(65 days)
K 031958
K 031958
No
The description details a simple thermistor-based thermometer with a microcomputer chip for processing resistance changes, with no mention of AI or ML terms or concepts.
No
The device measures body temperature, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
This device measures body temperature, which is a physiological parameter. While temperature can be an indicator of illness, the device's function is solely to measure, not to identify or diagnose a disease or condition.
No
The device description explicitly mentions a thermistor probe sensor, a metal tip, and a micro computer chip in the circuitry, indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as 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: This device measures body temperature directly from the body (oral, rectal, or axillary). It does not analyze any specimens taken from the body.
Therefore, based on the provided information, this digital thermometer is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 9 second Digital 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 a thermistor probe sensor to detect oral, rectal or axillary temperatures. It is intended for home use on people of all ages.
Product codes
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, rectal or axillary
Indicated Patient Age Range
all ages
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
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. This submitter concludes that the 9 second Digital Thermometer is therefore substantially equivalent to the predicate device "Microlife MT3001 (QT1JA1).
Key Metrics
Not Found
Predicate Device(s)
Microlife MT3001 (QTIJA) K 031958
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 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: | September 24, 2003 |
| Trade Name: | 9 second Digital Thermometer
Model BT-S09 |
| Classification: | Thermometer, Clinical, Electronic
Product Code: FLL
Regulation No. 880.2910
Class: II
Panel: 80 (General Hospital) |
| Predicate Devices: | Microlife MT3001 (QTIJA)
K 031958 |
1
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).
2
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.
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 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
4
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-