(50 days)
The Cardicare Model MT-301C and Model MT-301F digital thermometers are intended for use in the measurement of oral, axillary and rectal body temperature.
The Cardicare Model MT-301F & MT-301C Thermometers are thermometers of standard electrical transducer design, consisting of a sensor tip, connecting probe and display unit. The probe consists of a transducer and supporting plastic case, which houses the connection between the sensor and the circuitry. The display unit houses a 1.55V DC button battery, LCD and push button switch for controlling temperature and alert beeper.
The provided document is a 510(k) summary for a digital electronic thermometer, not a study of an AI-powered medical device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. This document pertains to a traditional medical device (thermometer) and its performance data relate to basic accuracy, precision, and repeatability, which are typically assessed through laboratory testing, not clinical studies with "ground truth" as described for AI or diagnostic imaging.
However, I can provide the available information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy | Confirmed |
| Precision | Confirmed |
| Repeatability | Confirmed |
Note: The document states that the performance data "confirmed accuracy, precision and repeatability measurements specified in labeling." However, the specific quantitative acceptance criteria and the measured values are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The "test set" and "data provenance" as understood in a study for an AI or diagnostic device are not relevant to a standard thermometer's performance testing described here. The performance data refers to "testing" performed in a lab, not a clinical study with patients or data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically established by experts for diagnostic or AI studies is not relevant for the performance testing of a digital thermometer.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for interpretation discrepancies in diagnostic studies, not for the direct measurement results of a thermometer.
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
Not applicable. This is not an AI-powered device, and no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone device (thermometer); the concept of an "algorithm only" performance without human interaction, as understood for AI, does not apply here. Its performance is its standalone performance.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic/AI studies. For a thermometer, the "ground truth" for accuracy would typically be established against a highly calibrated reference thermometer or a standardized temperature source in a laboratory setting. The document only states "accuracy, precision and repeatability measurements specified in labeling" were confirmed.
8. The Sample Size for the Training Set
Not applicable. No training set is involved for this type of device and its performance testing.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is involved.
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OCT 2 2 2003
510(K) SUMMARY- CARDICARE MODEL MT-301F & MT-301C THERMOMETER
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92
| Priority Name:Common/ Usual Name:Classification Name:Legally Marketed Device: | Cardicare Model MT-301F & MT-301CDigital Electronic ThermometerClinical Electronic Thermometer (per 21 CFR 880.2910)Jasun, Model DT-01F, Hangzhou Hua'an Medical & HealthInstruments Company. |
|---|---|
| Device Description: | The Cardicare Model MT-301F & MT-301C Thermometers arethermometers of standard electrical transducer design, consistingof a sensor tip, connecting probe and display unit. The probeconsists of a transducer and supporting plastic case, which housesthe connection between the sensor and the circuitry. The displayunit houses a 1.55V DC button battery, LCD and push buttonswitch for controlling temperature and alert beeper. |
| Intended Use: | The Cardicare MT-301F & MT-301C Thermometers have thesame intended use as the predicate device. It is indicated for use inthe measurement of oral, axillary and rectal temperature. The MT-301F & MT 301C Thermometers are intended for home use by thepatient. |
| TechonoligicalCharacteristic: | The Cardicare MT-301F & MT301-C Thermometers have thesame technological features as the predicate device: The mode ofoperation, physical specifications, operational and biologicalspecifications are identical. |
| Performance Data: | QC Lab by Sejoy Electronics testing, China, performed on theCardicare MT-301F & MT-301C Thermometers confirmedaccuracy, precision and repeatability measurements specified inlabeling. |
| Substantial Equivalence: | The information provided demonstrates that the Cardicare MT-301F & MT-301C Thermometers are substantially equivalent tothe predicate device since the devices have the same intended use, |
Viktoria
principles of operation and technological characteristics.
8/28/03
Contact Person:
Mario D. Manzano
Date Prepared
E-2
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Ms. Mario Manzano Director, Quality Assurance Lumiscope Company, Incorporated 122 Tices Lane East Brunswick, New Jersey 08816
Re: K032714
Trade/Device Name: Digital Fever Thermometer, Oral, Rectal and Axillary Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 13, 2003 Received: October 16, 2003
Dear Mr. Manzano:
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. Manzano
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 Runner
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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Page 1 of 1
510(k) Number (if known): K032714
Device Name: Digital Fever Thermometer, Oral, Rectal and Axillary
Indication For Use:
The Cardicare Model MT-301C and Model MT-301F digital thermometers are intended for use in the measurement of oral, axillary and rectal body temperature.
.
:
Patricia Cucente
(Division Sign-Off Division of Anesthesiology. General Hospital Infection Control, Dental
510(k) Number: K032714
(PLEASE DO NOT WRITE BELW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.