(168 days)
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature via the auditory canal in the neonatal, pediatric and adult population used at home.
The easytem Ear Thermometer is a hand held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
The provided text is a 510(k) summary for the Easytem Ear Thermometer, Model BT-020. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth for training was established.
The document focuses on:
- Administrative details: Submitter information, contact, date of summary, trade name, classification, and predicate devices.
- Device description: How it measures temperature (infrared sensor in the auditory canal).
- Intended use: Intermittent measurement and monitoring of human body temperature in the home for people of all ages.
- Technological characteristics: States that it has the same general design and performance characteristics as predicate devices, with the main difference being physical size, shape, and weight. It claims "no new questions of safety and effectiveness."
- Purpose of submission: New device for the USA, similar to approved predicate devices.
- FDA correspondence: The letter from the FDA confirming the substantial equivalence and allowing the device to be marketed.
Without specific performance data, I cannot complete the requested table or answer most of the questions.
Here's what can be inferred or explicitly stated based only on the provided text, with the understanding that key information is missing:
1. A table of acceptance criteria and the reported device performance
No acceptance criteria or reported device performance data are provided in the document. The 510(k) summary asserts "the same general design and performance characteristics as the predicate devices" but does not quantify these characteristics or provide test results.
2. Sample sized used for the test set and the data provenance
No information provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
No information provided.
4. Adjudication method for the test set
No information provided.
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 an ear thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a direct measurement tool, not an algorithm. Its performance is inherent in its design and operation.
7. The type of ground truth used
No information provided, as no study details are given. For a thermometer, "ground truth" performance typically involves comparison against a highly accurate reference thermometer in a controlled setting, but no such details are mentioned.
8. The sample size for the training set
Not applicable. This device is a hardware measurement device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not involve a training set.
Conclusion: The provided 510(k) summary for the Easytem Ear Thermometer focuses on establishing substantial equivalence to predicate devices based on design and intended use, rather than detailing a specific performance study with acceptance criteria and results. Therefore, most of the requested information regarding study details, sample sizes, and ground truth establishment is not available in the given document.
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Ko26520
AUG 0 6 2002
MTC
Media Trade Corporation
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: | February 12, 2002 |
| Trade Name: | easytem Ear Thermometer, Model BT-020 |
| Classification: | Thermometer, Clinical, ElectronicProduct Code: FLLRegulation No. 880.2910Class: IIPanel: 80 (General Hospital) |
| Predicate Devices: | Braun Thermoscan, IRT-3520K 983295 (Predicate #1)Omron Gentle Temp, MC-509K922344 (Predicate #2) |
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| Page -2- (510k Summary) | |
|---|---|
| Device Description: | The easytem Ear Thermometer is a hand heldinstrument that measures body temperature throuthe opening of the auditory canal. Operation isbased on measuring the natural thermal radiationemitted from the tympanic membrane and adjacentsurfaces. |
| Intended Use: | The easytem Ear Thermometer is intended for theintermittent measurement and monitoring of humanbody temperature in the home. It is intended for useon people of all ages. |
| Technological Characteristics: | The easytem Ear Thermometer has the same generaldesign and performance characteristics as thepredicate devices from Braun and Omron. The maindifference is the physical size, shape and weight.The easytem Ear Thermometer has the sameintended use, general design and incorporatessimilar materials and components, hence shouldtherefore raise no new questions of safety andeffectiveness.This submitter concludes that the easytemThermometer is therefore substantially equivalent tothe predicate devices "Braun ThermoscanIRT3020"and the "Omron Gentletemp Instant Ear |
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Page -2-
| Purpose of submission: | The Easytem Ear Thermometer, manufactured byMetatech Co., Ltd., Korea, is a new device intended to bemarketed in the USA. |
|---|---|
| The Easytem Ear Thermometer is similar to other Ear Thermometers, approved andmarketed in the USA, such as the predicate devices listed. | |
| Predicate Devices: | Braun Thermoscan, IRT-3520K 983295 (Predicate #1) |
| Omron Gentle Temp, MC-509K922344 (Predicate #2) | |
| U.S. Contact: | Guenter Ginsberg (Official Correspondent)Media Trade CorporationReg. No. 902380011820 Red Hibiscus DriveBonita Springs, FL 34135Tel: 941 948-2001 Fax: 941 948-2002E-mail: gg@mediatradecorp.com |
This application was prepared according to FDA Guidance Documents and includes all required data to demonstrate substantial equivalence to legally marketed predicate devices.
Sincerely yours,
J-C
Guenter Ginsberg President MTC
Notes about the attachments:
The attachments may include data and information not required by the FDA, but by European Institutions, and were left in the binder for convenience only.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird image. The logo is simple and iconic, representing the department's role in health and human services.
Public Health Service
AUG 0 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Metatech Company, limited C/O Mr. Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
Re: K020520
Trade/Device Name: Easytem Ear Thermometer, Model BT-020 Regulation Number: 21 CFR 880.2910 Regulation Name: Ear Thermometer Regulatory Class: II Product Code: FLL Dated: June 13, 2002 Received: June 17, 2002
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 mav, 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrly/dsma/dsmamain.html
Sincerely,
Timothy A. Ulatowski
Timothy Directo 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
510(k) NUMBER (IF KNOWN): ドバスク520
DEVICE NAME : METATECH Co. Ltd., Easytem Ear Thermometer Model BT-020 INDICATIONS FOR USE:
This device is an electronic clinical thermometer using an infrared sensor to detect body I his devioo is an electrolitory canal in the neonatal, pediatric and adult population used at home.
(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 \checkmark
(Optional Format 1-2-9
Patrice Cucenik
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K080520
§ 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.