(509 days)
The device measures the human body temperature from oral, armpit, and rectal. The device is reuseable and intended for clinical or home use on people of all ages.
The Clinical Electronic Thermometer is a thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans.
The provided text describes a 510(k) premarket notification for a Clinical Electronic Thermometer. Here's a breakdown of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM E1112 ("Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature") | The Clinical Electronic Thermometer conforms to ASTM E1112. |
| Conformance to IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) | The Clinical Electronic Thermometer conforms to IEC 60601-1. |
| Conformance to IEC 60601-1-2 (Collateral Standard: Electromagnetic compatibility – Requirements and tests) | The Clinical Electronic Thermometer conforms to IEC 60601-1-2. |
Note: The document states that these standards were met "In terms of physical requirements and operating parameters."
2. Sample Size Used for the Test Set and Data Provenance
No information is provided regarding the sample size used for any test set or the provenance of any data. The document explicitly states: "Controlled human clinical studies were not conducted using the Clinical Electronic Thermometer and predicate devices." This indicates that the device's performance was not evaluated through human clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no human clinical studies were conducted, there was no test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. No human clinical studies were conducted.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a thermometer, not an AI-assisted diagnostic tool for image interpretation, and no MRMC studies are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, an algorithm-only standalone performance study was not done in the context of an AI device. The device is a thermometer, and its performance was assessed against established engineering and safety standards (ASTM E1112, IEC 60601-1, IEC 60601-1-2).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for demonstrating the device's performance was conformance to established industry standards for electronic thermometers (ASTM E1112, IEC 60601-1, IEC 60601-1-2). These standards define acceptable performance characteristics for such devices.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (thermometer) and not an AI/machine learning model that typically involves training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/machine learning model, there was no training set or corresponding ground truth to establish.
{0}------------------------------------------------
DEC 27 2004
510(k) Summary
(As required by 21 CFR 807.92)
Premarket Notification Number: Applied for
-
- Submitter's Identification:
Cotronic Manufacturing 4F, Block 4, Fu Yuan Ind. Zone, Jiu Wei, Xi Xiang, Bao An zone, Shen Zhen, China Tel: +86-755-2747-7681 Fax: +86-755-2747-7680 Contact: Mr. Shine Wan
- Submitter's Identification:
Date Summary Prepared: July 15, 2003
-
- Name of the Device:
Clinical Electronic Thermometer
- Name of the Device:
3. Predicate Device Information:
Digital Thermometer classic type and flexible type, K023711, Acute Ideas Co., Ltd.
4. Device Description:
The Clinical Electronic Thermometer is a thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans.
5. Intended Use:
The device measures the human body temperature from oral, axillary and rectal. The device is reusable and intended for clinical or home use on people of all ages.
5
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K032434'. The characters are written in black ink on a white background.
6. Comparison to Predicate Devices:
The Clinical Electronic Thermometer is substantial equivalence to Acute Ideas' Digita! Thermometer Classic type and Flexible type.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
In terms of physical requirements and operating parameters, the Clinical Electronic Thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature", as well as IEC 60601-1 and IEC 60601-1-2 requirements.
8. Discussion of Clinical Tests Performed:
Controlled human clinical studies were not conducted using the Clinical Electronic Thermometer and predicate devices.
9. Conclusions:
The Clinical Electronic Thermometer has the same intended use and similar technological characteristics as predicate devices. Moreover, any differences in their technological characteristics that do exist would not have a significant effect on the safety or effectiveness of the device. Thus, the Clinical Electronic Thermometer is substantially equivalent to the predicate devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a circle of text surrounding it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 27 2004
Mr. Shine Wan Operation Manager Cotronic Manufacturing 4F, Block 4, Fu Yuan Ind. Zone, Jiu Wei, Xi Xiang, Bao An Zone, Shen Zhen, CHINA
Re: K032434
Trade/Device Name: Clinical Electronic Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 5, 2004 Received: October 5, 2004
Dear Mr Wan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{3}------------------------------------------------
Page 2 - Mr Wan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Irene Moreau for
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number(if known): K032434
Device Name: Clinical Electronic Thermometer
Indications For Use:
The device measures the human body temperature from oral, armpit, and rectal. The device is reuseable and intended for clinical or home use on people of all ages.
Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ﻟﺴﻨﺔ، ﻭﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ (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)
Kyle Hubbard fo Anthony Kalzon
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022437
§ 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.