(77 days)
Fudakang Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. BT-A11CN, BT-A21CN, BT-A41CN can be used for axillary measurement, oral measurement and rectal measurement.
Fudakang digital thermometers are hand-held, reusable, battery operated. The models include BT-A11CN, BT-A21CN, and BT-A41CN. All the models have the same indication for use. The difference points are their shapes, colors, voice function, and measurement speed. The operation principle is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. The digital thermometer comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result.
Acceptance Criteria and Device Performance for Fudakang Digital Thermometers
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard: ASTM E1112-2006) | Reported Device Performance (Fudakang Digital Thermometers) | Meets Criteria? |
|---|---|---|
| +/- 0.1°C (0.2°F) for specific range (e.g., 35.0 - 39.0°C) | 35.0 - 39.0°C (95.0 - 102.0°F): +/- 0.1°C (0.2°F) | Yes |
| +/- 0.2°C (0.3°F) for the rest of the range | The rest: +/- 0.2°C | Yes |
| (Implicit by compliance with ASTM E1112) | Accuracy, precision, and repeatability compliant with ASTM E1112-2006 requirements. | Yes |
| (Implicit by compliance with ASTM E1112) | Response time compliant with ASTM E 1112 requirements (Subject device 60s, Predicate device 30s). | Yes |
| Biocompatibility with patient contact materials | Patient contact materials (stainless steel, ABS plastic, thermoplastic rubber) comply with ISO10993-1, ISO10993-5, and ISO10993-10. | Yes |
| Compliance with general medical electrical equipment safety standards | IEC 60601-1 and IEC 60601-1-2 requirements met. | Yes |
| Environmental conditions | Compliance with IEC 60601-1 and ASTM E1112 requirements. | Yes |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally mentions "bench test confirmed" the accuracy, precision, and repeatability.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "bench test" likely refers to standardized laboratory testing rather than expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The evaluation was based on conformance to a recognized standard (ASTM E1112-2006) through bench testing, not through expert adjudication of output.
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:
Not applicable. This is a digital thermometer, not an AI-powered diagnostic imaging device. No human-in-the-loop performance or MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance evaluation described ("bench test confirmed that the accuracy, precision and repeatability of device are compliance with ASTM E1112-2006 requirements") is a standalone assessment of the device's inherent performance characteristics against a standard. The device operates autonomously without human intervention to interpret its output in the context of its accuracy claim.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance evaluation was established by a recognized standard for electronic thermometers, ASTM E1112-2006. This standard defines the acceptable range of deviation from a true or reference temperature measurement. Therefore, the ground truth is a standardized reference measurement.
8. The sample size for the training set:
Not applicable. This device is a digital thermometer based on traditional sensor and ASIC technology, not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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510(K) SUMMARY
AUG D& 2010
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 Name:
Fudakang Industrial Co., Ltd
No.8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town, Dongguan, Guangdong, China . .
Contact Person of applicant:
Mr. Bob Yu
No.8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town, Dongguan, Guangdong, China
TEL: +86-769-81098181 FAX: +86-769-81098187 Email: bobyu@fudakang.com
Contact Person of the Submission:
Mr. Stephen Ling
MEDLAB (Shenzhen) Information Service Co., LTD
Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road Shenzhen, Guangdong, P.R. China, 518034
TEL: +86-755-83089699 FAX: +86-755-83089760
Email: lingbensuo(@gmail.com, please CC sabrinawei(@hotmail.com
Section 5, Page 5-1
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2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Thermometer, electronic |
| Trade Name: | Digital Thermometer |
| Model: | BT-A11CN, BT-A21CN, BT-A41CN |
| Classification name: | Thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
3.0 Predicate Device Information
| Sponsor: | Famidoc Technology Co., Ltd. |
|---|---|
| Device: | Famidoc Digital Clinical Thermometer FDTH-V0-1,FDTH-V0-2, FDTH-V0-3, FDTH-V0-4. |
| 510(K) Number: | K072641 |
4.0 Device description
Fudakang digital thermometers are hand-held, reusable, battery operated. The models include BT-A11CN, BT-A21CN, and BT-A41CN. All the models have the same indication for use. The difference points are their shapes, colors, voice function, and measurement speed.
The operation principle is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. The digital thermometer comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result.
5.0 Intended Use
Fudakang Digital The mometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.
6.0 Performance Summary
The devices meet the ASTM Standard Specification for Electronic Thermometer for intermittent Determination of Patient Temperature ASTM E1112-2006, as well
Section 5, Page 5-2
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as IEC 60601-1 and IEC 60601-1-2 requirements. The bench test confirmed that the accuracy, precision and repeatability of device are compliance with ASTM E1112-2006 requirements.
The thermometers can be used for axillary, oral and rectal measurement. For axillary use, it directly contacts body skin. For oral or rectum use, it directly contacts membrane tissue. The patient contact materials in the device are made of stainless steel, ABS plastic, and thermoplastic rubber. They are all compliance with ISO10993-1 biocompatibility requirements, and pass the ISO10993-5 and ISO10993-10 tests.
7.0 Comparison to predicate device and conclusion
Compare with predicate device, they are very similar in design principle, intended use, functions, material and the adopting applicable standards. The differences between applicant device and predicate device do not raise and new questions of safety or effectiveness.
l ). Indication for use
Famidoc Digital Clinical Thermometer can be used for axillary measurement, oral measurement and rectal measurement. Fudakang Digital Thermometers, BT-A11CN, BT-A21CN, BT-A41CN have the same measurement application.
2). Environment conditions
The environment conditions of Fudakang Digital Thermometers are a little different from Famidoc Digital Clinical Thermometer. But they are both compliance with IEC 60601-1 and ASTM E1112 requirements. So the difference of environment conditions will not raise any safety or effectiveness issue.
3). Accuracy
The accuracy of subject device is: 95.0 - 102.0 F : +/- 0.2 F 35.0 - 39.0℃: +/- 0.1℃ The rest: +/- 0.2°C - - -
The accuracy of predicate device is: +/- 0.1℃ (0.2F ) for whole range
Although there is a little difference, but the subject device accuracy is compliance with ASTM E 1112 requirements. So the difference of accuracy will not raise any safety or effectiveness issue.
4). Response time
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The Subject Device is 60s. The Predicate Device is 30s.
The Response time of Fudakang Thermometers is a little different from Famidoc Digital Clinical Thermometer. They are all compliance with IEC 60601-1 and ASTM E 1112 requirements. The difference of Response time will not raise any safety or effectiveness issue.
Conclusions: Fudakang Digital Clinical Thermometers, model: BT-A11CN, BT-A21CN, BT-A41CN are substantially equivalent to the predicate devices.
Submission prepared date: March 23, 2010 8.0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Fudakang Industries Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526
AUG 03 2010
Re: K101387
Trade/Device Name: Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 9, 2010 Received: July 19, 2010
Dear Mr. Mouser:
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-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); 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,
Susan Buono
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
Enclosure
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Statement of Indications for Use
510(k) Number (if known):
Device Name: Digital Thermometer Models: BT-A11CN, BT-A21CN, BT-A41CN
AUG-0 3 2010
Indications For Use:
Fudakang Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.
BT-A11CN, BT-A21CN, BT-A41CN can be used for axillary measurement, oral measurement and rectal measurement.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
8/3/10
Page 1 of 1
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Powises Division of Anton, Dental Devices
510(k) Number: K101387
§ 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.