(49 days)
No
The summary describes a standard infrared thermometer and does not mention any AI or ML components or capabilities.
No
Explanation: The device is a non-contact thermometer used to measure body temperature and is not indicated for treating or diagnosing any condition.
No
The device is a non-contact infrared thermometer intended for determining body temperature. While temperature can be an indicator for health conditions, the device's primary function is measurement, not diagnosis.
No
The device description clearly states it is a "hand-held infrared thermometer" that measures infrared energy, indicating it is a physical hardware device, not solely software.
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).
- Tyto Thermometer Function: The Tyto Thermometer measures body temperature by detecting infrared energy emitted from the forehead. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
The description clearly states it's a "non-contact clinical infrared thermometer" for determining "human body temperature from the center of the forehead." This aligns with the function of a standard medical thermometer, which is not considered an IVD.
N/A
Intended Use / Indications for Use
The Tyto Thermometer is a non - contact clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Tyto Thermometer is a non-contact infrared thermometer that enables measuring of the human body temperature for persons of all ages. The device is a hand-held infrared thermometer that, when positioned within 2 inches of a patient's forehead, measures the infrared energy emitted from the surface of the skin and converts it to a Core body temperature scale (Celsius, Fahrenheit) as represented on the oral body site. The device is designed for use by professional as well as lay users in clinical or nonclinical environments. The device can optionally be connected wirelessly to a user's mobile phone for use with a dedicated app (TytoCare App). Measurement results are displayed on the device LCD screen and in parallel on the mobile phone. Results of temperature recordings can be stored on the Tyto Server.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.
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)
Clinical Performance validation: The clinical validation study in accordance with ASTM E1965-98 (R 2009) and ISO 80601-2-56 (2009) was conducted to compare the Tyto Thermometer and the predicate device. The validation study included data from 124 subjects. The subjects were divided into 3 study groups by age: Group 1: up to 1 year (Sub-group 1a up to 3 months and Sub-group 1b 3 months up to 1 year), Group 2: 1 to 5 years and Group 3: older than 5 years. Within each age group both afebrile and febrile subjects were represented. The results from the clinical validation demonstrated that the Tyto Thermometer meets its specifications and has substantially equivalent performance to the predicate Thermometer in all age groups with respect to the bias and standard deviation in comparison to the reference gold standard Welch Allyn contact thermometers. The repeatability of the Tyto Thermometer was clinically and statistically acceptable for all age groups and Sub-groups. Hence, the Tyto Thermometer was able to meet the pre-defined criteria for accuracy and precision and the primary performance endpoint of the study has been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2019
Tyto Care Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K190242
Trade/Device Name: Tyto Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: March 8, 2019 Received: March 11, 2019
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190242
Device Name
Tyto Thermometer
Indications for Use (Describe)
The Tyto Thermometer is a non - contact clinical infrared thermometer intent determination of human body temperature from the center of the forehead on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
3
Image /page/3/Picture/0 description: The image shows the logo for TytoCare. The logo features a stylized owl face on the left, followed by the word "tytocare" in a sans-serif font. Below the word "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font.
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name
and Address: | Tyto Care Ltd.
12 Haomanut Street
Netanya, Israel, 4250445 | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Contact Person: | Stella Raizelman Perry
RA Director
Email: stellar@tytocare.com
Phone Number: +972 72-2210750
Fax Number: +972 72-2210752 | |
| Establishment
Registration
Number: | 3012678246 | |
| 510(k) | K190242 | |
| Date Prepared: | March 15, 2019 | |
| Device Trade
Name(s): | Tyto Thermometer | |
| Device Common
Name: | Forehead Thermometer | |
| Classification: | Name: Clinical electronic thermometer
Product code: FLL
Regulation No: 21 CFR 880.2910
Class: II
Panel: General Hospital | |
| Predicate
Device(s): | | |
| Device name
No Touch + Forehead
Thermometer NFT3000 | 510(k) No.
K134043 | Date of Clearance
May 21, 2014 |
The CliniCloud Thermometer (K161325) is used as the Reference Device. The CliniCloud Thermometer provides an example of a cleared device that communicates wirelessly to a smart phone application.
4
Image /page/4/Picture/0 description: The image shows the TytoCare logo. The logo features a stylized owl face inside a circular shape on the left. To the right of the owl is the word "tytocare" in a sans-serif font, with a small "TM" symbol next to the "e". Below "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font.
Intended use / indication for use statement
The Tyto Thermometer is a non- contact clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.
Device description
The Tyto Thermometer is a non-contact infrared thermometer that enables measuring of the human body temperature for persons of all ages. The device is a hand-held infrared thermometer that, when positioned within 2 inches of a patient's forehead, measures the infrared energy emitted from the surface of the skin and converts it to a Core body temperature scale (Celsius, Fahrenheit) as represented on the oral body site. The device is designed for use by professional as well as lay users in clinical or nonclinical environments. The device can optionally be connected wirelessly to a user's mobile phone for use with a dedicated app (TytoCare App). Measurement results are displayed on the device LCD screen and in parallel on the mobile phone. Results of temperature recordings can be stored on the Tyto Server.
