(205 days)
A&D Medical UT-101 LifeSource Digital Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.
A&D Medical UT-101 LifeSource Digital Ear Thermometer
This is a clearance letter for a digital ear thermometer and lacks the detailed performance study information typically found in a 510(k) summary or premarket approval application. Therefore, most of the requested information cannot be extracted from this document.
Here's what can be provided based on the given text:
1. A table of acceptance criteria and the reported device performance
The provided document (a clearance letter) does not contain a table of acceptance criteria or specific reported device performance data beyond the device's intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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)
This information is not available in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
Given that the device is a simple digital ear thermometer, it is highly unlikely that an MRMC study involving human readers and AI assistance would be relevant or performed. This information is not mentioned in the provided document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Given that the device is a simple digital ear thermometer, it is unlikely to involve complex algorithms that would require a "standalone" performance study in the context of AI or advanced diagnostic imaging. The document does not mention any such study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a thermometer, the "ground truth" for accuracy would typically involve comparison to a highly accurate reference thermometer (e.g., a calibrated laboratory thermometer) across a range of temperatures, rather than expert consensus, pathology, or outcomes data in the medical diagnostic sense. However, the specific type of ground truth used is not detailed in this document.
8. The sample size for the training set
This information is not available in the provided document.
9. How the ground truth for the training set was established
This information is not available in the provided document.
Summary of available information from the document:
- Device Name: A&D Medical UT-101 LifeSource Digital Ear Thermometer
- Intended Use: Intermittent measurement and monitoring of human body temperature by consumers in the home, for use on people of all ages.
- Regulatory Class: II
- Product Code: FLL
- Clearance Status: Substantially equivalent to pre-amendment devices, allowing market entry subject to general controls.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2000
Mr. Jerry Wang Director of Engineering & QA A&D Engineering, Incorporated 1555 McCandless Drive Milpitas, California 95025
Re : K993116 Trade Name: A&D Medical UT-101 LifeSource Digital Ear Thermometer Regulatory Class: II Product Code: FLL Dated: January 31, 2000 Received: February 1, 2000
Dear Mr. Wang:
This letter corrects our substantially equivalent letter of April 12, 2000, regarding the Indication for Use Statement.
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. Wang
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 oc al its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Pastora Casanova ffa.
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): צו 1993 צו (נ
Device Name: A&D Medical UT-101 LifeSource Digital Ear Thermometer
Indications for Use:
A&D Medical UT-101 LifeSource Digital Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Cicceretti
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of General Hospital I 510(k) Number -
Prescription Use _
ог
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Over-The-Counter Use X
(Optional Format 1-2-96)
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.