(168 days)
K 983295, K922344
Not Found
No
The summary describes a standard infrared ear thermometer and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as descriptions of training or test sets typically associated with AI/ML development.
No.
The device is used to measure body temperature, which is a diagnostic function, not a therapeutic one. Therapeutic devices are designed to treat or alleviate a medical condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is an "electronic clinical thermometer using an infrared sensor to detect body temperature". Measuring body temperature is generally considered a monitoring or screening function, not a diagnostic one. Diagnosis involves identifying the nature of a disease or condition, which is not the stated purpose of this thermometer.
No
The device description explicitly states it is a "hand held instrument" that uses an "infrared sensor" to measure temperature, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- This Device's Function: The easytem Ear Thermometer measures body temperature directly from the auditory canal using an infrared sensor. This is a direct measurement of a physiological parameter within the body, not an analysis of a specimen taken from the body.
Therefore, based on the provided information, this device falls under the category of a clinical thermometer or medical device for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The easytem 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The easytem Ear Thermometer is a hand held instrument that measures body temperature throu the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal, tympanic membrane
Indicated Patient Age Range
all ages, neonatal, pediatric and adult population
Intended User / Care Setting
home
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 983295, K922344
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Ginsberg
Media Trade Corporation |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Address: | 11820 Red Hibiscus Drive
Bonita 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, Electronic
Product Code: FLL
Regulation No. 880.2910
Class: II
Panel: 80 (General Hospital) |
| Predicate Devices: | Braun Thermoscan, IRT-3520
K 983295 (Predicate #1)
Omron Gentle Temp, MC-509
K922344 (Predicate #2) |
1
| Page -2- (510k Summary) | |
|---|---|
| Device Description: | The easytem Ear Thermometer is a hand held |
| instrument that measures body temperature throu | |
| the opening of the auditory canal. Operation is | |
| based on measuring the natural thermal radiation | |
| emitted from the tympanic membrane and adjacent | |
| surfaces. | |
| Intended Use: | The easytem 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 easytem Ear Thermometer has the same general |
| design and performance characteristics as the | |
| predicate devices from Braun and Omron. The main | |
| difference is the physical size, shape and weight. | |
| The easytem 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 | |
| Thermometer is therefore substantially equivalent to | |
| the predicate devices "Braun Thermoscan | |
| IRT3020"and the "Omron Gentletemp Instant Ear |
2
Page -2-
| Purpose of submission: | The Easytem Ear Thermometer, manufactured by
Metatech Co., Ltd., Korea, is a new device intended to be
marketed in the USA. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Easytem Ear Thermometer is similar to other Ear Thermometers, approved and
marketed in the USA, such as the predicate devices listed. |
| Predicate Devices: | Braun Thermoscan, IRT-3520
K 983295 (Predicate #1) |
| | Omron Gentle Temp, MC-509
K922344 (Predicate #2) |
| U.S. Contact: | Guenter Ginsberg (Official Correspondent)
Media Trade Corporation
Reg. No. 9023800
11820 Red Hibiscus Drive
Bonita Springs, FL 34135
Tel: 941 948-2001 Fax: 941 948-2002
E-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.
3
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.
4
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
5
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