(270 days)
No
The device is a chemical indicator that changes color based on time, temperature, and steam exposure, not through computational analysis or learning.
No.
This device is a chemical indicator used to confirm that parameters necessary for steam sterilization have been achieved; it does not directly treat or diagnose a disease or condition in a patient.
No
The device is a chemical indicator used to confirm that specific parameters necessary for sterilization have been achieved, not to diagnose a medical condition in a patient.
No
The device is a physical paper strip with chemical indicator ink, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to indicate when specific parameters for steam sterilization in an autoclave have been achieved. This is a process control for sterilization equipment, not a diagnostic test performed on biological samples.
- Device Description: The device is a chemical indicator strip that changes color based on time, temperature, and the presence of steam. This mechanism is related to monitoring a physical process, not analyzing biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or predicting disease
- Providing information about a patient's health status
- Using imaging modalities for diagnostic purposes
- Having an indicated patient age range or anatomical site
The device is clearly designed to monitor the effectiveness of a sterilization process, which falls under the category of process indicators for medical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
JOJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
Page B-1
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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.
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 న.
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.
Page B-2
2
| Temperature | Time
(minutes) | Presence of
Steam | Regulatory
Status |
|-------------|-------------------|----------------------|----------------------|
| 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.
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.
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.
Page B-3
3
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
4
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
$\gamma$
5
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)
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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