Who is the manufacturer of HD Steth?

Hd Medical, Inc. filed the 510(k) submission for HD Steth (K201299).

What is the FDA product code for HD Steth?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HD Steth?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like HD Steth?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HD Steth

K201299 · Hd Medical, Inc. · DQD · Jul 10, 2020 · Cardiovascular

Device Facts

Record ID	K201299
Device Name	HD Steth
Applicant	Hd Medical, Inc.
Product Code	DQD · Cardiovascular
Decision Date	Jul 10, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2
Attributes	3rd-Party Reviewed

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.

Device Story

Electronic stethoscope with integrated electrodes; acquires heart sounds via diaphragm and 1-lead ECG via three fixed electrodes. Device features three auscultation modes (Bell, Diaphragm, Lung/Wide) and volume control. Simultaneously captures PCG and ECG signals; transmits data via Bluetooth to mobile application on smart device (phone/tablet) for visualization, recording, and replay. Displays indicative heart rate on device panel. Used in clinical settings by trained personnel to aid physician evaluation of cardiac sounds and rhythm. Clinicians interpret output to inform referral decisions. Benefits include high-fidelity audio and visual waveform observation to support clinical assessment.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, electrical safety, EMC (ANSI/AAMI/IEC 60601-1-2), wireless coexistence (ANSI C63.27), and verification/validation of mobile application software, hardware, firmware, and ECG/PCG simulation.

Technological Characteristics

Electronic stethoscope with 3-electrode 1-lead ECG and diaphragm-based PCG sensor. Powered by 3400mAh 3.7V Li-ion battery. Connectivity via Bluetooth to mobile application. Includes Bell, Diaphragm, and Lung (Wide) auscultation modes. Form factor includes integrated display panel for heart rate. Sterilization/biocompatibility addressed via standard testing.

Indications for Use

Indicated for use by trained, qualified clinicians in clinical settings to assist in capturing, recording, and replaying heart sounds (PCG) and 1-lead ECG rhythm for one patient at a time. Not for use as a diagnostic device; does not supersede clinician judgment.

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

Cardiosleeve (K131287)

Reference Devices

ViScope (K100531)

Related Devices

K230111 — CORE 500 Digital Stethoscope · Eko Devices, Inc. · May 26, 2023
K123148 — PARACE MD EKOSCOPE IS100 · Parace, LLC · Nov 19, 2013
K233609 — CORE 500 Digital Stethoscope · Eko Health, Inc. · Mar 28, 2024
K212709 — VoqX Electronic Stethoscope · Sanolla , Ltd. · Mar 15, 2022
K160023 — Electronic Stethoscope DS301 · Imediplus, Inc. · Sep 30, 2016

Submission Summary (Full Text)

{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. - 2. 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. - 3. 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. - 4. Battery (HDS060-004) Rechargeable Li-Ion 18650 (Size) 3400mAh 3.7 V– 1 No. - 5. Battery Charger (HDS060-005) Input: 100-240V AC, 50/60 Hz, Output: 5.0V DC, 2000 mA - 6. 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 Discharges | Pass | |--------------------------|------| | Voltage Dips | Pass | | Voltage Interruptions | Pass | | Bluetooth (BT) Coexistence Test (VOL_037_Coexistence testing) | | | | |---------------------------------------------------------------|-----------------------------------|-----------------------------------|------| | VOL 037 001_Report- HDMG0002 Combined | Wireless Coexistence | ANSI C63.27:2017 | Pass | | | Unintended Signal Baseline | (Method ANSI C63.27:2017 EN | Pass | | | waveform of the test signal | 300 328 V2.1.1:2016) | Pass | | | FCC15.247:2020 Bluetooth(FHSS) | ANSI C63.10:2013 KDB 558074 | Pass | | | Output Power | | Pass | | | Spurious Radiated Emissions | | Pass | | | Antenna Heights | | Pass | | | BLE power | | Pass | | | Low 2.716 dBM | | Pass | | | Medium 2.896 dBM | | Pass | | | High 1.723 dBM | | Pass | 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.