The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto stethoscope is intended for use by professional users in a clinical environment or in conjunction with patients or lay users in a non-clinical environment.

Device Description

The Tyto Stethoscope is designed for use by professional as well as lay users in clinical or nonclinical environments. It enables four types of stethoscope exams: Heart, Lungs, Heart Rate and Audio (Audio is for clinician only). The operation process of the Tyto Stethoscope uses four (4) primary functional elements:

(1) The Tyto Stethoscope (composed of a Stethoscope Tip and a Base Unit and supported with proprietary software)
(2) A mobile device (e.g., a smartphone, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare App is running),
(3) The Tyto Server platform (composed of server hardware not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary server software is running)
(4) A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary Clinician App is running).
Two operational flows are optional for using the Tyto Stethoscope: store-and-forward flow and on-line exam flow. Both flows are essentially similar and share the same fundamental steps: performing one or more measurements using the Tyto Stethoscope, recording the data and sending to a clinician, review of the recorded measurements by the clinician, and user receiving a written summary from the clinician presenting his/her assessment and/or recommendations. While in the store-and-forward flow the user can perform the measurements and send the recorded data to the clinician whenever convenient for him/her, an on-line flow may be executed only when also the clinician is available on-line.

AI/ML Overview

This document provides information about the Tyto Stethoscope, for which a 510(k) premarket notification was reviewed by the FDA. The document summarizes the device's intended use, description, and performance testing, but it does not explicitly state specific acceptance criteria or provide a detailed study that proves the device meets those criteria in the format requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information given, here's what can be inferred or stated:

Missing Information:
The provided document details the FDA's clearance for the Tyto Stethoscope but does not include:

A table of specific acceptance criteria and detailed reported device performance.
Sample size used for the test set or its provenance.
Number of experts, their qualifications, or adjudication methods for establishing ground truth.
Whether an MRMC comparative effectiveness study was done or effect size.
Whether a standalone algorithm-only performance study was done.
The sample size for the training set or how its ground truth was established.

Information Extracted from the Document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a tabular format. The document generally implies that the device should function as expected and be as safe and effective as predicate devices. The performance testing section lists categories of tests performed.
- Reported Device Performance: The document states, "Test results indicated that the Tyto Stethoscope functions as expected and is as safe and effective as its predicate devices for its intended use." No specific quantitative performance metrics are provided.
Sample size used for the test set and the data provenance: Not mentioned in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text.
Adjudication method for the test set: Not mentioned in the provided text.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned in the provided text. The device is a "Stethoscope," not an AI diagnostic tool in the sense of image interpretation assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The Tyto Stethoscope is an electronic stethoscope that records and transmits audio. Its "performance testing" likely refers to the fidelity of audio capture, heart rate measurement, and wireless transmission, as opposed to an AI algorithm making a diagnosis. The document does not describe a standalone algorithm-only performance as might be applicable to an AI diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned in the provided text. The testing seems to focus on functional performance (e.g., stethoscope performance, heart rate measurement) and safety rather than diagnostic accuracy against a disease ground truth.
The sample size for the training set: Not mentioned in the provided text.
How the ground truth for the training set was established: Not mentioned in the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring a symbol that resembles a human figure in profile, with flowing lines suggesting movement or connection.

October 19, 2016

Public Health Service

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

Tyto Care Ltd. Dr. Orna Oz President 155 Bialik St. Ramat Gan, 5252346 IL

Re: K160401 Trade/Device Name: Tyto Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: September 13, 2016 Received: September 13, 2016

Dear Dr. Orna Oz,

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.

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

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mada Jellm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K160401

Device Name

Tyto Stethoscope Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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FORM FDA 3881 (8/14)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 EF

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K160401 Page 1 of 3

510(K) SUMMARY 510(K) Number K160401

Applicant's Name:

Tyto Care Ltd. 12 Haomanut Street Netanya, 4250445, Israel Tel: +972-72-2210750 Fax: +972-72-2210752

Contact Person:

Ophir Lotan Tyto Care Ltd. 12 Haomanut Street Netanya, 4250445, Israel Tel: +972-52-8998865 Fax: +972-72-2210752 E-mail: ophirl@tytocare.com

Date Prepared:

October 6, 2016

Trade Name:

Tyto Stethoscope

Classification Name:

Electronic stethoscope

Product Code:

DQD

Device Class: II

Regulation Number:

870.1875

Panel:

Cardiovascular

Predicate Devices:

PCP PC Stethoscope [RNK Products, Inc.] cleared under K102893 ●
3M Littmann 3200 Stethoscope [3M Health Care] cleared under K083903 ●

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Intended Use / Indication for Use:

Device Description:

(1) The Tyto Stethoscope (composed of a Stethoscope Tip and a Base Unit and supported with proprietary software)
(2) A mobile device (e.g., a smartphone, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare App is running),
(3) The Tyto Server platform (composed of server hardware not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary server software is running)
(4) A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary Clinician App is running).

Two operational flows are optional for using the Tyto Stethoscope: store-and-forward flow and on-line exam flow. Both flows are essentially similar and share the same fundamental steps: performing one or more measurements using the Tyto Stethoscope, recording the data and sending to a clinician, review of the recorded measurements by the clinician, and user receiving a written summary from the clinician presenting his/her assessment and/or recommendations. While in the store-and-forward flow the user can perform the measurements and send the recorded data to the clinician whenever convenient for him/her, an on-line flow may be executed only when also the clinician is available on-line.

Substantial Equivalence:

The Tyto Stethoscope, like its two predicate devices, is an electronic stethoscope intended for projecting the sounds associated with the heart, lungs, arteries, veins, and other internal organs. Both the Tyto Stethoscope and the PCP PC Stethoscope are intended also to transmit the recorded auscultation sounds to a remote location where a clinician can listen to them. In addition, both these devices are indicated for use by lay users as well as by professional users.

The Tyto Stethoscope shares with its predicate devices similar structural design (i.e., device components and additional operational elements). In addition, similar principles and mode of operation are used:

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K160401 Page 3 of 3

. Both the Tyto Stethoscope and the PCP PC Stethoscope detect auscultation using a piezo sensor
Both the Tyto Stethoscope and the Littmann Stethoscope use Bell and Diaphragm filters
All three devices detect a comparable frequency range
Data transfer is enabled on-line by all three devices and a store-and-forward mode is ● enabled by both the Tyto and Littmann Stethoscopes.

Performance Testing:

Performance testing was conducted in order to demonstrate the performance, safety and usability of the Tyto Stethoscope. The testing plan included the following main tests:

Electrical safety and electromagnetic compatibility testing (according to IEC 60601-1 and . IEC 60601-1-2)
Biocompatibility assessment
Performance testing (e.g., stethoscope performance, heart rate measurement, wireless ●
coexistence) ●
SW validation testing and ●
A usability study ●

Test results indicated that the Tyto Stethoscope functions as expected and is as safe and effective as its predicate devices for its intended use. It is, therefore, concluded that the Tyto Stethoscope is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues.

Regulation Number and Section

§ 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.