(43 days)
Not Found
No
The description mentions a "built-in correction algorithm" but provides no indication that this algorithm utilizes AI or ML techniques. The performance studies focus on statistical equivalency of transmissivity, not on the performance of an AI/ML model.
No.
The device is indicated for the measurement and monitoring of human body temperature, which is a diagnostic function, not a therapeutic one.
No
The device is indicated for the "intermittent measurement and monitoring of human body temperature," which is a physiological measurement, not a diagnosis of a disease or condition.
No
The device description clearly states it is a "hand held instrument" that measures temperature using "infrared radiation" and includes a "probe cover," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intermittent measurement and monitoring of human body temperature". This is a physiological measurement, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device measures "natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces". This is a direct measurement of a physical property of the body.
- No mention of analyzing biological samples: The description focuses on measuring infrared radiation and using a probe cover as a sanitary barrier. There is no mention of collecting or analyzing any biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures body temperature directly, which falls outside the scope of IVD regulation.
N/A
Intended Use / Indications for Use
The Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use/professional use environment.
The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.
Product codes
FFL
Device Description
The Braun Thermoscan® Pro/IRT 4000 series 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 difference between the Pro 4000 series thermometer and the IRT 4000 series thermometer is that the Pro 4000 series sories themselver and any professional use in hospitals and healthcare or professional office settings, while the IRT 4000 series is meant for home use. There is no change to the thermometer or its manufacture as part of the modification described in this submission.
The probe cover (also called as lens filter) is a disposable plastic cover made of a biocompatible clarified polypropylene material (Pacur) that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people.
The manufacturing site for the probe cover has changed from Braun Ireland Ltd, Ireland to TekPackaging, Huntley, Illinois. In addition alternate materials (same family of plastics) will be used to manufacture the probe covers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal, ear canal, tympanic membrane
Indicated Patient Age Range
all ages
Intended User / Care Setting
consumers of all ages in a home use/professional use 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
Test Methods
- A. To show statistical equivalency, the Black welder method for showing statistical equivalency was used. The gold samples were used on the existing transmissivity test setup up to get a sample mean and standard deviation for the existing probe covers. The gold standard samples were then used on the new transmissivity test machine set up for a total of 1800 data points. A sample mean and standard deviation was then calculated based on these data points. This process was then repeated for samples manufactured at the new manufacturing site using the new material.
- B. Biocompatibility Testing: Tests for Cytotoxicity, Irritation and Sensitization in accordance with ISO 10993-1 and G95-1were carried out at an accredited ISO 17025 certified NAMSA laboratory.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Verification activities for equivalency and biocompatibility.
Sample Size: For transmisisivity testing, the gold standard samples were used, then 1800 data points were collected from the new transmissivity test machine setup. Ninety five (95) % confidence intervals were calculated for the gold standard samples and for the new probe covers.
Key Results:
- Transmissivity Equivalency: The 95% confidence intervals for the difference between the two dataset populations were within the acceptance criteria of ±0.01 deg F, indicating process and device equivalence between current and new probe covers in terms of their transmissivities. This led to the conclusion that probe covers made using the new process and new material will not affect temperature measurements.
- Biocompatibility: The new material passed all biocompatibility testing carried out in accordance with ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acceptance Criteria for Transmissivity: A tolerance (delta) of + 0.01 (10% of the tolerance or range of 0.2 deg C) was deemed adequate to show equivalency between the two data set populations. If the 95% confidence intervals for the difference between the two dataset populations were within these acceptance criteria, the two sets of data can be considered to be equivalent.
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
AUG 0 4 2010
510(K) STATEMENT / SUMMARY AS REQUIRED BY SECTION 807.92(c)
Braun Thermoscan® IRT 4000 Series/Pro 4000 Series Infra-Red Ear Thermometers with Probe Cover
1. SUBMITTED BY:
CONTACT PERSON: Raj S. Kasbekar
Kaz, USA Inc 250 Turnpike Road Southborough, MA 01772 Tel (508) 490-7280 Fax (508) 490-7270
2. DATE OF SUMMARY PREPARATION: July 12, 2010
3. DEVICE NAME:
| Device | Accessory | |
|---|---|---|
| Proprietary Name | Braun Thermoscan® Pro 4000 Series/IRT | |
| 4000 Series Thermometers | Probe Cover | |
| Common/Usual Name | Infra Red Ear Thermometer | Probe Cover |
| Classification Name | Clinical Electronic Thermometer | Probe over |
Table 1: Device and Accessory Names
4. DEVICE CLASSIFICATION:
Clinical Electronic Thermometer (21CFR 880.2910 Product Code FFL) has been classified under section 513 of the Act as Class II by the General Hospital Devices Panel.
5. DEVICE DESCRIPTION:
IRT/Pro 4000 Series Thermometer:
The Braun Thermoscan® Pro/IRT 4000 series 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 difference between the Pro 4000 series thermometer and the IRT 4000 series thermometer is that the Pro 4000 series sories themselver and any professional use in hospitals and healthcare or professional office
CONFIDENTIAL
3
1
settings, while the IRT 4000 series is meant for home use. There is no change to the thermometer or its manufacture as part of the modification described in this submission.
