(216 days)
The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.
The proposed Verify® Dry Heat Label consists of indicator ink applied to a substrate using a rotary screen printing method. When exposed to dry heat in the temperature range of 160°C to 180°C the indicator ink changes color from amber to black. The indicator is not intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a dry heat process.
The provided text describes a Verify® Dry Heat Label which is a chemical indicator for dry heat sterilization. Based on the information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C. | The Verify® Dry Heat Label undergoes a visual color change from amber to black when exposed to dry heat in the temperature range of 160°C to 180°C. |
| Conformance to ANSI/AAMI ST60: Applied to Class I process indicators for dry heat sterilization. | "Albert Browne Ltd. has performed testing which demonstrates that the Verify® Dry Heat Label conforms to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for dry heat sterilization." |
| Performance in Dry Heat Sterilization Cycles: As designed in the range of 160°C to 180°C. | "Additional testing showed that the indicator performed as designed in dry heat sterilization cycles in the range of 160°C to 180°C." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance. It only states that "Albert Browne Ltd. has performed testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the device (a chemical indicator with a clear color change) suggests that expert interpretation in the traditional sense (e.g., radiologists for medical images) might not be directly applicable for its primary function. However, the interpretation of "conforms to ANSI/AAMI ST60" would imply expert knowledge of the standard.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was mentioned. This type of study is more common for diagnostic devices where human interpretation is a critical variable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a physical chemical indicator, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. Its performance is inherent in its chemical reaction.
7. The Type of Ground Truth Used
The ground truth used for this device's performance is based on:
- Physical/Chemical Reaction: The color change of the indicator ink when exposed to specific temperatures.
- Conformance to Industry Standards: Meeting the requirements outlined in ANSI/AAMI ST60 for Class I process indicators for dry heat sterilization.
- Empirical Observation: The visual change from amber to black.
8. The Sample Size for the Training Set
This device is a chemical indicator, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is not applicable.
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510(k) Summary for
Verify® Dry Heat Label
1. SUBMITTER NAME AND ADDRESS
JUL 1 8 2006
Richard Bancroft Albert Browne Ltd., a Subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
Contact: Richard Bancroft Telephone number: 44 116 276 8636
Date Prepared: March 21, 2006
2. DEVICE NAME
| Proprietary Name: | Verify® Dry Heat Label |
|---|---|
| Common/Usual Name: | Chemical indicator |
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
3. PREDICATE DEVICES
- Dry Heat Sterilization Indicator Tape (SPS Medical Supply Corp., K890758) .
4. INTENDED USE
The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.
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న. DEVICE DESCRIPTION
The proposed Verify® Dry Heat Label consists of indicator ink applied to a substrate using a rotary screen printing method. When exposed to dry heat in the temperature range of 160°C to 180°C the indicator ink changes color from amber to black. The indicator is not intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a dry heat process.
6. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Verify® Dry Heat Label indicator and the predicate device are similar. Both the proposed and predicate devices consist of indicator ink applied to a substrate that can be applied to packaged goods prior to dry heat sterilization.
7. PERFORMANCE TESTING
Albert Browne Ltd. has performed testing which demonstrates that the Verify® Dry Heat Label conforms to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for dry heat sterilization. Additional testing showed that the indicator performed as designed in dry heat sterilization cycles in the range of 160°C to 180°C.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2006
Albert Browne Limited C/O Ms. Cynthia J.M. Nolte Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K053479
Trade/Device Name: Verify® Dry Heat Label Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: July 3, 2006 Received: July 3, 2006
Dear Ms. Nolte:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Nolte
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Li Lu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: VERIFY® Dry Heat Label
Indications for Use:
The Verify® Dry Heat Label is a process indicator that undergoes a visual color The Venty - Dry Heat Labor is a process manufacts.
change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ × (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shala M. Mingleur, 40 7/18/04
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In of Anesthesiology, General Hospital,
In of Anesthesiology, General Devices Devices in of Ambol, Dental Number
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§ 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).