(214 days)
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.
The easytem duo Forehead/Ear Thermometer is a dual purpose hand held instrument that measures body temperature on the forehead or through the opening of the auditory canal. The forehead operation is based on measuring the temperature on the surface of the forehead while the ear operation measures the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
The provided text describes the "easytem duo, Dual Thermometer, Forehead/Ear, Model BT-021" and its substantial equivalence to predicate devices, but it does not contain the detailed study information requested. Specifically, it lacks information on acceptance criteria, a performance study, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance. The document is primarily a 510(k) summary and FDA clearance letter, focusing on regulatory equivalence rather than a detailed performance study report.
Therefore, many of your requested fields cannot be filled from the provided text.
Here's what can be extracted related to the device and its regulatory status:
Device: easytem duo, Dual Thermometer, Forehead/Ear, Model BT-021
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating "substantial equivalence" to predicate devices, implying that the performance of the easytem duo should be comparable to the predicates, particularly in terms of accuracy for temperature measurement.
- Reported Device Performance: Not explicitly stated with specific numerical performance metrics. The document mentions: "The easytem duo Forehead/Ear Thermometer has the same general design and performance characteristics as the predicate devices from Braun, and SAAT." It also states, "This submitter concludes that the easytem duo Thermometer is therefore substantially equivalent in the 'ear mode' as to the predicate devices 'Braun Thermoscan RT3520' and to the 'ThermoTek 718F' in the 'forehead mode'." This is a statement of perceived equivalence rather than a direct report of performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a performance study with a test set.
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 applicable/Not provided. No performance study with expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No performance study with a test set.
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:
- No. This device is a thermometer, not an AI-assisted diagnostic tool for human readers. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not provided. While the device itself is a standalone thermometer, the document does not detail a standalone performance study with specific metrics, but rather relies on substantial equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No detailed performance study, and therefore no specific ground truth method, is described. For a thermometer, the "ground truth" would typically come from an accurate reference thermometer or controlled temperature environments, which are not mentioned.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device that would typically have a "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI/machine learning device.
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APR 3 0 2004
MTC C Media Trade Corporation
11820 Red Hibiscus Drive – Bonita Springs, FI. 34135 Tel (941) 948-2001 - Fax (941) 948-2002 E-mail: GG(@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: | easytem duo, Dual Thermometer, Forehead/EarModel BT-021 |
| Classification: | Thermometer, Clinical, ElectronicProduct Code: FLLRegulation No. 880.2910Class: IIPanel: 80 (General Hospital) |
| Predicate Devices: | Braun Thermoscan, IRT-3520K 983295 (Predicate #1)SAAT ThermoTek 718FK 002712 (Predicate #2) |
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Page -2- (510k Summary)
Device Description: The easytem duo Forehead/Ear Thermometer is a dual purpose hand held instrument that measures body temperature on the forehead or through the opening of the auditory canal. The forehead operation is based on measuring the temperature on the surface of the forehead while the ear operation measures the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. Intended Use: The easytem duo Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages. Technological Characteristics: The eusytem duo Forehead/Ear Thermometer has the same general design and performance characteristics as the predicate devices from Braun, and SAAT. The main difference is the physical size, shape and weight. The easytem duo Forehead/Ear 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 easytem duo Thermometer is therefore substantially equivalent in the 'ear mode' as to the predicate devices "Braun Thermoscan RT3520" and to the "ThermoTek 718F" in the 'forehead mode'.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2004
Metatech Company Limited C/O Mr. Guenter Ginsberg Official Correspondent Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
Re: K033077
.
Trade/Device Name: easytem duo, Forehead/Ear Thermometer, Model BT-021 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 23, 2004 Received: February 24, 2004
Dear Mr. Ginsberg:
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. 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 vour 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,
Churfs
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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510(k) NUMBER (IF KNOWN): K073077
DEVICE NAME : METATECH Co. Ltd., Easytem duo, Dual Forehead/ Ear Thermometer, Model BT-021 INDICATIONS FOR USE:
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.
Vick Hubbard for Anthony Wilson
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K 033077
(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 11 (Optional Format 1-2-96
§ 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.