(207 days)
No
The summary describes a multi-sensor device for data collection and transmission, with performance studies focused on the accuracy and equivalence of the sensor measurements compared to predicate devices and standards. There is no mention of AI, ML, deep learning, or any algorithms that would process the collected data for interpretation or diagnosis beyond simple display and transmission. The "Not Found" entries for mentions of AI/ML and training/test sets further support this conclusion.
No
The device is intended to measure, record, and transmit health data for monitoring and counseling, not to treat or alleviate a medical condition.
Yes
The device is intended to measure and record various physiological data points (auscultation sound, temperature, SpO2, pulse rate, and images) from the human body, which are then transmitted for potential counseling with a physician. While it doesn't state it provides a diagnosis itself, the collection of such medical data for evaluation, especially with the mention of "guidance and data examination by a remote physician," aligns with the function of a diagnostic device as it gathers information to aid in the diagnostic process.
No
The device description explicitly states it is comprised of a "handheld unit" and describes performance testing for hardware components like the thermometer, SpO2 sensor, stethoscope, and otoscope. This indicates it is a hardware device with accompanying software, not a software-only medical device.
Based on the provided information, the MyHomeDoc device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MyHomeDoc's Functionality: The MyHomeDoc device measures and records data directly from the human body (auscultation sound, temperature, SpO2, pulse rate, and images of body parts). It does not analyze samples taken from the body.
The device is a multi-sensor medical device intended for home use to collect physiological data and images for potential remote physician review. While it provides information that can be used in a diagnostic process, the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The MyHomeDoc device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
MyHomeDoc device is intended for use by adult lay users in a non-clinical environment. MyHomeDoc application enables counseling with the physician and transmission of the information over an IP network.
Product codes (comma separated list FDA assigned to the subject device)
DQD, FLL, DQA, ERA
Device Description
The MyHomeDoc device is a home use device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device.
The Device enables user's examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body (for auscultation sound and images of an examined body part), fingertip (for pulse oximeter), forehead (for thermometer)
Indicated Patient Age Range
Adult
Intended User / Care Setting
adult lay users in a non-clinical 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Thermometer Performance & Accuracy Testing:
- Study Type: Performance and accuracy testing in compliance to ASTM E1965-98.
- Key Results: The MyHomeDoc device met all acceptance criteria. The difference between the IR readings (the "Direct mode") and the Black body is less than 0.3°C.
ASTM E1965-98 Thermometer:
- Study Type: Compliance test.
- Key Results: The test tables demonstrate compliance of the MyHomeDoc Thermometer component with ASTM E1965-98, Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
MyHomeDoc Device vs. Braun Predicate Device for Oral Equivalence Test Report:
- Study Type: Equivalence test.
- Sample Size: 81 users.
- Key Results: The difference between MyHomeDoc and the Brown NTF3000 predicate device was less than or equal to 0.4°C. The MyHomeDoc device met the acceptance criteria.
SpO2 verification protocol and report:
- Study Type: Verification test.
- Key Results: The MyHomeDoc device met all acceptance criteria. Displayed SpO2 value for each simulator value. MyHomeDoc measurements of monotonic increasing/decreasing values are monotonic and align within the 20% range.
Pulse rate verification:
- Study Type: Verification test.
- Key Results: MyHomeDoc device measured pulse results between 30BPM to 250BPM. MyHomeDoc device met the acceptance criteria.
Pulse Oximeter Hypoxia Protocol and Report:
- Study Type: Hypoxia test to validate SpO2 measurements.
- Key Results: The MyHomeDoc device met all acceptance criteria.
Stethoscope Test Report:
- Study Type: Evaluation against Littman predicate stethoscope.
- Key Results: MyHomeDoc devices used in the test met the acceptance criteria.
Otoscope Test Report:
- Study Type: Evaluation of Line-pair separation, Color differentiation and Illumination flux.
- Key Results: MyHomeDoc devices used in the test met the acceptance criteria.
Otoscope-gold standard vs. MyHomeDoc ear test comparison report:
- Study Type: Comparison with gold standard.
- Key Results: MyHomeDoc images were cleared allowing clinical evaluation. Landmarks of the ear were easily identified and the physician subjective assessment was positive. The MyHomeDoc device met the acceptance criteria and MyHomeDoc images are equivalent to those of the gold standard.
Software Validation:
- Study Type: Software verification and validation testing.
