(70 days)
Not Found
No
The description focuses on infrared sensing and offset adjustments for temperature conversion, with no mention of AI/ML terms or related concepts like training/test sets.
No.
The device is a thermometer used for temperature measurement, which is a diagnostic function, not a therapeutic one. It does not treat or cure any medical condition.
No
The device is a thermometer used for measuring temperature, which is a vital sign, not for diagnosing a disease or condition. While temperature can be an indicator of illness, the device's function is solely to provide a measurement.
No
The device description explicitly states it is comprised of a battery-operated handheld thermometer unit tethered to a base station, indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, the Kendall Genius 2 Infrared Tympanic Electronic Thermometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Kendall Genius 2 measures temperature directly from the tympanic membrane in the ear canal. This is a direct measurement from the patient's body, not an analysis of a specimen taken from the body.
The device description and intended use clearly indicate it's a clinical thermometer for measuring body temperature, which falls under the category of general medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of core, oral, rectal, and axillary temperature based on the tympanic reading. The indications and intended use are the same as the predicate device, with the exception of the added axillary temperature equivalent.
Product codes
FLL
Device Description
The Genius 2 is a new infrared tympanic electronic thermometer comprised of a battery operated handheld thermometer unit tethered to a base station. This Class II device is an electronic clinical thermometer that measures temperature by sensing infrared emmisions from the tympanic membrane in the ear canal. Through offest adjustments, equivalent site temperatures can be displayed for oral, rectal, core, and axillary temperatures based on the tympanic reading. This clinical electronic thermometer offers a streamlined graphical user interface that walks the user through temperature measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane in the ear canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Acute and Alternate care settings
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)
Performance data for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer is compared to that of the predicate device identified in this 510(K) summary. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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) Summary
MAY 2 2 2006
Date Summary Was Prepared:
Submitter's Information:
Contact:
March 9, 2006
Kendall a Division of Tyco Healthcare Group LP 15 Hampshire Street Mansfield, MA 02048 Phone: 508-261-8000 Fax: 508-261-6644
Keith Martin Manager, Regulatory Affairs Kendall, a Division of Tyco Healthcare Group LP Telephone: 508-261-8440 Fax: 508-261-8461
Kendall Genius 2 Infrared Tympanic Electronic
Device Trade Name:
Device Common Name:
Tympanic Thermometer
Thermometer
Classification Panel:
General Hospital
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is substantially equivalent to the Kendall FirstTemp Genius Tympanic Thermometer (K920713) in intended use, materials, physical characteristics, and performance characteristics. The primary modifications attributed to the predicate device are the addition of the axillary equivalent reading, an improved algorithm for determining offsets, and improved accuracy.
Device Description:
The Genius 2 is a new infrared tympanic electronic thermometer comprised of a battery operated handheld thermometer unit tethered to a base station. This Class II device is an electronic clinical thermometer that measures temperature by sensing infrared emmisions from the tympanic membrane in the ear canal. Through offest adjustments, equivalent site temperatures can be displayed for oral, rectal, core, and axillary temperatures based on the tympanic reading. This clinical electronic thermometer offers a streamlined graphical user interface that walks the user through temperature measurement.
Confidential
03/08/06
1
The Genius 2 is designed to be compatible with the Tyco Healthcare/Kendall brand of disposable probe tip covers for patient safety and comfort. Probe covers are an existing legally marketed device and are not part of this 510(k) premarket notification submission. The Genius 2 is also designed to be compatible with the current FirstTemp Genius Field Calibrator for testing and verification of calibration status only.
Intended Use:
The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of core, oral, rectal, and axillary temperature based on the tympanic reading. The indications and intended use are the same as the predicate device, with the exception of the added axillary temperature equivalent.
Performance Data:
Performance data for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer is compared to that of the predicate device identified in this 510(K) summary. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2006
Mr. Keith Martin Manager, Regulatory Affairs Kendall, Tyco Healthcare Group, LP 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K060649
Trade/Device Name: Kendall Genius 2 Infrared Tympanic Electronic Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 9, 2006 Received: March 13, 2006
Dear Mr. Martin:
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. Martin
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/industry/support/index.html.
Sincerely yours,
Simita Y. Mchaimonis
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
4
Indications for Use
510(k) Number (if known): K060649
Device Name: Kendall Genius 2 Infrared Tympanic Electronic Thermometer
Indications For Use:
The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of oral, core, rectal, and axillary temperature based on the tympanic reading.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Shula A. Murphy, D.O. Anthony Wilson, CKOB
Control, Den
Number: K060 644