(65 days)
This device is an electronic clinical thermometer using a themistor probe sensor to detect oral, rectal or axillary temperatures. It is intended for home use on people of all ages.
The 9 second Digital Thermometer is designed to measure body temperature. The device is measuring oral, rectal or axillary temperatures by change of resistance in a thermistor located in the tip of the device. When the probe, particular the metal tip is in contact with the body, the thermistor in the probe will generate equivalent electrical resistance, which will be processed by a micro computer chip in the circuitry and then displayed.
This document describes a 510(k) submission for the 9 second Digital Thermometer, Model BT-S09 by Media Trade Corporation. The submission declares substantial equivalence to the predicate device, Microlife MT3001 (QTIJA).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy +/- X degrees, sensitivity, specificity). Instead, the basis for clearance is substantial equivalence to a predicate device.
The document states:
- "The 9 second Digital Thermometer has the same general design and performance characteristics as the predicate device from Microlife."
- "The main difference is the physical size, shape and weight."
- "The 9 second Digital Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness."
Therefore, the "acceptance criteria" can be inferred as meeting the performance (accuracy/precision) of the predicate device, although no specific values are given in this document.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Performance characteristics similar to predicate device (Microlife MT3001) | "The 9 second Digital Thermometer has the same general design and performance characteristics as the predicate device from Microlife." The document implies that the device meets the performance of the predicate device, but no specific performance data is provided. |
2. Sample size used for the test set and the data provenance:
The provided 510(k) summary does not contain details of any clinical or in-vivo testing to demonstrate performance specifically for the 9 second Digital Thermometer. The entire argument rests on technological characteristics and substantial equivalence to the predicate device. Therefore, there is no mention of a "test set" sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As no specific clinical or performance study details are provided, there is no information on the number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set:
Since no specific study with a test set is described, no adjudication method is mentioned.
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:
This device is a digital thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed/described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is a standalone electronic thermometer. The "study" described is a comparison of the device's technical characteristics to a predicate device for the purpose of demonstrating substantial equivalence. The document states:
- "The 9 second Digital Thermometer has the same Technological Characteristics: general design and performance characteristics as the predicate device from Microlife. The main difference is the physical size, shape and weight."
- "This submitter concludes that the 9 second Digital Thermometer is therefore substantially equivalent to the predicate device 'Microlife MT3001 (QT1JA1)'."
This constitutes the "study" or evidence presented for clearance, focusing on direct comparison of design and intended use rather than specific performance data against a ground truth.
7. The type of ground truth used:
Given the nature of the device and the submission (substantial equivalence based on technological characteristics), no specific "ground truth" in the traditional sense (e.g., pathology, outcomes data, expert consensus on disease presence) is mentioned or used. The ground truth, implicitly, is the established, legally marketed performance of the predicate device.
8. The sample size for the training set:
As this is not an AI/machine learning device, the concept of a "training set" is not applicable and no information is provided.
9. How the ground truth for the training set was established:
Not applicable, as no training set exists for this device.
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DEC - 3 2003
Image /page/0/Picture/2 description: The image shows the logo for Media Trade Corporation, with the acronym "MTC" in large, bold, black font on the left side. To the right of "MTC" is the full name "Media Trade Corporation" in a smaller, serif font. A horizontal black line runs beneath the text, emphasizing the company's name. The overall design is clean and professional, suggesting a well-established business.
11820 Red Hibiscus Drive Bonita Springs, FL 34135 Tel (941) 948-2001 – Fax (941) 948-2002 E-mail: GG(a)mediatradecorp.com Web: www.mediatradecorp.com
510(k) Summary
| Submitter's Name: | Guenter GinsbergMedia Trade Corporation |
|---|---|
| Address: | 11820 Red Hibiscus DriveBonita Springs, FL 34135 |
| Phone: | (941) 948-2001 |
| Fax: | (941) 948-2002 |
| E-mail: | gg@mediatradecorp.com |
| Contact: | Guenter Ginsberg |
| Date of Summary: | September 24, 2003 |
| Trade Name: | 9 second Digital ThermometerModel BT-S09 |
| Classification: | Thermometer, Clinical, ElectronicProduct Code: FLLRegulation No. 880.2910Class: IIPanel: 80 (General Hospital) |
| Predicate Devices: | Microlife MT3001 (QTIJA)K 031958 |
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Page -2- (510k Summary)
The 9 second Digital Thermometer is designed to Device Description: measure body temperature. The device is measuring oral, rectal or axillary temperatures by change of resistance in a thermistor located in the tip of the device. When the probe, particular the metal tip is in contact with the body, the thermistor in the probe will generate equivalent electrical resistance, which will be processed by a micro computer chip in the circuitry and then displayed. The 9 second Digital Thermometer is intended for Intended Use: the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages. The 9 second Digital Thermometer has the same Technological Characteristics: general design and performance characteristics as the predicate device from Microlife. The main difference is the physical size, shape and weight. The 9 second Digital Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and
effectiveness. This submitter concludes that the 9 second Digital Thermometer is therefore substantially equivalent to the predicate device "Microlife MT3001 (QT1JA1).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Metatech Corporation Limited C/O Mr. Guenter A. Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
Re: K033082
Trade/Device Name: Metatech Corporation Limited 9 Second Digital Thermometer, Model BT-S09 Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: FLL Product Code: II Dated: September 25, 2003 Received: September 29, 2003
Dear Mr. Ginsderg:
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 promarket 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 ( vour 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. Ginsberg
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 Runion
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
510(k) NUMBER (IF KNOWN): KC3308
DEVICE NAME : METATECH Co. Ltd., 9-second Digital Thermometer INDICATIONS FOR USE:
This device is an electronic clinical thermometer using a themistor probe sensor to detect This device is an electronic cinical mentions oral, rectal or axillary temperatures. It is intended for home use on people of all ages.
Palace Ceccenite
Division Sian-Off ivision of Anesthesiology, General Hospital ction Control, Dental D
510(k) Number. K033082
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use V (Optional Format 1-2-
§ 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.