LogoFDA 510(k) Search
K Number
K201299
Device Name
HD Steth
Manufacturer
HD Medical, Inc.
Date Cleared
2020-07-10

(56 days)

Product Code
DQDDPSDQC
Regulation Number
870.1875
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running. The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision. Caution: The sale of this device is restricted to licensed clinicians or entities referred to by a licensed clinician. It is intended for use by a licensed clinician only.
Device Description
HD Steth is an electronic audio-visual stethoscope with integrated electrodes for electrocardiogram (ECG or EKG) rhythm. HD Steth is designed to acquire heart sounds through a diaphragm and 1-lead EKG rhythm through three fixed electrodes integrated around the diaphragm. The device has 3 auscultation modes – Bell, Diaphragmand Lung (Wide). The EK G rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. Both the heart sounds or phonocardiogram (PCG) and the EKG rhythm are acquired simultaneously and can be visualized, recorded and replayed using an accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.
More Information

K131287

K100531

No
The summary describes a device that captures, records, and displays physiological signals (heart sounds and ECG rhythm) and calculates basic metrics like heart rate. There is no mention of algorithms that learn from data, make predictions, or interpret complex patterns, which are characteristic of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

No
The device is used to capture, record, and replay heart sounds and ECG rhythm, aiding in evaluation, rather than providing or directly supporting a treatment.

No

The "Intended Use / Indications for Use" section explicitly states, "HD Steth is not intended to be used as a diagnostic device." It also mentions it does not supersede the judgment of a qualified clinician and is intended to "aid the physician in the evaluation of PCG and EKG rhythm."

No

The device description explicitly states that HD Steth is an "electronic audio-visual stethoscope with integrated electrodes" and mentions "Hardware System Testing" in the performance studies, indicating it includes physical hardware components beyond just software.

Based on the provided text, the HD Steth is not an In Vitro Diagnostic (IVD) device.

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 provide information about a person's health.
  • HD Steth's Function: The HD Steth acquires and displays heart sounds (PCG) and electrocardiogram (ECG or EKG) rhythm directly from the patient's body. It does not analyze samples taken from the body.
  • Intended Use Statement: The "Intended Use / Indications for Use" explicitly states that the device is "meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm." It also clearly states, "HD Steth is not intended to be used as a diagnostic device."

Therefore, the HD Steth falls under the category of a medical device that interacts directly with the patient's body for physiological signal acquisition, not an IVD.

N/A

Intended Use / Indications for Use

HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running.

The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device.

The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision.

Caution: The sale of this device is restricted to licensed clinicians or entities referred to by a licensed clinician. It is intended for use by a licensed clinician only.

Product codes

DQD, DQC, DPS

Device Description

HD Steth is an electronic audio-visual stethoscope with integrated electrodes for electrocardiogram (ECG or EKG) rhythm. HD Steth is designed to acquire heart sounds through a diaphragm and 1-lead EKG rhythm through three fixed electrodes integrated around the diaphragm. The device has 3 auscultation modes – Bell, Diaphragmand Lung (Wide). The EK G rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. Both the heart sounds or phonocardiogram (PCG) and the EKG rhythm are acquired simultaneously and can be visualized, recorded and replayed using an accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.

Device Accessories:

    1. Diaphragm (HDS060-001)
      Use only HD diaphragm with the device. Use of non-HD diaphragms can result in faulty audio and display and possible analysis irregularities in any future detection/screening algorithms.
    1. USB Cable (HDS060-002)
      Micro USB Type-B Male connector to USB 4-Pin Type-A Male connector can be used to connect the device to the charger. Length is 1 meter.
    1. Earplugs (HDS060-003)
      Use only HD earplugs.
      Use of non-HD earplugs can result in pain in ears due to material hardness and may degrade audio.
    1. Battery (HDS060-004) Rechargeable Li-Ion 18650 (Size) 3400mAh 3.7 V– 1 No.
    1. Battery Charger (HDS060-005) Input: 100-240V AC, 50/60 Hz, Output: 5.0V DC, 2000 mA
    1. HD Speaker (HDS060-006) HD Speaker is used to replaying recorded audio.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm.

The device must be used in a clinical setting by trained and qualified personnel only.

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)

Performance testing was conducted to support the design and development of the proposed device including biocompatibility testing, electrical safety and electromagnetic compatibility (EMC) testing, and the verification and validation testing: Mobile Application Software, Hardware System Testing, Firmware System Testing and ECG (EKG) and PCG Simulation Testing.

