(56 days)
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal.
The provided document is a 510(k) clearance letter for an infrared ear thermometer (Michealth ET 1100/ET 1200). It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or specific performance metrics.
The letter confirms the device's classification, indications for use, and regulatory compliance. It does not include information from the technical submission (which would detail the design, testing, and performance studies).
Therefore, based solely on the provided text, I cannot describe:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a standalone thermometer.
- If a standalone performance (algorithm only without human-in-the-loop) was done: While the thermometer is a "standalone" device, the performance study details are not here.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as it's not an AI/ML algorithm requiring a training set in the modern sense. Performance is typically evaluated against calibrated reference thermometers.
- How the ground truth for the training set was established: Not applicable.
To answer your questions thoroughly, you would need to consult the actual 510(k) submission (e.g., the "traditional 510(k)" or "special 510(k)" documentation) that contains the detailed performance studies, clinical equivalency data, and engineering specifications. This letter is merely the FDA's decision based on reviewing that submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2002
Mr. Yi-Lang Lin Duteck Industrial Company Limited 3F-2. No. 26, 513 Lane Jui-Kuang Road Taipei 114 TAIWAN R.O.C
Re: K021601
Trade/Device Name: Michealth ET 1100/ET 1200 Infrared Ear Thermometer Regulation Number: 880.2910 Regulation Name: Electronic Thermometer (IR) Regulatory Class: II Product Code: FLL Dated: March 4, 2002 Received: May 15, 2002
Dear Mr. Lin:
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.
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
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requirements as set forth in the quality systems (OS) 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy Ulstowski
Timot 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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Page 1 of 1
510(k) Number :
Device Name : MicHealth ET1100/ET1200 Infrared Ear thermometer Indications For Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) OR
Over-The-Counter-Use_x (Optional Format 1-2-96)
Mr. Grant
(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices 510(k) Number_ K 02160/
§ 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.