(26 days)
For intermittent measurement of body temperature in patients of all ages in home environment.
NPaC Ear Thermometer TD402
This looks like a 510(k) clearance letter for an ear thermometer, not a study report. Therefore, much of the requested information about acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not typically found in this type of document.
However, I can extract the information that is present and explain why other requested details are absent.
Here's the breakdown based only on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance in the manner typically seen for algorithmic or diagnostic device studies (e.g., sensitivity, specificity, AUC).
For thermometers, acceptance criteria often relate to accuracy (e.g., ±0.2°C) when compared to a reference standard (like a rectal thermometer or oral thermometer) across a range of temperatures. The presented document is a regulatory clearance letter, not the study report itself.
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. The 510(k) clearance letter does not describe the specific performance testing conducted or its details.
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 applicable and not available for a simple ear thermometer. Temperature measurement does not typically involve expert interpretation for ground truth establishment; it's usually a direct comparison to a validated reference device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not available for an ear thermometer. Adjudication methods are relevant when expert interpretation can vary and a consensus is needed (e.g., image interpretation).
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
This information is not applicable and not available. An ear thermometer is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself, the "NpaC Ear Thermometer Model #TD402", is a standalone device. Its performance is measured directly by whether it accurately reports temperature, not in conjunction with human interpretation or an algorithm in the AI sense. The 510(k) clearance process inherently relies on the device performing its intended function accurately and safely in a standalone manner. The details of how that performance was assessed are not in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The exact type of ground truth is not specified in this document. However, for a thermometer, the ground truth for temperature measurement would typically be established by a primary reference thermometer (e.g., a calibrated mercury thermometer, a high-accuracy rectal thermometer, or an oral thermometer) that is considered a gold standard for body temperature.
8. The sample size for the training set
This information is not available and not applicable in the context of an ear thermometer. Training sets are relevant for machine learning algorithms. An ear thermometer relies on physical principles of infrared detection and conversion, not a learned model from a training set.
9. How the ground truth for the training set was established
This information is not available and not applicable for the same reasons as point 8.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
JAN 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Norm Pacific Automation Corporation C/O Mr. Chi-Chu Wu Chen New Century Technology 3F, No. 31, Hu-Pin Road #1 Sbip Hsin-Chu, CHINA (TAIWAN)
Re: K011704
Trade/Device Name: NpaC Ear Thermometer Model #TD402 Regulation Number: 880.2910 Regulatory Class: II Product Code: FLL Dated: May 28, 2001 Received: June 1, 2001
Dear Mr. Chen:
This letter corrects our substantially equivalent letter of June 27, 2001 regarding the trade name.
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). 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 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 - Mr. Chen
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 (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 continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Patricia Cucentoffer
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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4.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if know)
NPaC Ear Thermometer TD402 Device Name
For intermittent measurement of body temperature in Indications for Use: patients of all ages in home environment.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use __ (Per 21 CFR 801.109)
に、 Over-The-Counter Use
Peter Schmidt
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 011704 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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§ 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.