Report Document Number: Electromagnetic Compatibility Test (VOL_036_EMC)

  • Test Description: EMI/EMC test report

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Harmonics on AC Mains

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Voltage Fluctuation on AC Mains

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Mains Terminal Continuous Disturbance Voltage (Conducted Emission)

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Radiated Emission

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Radiated Radio-Frequency Electromagnetic Fields (Radiated Susceptibility)

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Proximity Fields From RF Wireless Communications Equipment

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Conducted Disturbances Induced by Radio-Frequency Fields (Conducted Susceptibility)

  • Referenced Standard: ANSI /AAMI /IEC 60601-1-2:2014 / EN 60601-1-2:2015

  • Test Result: Pass

  • Test Description: Power Frequency Magnetic Fields

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Electrical Fast Transients and Bursts

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Surges

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Electrostatic Discharges

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Voltage Dips

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Voltage Interruptions

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

Report Document Number: Bluetooth (BT) Coexistence Test (VOL_037_Coexistence testing)

  • Test Description: Wireless Coexistence

  • Referenced Standard: ANSI C63.27:2017

  • Test Result: Pass

  • Test Description: Unintended Signal Baseline

  • Referenced Standard: Not mentioned, but mentions "(Method ANSI C63.27:2017 EN 300 328 V2.1.1:2016)" for the next row waveform of the test signal

  • Test Result: Pass

  • Test Description: waveform of the test signal

  • Referenced Standard: (Method ANSI C63.27:2017 EN 300 328 V2.1.1:2016)

  • Test Result: Pass

  • Test Description: FCC15.247:2020 Bluetooth(FHSS)

  • Referenced Standard: ANSI C63.10:2013 KDB 558074

  • Test Result: Pass

  • Test Description: Output Power

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Spurious Radiated Emissions

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Antenna Heights

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: BLE power

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Low 2.716 dBM

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: Medium 2.896 dBM

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

  • Test Description: High 1.723 dBM

  • Referenced Standard: Not mentioned for this row

  • Test Result: Pass

Additional verification and validation testing also demonstrated successful assessment of Mobile Application Software, Hardware System, Firmware System and ECG (EKG) and PCG Simulation.

Key results: The collective performance testing demonstrates that HD Steth does not raise any different questions or effectiveness when compared to the predicate device. The results of performance testing demonstrate that the HD Steth performed as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Cardiosleeve, 510(k) K131287

Reference Device(s)

ViScope, 510(k) K100531

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 10, 2020

HD Medical, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K201299

Trade/Device Name: HD Steth Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DQC, DPS Dated: May 14, 2020 Received: May 15, 2020

Dear Prithul Bom:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K201299

Device Name HD Steth

Indications for Use (Describe)

HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running.

The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device.

The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision.

Caution: The sale of this device is restricted to licensed clinicians or entities referred to by a licensed clinician. It is intended for use by a licensed clinician only.

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.

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 Drug 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."

3

HD Medical, Inc.

510(k) SUMMARY - HD Steth

I. SUBMITTER

HD Medical Inc. 3561 Homestead Road, Suite #146, Santa Clara, CA 95051 USA Telephone: +1 408-338-6244 Contact Person: Venkat Raman Date Prepared: June 23, 2020

II. DEVICE

Name of Device: HD Steth
Common Name: Electronic Stethoscope
Classification Name: Electronic Stethoscope, Phonocardiograph, Cardiac monitor
(including cardiotachometer and rate alarm).
Regulation Number: 21 CFR §870.1875, 21 CFR §870.2390, 21 CFR §870.2340
Product Classification Code: DQD, DQC, DPS
Regulatory Class: Class II

III. PREDICATE/ REFERENCE DEVICE

PREDICATE DEVICE

Predicate Trade Name: Cardiosleeve, 510(k) K131287
Manufacturer: Rijuven
Classification Name: Electronic Stethoscope, Phonocardiograph
Regulation Number: 21 CFR §870.1875, 21 CFR §870.2390
Product Classification Code: DQD, DQC
Regulatory Class: Class II

REFERENCE DEVICE

Reference Trade Name: ViScope, 510(k) K100531
Manufacturer: HD Medical

IV. DEVICE DESCRIPTION

HD Steth is an electronic audio-visual stethoscope with integrated electrodes for electrocardiogram (ECG or EKG) rhythm. HD Steth is designed to acquire heart sounds through a diaphragm and 1-lead EKG rhythm through three fixed electrodes integrated around the diaphragm. The device has 3 auscultation modes – Bell, Diaphragmand Lung (Wide). The EK G rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. Both the heart sounds or phonocardiogram (PCG) and the EKG rhythm are acquired simultaneously and can be visualized, recorded and replayed using an

4

accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.