Probe Cover:
The probe cover (also called as lens filter) is a disposable plastic cover made of a biocompatible clarified polypropylene material (Pacur) that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people.
The manufacturing site for the probe cover has changed from Braun Ireland Ltd, Ireland to TekPackaging, Huntley, Illinois. In addition alternate materials (same family of plastics) will be used to manufacture the probe covers.
6. STATEMENT OF INTENDED USE / INDICATIONS FOR USE:
The Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use/professional use environment.
The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.
7. SUMMARY OF VERIFICATION ACTIVITIES
In order to show that the probe covers using the new material and made at the new manufacturing site that used the validated process are equivalent to the current probe covers and hence do not affect the temperature measurements taken by the Infra-red thermometer, verification activities were carried out to show that the transmissivity of the probe covers manufactured using the newly validated process were statistically equivalent to the probe covers currently produced (also referred to as the "gold standard samples"). This statistical analysis was carried out by an independent statistical contractor independent from Kaz. Biocompatibility testing in accordance with ISO 10993-1 and Memo G95-1 was also carried out for surface devices with a contact duration of less than 24 hours.
Test Methods
- A. To show statistical equivalency, the Black welder method for showing statistical equivalency was used. The gold samples were used on the existing transmissivity test setup up to get a sample mean and standard deviation for the existing probe covers. The gold standard samples were then used on the new transmissivity test machine set up for a total of 1800 data points. A sample mean and standard deviation was then calculated based on these data points. This process was then repeated for samples manufactured at the new manufacturing site using the new material.
- B. Biocompatibility Testing: Tests for Cytotoxicity, Irritation and Sensitization in accordance with ISO 10993-1 and G95-1were carried out at an accredited ISO 17025 certified NAMSA laboratory.
Kaz, USA, Inc
CONFIDENTIAL
2
Acceptance Criteria:
- A. A tolerance (delta) of + 0.01 (10% of the tolerance or range of 0.2 deg C) was deemed adequate to show equivalency between the two data set populations. If the 95% confidence intervals for the difference between the two dataset populations were within these acceptance criteria, the two sets of data can be considered to be equivalent.
- B. For Biocompatibility testing, acceptance criteria in accordance with ISO 10993 were chosen and are outlined in the Biocompatibility test reports.
Statistical Analysis
- A. For the gold standard samples as well as for the new probe covers made at the new site, ninety five (95) % confidence intervals were calculated for the difference between the two data set populations between the transmissivity test measurements using transmissivity testers at the current site and the new site. Since these 95% confidence intervals were within the chosen acceptance criteria of ±0.01 deg F, the acceptance criteria were met and therefore the data provided evidence of process and device equivalence between current and new probe covers in terms of their transmissivities.
- B. For Biocompatibility testing, statistical analysis was carried out in accordance with ISO 10993.
Conclusion
Based on these results, we can conclude that the probe covers made using the new process set up at the new manufacturing site with the new material will not affect the temperature measurements taken by the thermometer.
The new material also passed all the biocompatibility testing carried out as described above..
8. SUBSTANTIAL EQUIVALENCE:
There is no change to the intended use, indications for use, product specifications or technology or operating principle of the Braun Thermoscan® PRO 4000 series and Braun Thermoscan® IRT 4000 series Clinical Infrared Ear Thermometers or that of the probe covers (K031928).
The probe cover is a plastic cover that is used as a sanitary barrier between the infra red thermometer and the ear canal.
The manufacturing site for the probe cover has changed from Braun Ireland Ltd, Ireland to TekPackaging, Huntley, Illinois. In addition alternate materials (same family of plastics) will be used to manufacture the probe covers.
A process validation of the operation at the new manufacturing site and performance testing (biocompatibility testing in accordance with ISO10993-1 and Memo G95-1 for the alternate (0.000mpanent) volune that there are no new questions of safety and effectiveness when compared to the prodicate device (probe cover described in K031928). Hence the new probe cover manufactured at the new site is equivalent to the predicate device.
Kaz, USA, Inc
CONFIDENTIAL
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure embracing a sphere, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Mr. Raj Kasbekar Vice President, Regulatory Affairs KAZ USA. Incorporated (A Subsidiary of KAZ Inc.) 250 Turnpike Road Southborough, Massachusetts 01772
AUG 0 4 2010
Re: K101747
Trade/Device Name: Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 13, 2010 Received: July 15, 2010
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.
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Page 2- Mr. Kasbekar
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runnes
Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
AUG 0 4 2010
510(k) Number (if known): K101747
Device Name: Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometer
Indications For Use:
The Braun Thermoscan® IRT 4000 series and Braun Thermoscan@PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of thuman body temperature by consumers of all ages in a home use professional use environment respectively.
The probecover is used as a santary barnier between the mometer and the car canal.
Prescription Use (Part.21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.H. C. A
(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices of
510(k) Number: _
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