(121 days)
The devices are intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
The Digital Forehead Thermometer, Model KD -2200, consists of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature. The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing. The electronic signal was transferred to ASIC circuit on PC board through sensor of probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Disclaimer: This document is a 510(k) summary from 2007 for a medical device. The level of detail provided in such summaries is often limited, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive disclosure of all study specifics. Therefore, some information requested might not be explicitly available in the provided text.
Description of Acceptance Criteria and Proving Study
The K-jump Health Co., Ltd. Digital Forehead Thermometer, Model KD-2200, demonstrates compliance with acceptance criteria primarily through adherence to established international standards for electronic thermometers. The study mentioned focuses on demonstrating this compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Section | Requirement/Description | Reported Device Performance | Comments from Text |
|---|---|---|---|---|
| ASTM E1112-00 (Reapproved 2006) | N/A | "Electronic Thermometer for Intermittent Determination of Patient Temperature" | Complies with the standard. | This standard specifies accuracy, readability, response time, and other performance characteristics for electronic clinical thermometers. The document states the device complies. |
| EN 60601-1-2 (2001) | N/A | Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complies with the standard. | This standard covers electromagnetic compatibility, ensuring the device operates correctly in its intended electromagnetic environment. |
| EN 60601-1 (1997) | N/A | Medical electrical equipment - Part 1: General requirements for safety | Complies with the standard. | This standard outlines general safety requirements for medical electrical equipment. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the device "complies with" the ASTM E1112-00 standard, which implies a performance study was conducted according to that standard's testing requirements. The ASTM E1112 standard would define the required sample size and methodology for testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method for the test set. Given the nature of a thermometer, ground truth is typically established through a calibrated reference standard, not expert consensus or adjudication.
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
No, an MRMC comparative effectiveness study was not done. This device is a thermometer, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The provided text indicates that the device's performance was assessed in a standalone fashion conforming to the ASTM E1112-00 standard. A thermometer, by its nature, operates in a "standalone" mode, measuring temperature directly. The output (the temperature reading) is the direct result of the device's internal algorithms and sensors. There is no "human-in-the-loop" performance in the sense of interpreting an output that requires cognitive processing from a human.
7. The Type of Ground Truth Used
The ground truth used for assessing the performance of the thermometer would be calibrated reference temperatures. The ASTM E1112-00 standard dictates specific testing methodologies that involve comparing the device's readings to highly accurate and traceable reference thermometers or temperature sources. The text doesn't explicitly state "calibrated reference temperatures," but compliance with ASTM E1112-00 inherently implies this type of ground truth.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence models. This device is a traditional electronic thermometer, and therefore, there is no training set in the AI sense. Its "training" would be inherent in its design, calibration, and manufacturing processes.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this type of device in the context of AI/ML, this question is not applicable. The device's accuracy is established through design validation and verification against calibrated standards during its development and manufacturing, not through a "training set" with established ground truth.
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K07 0491
page 1 of 1
JUN 2 1 2007
EXHIBIT 11
510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Daniel Tsenq K-jump Health Co., Ltd. No. 56 Wu Kung 500 Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
Date Prepared: Feb. 14, 2007
Name of Device and Name/Address of Sponsor
Digital Forehead Thermometer, Model KD-2200
K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person : Danny Wanq
| Common or Usual Name | Clinic Thermometer |
|---|---|
| Classification Name | Class II §880.2910 Clinical ElectronicThermometer |
| Predicate Device | Up-grade Forehead Thermometer,K#032362, Medisim Ltd. |
Intended Use/Indications for Use
The devices are intended to measure the human body
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temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
Technology Characteristics
The Digital Forehead Thermometer, Model KD -2200, consists of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature. The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing. The electronic signal was transferred to ASIC circuit on PC board through sensor of probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement.
Performance Data
The Digital Forehead Thermometer, Model KD-2200 complies with the ASTM E1112-00(Reapproved 2006) "Electronic Thermometer for Intermittent Determination of Patient Temperature" standard, EN 60601-1-2 (2001) and EN 60601-1(1997).
Substantial Equivalence
The device is substantially equivalent to Up-grade Forehead Thermometer, K#032362. The device is share the same intended use an indication for use with the exception of small differences in their temperature measurement ranges, minimum operational temperature and humidity, minimum storage temperature and humidity, both devices are technologically identical.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Danny Wang Quality Representative K-jump Health Company, Limited No. 56 Wu Kung 5th Road Wu Ku Industrial Park, Taipei Hsien TAIWAN 248
JUN 2 1 2007
Re: K070491
Trade/Device Name: Digital Forehead Thermometer, Model KD-2200 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermoter Regulatory Class: II Product Code: FLL Dated: June 15, 2007 Received: June 18, 2007
Dear Mr. Wang:
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.
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Page 2 -- Mr. Wang
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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
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EXHIBIT A
Indications for Use
510(k) Number (if Known):
Device Name: Digital Forehead Thermometer, Model KD-2200
Indication for Use:
The Diqital Forehead Thermometer, Model KD-2200 is intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109)
OR Over-The-Counter Use_ v
C
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Kony 41
§ 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.