Device Accessories:

    1. Diaphragm (HDS060-001)
      Use only HD diaphragm with the device. Use of non-HD diaphragms can result in faulty audio and display and possible analysis irregularities in any future detection/screening algorithms.
    1. USB Cable (HDS060-002)
      Micro USB Type-B Male connector to USB 4-Pin Type-A Male connector can be used to connect the device to the charger. Length is 1 meter.
    1. Earplugs (HDS060-003)
      Use only HD earplugs.

Use of non-HD earplugs can result in pain in ears due to material hardness and may degrade audio.

    1. Battery (HDS060-004) Rechargeable Li-Ion 18650 (Size) 3400mAh 3.7 V– 1 No.
    1. Battery Charger (HDS060-005) Input: 100-240V AC, 50/60 Hz, Output: 5.0V DC, 2000 mA
    1. HD Speaker (HDS060-006) HD Speaker is used to replaying recorded audio.

V. INDICATIONS FOR USE

HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running.

The device has 3 auscultation modes - Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device.

The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician.

5

The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision.

VI. COMPARISON TO THE PREDICATE DEVICE

Both the HD Steth and the predicate device, Cardiosleeve (K131287) are both Class II, electronic stethoscopes intended for audio and visual display of heart sounds and electrocardiogram (ECG) rhythm using dry-electrodes, on a single patient at a time. The Cardiosleeve and HD Steth provide visual display of the phonocardiogram and 1-Lead EKG rhythm on a mobile application through Bluetooth connectivity for visualization. HD Steth and Cardiosleeve both use rechargeable batteries to power the devices.

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

| | HD Steth | Predicate Device:
Cardiosleeve (K131287) | Comments |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | Classification Comparison | | |
| Regulation Name | Electronic Stethoscope | Electronic
Stethoscope | Same |
| Regulation
Number | 21 CFR870.1875
21 CFR 870.2390
21 CFR 870.2340 | 21 CFR870.1875
21 CFR870.2390 | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | DQD, DQC, DPS | DQD, DQC | Same |
| Indication for Use Comparison | | | |
| Indications for
Use | HD Steth is an electronic
stethoscope meant to assist a
qualified clinician to capture,
record and replay heart sounds
and electrocardiogram (ECG or
EKG) rhythm. It is intended to be
used on one patient at a time.
Heart sounds (PCG) and 1-lead
EKG rhythm are acquired and
displayed simultaneously on
an accompanying | The CardioSleeve System
consisting of the
CardioSleeve Front-End
stethoscope and ECG
device, mobile heart
sound recording
application and the
remote diagnostic heart
murmur software is a
decision support device
intended to be used on a | Substantially
Equivalent |

Table 1: Comparison of HD Steth with Primary Predicate Device Cardiosleeve (K131287).

6

| mobile application on a hand-
held smart device like a phone or
tablet. The
waveforms can be recorded
and saved on the smart device
on which the app is running. | single patient to assist
the medical examiner in
analyzing cardiac sounds
for the identification and
classification of
suspected murmurs. It is
used to distinguish
between normal /
physiological and
pathological heart
murmurs by recording
the acoustic signal of the
heart and the ECG signal
simultaneously and
analyze these signals.
The acoustic heart signal
is analyzed to identify
specific heart sounds
that may be present.
Identified sounds include
S1, S2, and suspected
murmurs.
CardioSleeve indicates
whether or not a
recorded heart sound
contains a suspected
heart murmur. The
device must be used in
a clinical setting by
trained personnel with
the prescribed
accessories and all
relevant patient
information must be
taken into
consideration before a
diagnosis is made.
The interpretations of
heart sounds offered
by the CardioSleeve
device are only
significant when used
in conjunction with |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The device has 3 auscultation
modes – Bell, Diaphragm and
Lung (Wide). These modes and
volume levels can be changed by
the press of a button. The EKG
rhythm recording assists in
getting an indicative Heart Rate
(HR) that gets displayed on a
display panel on the device. | |
| The device must be used in a
clinical setting by trained and
qualified personnel only. HD
Steth is not intended to be
used as a diagnostic device. It
does not supersede the
judgement of a qualified
clinician. The device is
intended to aid the physician
in the evaluation of PCG and
EKG rhythm. The clinicians are
completely responsible for
reviewing and interpreting the
results, along with all other
relevant information, when
making a referral decision. | |
| Caution: The sale of this device
is restricted to licensed clinicians
or entities referred to by a
licensed clinician. It
is intended for use by a
licensed clinician only. | |

