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K Number
K161933
Device Name
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
Manufacturer
Kaz USA, Inc., A Helen of Troy Company
Date Cleared
2016-08-16

(33 days)

Product Code
FLL
Regulation Number
880.2910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intented for the intermittent measurement and monitoring of human body temperature by consumers in the home.
Device Description
The Braun ThermoScan® 3 High Speed Compact 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. The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is meant for intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use environment.
More Information

K052849

Not Found

No
The summary describes a standard infrared thermometer and does not mention any AI or ML capabilities. The performance studies focus on standard accuracy, safety, and usability testing, not on the performance of an AI/ML algorithm.

No.
The device measures body temperature, which is used for diagnosis or monitoring, not for treating a condition.

No

This device is intended for the intermittent measurement and monitoring of human body temperature. While temperature can be a symptom of illness, the device itself does not provide a diagnosis of a disease or condition; it only provides a measurement.

No

The device description explicitly states it is a "hand held instrument" that measures infrared radiation, indicating it is a physical hardware device, not software only. The performance studies also detail testing of physical components and manufacturing processes.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are 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 Braun ThermoScan® 3 High Speed Compact Ear Thermometer measures human body temperature directly from the ear canal. It does not analyze any biological specimens.
  • Intended Use: The intended use is for "intermittent measurement and monitoring of human body temperature," which is a direct physiological measurement, not an analysis of a sample.

Therefore, based on the provided information, this device falls under the category of a general medical device for physiological measurement, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intented for the intermittent measurement and monitoring of human body temperature by consumers in the home.

Product codes

FLL

Device Description

The Braun ThermoScan® 3 High Speed Compact 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. The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is meant for intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use environment.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

auditory canal, tympanic membrane and adjacent surfaces

Indicated Patient Age Range

consumers of all ages

Intended User / Care Setting

consumers in the home

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)

Non-clinical performance reports were provided to document verification and validation activities which are intended to demonstrate substantial equivalence of the subject device with the noted changes, to the predicate device:

  • A. Design Qualification Testing is completed to ensure that the device meets the product requirements.
    • a. Functional testing of software error handling per ASTM E1965 and ISO 80601-2-56
    • b. Functional testing of all functions after accelerated aging per ASTM F 1980-07 and ASTM D3045.
    • c. Labeling verification per requirements within ASTM E1965, ISO 80601-2-56, and IEC 60601-1
  • B. Engineering testing is completed to ensure that the device meets the performance standard requirements of ASTM E1965 and ISO 80601-2-56.
    • a. Measurement accuracy after preconditioning per standard requirements: Laboratory accuracy test: passed requirements per ISO 80601-2-56 ●
      • Clause 201.101.2 and ASTM E1965 Clause 5.3.1
      • Clinical accuracy validation test: passed requirements per ASTM E1965 ● Clause 5.5
    • b. Tests for other requirements of ISO 80601-2-56and ASTM E1965
      • · Passed requirements per ISO 80601-2-56
        • Clause 201.7: ME equipment identification, marking and . documents
        • Clause 201.12: Accuracy of controls and instruments and . protection against hazardous outputs
      • Passed requirements per ASTM E1965 ●
        • Clause 5.2: Displayed Temperature Range ●
        • Clause 5.3 Maximum Permissible Laboratory Error .
        • Clause 5.5 Special Requirements ●
        • Clause 5.6 Ambient Conditions ●
        • Clause 5.7 Low Power Supply Operation
        • Clause 5.8 Display and Human Interface ●
        • Clause 5.9 Construction
        • Clause 5.10 Labeling and Marking ●
        • Clause 6 Test Method
        • Clause 7 Documentation ●
  • C. Process Validation was completed to ensure that the installation qualification, operational qualification and performance qualification were successfully completed for validating the manufacturing process.
    • a. Soldering iron.
    • Electric screw driver. ❑
    • Constant temperature water tank C.
    • d. Pad printing machine
    • Injection molding e.
    • 25C and 37C validation f.
  • D. Biocompatibility Testing was completed in accordance with ISO-10993-1, 10993-5, 10993-10 and FDA Bluebook Memo G95-1.
  • E. Usability Testing was completed in accordance with IEC 62366 and FDA Guidance Document on Human Factors titled "Applying Human Factors and Usability Engineering to Medical devices" issued on February 3, 2016.
  • F. Electrical Safety, and Electromagnetic Compatibility testing was completed in accordance with IEC 60601-1:2005 and IEC 60601-1-2: 2007
    There is no change to the technological characteristics, operating principle, or intended use, of the thermometer for Braun ThermoScan® 3 High Speed Compact Ear Thermometer in comparison to the predicate device, thus clinical testing was deemed unnecessary.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy for body temperature measurement:
±0.2°C/0.4°F 35.5°C42.0°C (95.9°F107.6°F);
±0.3°C/0.5°F 34.0°C35.4°C (93.2°F95.7°F);
±0.3°C/0.5°F 42.1°C42.2°C (107.8°F108.0°F)