- Key Results: Documentation was provided as recommended by FDA's guidance, and the software level of concern is moderate.
Electrical Safety and EMC:
- Study Type: Electrical Safety and Electromagnetic compatibility testing.
- Key Results: Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62471 First edition, ISO 80601-2-61, IEC 60529, and wireless coexistence testing.
Usability testing:
- Study Type: Usability study.
- Key Results: Demonstrated that MyHomeDoc device can be used by the intended users for the intended uses and under the expected use conditions without serious use errors or problems.
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
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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March 23, 2021
MyHomeDoc Ltd. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
Re: K202483
Trade/Device Name: MyHomeDoc Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, FLL, DQA, ERA Dated: March 23, 2021 Received: March 22, 2021
Dear Jonathan Kahan:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: 06/30/2023 |
| See PRA Statement below. |
| 510(k) Number ( if known ) | K202483 |
|---|---|
| Device Name |
MyHomeDoc device
Indications for Use (Describe)
The MyHomeDoc device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
MyHomeDoc device is intended for use by adult lay users in a non-clinical environment. MyHomeDoc application enables counseling with the physician and transmission of the information over an IP network.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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FORM FDA 3881 (6/20) Page 1 of 1 FDA PSC Publishing Services (301) 443-6740 EF
Page 1
3
Traditional Premarket Notification Submission - 510(k) MyHomeDoc device 510(k) Number K202483
Date Prepared: August 28, 2020
I. SUBMITTER
MyHomeDoc Ltd. 13 Zarchin St. Ra'anana, 4366241 Tel: +972-(0)4- 9874202
Contact Person
Jonathan Kahan, Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 Tel:+1 202 637 5794 jonathan.kahan@hoganlovells.com
Back-up Company Contact:
Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma@gmail.com
II. DEVICE
Name of Device: MyHomeDoc device Common or Usual Name: MyHomeDoc device Classification Name: Oximeter, Clinical Electronic Thermometer, Oximeter and Otoscope Regulatory Class: II Product Code: DQD, FLL, DQA, ERA
PREDICATE DEVICE III.
MyHomeDoc Ltd. believes that the MyHomeDoc device is substantially equivalent to the following predicate devices:
- Pulse Oximeter- PulseOx 5500 Finger Device, manufactured by SPO Medical Ltd cleared under K040178, Classification name: Oximeter, Product code: DQA, Regulation: 21 CFR 870.2700
4
- Stethoscope- Tyto Stethoscope manufactured by Tyto care Ltd. cleared under ● K160401, Classification name Electronic stethoscope, Product code: DQD, Regulation: 21 CFR 870.1875
- . Thermometer- Braun No Touch + Forehead NTF3000 Thermometer, manufactured by Kaz USA, Inc, cleared under K163516, Classification: Clinical Electronic Thermometer, Product code: FLL, Regulation: 21 CFR 880.2910
In addition, the following reference device is used in this 510(k):
- Electronic Stethoscope Model 3200, manufactured by 3M Littman, cleared under ● K101834, Classification name Electronic stethoscope, Product code: DRG, Regulation: 21 CFR 870.2910
IV. DEVICE DESCRIPTION
The MyHomeDoc device is a home use device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device.
The Device enables user's examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data.
V. INDICATIONS FOR USE
The MyHomeDoc device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
MyHomeDoc device is intended for use by adult lay users in a non-clinical environment. MyHomeDoc application enables counseling with the physician and transmission of the information over an IP network.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE AND REFERENCE DEVICE
The MyHomeDoc device is substantially equivalent to its predicate devices.
MyHomeDoc device intended use combines the indications of the cleared predicate devices.
5
The MyHomeDoc device, like the Tyto Stethoscope, is intended for adults to record sounds from adult and pediatric patients' heart and lungs and abdomen in a home environment. Like the PulseOx 5500 predicate, the MyHomeDoc device is intended for saturation and pulse rate measurements. Similar to the Braun Forehead NTFF3000 thermometer, MyHomeDoc device is intended for body temperature determination.
The MyHomeDoc device has similar technological characteristics as the predicate Tyto Stethoscope in that it records and wirelessly transmits the patient's data to the care provider at a different location. Both devices contain software guidance that instructs the user where to place the sensor to measure the auscultation signal. An additional similarity is that the Tyto includes a class I otoscope as well.