Substantial Equivalence to Predicate Devices
| Proposed Device | Predicate | |
|---|---|---|
| Device Name | Tyto Thermometer | No Touch + Forehead |
| Thermometer (Model | ||
| NTF3000US) | ||
| Device Class | Class II | Class II |
| Classification | ||
| Panel | General Hospital and | |
| Personal use Monitoring | ||
| Devices | General Hospital and | |
| Personal use Monitoring | ||
| Devices | ||
| Product code | FLL | FLL |
| Regulation number | 21 CFR 880.2910 | |
| Clinical electronic | ||
| thermometer | 21 CFR 880.2910 | |
| Clinical electronic | ||
| thermometer | ||
| Regulation | ||
| description | Clinical electronic | |
| thermometer | Clinical electronic | |
| thermometer | ||
| Intended use and | ||
| indication for use | The Tyto Thermometer is a | |
| clinical infrared | The No Touch + Forehead | |
| Thermometer (Model | ||
| Proposed Device | Predicate | |
| thermometer intended for | ||
| intermittent determination | ||
| of human body temperature | ||
| on the center of the | ||
| forehead as the | ||
| measurement site on | ||
| people of all ages. The | ||
| Tyto Thermometer is | ||
| intended for use by both | ||
| adult lay users and | ||
| clinicians. It can be used | ||
| both at home and in clinic | ||
| environments. | NTF3000US) is a non- | |
| sterile, reusable | ||
| clinical thermometer | ||
| intended for the | ||
| intermittent determination | ||
| of human body | ||
| temperature in a touch and | ||
| no touch on the center of | ||
| the forehead as the | ||
| measurement | ||
| site on people of all ages. | ||
| Technological | ||
| Characteristics | Infrared sensor | Infrared sensor |
| Measuring Method | Detection of infrared | |
| energy and use | ||
| of predictive algorithms to | ||
| estimate | ||
| the body temperature | Detection of infrared | |
| energy and use | ||
| of predictive algorithms to | ||
| estimate | ||
| the body temperature | ||
| Resolution | 0.1°C / 0.1°F | 0.1°C / 0.1°F |
| Laboratory | ||
| Accuracy | ±0.2°C (0.4°F) on 36°C - | |
| 39°C (96.8°F - 102.2°F) | ||
| range, | ||
| ±0.3°C (0.5°F) accuracy | ||
| outside the above range. | ± 0.2°C on 35.5°C – | |
| 42.0°C range | ||
| (± 0.4°F on 95.9°F – | ||
| 107.6°F range) | ||
| ± 0.3°C (± 0.5°F) outside | ||
| this range | ||
| Temperature | ||
| Display | LCD | |
| Graphical display | Liquid Crystal Display, 4 | |
| digits plus | ||
| special icons | ||
| Measurement Site | Forehead: center | Forehead: center |
| Operating | ||
| Conditions | ||
| of use (ambient | ||
| temperature) | 16°C - 40°C | |
| (60.8 - 104°F) | 15 °C - 40 °C | |
| (59 °F - 104 °F) | ||
| Storage Conditions | ||
| (temperature/ | ||
| humidity/air | ||
| pressure) | -20°C – 60 °C | |
| (-4 - 140°F) | -25 °C - 60 °C | |
| (-13°F - 140 °F) | ||
| Measuring Range | 34.4°C - 42.2 °C | |
| (94.0 - 108.0 °F) | 34.4 °C - 42.2 °C | |
| (94.0 - 108 °F) | ||
| Power | ||
| Requirements | Li-ion, built-in, | |
| rechargeable | 2 AA Batteries | |
| Proposed Device | Predicate | |
| Wireless | ||
| Communication | wi-fi connection & data | |
| transfer to the mobile | ||
| device running the | ||
| TytoCare app. | None | |
| Display | Liquid Crystal Display | Liquid Crystal Display |
| Battery Life | Up to 300 cycles of | |
| charge/discharge | Up to 1000 measurements | |
| Power supply | Proprietary plug, 2A wall | |
| charger, US plug, Input: | ||
| 100-240Vac ~50-60Hz, | ||
| 500mA; Output: | ||
| 5Vdc@2A | N/A | |
| Size | 85 x 73 x 47 mm | |
| (3.35 x 2.87 x 1.85 inch) | L = 148 mm (5.83 in.) x | |
| Diameter=50mm(1.97in) | ||
| Weight | 0.33 lbs. (150g) | 99.5 g (with batteries), |
| 77.1 g (w/o batteries) | ||
| Biocompatibility | All parts that are in | |
| contact with the operator | ||
| comply with the | ||
| requirements of ISO | ||
| 10993-1 | All parts that are in | |
| contact with | ||
| patient/operator | ||
| comply with the | ||
| requirements of ISO | ||
| 10993-1 | ||
| Software | was verified and validated | |
| according to the FDA | ||
| guidance. | was verified and validated | |
| according to the FDA | ||
| guidance. |
The following table compares the Tyto Thermometer to the predicate device:
5
Image /page/5/Picture/0 description: The image shows the logo for TytoCare. The logo features a stylized owl head to the left of the word "tytocare". Below the word "tytocare" is the tagline "Health is in your hands".
