(62 days)
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Not Found
No
The summary describes a standard thermometer for temperature measurement and contains no mention of AI, ML, or related concepts.
No
A therapeutic device is used to treat a disease or condition. This device is for "intermittent measurement of body temperature," which is a diagnostic or monitoring function, not a therapeutic one.
No
The device measures body temperature, which is a physiological parameter, but its primary purpose is not to diagnose a disease or condition. It provides information that can be used in a diagnostic process, but it is not a diagnostic device itself.
No
The summary describes a device for measuring body temperature using oral, axillary, or rectal methods. These methods inherently require a physical sensor to interact with the body and measure temperature, indicating a hardware component is necessary. The lack of a "Device Description" section prevents confirmation, but the intended use strongly suggests a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intermittent measurement of body temperature". This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Anatomical Site: The measurements are taken orally, axillary, or rectally, which are all locations on or within the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device measures a physical property (temperature) directly from the body.
N/A
Intended Use / 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.
Product codes
FLL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral, axillary or rectal
Indicated Patient Age Range
all ages
Intended User / Care Setting
Home environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads.
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