(56 days)
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.
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.
The HD Steth device, an electronic stethoscope, was submitted for 510(k) clearance. The provided document focuses primarily on establishing substantial equivalence to the predicate device, Cardiosleeve (K131287), rather than presenting a standalone study with detailed acceptance criteria and performance against those criteria.
However, based on the documented performance testing, some information can be inferred.
1. A table of acceptance criteria and the reported device performance
The provided document describes general "Performance Data" rather than specific acceptance criteria thresholds. The performance is reported as "Pass" for all tested items.
| Acceptance Criteria Category | Specific Test Description | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility | 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) | Pass | |
| Power Frequency Magnetic Fields | Pass | |
| Electrical Fast Transients and Bursts | Pass | |
| Surges | Pass | |
| Electrostatic Discharges | Pass | |
| Voltage Dips | Pass | |
| Voltage Interruptions | Pass | |
| Bluetooth (BT) Coexistence | Wireless Coexistence | Pass |
| Unintended Signal Baseline waveform of the test signal | Pass | |
| Output Power | Pass | |
| Spurious Radiated Emissions | Pass | |
| Antenna Heights | Pass | |
| BLE power (Low, Medium, High) | Pass | |
| Verification & Validation | Mobile Application Software | Successful Assessment |
| Hardware System | Successful Assessment | |
| Firmware System | Successful Assessment | |
| ECG (EKG) and PCG Simulation | Successful Assessment |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a separate "test set" in the context of clinical or performance data from human subjects. The performance data primarily refers to engineering and software verification and validation tests. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The performance data is largely technical validation, not clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as an "electronic stethoscope meant to assist a qualified clinician" and "not intended to be used as a diagnostic device" nor does it "supersede the judgement of a qualified clinician." The focus is on providing high fidelity audio and visual display of PCG and EKG rhythm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "ECG (EKG) and PCG Simulation Testing" as part of the performance data, which suggests some standalone algorithmic or system testing. However, detailed results or specific performance metrics from this simulation are not provided beyond a "Successful Assessment." The device's primary function is described as acquiring and displaying waveforms for clinician review, implying it's not a fully autonomous diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance tests mentioned (EMC, Bluetooth, Software, Hardware, Firmware, ECG/PCG Simulation), the "ground truth" would be established by verifying adherence to the referenced technical standards (e.g., ANSI/AAMI/IEC 60601-1-2:2014, ANSI C63.27:2017, FCC15.247:2020), rather than clinical ground truth from expert consensus or pathology. The document does not indicate the use of clinical ground truth for validation of the device's basic function.
8. The sample size for the training set
The document does not describe any machine learning components with a "training set." The device is presented as an electronic stethoscope for capturing, recording, and replaying heart sounds and EKG rhythm, not as a device with a feature that requires a training set (e.g., an AI diagnostic algorithm).
9. How the ground truth for the training set was established
As there is no mention of a "training set" for a machine learning component, this information is not applicable and not provided.
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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
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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
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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) |
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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
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accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.
Device Accessories:
-
- 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.
- Diaphragm (HDS060-001)
-
- 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.
- USB Cable (HDS060-002)
-
- Earplugs (HDS060-003)
Use only HD earplugs.
- Earplugs (HDS060-003)
Use of non-HD earplugs can result in pain in ears due to material hardness and may degrade audio.
-
- Battery (HDS060-004) Rechargeable Li-Ion 18650 (Size) 3400mAh 3.7 V– 1 No.
-
- Battery Charger (HDS060-005) Input: 100-240V AC, 50/60 Hz, Output: 5.0V DC, 2000 mA
-
- 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.
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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 | ElectronicStethoscope | Same |
| RegulationNumber | 21 CFR870.187521 CFR 870.239021 CFR 870.2340 | 21 CFR870.187521 CFR870.2390 | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | DQD, DQC, DPS | DQD, DQC | Same |
| Indication for Use Comparison | |||
| Indications forUse | HD Steth is an electronicstethoscope meant to assist aqualified clinician to capture,record and replay heart soundsand electrocardiogram (ECG orEKG) rhythm. It is intended to beused on one patient at a time.Heart sounds (PCG) and 1-leadEKG rhythm are acquired anddisplayed simultaneously onan accompanying | The CardioSleeve Systemconsisting of theCardioSleeve Front-Endstethoscope and ECGdevice, mobile heartsound recordingapplication and theremote diagnostic heartmurmur software is adecision support deviceintended to be used on a | SubstantiallyEquivalent |
Table 1: Comparison of HD Steth with Primary Predicate Device Cardiosleeve (K131287).
