(15 days)
Not Found
No
The description details standard infrared sensor technology and an ASIC for signal processing, with no mention of AI or ML algorithms.
No.
The device is used for measuring and monitoring body temperature, a diagnostic function, rather than for treating or mitigating a disease or condition.
No
The device is described as an infrared thermometer intended for "intermittent measurement and monitoring of human body temperature," which is a measurement function, not a diagnostic one. Diagnostic devices are typically used to identify or confirm a medical condition or disease.
No
The device description explicitly states it is a "hand-held, reusable, battery operated, maximum device" and details hardware components like an "Infrared Sensor," "ASIC," and "LCD." This indicates it is a physical hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intermittent measurement and monitoring of human body temperature". This is a physiological measurement taken directly from the body (forehead or ear).
- Device Description: The device measures temperature using an infrared sensor. This is a physical measurement of heat emitted by the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
This device does not perform tests on samples taken from the body. It directly measures a physiological parameter (temperature) from the body itself. Therefore, it falls under the category of a medical device, but not specifically an IVD.
N/A
Intended Use / Indications for Use
Model: FDIR-V1 is intended for the Thermometer Infrared intermittent measurement and monitoring of human body temperature, by consumers in the home.
The device is intended for the intermittent measurement and monitoring of human body temperature, by consumers in the home.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Infrared Thermometer Model: FDIR-VI is a hand-held, reusable, battery operated, maximum device that can measures human body temperature by two ways.
-
on forehead, the skin temperature on one's forehead.
-
in ear, the tympanic temperature in one's ear.
The operation principle is based on Infrared Sensor technology. IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature, an ASIC can turn the signal from IR Sensor to a digital value and display it by LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead, ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumers in the 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)
The device conforms to applicable standards included ASTM E1965-98, EN 12470-5: 2003, IEC 60601-1 and IEC 60601-1-2 requirements.
Our Infrared Thermometer Model FDIR-V1 is substantially equivalent to AVITA 3 in 1 Ear/Forehead/Room Thermometer for the TS8 Series Model TS-802, It's 510(k) number is K031503.
The two device are very similar in design principle, intended use, functions, material and the adopting applicable standards.
Only their outlook and some parameter such as measurement range, battery life are different. moreover, tests in this submission provide demonstrate these small difference do not raise and new questions of safety or effectiveness.
Conclusions: the Infrared Thermometer Model FDIR-V1 is substantially equivalent to the predicate devices.
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.
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
OCT 26 2005
K052849 (f. 1 of 2)
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR § 807.92
| 1.0 Submitter's Name: | FAMIDOC TECHNOLOGY CO., LTD. |
|---|---|
| Address: | 3rd Floor, East Block4, Chegongmiao Anhua |
| Industrial Zone Shenzhen P.R.China | |
| Phone: | +86-755-83412736 |
| Fax: | +86-755-83429513 |
| Contact: | Mr. Steeljin, |
| E-mail: | steeljin@famidoc.com |
| Jason@famidoc.com |
| 2.0 Device Name: | Infrared Thermometer |
|---|---|
| Model: FDIR-V1 | |
| Classification Name: | Clinical Electronic Thermometer |
- 3.0 Classification: Class N
4.0 Predicate Device Information:
AVITA TS8 Series IR Ear/Forehead Thermometer. Model NO.: TS-802 3 in 1 Ear/Forehead/Room Thermometer for the TS8 Series.
It's 510(k) number is K031503.
5.0 Device Description:
Infrared Thermometer Model: FDIR-VI is a hand-held, reusable, battery operated, maximum device that can measures human body temperature by two ways.
-
on forehead, the skin temperature on one's forehead.
-
in ear, the tympanic temperature in one's ear.
The operation principle is based on Infrared Sensor technology. IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature, an ASIC can turn the
1
signal from IR Sensor to a digital value and display it by LCD.
6.0 Intended Use:
Model: FDIR-V1 is intended for the Thermometer Infrared intermittent measurement and monitoring of human body temperature, by consumers in the home.
7.0 Performance Summary
The device conforms to applicable standards included ASTM E1965-98, EN 12470-5: 2003, IEC 60601-1 and IEC 60601-1-2 requirements.
8.0 Comparison to Predicate Devices and conclusions
Our Infrared Thermometer Model FDIR-V1 is substantially equivalent to AVITA 3 in 1 Ear/Forehead/Room Thermometer for the TS8 Series Model TS-802, It's 510(k) number is K031503.
The two device are very similar in design principle, intended use, functions, material and the adopting applicable standards.
Only their outlook and some parameter such as measurement range, battery life are different. moreover, tests in this submission provide demonstrate these small difference do not raise and new questions of safety or effectiveness.
Conclusions: the Infrared Thermometer Model FDIR-V1 is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
OCT 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Famidoc Technology Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated Laboratory and Testing 2600 NW Lake Road Camas, Washington 98607-8542
Re: K052849
Trade/Device Name: INFRARED THERMOMETER, FDIR-VI Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 5, 2005 Received: October 11, 2005
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatinent date of the enactment date of the Medical Device Amendments, or to conimered proz to they 2011 11:25 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierelore, mains of the Act include requirements for annual registration, listing of general controls provisioning practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it 11 your de vice is elabilities (tional controls. Existing major regulations affecting your device can may be subject to sueritadors. Title 21, Parts 800 to 898. In addition, FDA may be found in the obas acements concerning your device in the Federal Register.
3
Page 2 - Mr. Mouser
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 erth 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 (240) 276-0115. 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 other generals, 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/industry/support/index.html.
Sincercly yours,
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
Indications for Use
Ψ52849
510(k) Number (if known):
Device Name: Infrared Thermometer
Indications for Use:
The device is intended for the intermittent measurement and monitoring of human body temperature, by consumers in the home.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
のお気になると、それでは、それは、それは、この時には、この時には、この時には、この時に、この時に
se
$\times$
C)
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cinta Dm
Sien-City tion of Anas Instology, Ganeral Hospital, cilon Control, Demal Devices
Page 1 of 1
719(k) Number _ K45284 9