The temperature sensor in the MyHomeDoc device is equivalent to its predicate in that both are contact/non-contact IR sensors that measure temperature from the center of the forehead. Both devices then convert this temperature to the oral equivalent and display this temperature in Fahrenheit or Celsius. While the thermometers have the same accuracy, there are slight differences in regards to the measurement range, but as the subject device has a greater range, this does not raise any questions. The company has performed testing demonstrating the performance of the thermometer over this temperature range.
The pulse oximeter in the MyHomeDoc device and the predicate are equivalent in that they both measure change in light intensity at 660 and 880 nm. Both devices perform spot measurement of oxygen saturation and pulse rate at the patient's fingertip. The measurement methods slightly differ in that the predicate measures the transmitted signal. while the subject device assesses the reflected signal.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility evaluation in compliance with ISO 10993-1. -
Cleaning, Packaging -
Cleaning validation testing, transportation and use life calculation of the MyHomeDoc device was performed to demonstrate compliance with the relevant standards. All tests were successfully completed.
Performance Testing -
Performance testing included the following:
6
| Name of test | Test description |
|---|---|
| Thermometer | |
| Thermometer performance & accuracy | |
| testing | Test in compliance to ASTM E1965-98.The |
| MyHomeDoc device met all acceptance criteria. | |
| The results of this test demonstrate that the | |
| difference between the IR readings (the "Direct | |
| mode") and the Black body is less than 0.3°C | |
| ASTM E1965-98 Thermometer | The test tables demonstrate compliance of the |
| MyHomeDoc Thermometer component with | |
| ASTM E1965-98, Standard Specification for | |
| Infrared Thermometers for Intermittent | |
| Determination of Patient Temperature | |
| MyHomeDoc Device vs. Braun | |
| Predicate Device for Oral Equivalence | |
| Test Report | The difference between MyHomeDoc and the |
| Brown NTF3000 predicate device was less than | |
| or equal to 0.4°C in a 81users. Therefore, the | |
| MyHomeDoc device met the acceptance criteria. | |
| Pulse oximeter | |
| SpO2 verification protocol and report | The MyHomeDoc device met all acceptance |
| criteria. |
- displayed SpO2 value for each simulator value.
- MyHomeDoc measurements of monotonic
increasing/decreasing values are monotonic and
align within the 20% range. |
| Pulse rate verification | MyHomeDoc device measured pulse results
between 30BPM to 250BPM.
MyHomeDoc device met the acceptance criteria. |
| Pulse Oximeter Hypoxia Protocol and
Report | The pulse oximeter hypoxia test performed in
order to validate the MyHomeDoc device SpO2
measurements. The MyHomeDoc device met all
acceptance criteria. |
| Stethoscope | |
| Stethoscope Test Report | The MyHomeDoc device and the Littman
predicate stethoscope where evaluated.
MyHomeDoc devices used in the test met the
acceptance criteria. |
| Otoscope | |
| Otoscope Test Report | Line-pair separation test, Color differentiation and
Illumination flux were evaluated. MyHomeDoc
devices used in the test met the acceptance criteria |
| Otoscope-gold standard vs. MyHomeDoc
ear test comparison report | MyHomeDoc images were cleared allowing
clinical evaluation, Landmarks of the ear were
easily identified and the physician subjective
assessment was positive. Therefore, the
MyHomeDoc device met the acceptance criteria
and MyHomeDoc images are equivalent to those |
| Name of test | Test description |
| | of the gold standard. |
7
All tests met the predefined acceptance criteria.
Software Validation -
The MyHomeDoc software level of concern is moderate. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Electrical Safely and EMC -
Electrical Safety per IEC 60601-1 and Electromagnetic compatibility (EMC) per IEC 60601-1-2 and IEC 60601-1-6 were conducted on the MyHomeDoc device. In addition, the system complies with IEC 60601-1-11, IEC 62471 First edition, ISO 80601-2-61 and IEC 60529, wireless coexistence testing.
Usability testing -
Usability study was conducted to evaluate the use-related safety and effectiveness of the MyHomeDoc when used by lay-user via observational data, knowledge task data, and interview data. The purpose of the current study is to demonstrate that MyHomeDoc device can be used by the intended users for the intended uses and under the expected use conditions without serious use errors or problems.
VII. CONCLUSIONS
The MyHomeDoc device was determined to be substantially equivalent to the predicate devices.