(228 days)
Not Found
No
The device description details a simple electronic circuit that converts temperature changes to frequency changes, which is a standard method for digital thermometers and does not involve AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is a digital thermometer, intended for measuring body temperature. It does not provide any therapeutic effect or treatment.
Yes
The device is described as "intended to measure the human body temperature," which is a diagnostic purpose to identify or monitor a condition (fever).
No
The device description explicitly details hardware components (thermistor, R-C oscillator circuit) and their function in measuring temperature, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described digital thermometers measure human body temperature directly, not by analyzing a sample taken from the body. They are external measurement devices.
- Intended Use: The intended use is to measure body temperature orally, rectally, or under the arm, which are direct measurements on the body.
Therefore, the function and intended use of these digital thermometers do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The model MT series digital thermometers (MT-201, 301, 402 and 403) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages.
The device model MT-405 is intended to measure oral temperature only. It is reusable for clinical or home use for children under the age of four.
Product codes
21 CFR 880.2910
Device Description
Digital Thermometer Model MT series (MT-201, MT-301, MT-402, MT-403 and MT-405) enable fast and reliable measurements. These thermometers provide very high clinical accuracy, and have been designed to provide maximum userfriendliness.
The basic principle of these thermometers is that a change of thermistor resistance, caused by changes of temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of the oscillator.
For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally or under the arm (for MT-201, MT-301, MT-402, MT-403); oral (for MT-405)
Indicated Patient Age Range
People of all ages (for MT-201, MT-301, MT-402, MT-403); children under the age of four (for MT-405)
Intended User / Care Setting
clinical or home use
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)
Controlled human clinical studies were conducted using the digital thermometer model MI series. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline.
Compliance to applicable voluntary standards includes ASTM E I 112, as well as IEC60601-1 and IEC60601-1-2 requirements. Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
MAY - 4 2007
18/300/1800
្រះ
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
The assigned 510(k) number is: ___________________________
l. Submitter's Identification:
Name: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD Address: 4th Floor, B2 Building, Feng-Tan-Lu Industrial Zone, West Lake District, Hangzhou, P. R. China
2. Name of the Device:
| Digital thermometer Model MT Series | |
|---|---|
| Including: Digital Thermometer | MT-201 |
| Basal Digital Thermometer | MT-301 |
| Flexible Digital Thermometer | MT-402 |
| Instant Flexible Thermometer | MT-403 |
| Pacifier Thermometer | MT-405 |
3. Predicate Device Information:
For submitted devices MT-201 and MT-301: * BD DIGITAL THERMOMETER 510(k) number: K945427 Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYIC Owner: BECTON, DICKINSON & CO.
For submitted devices MT-402 and MT-403:
- BD FLEXIBLE DIGITAL THERMOMETER 510(k) number: K902624 Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYIC Owner: BECTON, DICKINSON & CO.
For submitted device MT-405:
- Digital Pacifier Thermometer Model NT-01
510(k) number: K041694
Applicant: Hangzhou Hua'an Medical & Health Instrument Company Limited Owner: Hangzhou Hua'an Medical & Health Instrument Company Limited
1
4. Device Description:
Digital Thermometer Model MT series (MT-201, MT-301, MT-402, MT-403 and MT-405) enable fast and reliable measurements. These thermometers provide very high clinical accuracy, and have been designed to provide maximum userfriendliness.
The basic principle of these thermometers is that a change of thermistor resistance, caused by changes of temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of the oscillator.
For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
5. Intended Use:
The devices Model MT series (MT-201, MT-402, and MT-403) are intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the devices are reusable for clinical or home use on people of all ages. The device model MT-405 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old.
6. Comparison to Predicate Devices:
The device models MT-201, MT-301 are similar in design and intended use to the BD DIGITAL THERMOMETER, BECTON, DICKINSON & CO., differing only in physical dimensions, display resolution, battery replacement method.
The device models MT-402, MT-403 are similar in design and intended use to the BD FLEXIBLE DIGITAL THERMOMETER, BECTON, DICKINSON & CO., differing only in physical dimensions, display resolution, battery replacement method.
The device model MT-405 Pacifier Thermometer is similar in design and intended use to the Digital Pacifier Thermometer Model NT-01, Hangzhou Hua'an Medical & Health Instrument Company Limited, differing only in physical dimensions, battery replacement method.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E I 112, as well as IEC60601-1 and IEC60601-1-2 requirements. Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers.
2
8. Discussion of Clinical Tests Performed:
Controlled human clinical studies were conducted using the digital thermometer model MI series. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline.
9. Conclusions:
The digital thermometer model MT series, Model MT-201 and MT-301 have the same intended use and similar technological characteristics as the BD DIGITAL THERMOMETER.
The Model MT-402 and MT-403 have the same intended use and similar technological characteristics as the BD FLEXIBLE DIGITAL THERMOMETER.
Pacifier Thermometer MT-405 has the same intended use and similar technological characteristics as the Hua'an Medical & Health Instrument Co. LTD's Digital Pacifier Thermometer Model NT-01.
Moreover, information contained in this submission demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Digital Thermometer Model MT Series Thermometers are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sejoy Electronics & Instruments Company Limited C/O Mr. Paul Ware President PW Resources, Incorporated 34 McNamara Street Stoughton, Massachusetts 02072
- 4 2007 MAY
Re: K062784
Trade/Device Name: Digital Thermometer Model MT Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Dated: May 4, 2007 Received: May 4, 2007
Dear Mr. Ware:
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.
4
Page 2 - Mr. Ware
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Runne
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
5
Indications for Use
510(k) Number (if known):
Device Name: Digital Thermometer Model MT series Indications For Use:
The model MT series digital thermometers (MT-201, 301, 402 and 403) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages.
The device model MT-405 is intended to measure oral temperature only. It is reusable for clinical or home use for children under the age of four.
Prescription Use AND/OR Over-The-Counter Use V (Part 21 CFR 801 Subpart D) (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)
Susa Bunne
esthesiology, General Hospital, trol, Dental Devices
Page 8 of 45