(174 days)
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Clinical Electronic Thermometer
The provided text concerns an FDA 510(k) clearance for a "Clinical Electronic Thermometer" (K982140). The documents focus on the regulatory approval process and indications for use, rather than a detailed study description of acceptance criteria and device performance. Therefore, I cannot extract the specific information requested in your prompt based on the provided text.
The text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication method for the test set.
- Information on any multi-reader multi-case (MRMC) comparative effectiveness study.
- Details about a standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document is a letter from the FDA to Valeo Corporation granting 510(k) clearance for their Clinical Electronic Thermometer, indicating it is "substantially equivalent" to legally marketed predicate devices. The "Indications for Use" document specifies the purpose of the device (measures body temperature via a sensor, amplification, and digital display, reusable, intended for oral, axillary, or rectal measurements).
To provide the requested information, you would need a clinical study report or a detailed 510(k) summary that includes performance data and validation methodology for the device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 8 1998
Valeo Corporation C/O Mr. Phil Zulueta Z7 International 26792 Via Alcala Mission Viejo, California 92691-3432
K982140 Re : Clinical Electronic Thermometers Trade Name: Requlatory Class: II Product Code: ELL September 21, Dated: 1998 September 28, 1998 Received:
Dear Mr. Zulueta:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Paqe 2 - Mr. Zulueta
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
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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2 Statement of Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name:_ Clinical Electronic Thermometer
Indications for Use:
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Palazzo Cucorete
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K982140
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Z7 International
"Serving the Electronics Industry"
§ 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.