(199 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on infrared technology for temperature measurement without mentioning any AI/ML components.
No
This device is intended for measurement and monitoring of body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device is a thermometer, intended for monitoring body temperature, not for diagnosing diseases or conditions.
No
The device description explicitly states it is an "Infrared Forehead Thermometer" that "utilizes infrared technology to measure infrared energy emitted from the skin surface," indicating it is a hardware device with a physical sensor.
Based on the provided information, the FORA Diamond Nexus Mini Thermometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "intermittent measurement and monitoring of human body temperature from forehead measurement at home." This is a direct measurement of a physiological parameter (body temperature) from the body surface.
- Device Description: It measures "human body temperature from the surface of human skin" using infrared technology. This is a non-invasive measurement of a physical property.
- 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. The FORA thermometer does not analyze samples taken from the body.
Therefore, the FORA Diamond Nexus Mini Thermometer falls under the category of a medical device that measures a physiological parameter directly from the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FORA Diamond Nexus Mini Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
FORA Diamond Nexus Mini Infrared Forehead Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
forehead
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at 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 FORA Diamond Nexus Mini Infrared Forehead Thermometer was validated by the tests According to ASTM E1965-98 standard and met the requirements of EN12470-5:2000 standard.
Clinical accuracy test with a sample size of 120, showing a pooled clinical bias of -0.08 and an uncertainty of 0.02.
The pooled clinical repeatability was 0.11.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The pooled clinical bias: -0.08
Bias+1.96 SD: 0.44
Bias-1.96 SD: -0.60
Uncertainty: 0.02
The pooled clinical repeatability: 0.11
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
FEB 2 1 2014
Image /page/0/Picture/2 description: The image shows the logo for Biocare Asia Co., LTD. The logo includes the letters 'bca' in a stylized font, with a heart shape inside the letter 'c'. To the right of the letters is the company name in Chinese characters. Below the logo is the full company name, 'BIOCARE ASIA CO., LTD.', in a bold, sans-serif font.
510(k) Summary
Jan.8 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: K132457
1. Submitter's Name: BioCare Asia Co., LTD
Address: No.260, Mayun Road, New District Suzhou, Jiangsu, 215129, P.R.C
Contact person: Shuchi Chang / Administrator Phone: +886-3-2616678#6533
+886-3-2616679 Fax:
E-mail:shuchichang@biocare.com.tw
2. Device Name and Classification
Trade name: FORA Diamond Nexus Mini Infrared Forehead Thermometer Common name: Clinical electronic thermometer Regulation section: 21 CFR 880.2910 Classification Code: FLL, Clinical electronic thermometer Classification Panel: General Hospital (80) Device Classification: Class II
3. Predicate Device
The predicate device is URIGHT TD-1240 Thermometer (K113159) marketed by TaiDoc Technology Corporation.
4. Device Description
FORA Diamond Nexus Mini Infrared Forehead Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared
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Image /page/1/Picture/0 description: The image shows the logo for BIOCARE ASIA CO., LTD. The logo features the letters 'bca' in a stylized font, with a heart shape inside the 'c'. To the right of the letters is Chinese text, and below the letters is the company name in English.
technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
5. Intended Use
FORA Diamond Nexus Mini Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home.
6. Comparison with predicate:
FORA Diamond Nexus Mini Infrared Forehead Thermometer has the following similarities to the predicate device:
- V Same Indications for use.
- A Same operating principle and fundamental scientific technology.
- 公 Incorporates the same materials.
- A Same shelf life.
- Packaged using the same materials. A
- Has the same memory storage capacity. V
The FORA Diamond Nexus Mini Infrared Forehead Thermometer has the following dissimilarity to the predicate device:
| Item | FORA Diamond Nexus Mini
Infrared Forehead
Thermometer | U-RIGHT TD-1240
Thermometer (K113159) |
|---------------------------|-------------------------------------------------------------|------------------------------------------|
| Body Measuring Range | 89.6°F to 109.4°F
(32°C to 43°C). | 73.4°F to 111.2°F |
| Operating temperature | 60.8°F to 104°F
(16°C to 40°C). | 50°F to 104°F |
| Storage temperature range | -13°F to 131°F
(-25°C to 55°C) | -4°F to 140°F |
| power down time | 15 seconds | 3 minutes |
2
| battery type | One 3V CR2032 lithium
battery | 1.5V AA |
|---------------|----------------------------------|---------|
| LCD Backlight | white | blue |
The differences between the two devices list as: display, parameters and appearance. There are no significant differences that affect the safety and effectiveness. Therefore, BioCare Asia FORA Diamond Nexus Mini Infrared Forehead Thermometer is substantially equivalent to the legally marketed device U-RIGHT TD-1240 Thermometer manufactured by TaiDoc Technology Corporation, K113159.
