(228 days)
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.
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.
This document describes the Sejoy Electronics & Instruments Co., LTD Digital Thermometer Model MT Series. The provided text, however, is a 510(k) summary for regulatory clearance and does not contain the detailed acceptance criteria or the specific study results in the format requested. While it mentions clinical studies were conducted, it does not provide the quantitative data needed to complete the table or answer all of your specific questions.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated, but implied by regulatory compliance) | Reported Device Performance (Implied by regulatory clearance and substantial equivalence) |
|---|---|
| Compliance with ASTM E 1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Implicitly met, as stated in "Discussion of Non-Clinical Tests Performed" |
| Compliance with IEC60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Implicitly met, as stated in "Discussion of Non-Clinical Tests Performed" |
| Compliance with IEC60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests) | Implicitly met, as stated in "Discussion of Non-Clinical Tests Performed" |
| Clinical accuracy (bias, uncertainty, repeatability) | Evaluated using a "Sejoy Clinical Test Protocol outline" (Specific quantitative results not provided) |
| Substantial equivalence to predicate devices in intended use and technological characteristics | Determined by FDA, as evidenced by 510(k) clearance |
Detailed Study Information (Based on the provided text, much of this is not available):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Controlled human clinical studies were conducted using the digital thermometer model MI series."
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The specific method for establishing "ground truth" (e.g., how the reference temperature was obtained in the clinical studies) is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 device is a digital thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or "AI assistance" is not relevant to its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense for an AI algorithm. The device is the "standalone" measurement tool. The "performance" being evaluated is the accuracy of the thermometer itself, not an algorithm's interpretation of data for human review.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For clinical thermometers, the ground truth is typically established by extremely accurate reference thermometers or highly controlled temperature environments calibrated against international standards. The document mentions "clinical bias, clinical uncertainty and clinical repeatability," which implies comparison against a reference standard, but the specific type of ground truth (e.g., calibrated reference thermometer readings) is not explicitly detailed.
8. The sample size for the training set
- Not applicable in the context of machine learning model training. This device is a hardware-based digital thermometer, not an AI model that undergoes training.
9. How the ground truth for the training set was established
- Not applicable as there is no "training set" in the context of an AI model for this device. The device's calibration and accuracy are established through engineering design, manufacturing processes, and testing against known temperature standards.
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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
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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.
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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.
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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.
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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
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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
§ 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.