(178 days)
Not Found
No
The description focuses on standard infrared temperature measurement and digital display, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is an infrared clinical electronic thermometer for measuring forehead temperature. While temperature measurement can be part of a diagnostic process, the device itself does not provide therapy or treatment.
No
Explanation: A diagnostic device is used to identify or determine the nature of a disease or condition. This device is a thermometer, which measures temperature, a symptom, but does not provide a diagnosis of a disease or condition itself.
No
The device description explicitly states it is an "electronic infrared digital forehead thermometer" and describes physical components like scanning the forehead area and displaying results digitally and audibly, indicating it is a hardware device with embedded software, not a standalone software-only device.
Based on the provided information, 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.
- Device Function: This device measures the temperature of the skin on the forehead using infrared technology. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the intermittent measurement and assessment of skin forehead temperature, which is a physical measurement, not a diagnostic test performed on a biological sample.
Therefore, this device falls under the category of a medical device, specifically a clinical electronic thermometer, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
This device is an electronic infrared digital forehead thermometer. It scans the forehead area for temperature of the arterial blood supply under the skin. The thermometer displays the results digitally as well as by talking, between 35℃ (95ºF) and 42.2ºC (108ºF). This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift. HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all age ranges
Intended User / Care Setting
over-the-counter
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.
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
510(k) Summary
As Required by 21 section 807.92 ( c )
Mansour Consulting LLC 1-Submitter Name:
- 1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA
- (770) 777- 4146 3-Phone:
- (678) 623- 3765 4-Fax:
5-Contact Person: Jay Mansour
6-Date summary prepared: August 21*, 2003
-
7-Device Trade or Proprietary Name: IR FOREHEAD THERMOMETER, HV-T36
8-Device Common or usual name: Forehead Electronic Thermometer -
Clinical Electronic Thermometer 9-Device Classification Name:
10-Substantial Equivalency is claimed against the following device: -
FT101 Forehead Infrared Digital Thermometer, manufactured by IDT Technology . Limited and distributed in US by Oregon Scientific. 510k # K020433
11-Description of the Device:
This device is an electronic infrared digital forehead thermometer. It scans the forehead area for temperature of the arterial blood supply under the skin. The thermometer displays the results digitally as well as by talking, between 35℃ (95ºF) and 42.2ºC (108ºF).
This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift.
HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.
12-Intended use of the device:
This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Image /page/0/Picture/22 description: The image shows an oval shape with the text "PAGE 10" written inside. The text is handwritten in a simple, slightly messy style. The oval shape is outlined in black, and the text is also in black.
1
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SIMILAR to the predicate device.
| FDA file reference number | 510k # K020433 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three distinct head profiles, suggesting a focus on people and health.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2004
Oriental Inspiration Limited C/O Mr. Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharette, Georgia 30022
Re: K032612
Trade/Device Name: IR Forehead Thermometer, HV-T36 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 1, 2003 Received: December 4, 2003
Dear Mr. Mansour
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. Mansour
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,
Chiu-Ling, Ph.D.
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
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Page I of 1
510(k) Number (if known): //326/2
Device Name: IR FOREHEAD THERMOMETER, HV-T36
Indications for Use:
This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all ages. The measured temperature correlates to axillary temperature
/ Over-the-Counter
Prescriptum
Clus-Ps
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032622
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE. OF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurence of CDRH, Office of Device Evaulation (ODL)
(Optional Format 3-10-98)
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