(261 days)
Famidoc Infrared Thermometers, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.
Famidoc Infrared FDIR series Thermometers are hand-held, reusable, battery operated devices, which can measure human body temperature in 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. The IR sensor can output different signal when measuring different object temperature or in different ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital value and display it on the LCD.
The subject devices (Models: FDIR-V2, FDIR-V4, FDIR-V6, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15) are the same series in Famidoc. Their design principle, intended use, indications for use, material, control keys, software and the applicable standards are the same. The differences between them are appearance, some parameters (e.g. LCD size), and some minor functions (e.g. Voice function).
The provided document is a 510(k) summary for an Infrared Thermometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/device.
Therefore, the requested information cannot be fully extracted as it pertains to a different type of device evaluation (e.g., for an AI/ML medical device).
However, I can provide what information is available in the document regarding performance and equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the thermometer's accuracy against a ground truth. Instead, it relies on conformance to standards.
| Acceptance Criteria (Inferred from standards conformance) | Reported Device Performance (from the document) |
|---|---|
| Conforms to ASTM E1965-98 (Standard Specification for Clinical Thermometers for Intermittent Determination of Patient Temperature) | The devices conform to applicable standards including ASTM E1965-98 |
| Conforms to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The devices conform to applicable standards including IEC 60601-1 |
| Conforms to IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests) | The devices conform to applicable standards including IEC 60601-1-2 |
| Substantial equivalence to predicate device (Famidoc Infrared Thermometer, model FDIR-V1, K052849) | "The subject devices and the predicate device are the same in design principle, intended use, functions, material and the applicable standards." |
| No new issues of safety and effectiveness due to appearance or minor functional differences | "But the tests in this submission provide demonstrate these differences do not raise new issue of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a specific "test set" in the context of clinical data for performance evaluation. The "tests in this submission" likely refer to bench testing for compliance with the mentioned standards (ASTM, IEC). No information on sample size, country of origin, or retrospective/prospective nature of data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The evaluation is based on technical standards conformance and substantial equivalence, not a clinical study requiring expert ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. This is an infrared thermometer, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is a standalone medical device, but not one that employs an algorithm in the AI/ML sense where "standalone performance" against a human baseline would be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" used for this type of device is typically established against calibrated reference thermometers and environmental conditions during testing for compliance with standards like ASTM E1965-98. The document does not specify the exact methods or type of ground truth beyond conformance to these standards.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" in the context of machine learning, as this is a traditional medical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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Sponsor: Famidoc Technology Co, Ltd. Infrared Thermometer, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, Subject Device: FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V10, FDIR-V15 File No.: 510(k) submission file (V1.1) - Chapter 7
510(k) Summary
SEP 7 2012
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 Information
Establishment Registration:
Famidoc Technology Co., Ltd.
Address 1: East 2/F Zhixiang Building, 71 Block Baoan District, Shenzhen 518101,
Guangdong, P.R. China
Phone: +86-755-27864342
Fax: +86-755-27864151
Address 2: No. 212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town, Dongguan ,
Guangdong Province, P.R.China.
Contact Person: Mr. Cao Liang E-mail: leon@famidoc.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Famidoc Infrared Thermometer |
| Model: | FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, |
| FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15 | |
| Classification name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Device Class: | 2 |
| Regulation Number: | 880.2910 |
3.0 Predicate Device Information
| Sponsor: | Famidoc Technology Co., Ltd. |
|---|---|
| Device: | Infrared Thermometer, model FDIR-V1 |
| 510(K) Number: | K052849 |
Chapter 7, Page 1 of 3
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Famidoc Technology Co, Ltd. Sponsor: Infrared Thermometer, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, Subject Device: FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15 510(k) submission file (V1.1) - Chapter 7 File No.:
4.0 Device Description
Famidoc Infrared FDIR series Thermometers are hand-held, reusable, battery operated devices, which can measure human body temperature in 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. The IR sensor can output different signal when measuring different object temperature or in different ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital value and display it on the LCD.
The subject devices (Models: FDIR-V2, FDIR-V4, FDIR-V6, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15) are the same series in Famidoc. Their design principle, intended use, indications for use, material, control keys, software and the applicable standards are the same. The differences between them are appearance, some parameters (e.g. LCD size), and some minor functions (e.g. Voice function).
5.0 Intended Use
Famidoc Infrared Thermometers, Models: FDIR-V2, FDIR-V4, FDIR-V6, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.
6.0 Performance Summary
The devices conform to applicable standards including ASTM E1965-98, IEC 60601-1 and IEC 60601-1-2 requirements.
7.0 Comparison to predicate device and conclusion
The subject device "Infrared Thermometers, models: FDIR-V4, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15", and the predicate device "Infrared Thermometer, model: FDIR-V1" are the same series infrared thermometer in Famidoc.
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Sponsor: Famidoc Technology Co, Ltd. Infrared Thermometer, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, Subject Device: FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15 File No.: ' 510(k) submission file (V1.1) - Chapter 7
The subject devices and the predicate device are the same in design principle, intended use, functions, material and the applicable standards.
Only their appearance and some characteristics (e.g. control keys, software, and voice function) are different. But the tests in this submission provide demonstrate these differences do not raise new issue of safety and effectiveness.
8.0 Conclusions
The Infrared Thermometer, Models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, and FDIR-V15 are substantially equivalent to the predicate device.
9.0 Summary prepared date
September 6, 2012
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Image /page/3/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 overlapping wing segments, symbolizing health and human services. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP
Mr. Cao Liang General Manager Famidoc Technology Company, LIMITED No. 212 Yilong Road , Hexi Industrial Zone Jinxia, Changan Town, Dongguan Guangdong Province, P R China
Re: K113761
Trade/Device Name: Famidoc Infrared Thermometer, Models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 23, 2012 Received: July 23, 2012
Dear Mr. Liang
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.
7 2012
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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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
For Robert Smith, M.D.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Famidoc Technology Co, Ltd. Sponsor: Infrared Thermometer, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, Subject Device: FDIR-V9. FDIR-V9-3. FDIR-V10, FDIR-V10, FDIR-V15 510(k) submission file (V1.0) - Chapter 6 File No.:
Indications for Use
510(k) Number (if known):
Device Name: Famidoc Infrared Thermometer Models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15
Indications for Use:
Famidoc Infrared Thermometers, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.
Prescription Use Over-The-Counter Use X Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
RH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Chapter 6, Page 1 of 1
§ 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.