(50 days)
Not Found
Not Found
No
The device description and performance studies focus on standard electrical transducer design and basic accuracy/precision testing, with no mention of AI/ML terms or data-driven algorithms.
No.
The device is a digital thermometer used for measuring body temperature, which is a diagnostic function, not a therapeutic one.
No
Explanation: The device is a digital thermometer intended for measuring body temperature, which is a physiological parameter, not for diagnosing a disease or condition. While temperature measurement can be a part of a diagnostic process, the device itself is not designed to diagnose.
No
The device description explicitly states it consists of hardware components including a sensor tip, connecting probe, display unit, battery, LCD, and push button switch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure body temperature (oral, axillary, and rectal). 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).
- Device Description: The description details a standard digital thermometer with a sensor, probe, and display. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, etc.)
- Detection of specific substances or markers in samples
- Use in a laboratory setting (though some IVDs are for home use, the core function is sample analysis)
Therefore, the Cardicare Model MT-301C and Model MT-301F digital thermometers are considered medical devices for measuring body temperature, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Cardicare MT-301F & MT-301C Thermometers have the same intended use as the predicate device. It is indicated for use in the measurement of oral, axillary and rectal temperature. The MT-301F & MT 301C Thermometers are intended for home use by the patient.
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, axillary and rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use by the patient
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)
QC Lab by Sejoy Electronics testing, China, performed on the Cardicare MT-301F & MT-301C Thermometers confirmed accuracy, precision and repeatability measurements specified in labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Jasun, Model DT-01F
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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-301C
Digital Electronic Thermometer
Clinical Electronic Thermometer (per 21 CFR 880.2910)
Jasun, Model DT-01F, Hangzhou Hua'an Medical & Health
Instruments Company. |
|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | 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. |
| Intended Use: | The Cardicare MT-301F & MT-301C Thermometers have the
same intended use as the predicate device. It is indicated for use in
the measurement of oral, axillary and rectal temperature. The MT-
301F & MT 301C Thermometers are intended for home use by the
patient. |
| Techonoligical
Characteristic: | The Cardicare MT-301F & MT301-C Thermometers have the
same technological features as the predicate device: The mode of
operation, physical specifications, operational and biological
specifications are identical. |
| Performance Data: | QC Lab by Sejoy Electronics testing, China, performed on the
Cardicare MT-301F & MT-301C Thermometers confirmed
accuracy, precision and repeatability measurements specified in
labeling. |
| Substantial Equivalence: | The information provided demonstrates that the Cardicare MT-
301F & MT-301C Thermometers are substantially equivalent to
the 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
1
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.
2
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
3
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)