(62 days)
For intermittent measurement of body temperature in patient of all ages in home environment. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Not Found
This document is a 510(k) clearance letter for a digital thermometer. It does not contain the specific technical details or study results required to construct the table and answer all the questions about acceptance criteria and performance studies. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.
However, I can extract the following information that is present:
- Device Name: NPaC Digital Thermometer Models ET300, ET303, ET350, ET351 ET400, ET403, ET450, ET451 ET500, ET503, ET550, ET551
- Indications for Use: For intermittent measurement of body temperature in patients of all ages in a home environment. The device is reusable and intended for oral, axillary, or rectal temperature measurements.
- Regulatory Class: II
- Product Code: FLL
- Regulation Number: 21 CFR 880.2910 (Clinical Electronic Thermometer)
- 510(k) Number: K031907
Based on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria and performance studies. This type of information is typically found in the 510(k) submission document itself, not in the FDA's clearance letter.
To fully answer your questions, I would need access to the actual 510(k) submission (K031907) which would include the performance data and testing details.
Here's what I can state based only on the provided document, addressing the questions where possible, and noting when information is absent:
1. A table of acceptance criteria and the reported device performance
- Information Absent: This document is a clearance letter, not the performance study itself. It does not contain a table of acceptance criteria or reported device performance metrics (e.g., accuracy, precision). For a digital thermometer, acceptance criteria would typically relate to accuracy (e.g., +/- 0.1°C or 0.2°F within a certain range), stability, and repeatability, as well as safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Absent: The clearance letter does not specify the sample size, data provenance, or the nature of the study (retrospective or prospective) used to support the substantial equivalence.
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)
- Information Absent: This is not relevant for a digital thermometer's performance study, which typically relies on comparison to a traceable reference standard (e.g., a standardized temperature bath or a clinical reference thermometer) rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Absent: Not applicable for a digital thermometer's objective performance testing against a reference standard.
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
- Information Absent: Not applicable. This device is a standalone digital thermometer, not an AI-assisted diagnostic tool that involves human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Present & Indirectly Applicable: While not explicitly detailed, the performance study for a digital thermometer is inherently a "standalone" performance test. The device simply measures and displays temperature. There is no "human-in-the-loop" interpretation of results that would alter its measurement function. The study (which is not detailed here) would have evaluated the accuracy and precision of the device's measurements directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Absent (but inferable for a thermometer): For a digital thermometer, the ground truth would typically be established using a traceable reference standard (e.g., highly accurate laboratory thermometer, calibrated temperature bath, or a clinical reference thermometer) that is significantly more accurate than the device under test. It would not typically involve expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic imaging or clinical decision support systems.
8. The sample size for the training set
- Information Absent: This device is not described as an AI/ML device that requires a training set. Its function is based on physical principles, not learned patterns from data.
9. How the ground truth for the training set was established
- Information Absent: Not applicable, as this device does not use a training set.
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AUG 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Norm Pacific Automation Corporation C/O Mr. Chi-Chu Wu Chen Regulatory Consultant New Century Technology 3F, No.31, Hu-Pin Road #1 Science Base Industrial Park Hsin-Chu, Taiwan, R.O.C. (300)
Re: K031907
Trade/Device Name: NPaC Digital Thermometer Models ET300, ET303, ET350, ET351 ET400, ET403, ET450, ET451 ET500, ET503, ET550, ET551 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 17, 2003 Received: June 20, 2003
Dear Mr. Wu Chen:
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 - Mr. Wu 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 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Suen Runner
Susan Runner, DDS, MA Interim 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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3.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if know)
Device Name: NPaC Digital Thermometer Models ET 300, ET 303, ET 350, ET 351 ET 400, ET 403, ET 450, ET 451 ET 500, ET 503, ET 550, ET 551
Indications for Use: For intermittent measurement of body temperature in patient of all ages in home environment. The device is reusable and intended for oral, axillary or rectal temperature measurements.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
Silvano Lucenti
Infortion Control De
510(k) Number: K031907
§ 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.