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).