(160 days)
No
The description mentions a "built-in correction algorithm" and a "technique compensation feature" using capacitive rings and measurements of outer ear temperature. While these are algorithms, they are described as deterministic and rule-based, not as learning from data or adapting over time, which are characteristics of AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is used for measurement and monitoring of body temperature, which is a diagnostic function, not a therapeutic one.
No
The device is an ear thermometer, which measures body temperature. While temperature can be an indicator of health status, the device itself does not provide a diagnosis of a disease or condition; it only provides a measurement. Its intended use is "intermittent measurement and monitoring of human body temperature," not the diagnosis of a specific condition.
No
The device description clearly states it is a "hand held instrument" that measures infrared radiation and includes "capacitive rings mounted in the speculum," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Braun Thermoscan® PRO 6000 Ear Thermometer measures human body temperature by detecting infrared radiation emitted from the ear. This is a direct measurement of a physiological parameter within the living body.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient.
Therefore, based on its intended use and how it functions, the Braun Thermoscan® PRO 6000 Ear Thermometer is a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Braun Thermoscan® PRO 6000 Ear Thermometer is indicated for the intermittent measurement and monitoring of human body temperature for patients of all ages in a professional use environment. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Braun Thermoscan® PRO 6000 Ear Thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. The Braun Thermoscan® PRO 6000 Ear Thermometer also includes a technique compensation feature to detect depth of insertion to compensate for common methods of misuse, this feature uses capacitive rings mounted in the speculum of the thermometer to detect insertion and depth and measurements of the outer ear temperature during insertion to detect misuse and correct accordingly. The Braun Thermoscan® PRO 6000 Ear Thermometer is meant for professional use in hospitals and healthcare or professional office settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
professional use environment, professional use in hospitals and healthcare or professional office 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)
A comparison study and clinical repeatability testing was performed on the following four age groups: 0-12 months, 12 months-
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are simple and abstract, with flowing lines suggesting hair or head coverings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2016
KAZ USA, Inc (a Subsidiary of Helen of Troy, Inc) Mr. Raj Kasbekar Vice President, Regulatory Affairs 250 Turnpike Road Southborough, Massachusetts 01772
Re: K152748
Trade/Device Name: Braun Thermoscan® PRO 6000 Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 4, 2016 Received: December 8, 2016
Dear Mr. Kasbekar:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement Section 4:
Indications for Use
510(k) Number (if known): K152748
Braun Thermoscan® PRO 6000 Ear Thermometer Device Name:
Indications for Use:
The Braun Thermoscan® PRO 6000 Ear Thermometer is indicated for the intermittent measurement and monitoring of human body temperature for patients of all ages in a professional use environment. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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
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Image /page/3/Picture/0 description: The image shows the logo for Kaz USA, Incorporated. The logo is a stylized "kaz" in white letters against a blue background. Below the logo is the text "Kaz USA, Incorporated" followed by the address "250 Turnpike Road, Southborough, MA 01772".
K152748 510(k) Summary
Braun Thermoscan® PRO 6000 Ear Thermometer
1.0 Preparation Date:
February 19, 2016
2.0 Submitted By:
KAZ USA, Inc., a Helen of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752
Primary Contact Person/Prepared by:
Raj S Kasbekar, Global VP Regulatory & Clinical Affairs
KAZ USA, Inc., a Helen of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752
3.0 Device Identification:
3.1 Trade Name
Braun Thermoscan® PRO 6000 Ear Thermometer
Models:
US: PRO6000SCMN (Thermometer with Small Cradle), PRO6000LCMN (Thermometer with Large Cradle), PRO6000BSNA (Charge Dock) [Braun Thermoscan® PRO 6000 Ear Thermometer]
3.2 Common Name
Infrared Ear Thermometer
3.3 Classification Name
Thermometer, Clinical, Electronic
4
(21CFR 880.2910: Product code - FLL)
4.0 Predicate Device:
| Predicate | Manufacturer | Docket
Number |
|-----------------------------------------------|--------------------------------------|------------------|
| Braun Thermoscan® PRO 4000 Ear
Thermometer | Kaz USA, Inc
Contract: Keytronics | K103800 |
5.0 Device Description:
The Braun Thermoscan® PRO 6000 Ear Thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. The Braun Thermoscan® PRO 6000 Ear Thermometer also includes a technique compensation feature to detect depth of insertion to compensate for common methods of misuse, this feature uses capacitive rings mounted in the speculum of the thermometer to detect insertion and depth and measurements of the outer ear temperature during insertion to detect misuse and correct accordingly. The Braun Thermoscan® PRO 6000 Ear Thermometer is meant for professional use in hospitals and healthcare or professional office settings.
6.0 Indications for Use:
The Braun Thermoscan® PRO 6000 Ear Thermometer is indicated for the intermittent measurement and monitoring of human body temperature for patients of all ages in a professional use environment. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.
7.0 Validation Results:
Clinical Study to show substantial equivalence:
A comparison study and clinical repeatability testing was performed on the following four age groups: 0-12 months, 12 months- 42deg C | 0.3 deg C for 42 deg C | Meets ASTM E1965,
EN12470-5 and
ISO 80601-2-56 |
| Precision (SD) |