(101 days)
K# 983295, K# 000969
Not Found
No
The device description and performance studies focus on standard infrared temperature measurement and comparison to predicate devices, with no mention of AI or ML algorithms for data processing or interpretation.
No.
A therapeutic device is used to treat a disease or condition, whereas this device is a thermometer used for measurement and diagnosis.
Yes
Explanation: The device measures human body temperature, which is a physiological parameter. While not directly diagnosing a disease, it provides data that can be used by a healthcare professional to identify or monitor a medical condition (e.g., fever), thus serving a diagnostic purpose in a broader sense.
No
The device description explicitly lists hardware components such as an IR sensor, Micom IC, LCD module, ambient temperature sensor, keys, and a battery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The DX-707 Infrared Ear Thermometer measures body temperature by detecting infrared radiation emitted from the ear. This is a direct measurement of a physiological parameter in vivo (within the living body), not an analysis of a specimen in vitro (outside the living body).
- Intended Use: The intended use is for "intermittent measurement of human body temperature," which is a direct physiological measurement.
Therefore, the DX-707 Infrared Ear Thermometer falls under the category of a general medical device, specifically a clinical thermometer, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Ear Thermometer, Model DX-707 is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.
Product codes
FLL
Device Description
The DX-707 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer using an infrared sensor that measures patient body temperature through the opening of the auditory canal. Its operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
The DX-707 Infrared Ear Thermometer consists mainly of five parts with the associated circuit: (1) IR sensor, (2) Micom IC, (3) LCD module, (4) an ambient temperature sensor (thermistor), and (5) Keys, "I/O", "Measure". The DX-707 thermometer is powered by internal DC 3V battery, size CR2032 and it is supplied with probe cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane and adjacent surfaces
Indicated Patient Age Range
all ages
Intended User / Care Setting
home care environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A comparison study and clinical repeatability testing was performed on the following four ages group; 0-3years, 4-10 years, 11-65 years, and >65 years. Approximately 39% of the patients participating in the study were considered febrile. The comparison study demonstrated that the DX-707 Infrared Ear Thermometer measured ear temperature equivalently to the predicate devices in all age groups. The clinical repeatability is statistically and clinically acceptable.
Key Metrics
Not Found
Predicate Device(s)
K# 983295, K# 000969
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Submission
4 2002 MAR
Instant Infrared Thermoscanner, DX-707
SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information in accordance with the requirements
Of SMDA 1990 and 21 CFR 807.92
Infrared Ear Thermometer, Model DX-707
1. SUBMITTER'S IDENTIFICATION
| Submitter's Name: | Jawon Medical Co., Ltd. |
|---|---|
| Submitter's Address: | 7F Jeong Ju Bldg., 1451-38 Seocho-Dong, |
| Seocho-Ku, Seoul, Korea | |
| Contact Person: | Won-Hee Park/President |
| TEL: (011) 82-2-587-4056 / FAX: (011) 82-2-588-1937 |
DEVICE DENTIFICATION 2.
| Trade/Proprietary Name: | Infrared Ear Thermometer, Model DX-707 |
|---|---|
| Common Name: | Radiation Thermometer (Tympanic Thermometer) |
| Classification Name: | Clinical Electronic Thermometer, Class II, 80FLL |
INFORMATION OF 510(K) CLEARED DEVICES (PREDICATE DEVICES): 3.
- Braun ThermoScan® Instant Thermometer, K# 983295, Braun ThermoScan (Models IRT . 3020/3520)
- Microlife Digital Infrared Ear Thermometer, K# 000969, model IRIDA1, Microlife . Corporation, 9f, 431 Rui Guang Road, Nei Hu, Taipei 114, Taiwan, Republic of China.
DEVICE DESCRIPTION: 4.
The DX-707 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer using an infrared sensor that measures patient body temperature through the opening of the auditory canal. Its operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
000010
The DX-707 Infrared Ear Thermometer consists mainly of five parts with the
1
associated circuit: (1) IR sensor, (2) Micom IC, (3) LCD module, (4) an ambient temperature sensor (thermistor), and (5) Keys, "I/O", "Measure". The DX-707 thermometer is powered by internal DC 3V battery, size CR2032 and it is supplied with probe cover.
INTENDED USES: ર.
The DX-707 Infrared Ear Thermometer is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS: 6.
The DX-707 Infrared Ear Thermometer and the predicate devices have the same general design, incorporate similar technology.
The primary function of the DX-707 Infrared Ear Thermometer is the same as the predicate devices. The device is to be used for the measurement of body temperature. The DX-707 raise no new questions of safety and effectiveness.
Jawon Medical Co., Ltd., concludes that the DX-707 Infrared Ear Thermometer is the substantially equivalent to the predicate devices.
PERFORMANCE SUMMARY 7.
The DX-707 Infrared Ear Thermometer has been tested and has proven to function in an equivalent manner as the predicate devices. Based on the results of the bench testing the DX-707 Infrared Ear Thermometer is considered safe and effective when used as intended.
Compliance to applicable voluntary standards includes IEC60601-1 and IEC60601-1-2 requirements. In addition, this infrared thermometer meets the requirements established in ASTM Standard E1965-98, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature". Full responsibility of the conformance of this product to the standard is assumed by Jawon Medical Co., Ltd.
000011
2
Clinical Results
A comparison study and clinical repeatability testing was performed on the following four ages group; 0-3years, 4-10 years, 11-65 years, and >65 years. Approximately 39% of the patients participating in the study were considered febrile. The comparison study demonstrated that the DX-707 Infrared Ear Thermometer measured ear temperature equivalently to the predicate devices in all age groups. The clinical repeatability is statistically and clinically acceptable.
000012
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health, Service
Image /page/3/Picture/2 description: The image is a black and white circular logo. The logo features an abstract image of an eagle in the center. The words "HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2002 MAR
Jawon Medical Company Limited C/O Mr. John So Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526
Re: K013876
Trade/Device Name: Infrared Ear Thermometer, DX-707 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 18, 2002 Received: February 20, 2002
Dear Mr. So:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becases or child 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 mensiale conmisees prior to that have been reclassified in accordance with the provisions of Amendinents, of to devroos that nave ooch (Act) that do not require approval of a premarket the rederal I vou, Drug, and Commonsy, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condors providents or 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 (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundsh further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be advisod that I DTP is issualles on that your device complies with other requirements
4
of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with a!l 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
K. Whilton A
Tim A. Ulatowski Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
5
510(k) Submission
(if known): 510(k) Number: Infrared Ear Thermometer, DX-707 Devicc Name:
Indication For Use:
The Infrared Ear Thermometer, Model DX-707 is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINU ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Palusta Cuccento
Sign-Off) of Dental, Infection Control, eral Hospi החבר
Prescription Use __ (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________