6
Image /page/6/Picture/0 description: The image shows the TytoCare logo. The logo features a stylized owl face inside a circular shape on the left. To the right of the owl is the word "tytocare" in a sans-serif font, with a small "TM" symbol next to the "e". Below "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font.
All above devices are indicated for over the counter use. The Tyto Thermometer, like its predicate device the Kaz NTF3000 (K134043) are both intended for intermittent determination of human body temperature for people of all ages. Thus, the device meets the first requirement for a finding of substantial equivalence. The submission includes comparison of technological elements of the subject devices and predicate device in accordance with the Clinical Thermometer FDA guidance document, including comparison of labeling, components, materials, precision and repeatability and response time among others. The subject and predicate device have similar design features, both are handheld devices used for performing non-contact temperature recordings using infrared sensor to record a user's forehead temperature, which is converted to an oral equivalent temperature. The temperature measure for the subject device and the predicate thermometer is performed using a thermopile sensor with
7
Image /page/7/Picture/0 description: The image is a logo for TytoCare. The logo features a stylized owl face on the left, followed by the word "tytocare" in a sans-serif font. Below "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font. The owl face and the word "tytocare" are in a dark blue color, while the tagline is in a light gray color.
integrated thermistor for the target reading. Both the Tyto Thermometer and the predicate also use a thermistor for ambient temperature readings. Temperature measurements are obtained within 3 seconds, comparable to the 2 second response time of the predicate device. The temperature reading is obtained very quickly with both the Tyto device and the Kaz predicate, and the additional 1 second to obtain the reading does not raise any questions of safety or effectiveness.
Materials used in the manufacture of the subject device are similar to the predicate device. All skin contacting materials used meet the requirements for biocompatibility in accordance with ISO 10993-1.
Any minor differences between the Tyto Thermometer and its predicate device do not raise different questions of safety and efficacy. Additionally, test methods equivalent to those used to evaluate the predicates exist to evaluate the device and the testing demonstrated comparable performance.
Performance testing - Bench:
A testing plan was developed and performed in order to verify that the Tyto Thermometer meets its specifications and demonstrates, based on comparable characteristics, similar performance and safety as compared to its predicate device. The main aspects of the testing plan included:
- . Electrical safety and electromagnetic compatibility testing (according to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) +Am.1 (2012) , IEC 60601-1-11: 2015 and IEC 60601-1-2: 2014 )
- Biocompatibility assessment according to ISO 10993-1:2009 Biological ● evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", "ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity" and "ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization"
8
Image /page/8/Picture/0 description: The image shows the TytoCare logo. The logo features a stylized owl icon on the left, followed by the word "tytocare" in a bold, sans-serif font. Below the word "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font. The overall design is clean and modern, with a focus on conveying a sense of health and well-being.
- . Performance testing (According to ASTM E1965 – 98 ( R 2009) Standard for Infrared Clinical Thermometers, wireless coexistence)
- . The software was assessed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005". The overall level of concern was found to be moderate, with verification and validation testing confirming that the software performs as intended and is compliant to requirement and specification documents
- Cybersecurity Threat Analysis to assess the cybersecurity threats was . performed according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued on October 2, 2014"
The results from this testing demonstrate that the Tyto Thermometer meets its specifications, and has substantially equivalent performance to its predicate.
Clinical Performance validation
The clinical validation study in accordance with ASTM E1965-98 (R 2009) and ISO 80601-2-56 (2009) was conducted to compare the Tyto Thermometer and the predicate device. The validation study included data from 124 subjects. The subjects were divided into 3 study groups by age: Group 1: up to 1 year (Sub-group 1a up to 3 months and Sub-group 1b 3 months up to 1 year), Group 2: 1 to 5 years and Group 3: older than 5 years. Within each age group both afebrile and febrile subjects were represented. The results from the clinical validation demonstrated that the Tyto Thermometer meets its specifications and has substantially equivalent performance to the predicate Thermometer in all age groups with respect to the bias and standard deviation in comparison to the reference gold standard Welch Allyn contact thermometers. The repeatability of the Tyto Thermometer was clinically and statistically acceptable for all age groups and Sub-groups. Hence, the Tyto Thermometer was able to meet the pre-defined criteria for accuracy and precision and the primary performance endpoint of the study has been met.
9
Image /page/9/Picture/0 description: The image shows the logo for TytoCare. The logo features a stylized owl icon to the left of the word "tytocare" in a sans-serif font. Below the word "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font.
Conclusion
As outlined in this section, the Tyto Thermometer has similar intended use and fundamental technological characteristics as its predicate device, the KAZ NFT3000 (K134043). Any minor differences in intended use or technology between the Tyto Thermometer and its predicate do not raise different questions of safety or effectiveness. Furthermore, testing and clinical validation demonstrate that the performance of the Tyto Thermometer is comparable to its predicate device. Consequently, it is concluded that the Tyto Thermometer can be considered substantially equivalent to its predicate device.