(199 days)
FORA Diamond Nexus Mini Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FORA Diamond Nexus Mini Infrared Forehead Thermometer:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on non-clinical performance characteristics validated against existing standards (ASTM E1965-98 and EN12470-5). Clinical accuracy is also reported.
| Item | Standard Complied | Acceptance Criteria | Reported Device Performance (pooled clinical bias) |
|---|---|---|---|
| Clinical accuracy (Bias) | ASTM E 1965-98, EN-12470-5 | ± 0.3°C (± 0.5°F) | -0.08°C |
| Clinical accuracy (Repeatability) | ASTM E 1965-98, EN-12470-5 | Not explicitly stated as a separate criterion, but inherent in overall accuracy. | 0.11°C |
| Laboratory accuracy | ASTM E 1965-98, EN-12470-5 | ± 0.3°C (± 0.5°F) | (Not explicitly detailed in this summary) |
| Shock test | ASTM E 1965-98 | ± 0.3°C (± 0.5°F) | (Not explicitly detailed in this summary) |
| Storage environment test | ASTM E 1965-98 | ± 0.3°C (± 0.5°F) | (Not explicitly detailed in this summary) |
| Displayed temperature range | ASTM E 1965-98 | ± 0.3°C (± 0.5°F) | (Not explicitly detailed in this summary) |
| Operating condition range 36-39°C (96.8-102.2°F) | ASTM E 1965-98, EN-12470-5 | ± 0.2°C (± 0.4°F) | (Not explicitly detailed in this summary) |
| Operating condition range <36°C (96.8°F) or >39°C (102.2°F) | ASTM E 1965-98, EN-12470-5 | ± 0.3°C (± 0.5°F) | (Not explicitly detailed in this summary) |
| Safety | IEC 60601-1 | Evaluated by SGS | Evaluated by SGS |
| Electromagnetic compatibility (EMC) | IEC 60601-1-2 | Evaluated by SGS | Evaluated by SGS |
| Home Healthcare Equipment | IEC 60601-1-11 | Evaluated by SGS | Evaluated by SGS |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Accuracy Test: 120 subjects (labeled as "Sample size" for the clinical bias and repeatability tables).
- Data Provenance: Not explicitly stated in the provided summary (e.g., country of origin). It is also not specified whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The method for establishing ground truth is not detailed beyond the use of standards. For clinical accuracy, it can be inferred that a reference thermometer was used as a comparative ground truth, but the details of its operation or the involvement of experts in establishing that ground truth are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data alongside AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The entire submission describes the performance characteristics of the thermometer itself, independently measuring and displaying temperature. There is no human-in-the-loop component for reading or interpreting the thermometer's direct output.
7. The Type of Ground Truth Used
- The ground truth for the performance tests (clinical and laboratory accuracy) is implicitly based on established metrological standards and reference devices compliant with those standards (ASTM E1965-98, EN-12470-5). For clinical accuracy, this would typically involve comparison against a highly accurate reference thermometer. For laboratory accuracy, it would involve comparison against calibrated temperature sources. The document does not specify a separate "expert consensus," "pathology," or "outcomes data" as ground truth beyond adherence to these technical standards.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a traditional infrared thermometer, not an AI/machine learning algorithm that requires a training set in that context. The "training" here would be the device's calibration and design against engineering principles and standards, not a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an AI algorithm. The device's accuracy and performance are established through adherence to and testing against the specified international standards (ASTM E1965-98 and EN-12470-5).
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FEB 2 1 2014
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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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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 MiniInfrared ForeheadThermometer | U-RIGHT TD-1240Thermometer (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 |
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| battery type | One 3V CR2032 lithiumbattery | 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 1965-98EN-12470-5 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 23 |
| Laboratory accuracy | ASTM E 1965-98EN-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 range36-39°C (96.8-102.2°F) | ASTM E 1965-98EN-12470-5 | $\pm$ 0.2°C ( $\pm$ 0.4°F) | 28 |
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| Operating condition range<36°C(96.8°F) or >39°C (102.2°F) | ASTM E 1965-98EN-12470-5 | $\pm$ 0.3°C ( $\pm$ 0.5°F) | 28 |
|---|---|---|---|
| Safety | IEC 60601-1 | Evaluated by SGS | 19 |
| Electromagneticcompatibility (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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§ 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.