(175 days)
This clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum.
The clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum. The device has the following skin contact parts: stainless steel tip, ABS plastic housing, and Ethylene/Butylene-Styrene Block thermoplastic housing. The method used to measure the temperature of a human follows the standard ASTM E1112(Standard Specifications for Electronic Thermometer for Intermittent Determination of Patient Temperature).
The provided text describes the Cotronic Clinical Electronic Thermometer Models TM12 and TM21. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance for specific clinical metrics like accuracy against a reference standard. Instead, it indicates compliance with recognized standards.
| Criterion Type | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Temperature Measurement | ASTM E1112 (Standard Specifications for Electronic Thermometer for Intermittent Determination of Patient Temperature) | The device follows this standard. |
| Electrical Safety | IEC60601-1 | The device follows this standard. |
| Electromagnetic Comp. | IEC60601-1-2 | The device follows this standard. |
| Biocompatibility | ISO 10993-5:2009(E) (Cytotoxicity) | The device meets this standard. |
| Biocompatibility | EPA Nitro-amines - USA 21 CFR Part 58 | The device meets this standard (presumably for testing of materials). |
| Biocompatibility | ISO 10993-10:2002/Amd.1:2006, idt EN10993-10:2009 (Irritation and Skin Sensitization) | The device meets this standard. |
| Biocompatibility | ISO 10993-12:2007 (Sample preparation and reference materials) | The device meets this standard. |
Study Proving Device Meets Acceptance Criteria:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study proving performance against novel acceptance criteria.
The study that proves the device meets the acceptance criteria is a comparison to the following standards: ASTM E1112, IEC60601-1, IEC60601-1-2, ISO 10993-5:2009(E), EPA Nitro-amines - USA 21 CFR Part 58, ISO 10993-10:2002/Amd.1:2006, idt EN10993-10:2009, and ISO 10993-12:2007 Bioevaluation.
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for clinical test sets as it relies on compliance with existing standards and comparison to a predicate device rather than a new clinical performance study. The data provenance is not specified beyond the device being manufactured by Cotronic Manufacturing in Shenzhen, Guang Dong, P.R. China. There is no information provided to indicate whether 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 applicable and not provided. The 510(k) summary relies on compliance with recognized performance standards for thermometers, not on a human expert-adjudicated ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There wasn't a "test set" in the context of human adjudication mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices or diagnostic algorithms where human readers' performance is evaluated with and without AI assistance. This document pertains to an electronic clinical thermometer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device operates "standalone" in that it directly measures temperature, the term "algorithm only without human-in-the-loop performance" is typically used for AI/software devices. For a simple electronic thermometer, the performance is inherent to the device's design and function in accordance with set standards. No specific "standalone algorithm performance study" beyond meeting the mentioned ASTM and IEC standards is described here.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the thermometer is defined by the standards themselves, specifically ASTM E1112 for temperature measurement accuracy. For biocompatibility, the ground truth is adherence to the specified ISO and EPA biocompatibility standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. Electronic thermometers do not typically use "training sets" in the context of machine learning algorithms. Their performance is based on their physical design and calibration against established measurement practices according to standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" for this device.
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Cotronic Manufacturing
Floor 4-6, Block 7, West of Zhoushi Road, Xixiang Street, BaoAn zone, ShenZhen, Guang Dong, P.R. China
K103407|S1
MAY 1 3 2011
510K Summary 510(K)#103407
Date: October 16, 2010
U.S. Agent and Primary Contact
Yan Dur Lin Abertek Company 23 Josiah Ave San Francisco, CA 94112 415-637-8395 DALEYDLIN@YAHOO.COM FDA CDRH DMC
APR 1 9 2011
RCDollibri
510K Holder
Cotronic Manufacturing Floor 4-6, Block 7, West of Zhoushi Road, Xixiang Street BaoAn Zone, ShenZhen, Guang Dong, P. R. China +86 755-81453681-1030 TaniMokr@contriver.com.hk
Manufacturer
Cotronic Manufacturing F4 Block4, FuYuan Ind Zone, Jiu Wei, XiXiang, BaoAn Zone, ShenZhen, GuangDong, P. R. China +86 755-81453681-1030 Owner/Opeartor Number: 9057884 FDA Registration Number: 3004215929
Device Information
| Trade Name: | Clinical Electronic Thermometer |
|---|---|
| Model: | TM12 and TM21 |
| Common Name: | Oral Thermometer |
| Classification Name: | Thermometer, Clinical, Electronic |
| Class: | II |
| Regulation: | 880.291 |
| Product Code: | FLL - Clinical Electronic Thermometer |
Device Description
The clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum. The device has the following skin contact parts: stainless steel tip, ABS plastic housing, and Ethylene/Butylene-Styrene Block thermoplastic housing. The method used to measure the temperature of a human follows the standard ASTM E1112(Standard Specifications for Electronic Thermometer for Intermittent Determination of Patient Temperature).
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Cotronic Manufacturing
Floor 4-6, Block 7, West of Zhoushi Road, Xixiang Street, BaoAn zone, ShenZhen, Guang Dong, P.R. China
Performance Summary
The device follows the following standards: ASTM E112, IEC60601-1, and IEC60601-1-2. The device meets Biocompatibility Standards for ISO 10993-5:2009(E), EPA Nitro-amines - USA 21 CFR Part 58, ISO 10993-10:2002/Amd.1:2006, idt EN10993-10:2009, and ISO 10993-12:2007 Bioevaluation.
Predicate Device
Cotronic Clinical Electronic Thermometer, Model TM01 and TM02.
Conclusion
The Clinical Electronic Thermometer, TM12 and TM21, is substantially equivalent to the legally marketed device by Cotronic's Clinical Electronic Thermometer, TM01 and TM02, any difference in their technological characteristics that do exist would not have a significant effect on the safety or effectiveness of the device. TM12 and TM21 are substantially equivalent to the predicate devices, TM01 and TM02.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
Cotronic Manufacturing C/O Mr. Yan Dur Lin General Manager and Owner Abertek 23 Josiah Avenue San Francisco, California 94112
Re: K103407
Trade/Device Name: Cotronic Digital Thermometer Regulation Number: 21 CFR 80.2910 Regulation Name: Thermometer, Clinical Electronic Regulatory Class: II Product Code: FLL Dated: October 16, 2011 Received: April 19, 2011
Dear Mr. Lin:
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. Lin
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.
h for
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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Indications for Use
Clinical Electronic Thermometer Model TM12 and TM21
This clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use X (21 CFR 801 Subpart C)
Liddell: for AZC May 13, 2011
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anool.neers - 1999
Infection Control, Dental Devices
K103407 510(k) Number:
§ 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.