7

| | | well as consideration
of all other relevant
patient data.
CardioSleeve is not
intended to be a
diagnostic device. It
does not supersede
the judgment of the
qualified medical
personnel. The device is
intended to aid the
physician in the
evaluation of heart
sounds. The physicians
are responsible for
reviewing and
interpreting the results,
along with
the auscultation
findings and medical
history, when making a
referral decision.
Caution: This device is
intended for sale to
and use by a licensed
clinician only. | |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Technological Characteristics Comparison | | |
| EKG Rhythm
Capabilities | Yes (3 Electrodes) 1-Lead | Yes (3 Electrodes) 1-Lead | HD Steth and
Cardiosleeve
have the
capability to
acquire
1-Lead EKG
rhythm and
Cardiosleeve, the
HD Steth also
provides an EKG
Rhythm by using
three dry
electrodes |
| | | | |
| Phonocardiogram
and visualization
of sounds | Yes
On accompanying App | Yes
On accompanying
App | The Cardiosleeve
and HD Steth
provides visual
display of the
phonocardiogram and
1-Lead EKG
rhythm on a
mobile
application
through
Bluetooth
connectivity. |
| Signal
transmissions to
Mobile
Application via
Bluetooth | Yes - uses Bluetooth
Compatible with
Android devices | Yes - uses Bluetooth
Compatible with iOS
and Android devices | The Cardiosleeve
and HD Steth use
Bluetooth
technology to
connect their
respective Mobile
Application for
Visualization |
| Operating
Indications | Operating Mode
Battery Charge
Level,
Record Indication,
Bluetooth Connectivity, Audio
modes | LED on Device for Battery
ChargeLevel,
Record Indication,
Bluetooth Connectivity | HD Steth and
Cardiosleeve
have display
indications for
the features/
modes of the
device. |
| Power Source | One Li-ion battery 3400mAh, 3.7V | One 3.7 V Lithium Ion
Rechargeable Batteries | HD Steth and
Cardiosleeve
both use
Rechargeable
Batteries to
power the
devices |

8

9

VII. PERFORMANCE DATA

Performance testing was conducted to support the design and development of the proposed device including biocompatibility testing, electrical safety and electromagnetic compatibility (EMC) testing, and the verification and validation testing: Mobile Application Software, Hardware System Testing, Firmware System Testing and ECG (EKG) and PCG Simulation Testing.

| Report
Document
Number | Test Description | Referenced
Standard | Test Result |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------|
| Electromagnetic Compatibility Test (VOL_036_EMC) | | | |
| VOL 036
001_19646664
001 - Test report

  • EMI-EMC | EMI/EMC test report | | Pass |
    | | Harmonics on AC Mains | | Pass |
    | | Voltage Fluctuation on
    AC Mains | | Pass |
    | | Mains Terminal
    Continuous Disturbance
    Voltage (Conducted
    Emission) | | Pass |
    | | Radiated Emission | | Pass |
    | | Radiated Radio-
    Frequency
    Electromagnetic Fields
    (Radiated Susceptibility) | | Pass |
    | | Proximity Fields From RF
    Wireless Communications
    Equipment | | Pass |
    | | Conducted Disturbances
    Induced by Radio-
    Frequency Fields
    (Conducted Susceptibility) | ANSI /AAMI
    /IEC 60601-1-
    2:2014 / EN
    60601-1-2:2015 | Pass |
    | | Power Frequency
    Magnetic Fields | | Pass |
    | | Electrical Fast Transients
    and Bursts | | Pass |
    | | Surges | | Pass |

10

HD Medical, Inc.

Electrostatic DischargesPass
Voltage DipsPass
Voltage InterruptionsPass
Bluetooth (BT) Coexistence Test (VOL_037_Coexistence testing)
VOL 037
001_Report-
HDMG0002
CombinedWireless CoexistenceANSI
C63.27:2017Pass
Unintended Signal
Baseline(Method ANSI
C63.27:2017 ENPass
waveform of the test signal300 328
V2.1.1:2016)Pass
FCC15.247:2020
Bluetooth(FHSS)ANSI
C63.10:2013
KDB 558074Pass
Output PowerPass
Spurious Radiated
EmissionsPass
Antenna HeightsPass
BLE powerPass
Low 2.716 dBMPass
Medium 2.896 dBMPass
High 1.723 dBMPass

Additional verification and validation testing also demonstrated successful assessment of Mobile Application Software, Hardware System, Firmware System and ECG (EKG) and PCG Simulation.

The collective performance testing demonstrates that HD Steth does not raise any different questions or effectiveness when compared to the predicate device. The results of performance testing demonstrate that the HD Steth performed as intended.

VIII. CONCLUSIONS

The indications for use, technological characteristics and performance testing support that the proposed device is substantially equivalent, and as safe and effective as the predicate device, and raises no new issues of safety or effectiveness.