Tyto Stethoscope

K160401 · Tyto Care , Ltd. · DQD · Oct 19, 2016 · Cardiovascular

Device Facts

• Record ID: K160401
• Device Name: Tyto Stethoscope
• Applicant: Tyto Care , Ltd.
• Product Code: DQD · Cardiovascular
• Decision Date: Oct 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

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 Story

Electronic stethoscope system capturing heart, lung, and heart rate auscultation sounds via piezo sensor; utilizes bell and diaphragm filters. System comprises stethoscope tip, base unit, mobile app (smartphone), Tyto server, and clinician platform. Operates in store-and-forward or on-line exam modes. Patient or lay user performs exam; data transmitted over IP network to clinician. Clinician reviews recorded sounds on remote platform to provide assessment/recommendations. Facilitates remote clinical decision-making; enables access to professional auscultation in non-clinical settings.

Clinical Evidence

Bench testing only. Performance testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility, stethoscope performance, heart rate measurement, wireless coexistence, software validation, and a usability study. Results demonstrated the device functions as expected and meets safety and effectiveness requirements.

Technological Characteristics

Electronic stethoscope using piezo sensor technology. Features bell and diaphragm filters. Connectivity via IP network (mobile device/server platform). Software-supported. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for professional and lay users to perform heart, lung, and heart rate auscultation exams in clinical or non-clinical environments, enabling remote transmission of sound data for clinician assessment.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• PCP PC Stethoscope (K102893)
• 3M Littmann 3200 Stethoscope (K083903)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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FORM FDA 3881 (8/14)

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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: [phone] Fax: [phone]

#### Contact Person:

Ophir Lotan Tyto Care Ltd. 12 Haomanut Street Netanya, 4250445, Israel Tel: [phone] Fax: [phone] E-mail: [e-mail]

#### 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:

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 nonclinical 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.

## 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.