7. Performance Characteristics: (Non-clinical testing data)
The FORA Diamond Nexus Mini Infrared Forehead Thermometer was validated by the tests According to ASTM E1965-98 standard and met the requirements of EN12470-5:2000 standard.
A brief description for each test was given in this section. Following table lists items of tests, related standard complied and acceptance criteria.
| Item | Standard complied | Acceptance criteria | Attachment |
|---|---|---|---|
| Clinical accuracy | ASTM E 1965-98 | ||
| EN-12470-5 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 23 | |
| Laboratory accuracy | ASTM E 1965-98 | ||
| EN-12470-5 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 23 | |
| Shock test | ASTM E 1965-98 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 25 |
| Storage environment test | ASTM E 1965-98 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 26 |
| Displayed temperature range | ASTM E 1965-98 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 27 |
| Operating condition range | |||
| 36-39°C (96.8-102.2°F) | ASTM E 1965-98 | ||
| EN-12470-5 | $\pm$ 0.2°C ( $\pm$ 0.4°F) | 28 |
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Image /page/3/Picture/0 description: The image shows the logo for BIOCARE ASIA CO., LTD. The logo consists of the letters "bca" in a stylized font, with a heart shape inside the letter "c". To the right of the letters is the company name in Chinese characters. Below the logo is the company name in English, "BIOCARE ASIA CO., LTD."
| Operating condition range
39°C (102.2°F) | ASTM E 1965-98
EN-12470-5 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 28 |
|---------------------------------------------------------------|------------------------------|----------------------------|----|
| | | | |
| Safety | IEC 60601-1 | Evaluated by SGS | 19 |
| Electromagnetic
compatibility (EMC) | IEC 60601-1-2 | Evaluated by SGS | 22 |
| Home Healthcare Equipment | IEC 60601-1-11 | Evaluated by SGS | 20 |
8. Performance Characteristics: (Clinical testing data)
Two kind of errors were represented in clinical accuracy: clinical bias and clinical repeatability. Following table is the pooled clinical bias and its standard deviation of 1267.
| Device | Sample size | The pooled clinical bias | Bias+1.96 SD | Bias-1.96 SD | Uncertainty |
|---|---|---|---|---|---|
| 1267 | 120 | -0.08 | 0.44 | -0.60 | 0.02 |
The following show the pooled clinical repeatability of 1267.
| Device | Sample size | The pooled clinical bias |
|---|---|---|
| 1267 | 120 | 0.11 |
7. Test Principle:
The thermometer measures temperature by reading infrared radiation emitting from the skin and converts it into a temperature value.
8. Conclusions
Based on the information provided in this submission, the FORA Diamond Nexus Mini Infrared Forehead Thermometer is substantially equivalent to the predicate U-RIGHT 1240 Thermometer, model TD-1240.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2014
BioCare Asia Corporation, Limited Ms. Shuchi Chang Administrator, R&D Department No.260, Mayun Road New District Suzhou, Jiangsu 215129 P.R. China
Re: K132457
Trade/Device Name: FORA Diamond Nexus Mini Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 15, 2014 Received: January 17, 2014
Dear Ms. Chang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Chang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
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for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132457
Device Name
FORA Diamond Nexus Mini Infrared Forehead Thermometer
Indications for Use (Describe)
FORA Diamond Nexus Mini Infrared Forehead Thermittent messurement and monitoring of human body temperature from forehead measurement at home.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over - The - Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE CHILIFORNIA CONTRACTOR FOR FOR FOR FOR FOR FOR FOR FOR FOR THE FOR FOR THE FOR A FOR A FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman Date: 2014.02.19 14:49:37 -05'00'
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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