(180 days)
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No
The summary describes a standard infrared ear thermometer and does not mention any AI or ML components or capabilities.
No
The device is a diagnostic tool used to measure body temperature, not to treat or alleviate a medical condition.
No
Explanation: The device is described as an "electronic clinical thermometer" used to "detect body temperature," which is a measurement function rather than a diagnostic one. While temperature can be an indicator for diagnosis, the device itself performs a measurement, not a diagnosis.
No
The device description clearly states it is a "hand held instrument" using 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Thermo Buddy Ear Thermometer measures body temperature directly from the auditory canal using infrared radiation. This is a measurement taken on the body, not on a sample taken from the body.
Therefore, based on the provided information, the Thermo Buddy Ear Thermometer falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Thermo Buddy 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.
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used at home.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Thermo Buddy 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
auditory canal / tympanic membrane and adjacent surfaces
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
APR 0 9 2003
K0234/2
MTC
Media Trade Corporation
11820 Red Hibiscus Drive - Bonita Springs, FL 34135 Tel (239) 948-2001 -- Fax (239) 948-2002 E-mail: mediatradecorpla gmx.net 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: | (239) 948-2001 | |
| Fax: | (239) 948-2002 | |
| E-mail: | mediatradecorp@gmx.net | |
| Contact: | Guenter Ginsberg | |
| Date of Summary: | October 04, 2002 | |
| Trade Name: | Thermo Buddy, Ear Thermometer, Model TB-100 | |
| Classification: | Thermometer, Clinical, Electronic
Product Code: FLL
Regulation No. 880.2910
Class: Il
Panel: 80 (General Hospital) | |
1
Page -2- (510k Summary) The Thermo Buddy Ear Thermometer is a hand Device Description: 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 Thermo Buddy Ear Thermometer is intended Intended Use: for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages. The Thermo Buddy Ear Thermometer has the Technological Characteristics: 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 Thermo Buddy 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 Thermo Buddy Thermometer is therefore substantially equivalent to the predicate devices "Braun Thermoscan IRT3020"and the "Omron Gentletemp Instant Ear Thermometer MC-509".
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or bird-like shapes, stacked on top of each other.
APR 0 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hubdic Company, Limited C/O Mr. Guenter Ginsberg Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
Re: K023412
Trade/Device Name: Thermo Buddy Ear Thermometer Model TB-100 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 21, 2003 Received: January 24, 2003
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.
3
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 Runge
Susan Runner, DDS, MA Interim 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 / of /
510(k) Number (if known): K023412
Hubdis Co Ltd
Thonmo Rudo
Hubdic Co. Ltd., Thermo Buddy Ear Thermometer Model TB-100 Device Name:_
Indications For Use:
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used at home.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER:PAGE (F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | Patrice Lucente |
| (Division Sign-Off) |
OR
| Over-The-Counter Use | ✓ |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023412