(126 days)
The Wireless Thermometer, model WTM-B530-I, is a battery-operated elected electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and is intended for armpit temperature monitoring for persons over two years old.
The proposed device is use to measure, monitor and record the body temperature in armpit, and transmits the data recorded to receiver for display by wireless (blue tooth) way in real time.
The provided text describes a 510(k) submission for the Raiing Medical Company Wireless Thermometer, Model WTM-BT30-I. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with detailed acceptance criteria and performance data for the proposed device itself.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly define "acceptance criteria" for clinical performance in the context of a new study for the WTM-BT30-I, but rather implies meeting established standards through conformity to recognized performance standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Conformity) |
|---|---|
| Biocompatibility (ISO 10993-1, ISO 10993-5, ISO10993-10, ISO10993-12) | Conformed to ISO 10993-1, ISO 10993-5, ISO10993-10, ISO10993-12. |
| Electrical Safety (IEC 60601-1) | Conformed to IEC 60601-1 |
| Electromagnetic Compatibility (IEC 60601-1-2 and FCC) | Conformed to IEC 60601-1-2 and FCC |
| Performance (ASTM E1112) | Conformed to ASTM E1112 |
2. Sample size used for the test set and the data provenance
The document does not describe a specific clinical test set and therefore does not provide information on its sample size or data provenance. The assessment is based on conformity to existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no described clinical test set for the proposed device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no described clinical test set for the proposed device.
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. The device is a thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the thermometer) independent of human interpretation. The claim is that the device "Conformed to ASTM E1112" for performance, which is a standard for electronic thermometers. This implies standalone performance testing against recognized accuracy standards, but the specific results are not detailed beyond conformity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance claim (conformity to ASTM E1112), the ground truth would be established by the reference measurement standards and methods defined within the ASTM E1112 standard itself for evaluating thermometer accuracy. This typically involves comparison to highly accurate reference thermometers in controlled environments.
8. The sample size for the training set
Not applicable. This device is a thermometer, not a machine learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable.
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Section 1 510(k) Summary
As required by 807.92
The assigned 510(k) Number is 12 1696
Sponsor
Raiing Medical Company No. 11, Huatong Rd., Beijing, China 102200 Mr. Wu Wei, General Engineer Tel:+86-10-64118658 Fax: +86-10-80115555 ext. 776445 Email: tjww@raiing.com
Submission Correspondent Mr. Wu Wei Raiing Medical Company No. 11, Huatong Rd., Beijing, China 102200 Tel: +86-10-64118658 Fax: +86-10-80115555 ext. 776445 Email: tjww@raiing.com
Wireless Thermometer
WTM-BT30-I
21 CFR 880.2910
FLL
Class II
New Device
Proposed Product
Trade Name Model Product Code: Regulation Number: Device Class:
Submission Purpose:
Predicate Device:
K100226/RIO FLEXON TECHNOLOGY CO., LTD.
The proposed device is use to measure, monitor and record Device Description the body temperature in armpit, and transmits the data recorded to receiver for display by wireless (blue tooth) way in real time.
Test Conclusion IEC 60601-1 IEC 60601-1-2 ASTM E1112-00
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FCC Part 15 Performance Test
The proposed device is Substantially Equivalent (SE) to the SE Determination predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness. Please refer to the brief SE Comparison Table as following.
Intended Use/Indication for Use
The Wireless Thermometer, model WTM-BT30-I, is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and is intended for armpit temperature monitoring for persons over two years old.
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| Comparison Elements | Proposed Device | Predicate Device (K100226) | |
|---|---|---|---|
| Intended Use | The Wireless Thermometer, model WTM-B530-I, is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and is intended for armpit temperature monitoring for persons over two years old. | The Wireless body temperature monitor, model BTM-D1x series are the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitors armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurements as well as the armpit temperature monitor for the person above two years old. | |
| Device Specifications | The proposed device has the similar device specification with the predicate device without new risk of safety and effectiveness. | ||
| Material Specification | All materials used for skin-connecting are meet the requirements of FDA and the biocompatibility test has been conducted. | ||
| Safety and Performance | Biocompatibility | Conformed to ISO 10993-1, ISO 10993-5, ISO10993-10, ISO10993-12. | Conformed to ISO 10993-1, ISO 10993-5, ISO10993-10, ISO10993-12. |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 | |
| Electromagnetic Compatibility | Conformed to IEC 60601-1-2 and FCC | Conformed to IEC 60601-1-2 and FCC | |
| Performance | Conformed to ASTM E1112 | Conformed to ASTM E1112 |
:
Brief SE Comparison Table between the Proposed Device and Predicate Device
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Raiing Medical Company
Mr. Wu Wei
General Engineer
No. 11, Huatong Road
Beijing, China 102200
OCT 1 1 2012
Re: K121696
Trade/Device Name: Wireless Thermometer WTM-BT30-I Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 10, 2012 Received: September 10, 2012
Dear Mr. Wei:
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. Wei
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For S. Shultz
Anthony D. Watson, B.S., M.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
510(k) Number (if known): _ K121696
Device Name: Wireless Themometer /Model: WTM-BT30-I
Indications For Use:
The Wireless Thermometer, model WTM-B530-I, is a battery-operated elected electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and is intended for armpit temperature monitoring for persons over two years old.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rill Chaye 9/21/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K121696
§ 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.