(79 days)
For intermittent measurement of body temperature in patients of all ages in home environment
Not Found
The provided document is a 510(k) clearance letter from the FDA for a clinical electronic thermometer. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested.
The document states that the device is a "NPAC Multi-Use Ear Thermometer, Models TP 700, TP 702" and its indications for use are "For intermittent measurement of body temperature in patients of all ages in home environment."
To answer the questions about acceptance criteria and a study, one would typically need access to the 510(k) submission document itself, which would detail the performance data and the comparison to a predicate device. This letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, none of the requested information (acceptance criteria table, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, or ground truth establishment for training set) can be extracted from the provided text.
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Public Health Service
SEP 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Norm Pacific Automation Corporation C/O Dr. Chi-Chu Wu Chen Regulatory Consultant New Century Technology 3F, No. 31, Hu-Pin Road #1 SBIP, HSIN-CHU TAIWAN
Re: K051835
Trade/Device Name: NPAC Multi-Use Ear Thermometer, Models TP 700, TP 702 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 26, 2005 Received: September 1, 2005
Dear Dr. Chi-Chu 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 – Dr. Chi-Chu 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 vour 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely vours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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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Letter to Mr. Chapman Special 510(k) K051835
Exhibit #1
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: NPaC Multi-Use Ear Thermometers TP700 series Models TP700, TP702
Indications For Use: For intermittent measurement of body temperature in patients of all ages in home environment
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton D. mwe
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number:__
§ 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.