(29 days)
K# 034023
Not Found
No
The device description and intended use focus on standard infrared temperature measurement technology and do not mention any AI or ML components or capabilities.
No.
The device is a thermometer used to measure body temperature, which is a diagnostic tool, not a therapeutic one. It does not treat or alleviate any medical condition.
Yes
The device measures body temperature, which is a diagnostic indicator used to identify conditions like fever. While simple, it provides objective information about a patient's state.
No
The device description explicitly lists hardware components such as an IR Thermopile Sensor, ASIC, E2PROM IC, LCD, Blacklight, Kev2, and Buzzer1. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The AMPLIFE Digital Infrared Ear Thermometer measures body temperature by detecting infrared radiation from the ear. This is a measurement taken on the body, not a test performed on a sample taken from the body.
Therefore, based on the provided information, the AMPLIFE Digital Infrared Ear Thermometer is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is a Digital Infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting.
The device is used without a probe cover.
Product codes
FLL
Device Description
The AMPLIFE Digital Infrared Ear Thermometer, Model E100 is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD.
Its operation is based on measuring the natural thermal radiation emanating from the eardrum.
The AMPLIFE Digital Infrared Ear Thermometer, consists mainly of five parts:
- a) IR Thermopile Sensor
- b) ASIC
c) E2PROM IC
d) LCD and Blacklight - e) Kev2, Buzzer1
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear / eardrum
Indicated Patient Age Range
neonatal, pediatric and adult population
Intended User / Care Setting
Home setting / Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Controlled human clinical studies were conducted using the AMPLIFE Infrared Ear Thermometer E100. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per AMPLIFE clinical test protocol for infrared Ear Thermometer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Microlife Intellectual Property GmBH Infrared Ear Thermometer, Model IR1DE1-1, K# 034023
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
NOV 19 2004
yagou(l.1.f3)
Exhibit #1
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the reguirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :_______________________________________________________________________________________________________________________________________________
1. Submitter's Identification:
AMPLIFE Corporation 10F. No. 69, Sec. 3, Hue Jung Rd Taichung, Taiwan, R.O.C Tel: +0422587766 Fax: +0422587558
Date Summary Prepared: September 23, 2004
Contact: Mr. Laurence Yang
2. Name of the Device:
AMPLIFE Digital Infrared Ear Thermometer, Model E100
Common Name or Classification Name:
Infrared Ear Thermometer/Clinical Electronic Thermometer
3. Predicate Device Information:
Microlife Intellectual Property GmBH Infrared Ear Thermometer, Model IR1DE1-1, K# 034023.
4. Device Description:
The AMPLIFE Digital Infrared Ear Thermometer, Model E100 is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD.
Its operation is based on measuring the natural thermal radiation emanating from the eardrum.
The AMPLIFE Digital Infrared Ear Thermometer, consists mainly of five parts:
- a) IR Thermopile Sensor
- b) ASIC
c) E2PROM IC
1
φ429φb (P.αof3)
d) LCD and Blacklight
- e) Kev2, Buzzer1
5. Intended Use:
The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting.
This device is used without a probe cover.
દ. Comparison to Predicate Devices:
The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is substantially equivalent to the Microlife Intellectual Property Digital Ear Thermometer, Model IR1DE1-1, which has the same intended use and is similar in design to the predicate device.
The AMPLIFE Digital Infrared Ear Thermometer. Model E100 and the predicate device are identical in functionality and performance with the difference being the external shape of the devices, and PCB layout of the devices, performance specifications, ergonomics of the user interface, dimensional specifications, The temperature measurements algorithm and its fundamental scientific technology are identical to the predicate device.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC60601-1 and IEC60601-1-2 requirements.
Guidance documents included the "FDA Guidance on the content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".
Discussion of Clinical Tests Performed: 8.
Controlled human clinical studies were conducted using the AMPLIFE Infrared Ear Thermometer E100. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per AMPLIFE clinical test protocol for infrared Ear Thermometer.
2
K442906 (p.3 of 3)
Conclusions: 9.
The AMPLIFE Infrared Ear Thermometer, Model E100, has the same intended use and similar technological characteristics as the Microlife Intellectual Property Infrared Ear thermometer Model IR1DE1-1. Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the AMPLIFE Infrared Ear Thermometer, Model E100, is substantially equivalent to the predicate device.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
AMPLIFE Corporation C/O Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548
Re: K042906
Trade/Device Name: AMPLIFE Digital Ear Thermometer E100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 15, 2004 Received: November 17, 2004
Dear Mr. Devine:
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.
4
Page 2 - Mr. Devine
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,
Clus
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
5
Exhibit B
Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _