(24 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description is also not available, which could potentially contain relevant information.
No
The device is used for measurement of body temperature, which is a diagnostic function, not a therapeutic intervention.
No
Explanation: The device is described as an "intermittent measurement of body temperature," which is a monitoring function, not a diagnostic one. Diagnostic devices typically identify or confirm a medical condition.
Unknown
The provided summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended use mentions "measurement of body temperature," which typically involves a physical sensor, but without a description, it's impossible to confirm.
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 in patients of all ages in home environment." This describes a device that measures a physiological parameter directly from the body (temperature), not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Anatomical Site: The anatomical site is the "Ear," which is a part of the body where the measurement is taken directly.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures body temperature directly, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
For intermittent measurement of body temperature in patients of all ages in home environment.
Product codes
FLL
Device Description
NPaC Multi-Use Ear Thermometers TS, TD, and TN 600 series, Models: TS 600, TS 610, TS 620, TS 630 TS 602, TS 612, TS 622, TS 632 TD 600, TD 610, TD 620, TD 630 TD 602, TD 612, TD 622, TD 632 TN 600, TN 610, TN 620, TN 630 TN 602, TN 612, TN 622, TN 632
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
all ages
Intended User / Care Setting
home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and connection. The figure is positioned to the right of a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2003
Norm Pacific Automation Corporation C/O Dr. Chi-Chu Wu Chen Regulatory Consultant New Century Technology 3F. No 31. Hu-Pin Road # 1 Science Based Industrial Park Hsin-Chu, TAIWAN R.O.C. 300
Re: K030126
Trade/Device Name: NPaC Multi-Use Ear Thermometers TS, TD, and TN 600 series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 11, 2003 Received: January 14, 2002
Dear Dr. 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.
1
Page 2 - Dr. 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 (QS) 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,
Susan Runser
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
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4.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if know)
Device Name: NPaC Multi-Use Ear Thermometers TS, TD, and TN 600 series, Models: TS 600, TS 610, TS 620, TS 630 TS 602, TS 612, TS 622, TS 632 TD 600, TD 610, TD 620, TD 630 TD 602, TD 612, TD 622, TD 632 TN 600, TN 610, TN 620, TN 630 TN 602, TN 612, TN 622, TN 632
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)
Prescription Use
or
Over-The-Counter Use --------
(Per 21 CFR 801.109)
Patricia Cuscenti
vision of Anesthesiology. General Hospital, Infection Control. Dental Devices
510(k) Number:
4-1