Predicate Device(s)

K052849

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2016

Kaz USA, Inc., A Helen of Troy Company Ms. Amy Liu Associate Director, Clinical and Regulatory Affairs 400 Donald Lynch Blvd., Suite 300 Marlborough, Massachusetts 01752

Re: K161933

Trade/Device Name: Braun ThermoScan® 3 High Speed Compact Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 11, 2016 Received: July 18, 2016

Dear Ms. Liu:

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

Page 2 - Ms. Amy Liu

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,

Tina Kiang -S

Tina Kiang, Ph.D. Acting 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

510(k) Number (if known) K161933

Device Name

Braun ThermoScan® 3 High Speed Compact Ear Thermometer

Indications for Use (Describe)

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intented for the intermittent measurement and monitoring of human body temperature by consumers in the home.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary - K161933

1. Company Name and Address

Kaz USA, Inc. A Helen of Troy Company 400 Donald Lynch Blvd., Suite 300 Marlborough, MA 01752

2. Establishment Registration Number

3006169981

3. Manufacturing Sites

Famidoc Technology Co., Ltd.

No.212 Yilong Road Hexi Industrial Zone Jinxia ,Changan Town Dongguan,Guangdong Province,China.

4. Device Name

Braun ThermoScan® 3 High Speed Compact Ear Thermometer

5. Device

Classification name: Thermometer, Clinical, Electronic Classification number - 21CFR 880.2910 Product code: FLL Requlatory Class: II

6. Predicate Device Information

Predicate device: Famidoc FDIR-V1 - 510(k)#: K052849

7. Performance Standards

  1. ASTM E1965-98:2003 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

  2. IEC 60601-1 31d edition:2005: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

  3. BS EN ISO 15223-1: 2012: Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements.

  4. IEC 60601-1-2:2007: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.

4

  1. IEC 62366-1: 2015 Medical devices - Part 1: Application of usability engineering to medical devices. 6) ISO 14971:2007: Medical devices - Application of risk management to medical devices. 7) ISO 10993-1 / ISO 10993-5 / ISO 10993-10: Biological Evaluation of Medical Devices.

8. Indications for Use

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.

9. Device Description and Product Change Description

The Braun ThermoScan® 3 High Speed Compact 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. The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is meant for intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use environment.

10. Technological Characteristics

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is identical to the predicated thermometer, FDIR-V1, with exception to the following changes:

  • -Addition of lens filter as a sanitary barrier between the infrared thermometer and the ear canal.
  • -Change in outer casing and associate industrial design to meet internal requirements.
  • -Update the brand name of the device.

11. Substantial Equivalence

Based on the comparison chart above, we believe that the Braun ThermoScan® 3 High Speed Compact Ear Thermometer is substantially equivalent to its predicate device cited above and does not raise any new safety and/or effectiveness issues.

| Elements of
Comparison | Subject Device | Predicate Device
(Famidoc FDIR-V1) | Comparison |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Infrared Ear
Thermometer | Infrared Thermometer | Similar |
| Models | The Braun ThermoScan®
3 High Speed Compact
Ear Thermometer | FDIR-V1 | Similar |
| 510(k) Number | Pending | K052849 | Similar |
| Manufacturer(legal) | Kaz USA, Inc., a Helen of
Troy Company | Famidoc Technology
Co., Ltd. | Similar |
| Contract Manufacturer | Famidoc Technology Co., | Famidoc Technology | Same |
| | Ltd. | Co., Ltd. | |
| Intended for use | The Braun ThermoScan®
3 High Speed Compact
Ear Thermometer is
intended for the
intermittent measurement
and monitoring of human
body temperature by
consumers in the home. | The device is intended
for the intermittent
measurement and
monitoring of human
body temperature, by
consumers in the home | Similar |
| Sensor | Infrared sensor | Infrared sensor | Similar |
| Microcontroller Unit | XWIC008
34.0°C42.2°C (93.2°F
108.0°F) | XWIC008
32.0°C42.9°C (89.6°F
109.2°F) | Similar
Similar (The
measurement range
was selected based on
the range specified in
ASTM E1965. This
range was then
included in the PRD
and communicated to
Famidoc (supplier) for
inclusion in the
engineering
specification. Since this
current range is a
subset of the predicate
device range it does not
raise new questions
regarding the
performance and
safety. All of the
verification testing was
completed for the
selected range from
ASTM E1965) |
| Accuracy for body
temperature
measurement | ±0.2°C/0.4°F
35.5°C42.0°C
(95.9°F107.6°F);
±0.3°C/0.5°F
34.0°C35.4°C
(93.2°F95.7°F);
±0.3°C/0.5°F
42.1°C42.2°C
(107.8°F108.0°F) | ±0.2°C/0.4°F 35.5°C
42.0°C
(95.9°F107.6°F);
±0.3°C/0.5°F 32.0°C
35.4°C (89.6°F95.7°F);
±0.3°C/0.5°F 42.1°C
42.9°C
(107.8°F109.2°F) | Similar |
| Resolution of display | 0.1°C/0.1°F | 0.1°C/0.1°F | Similar |
| Signal output and
display | LCD, Buzzer | LCD, Buzzer | Similar |
| Power supply | One 3V CR2032 button
Li-MnO2 battery | One 3V CR2032 button
Li-MnO2 battery | Similar |
| Fundamental
Technology
&Operating Principle | Uses Infrared Sensor and
signal acquisition,
conditioning, processing
with embedded
microprocessor and | Uses Infrared Sensor
and signal acquisition,
conditioning, processing
with embedded
microprocessor and | Similar |
| | software | software. | |
| Lens filter | Yes, used | No | Demonstrated to not
raise questions of
safety and
effectiveness through
requirements within
standard ASTM E1965,
ISO80601-2-56, ISO
10993 |
| Performance | Meets ASTM E 1965, EN
12470-5 and ISO80601-
2-56 | Meets ASTM E 1965,
EN 12470-5 and
ISO80601-2-56 | Similar |
| Biocompatibility | Meets ISO 10993 and
FDA Bluebook memo
G95-1 | Meets ISO 10993 and
FDA Bluebook memo
G95-1 | Similar |
| Electrical Safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Similar |
| EMC | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Similar |