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| mobile application on a hand-held smart device like a phone ortablet. Thewaveforms can be recordedand saved on the smart deviceon which the app is running. | single patient to assistthe medical examiner inanalyzing cardiac soundsfor the identification andclassification ofsuspected murmurs. It isused to distinguishbetween normal /physiological andpathological heartmurmurs by recordingthe acoustic signal of theheart and the ECG signalsimultaneously andanalyze these signals.The acoustic heart signalis analyzed to identifyspecific heart soundsthat may be present.Identified sounds includeS1, S2, and suspectedmurmurs.CardioSleeve indicateswhether or not arecorded heart soundcontains a suspectedheart murmur. Thedevice must be used ina clinical setting bytrained personnel withthe prescribedaccessories and allrelevant patientinformation must betaken intoconsideration before adiagnosis is made.The interpretations ofheart sounds offeredby the CardioSleevedevice are onlysignificant when usedin conjunction with |
|---|---|
| The device has 3 auscultationmodes – Bell, Diaphragm andLung (Wide). These modes andvolume levels can be changed bythe press of a button. The EKGrhythm recording assists ingetting an indicative Heart Rate(HR) that gets displayed on adisplay panel on the device. | |
| The device must be used in aclinical setting by trained andqualified personnel only. HDSteth is not intended to beused as a diagnostic device. Itdoes not supersede thejudgement of a qualifiedclinician. The device isintended to aid the physicianin the evaluation of PCG andEKG rhythm. The clinicians arecompletely responsible forreviewing and interpreting theresults, along with all otherrelevant information, whenmaking a referral decision. | |
| Caution: The sale of this deviceis restricted to licensed cliniciansor entities referred to by alicensed clinician. Itis intended for use by alicensed clinician only. |
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| well as considerationof all other relevantpatient data.CardioSleeve is notintended to be adiagnostic device. Itdoes not supersedethe judgment of thequalified medicalpersonnel. The device isintended to aid thephysician in theevaluation of heartsounds. The physiciansare responsible forreviewing andinterpreting the results,along withthe auscultationfindings and medicalhistory, when making areferral decision.Caution: This device isintended for sale toand use by a licensedclinician only. | |||
|---|---|---|---|
| Technological Characteristics Comparison | |||
| EKG RhythmCapabilities | Yes (3 Electrodes) 1-Lead | Yes (3 Electrodes) 1-Lead | HD Steth andCardiosleevehave thecapability toacquire1-Lead EKGrhythm andCardiosleeve, theHD Steth alsoprovides an EKGRhythm by usingthree dryelectrodes |
| Phonocardiogramand visualizationof sounds | YesOn accompanying App | YesOn accompanyingApp | The Cardiosleeveand HD Stethprovides visualdisplay of thephonocardiogram and1-Lead EKGrhythm on amobileapplicationthroughBluetoothconnectivity. |
| Signaltransmissions toMobileApplication viaBluetooth | Yes - uses BluetoothCompatible withAndroid devices | Yes - uses BluetoothCompatible with iOSand Android devices | The Cardiosleeveand HD Steth useBluetoothtechnology toconnect theirrespective MobileApplication forVisualization |
| OperatingIndications | Operating ModeBattery ChargeLevel,Record Indication,Bluetooth Connectivity, Audiomodes | LED on Device for BatteryChargeLevel,Record Indication,Bluetooth Connectivity | HD Steth andCardiosleevehave displayindications forthe features/modes of thedevice. |
| Power Source | One Li-ion battery 3400mAh, 3.7V | One 3.7 V Lithium IonRechargeable Batteries | HD Steth andCardiosleeveboth useRechargeableBatteries topower thedevices |
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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.
| ReportDocumentNumber | Test Description | ReferencedStandard | Test Result |
|---|---|---|---|
| Electromagnetic Compatibility Test (VOL_036_EMC) | |||
| VOL 036001_19646664001 - Test report- EMI-EMC | EMI/EMC test report | Pass | |
| Harmonics on AC Mains | Pass | ||
| Voltage Fluctuation onAC Mains | Pass | ||
| Mains TerminalContinuous DisturbanceVoltage (ConductedEmission) | Pass | ||
| Radiated Emission | Pass | ||
| Radiated Radio-FrequencyElectromagnetic Fields(Radiated Susceptibility) | Pass | ||
| Proximity Fields From RFWireless CommunicationsEquipment | Pass | ||
| Conducted DisturbancesInduced by Radio-Frequency Fields(Conducted Susceptibility) | ANSI /AAMI/IEC 60601-1-2:2014 / EN60601-1-2:2015 | Pass | |
| Power FrequencyMagnetic Fields | Pass | ||
| Electrical Fast Transientsand Bursts | Pass | ||
| Surges | Pass |
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HD Medical, Inc.
| Electrostatic Discharges | Pass |
|---|---|
| Voltage Dips | Pass |
| Voltage Interruptions | Pass |
| Bluetooth (BT) Coexistence Test (VOL_037_Coexistence testing) | |||
|---|---|---|---|
| VOL 037001_Report-HDMG0002Combined | Wireless Coexistence | ANSIC63.27:2017 | Pass |
| Unintended SignalBaseline | (Method ANSIC63.27:2017 EN | Pass | |
| waveform of the test signal | 300 328V2.1.1:2016) | Pass | |
| FCC15.247:2020Bluetooth(FHSS) | ANSIC63.10:2013KDB 558074 | Pass | |
| Output Power | Pass | ||
| Spurious RadiatedEmissions | 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.
§ 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.