Braun ThermoScan® 3 High Speed Compact Ear Thermometer

5

6

12. Non-clinical testinq

Non-clinical performance reports were provided to document verification and validation activities which are intended to demonstrate substantial equivalence of the subject device with the noted changes, to the predicate device:

  • A. Design Qualification Testing is completed to ensure that the device meets the product requirements.
    • a. Functional testing of software error handling per ASTM E1965 and ISO 80601-2-56
    • b. Functional testing of all functions after accelerated aging per ASTM F 1980-07 and ASTM D3045.
    • c. Labeling verification per requirements within ASTM E1965, ISO 80601-2-56, and IEC 60601-1
  • B. Engineering testing is completed to ensure that the device meets the performance standard requirements of ASTM E1965 and ISO 80601-2-56.
    • a. Measurement accuracy after preconditioning per standard requirements: Laboratory accuracy test: passed requirements per ISO 80601-2-56 ●
      • Clause 201.101.2 and ASTM E1965 Clause 5.3.1
      • Clinical accuracy validation test: passed requirements per ASTM E1965 ● Clause 5.5
    • b. Tests for other requirements of ISO 80601-2-56and ASTM E1965
      • · Passed requirements per ISO 80601-2-56
        • Clause 201.7: ME equipment identification, marking and . documents
        • Clause 201.12: Accuracy of controls and instruments and . protection against hazardous outputs
      • Passed requirements per ASTM E1965 ●
        • Clause 5.2: Displayed Temperature Range ●
        • Clause 5.3 Maximum Permissible Laboratory Error .
        • Clause 5.5 Special Requirements ●

7

  • Clause 5.6 Ambient Conditions ●
  • Clause 5.7 Low Power Supply Operation
  • Clause 5.8 Display and Human Interface ●
  • Clause 5.9 Construction
  • Clause 5.10 Labeling and Marking ●
  • Clause 6 Test Method
  • Clause 7 Documentation ●
  • C. Process Validation was completed to ensure that the installation qualification, operational qualification and performance qualification were successfully completed for validating the manufacturing process.
    • a. Soldering iron.
    • Electric screw driver. ﻘ
    • Constant temperature water tank C.
    • d. Pad printing machine
    • Injection molding e.
    • 25C and 37C validation f.
  • D. Biocompatibility Testing was completed in accordance with ISO-10993-1, 10993-5, 10993-10 and FDA Bluebook Memo G95-1.
  • ய Usability Testing was completed in accordance with IEC 62366 and FDA Guidance Document on Human Factors titled "Applying Human Factors and Usability Engineering to Medical devices" issued on February 3, 2016.
  • ட Electrical Safety, and Electromagnetic Compatibility testing was completed in accordance with IEC 60601-1:2005 and IEC 60601-1-2: 2007

13. Clinical testing

There is no change to the technological characteristics, operating principle, or intended use, of the thermometer for Braun ThermoScan® 3 High Speed Compact Ear Thermometer in comparison to the predicate device, thus clinical testing was deemed unnecessary.

14. Conclusion

Based on the performance testing and compliance with acceptable voluntary standards, we believe that the Braun ThermoScan® 3 High Speed Compact Ear Thermometer is substantially equivalent to the predicate device cited above.