doctorgram Stethoscope DES-I

K210736 · Gv Concepts · DQD · Jul 27, 2021 · Cardiovascular

Device Facts

• Record ID: K210736
• Device Name: doctorgram Stethoscope DES-I
• Applicant: Gv Concepts
• Product Code: DQD · Cardiovascular
• Decision Date: Jul 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The doctorgram™ Stethoscope DES-I is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The doctorgram™ Stethoscope DES-I is intended for use on pediatric and adult patients. The doctorgram™ Stethoscope DES-I is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

Device Story

Electronic stethoscope system comprising handheld unit and mobile application (Doctor's Ear). Handheld unit uses transducer/microphone to capture acoustic body sounds; converts to electronic form; provides analog output via 3.5mm jack or digital transmission via Bluetooth to mobile app. Mobile app provides visualization, recording, playback, and sharing of audio data. Used by clinicians for patient monitoring/telemedicine or by lay users to record/share sounds with physicians. Enables remote auscultation via network. Benefits include enhanced sound amplification and ability to share clinical data for second opinions or telemedicine consultations.

Clinical Evidence

Bench testing only. Includes software verification and validation, electrical safety (IEC 60601-1, IEC 60601-1-11), EMC (IEC 60601-1-2), Bluetooth SIG qualification, and usability testing for OTC use.

Technological Characteristics

Standalone electronic stethoscope; ABS body; transducer/electro-microphone sensing; 20 Hz to 2 kHz frequency range; Bluetooth connectivity; Lithium-ion battery; 3.5mm headphone jack; Micro USB charging; non-sterile.

Indications for Use

Indicated for pediatric and adult patients for auscultation of heart, lungs, bowel, arteries, and veins. Intended for use by professional users in clinical environments or lay users in nonclinical environments. Not intended for self-diagnosis.

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

• Eko CORE Electronic Stethoscope System (K200776)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 27, 2021

GV Concepts Faye Liu Official Correspondent 3034 Bradshaw Dr San Jose, California 95148

Re: K210736

Trade/Device Name: doctorgram Stethoscope DES-I Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: June 26, 2021 Received: June 29, 2021

Dear Faye Liu:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

LCDR 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)

K210736

#### Device Name

doctorgram™ Stethoscope DES-I

#### Indications for Use (Describe)

The doctorgram™ Stethoscope DES-I is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The doctorgram™ Stethoscope DES-I is intended for use on pediatric and adult patients. The doctorgram™ Stethoscope DES-I is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the logo for G Concepts, Inc. in red. Below the logo is the text "Traditional 510(k) Premarket Notification" in bold font. The text "doctorgram™ Stethoscope DES-I" is below the bolded text.

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### General Information 1.

| 510(k) Sponsor: | GV Concepts Inc |
|---------------------------|--------------------------------------------------------------------------------|
| Address: | 3240 S. White Road, #286, San Jose, CA 95148 |
| Applicant Contact Person: | Ching-Kay Chow<br>Phone: [phone]<br>Email: [e-mail] |
| Correspondence person: | Faye Liu, Ph.D., RAC<br>Phone: [phone]<br>Email: [e-mail] |

### 2. Device Identification

| Proposed Device: | |
|----------------------|-------------------------------|
| Proprietary Name: | doctorgram™ Stethoscope DES-I |
| Classification Name: | Electronic Stethoscope |
| Regulation Number: | 870.1875 |
| Product Code: | DQD |
| Regulatory Class: | II |

### Predicate Device:

| Proprietary Name: | Eko CORE Electronic Stethoscope System |
|-------------------------|----------------------------------------|
| Premarket Notification: | K200776 |
| Classification Name: | Electronic Stethoscope |
| Regulation Number: | 870.1875 |
| Product Code: | DQD |
| Regulatory Class: | II |

### 3. Device Description

The doctorgram™ Stethoscope DES-I (hereafter referred to as DES-I stethoscope) is a digital stethoscope device designed for use by health care professionals as well as lay users in clinical or non-clinical environments. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing or can transmit the data for telemedicine use. It also enables regular users to listen to their body sounds (lungs, heart, arteries, veins, Gastrointestinal tract, etc.) and record and share it with their physicians.

Section 5, Page 1

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Image /page/4/Picture/1 description: The image shows a logo and text related to a medical device. The logo features a stylized red "G" with the words "CONCEPTS, INC." in smaller font above and to the right. Below the logo, the text "Traditional 510(k) Premarket Notification" is displayed in bold. The text "doctorgram™ Stethoscope DES-I" is located below the bolded text.

510(k) SUMMARY OF SAFETY EFFECTIVENESS

It consists of two primary components: 1) The DES-I stethoscope handheld piece, a stand-alone electronic stethoscope and 2) Doctor's Ear, a mobile application that pairs with the Doctorgram Stethoscope.

- The DES-I stethoscope handheld piece is used to convert sound to electronic form, for monitoring directly using headphones/earbuds and/or transmitting the audio data to a mobile device via Bluetooth®. It includes a power button, volume adjustment buttons, Bluetooth® button and LED light indicators.
- The mobile application captures audio data from the handheld piece and provides data visualization, secure data storage, audio playback, and sharing features. The Doctor's Ear application can be directly downloaded from Apple App Store.

These features enable a healthcare professional to monitor patients, seek out second opinions from a specialist or use the device for telemedicine use.

### 4. Intended Use/Indications for Use

The doctorgram™ Stethoscope DES-I is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The doctorgram™ Stethoscope DES-I is intended for use on pediatric and adult patients. The doctorgram™ Stethoscope DES-I is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

### 5. Technological Comparison

The DES-I stethoscope has similar overall operational and technological characteristics as compared to the predicate device. The predicate device has the ability to attach to a standard analog stethoscope; the DES-I stethoscope is a stand-alone electronic stethoscope with a built-in analog stethoscope head. Both devices include both digital and analog auscultation modes. Both devices connect via Bluetooth to the accompanying mobile App for visualization, recording and transfer of data. Both devices included on/off power buttons and volume adjustment controls. Both devices have the same frequency range and have similar maximum sound level.

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Image /page/5/Picture/1 description: The image shows the logo for Concepts, Inc. above the title "Traditional 510(k) Premarket Notification". Below the title is the text "doctorgram Stethoscope DES-I". The logo is a stylized red letter G with a lightning bolt through it.

SECTION 5

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

A table comparing the key features of the subject and predicate devices is provided in Table 5-1, Substantial Equivalence Discussion.

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| <br>Traditional 510(k) Premarket Notification<br>doctorgram™ Stethoscope DES-I | <b>SECTION 5</b><br><br><b>510(k) SUMMARY OF SAFETY AND<br/> EFFECTIVENESS</b> |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|

# Table 5-1, Substantial Equivalence Discussion

| Elements of<br>comparison | doctorgram Stethoscope DES-I<br>(Candidate Device) | Eko Electronic Stethoscope System (OTC)<br>(Predicate device), K200776 | Comparison |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Regulatory Data | | | |
| Regulatory Class | Class II | Class II | Identical |
| Classification<br>name | Electronic Stethoscope | Electronic Stethoscope | Identical |
| Regulation<br>Number | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical |
| Product code | DQD; Electronic stethoscope | DQD; Electronic stethoscope | Identical |
| Manufacturer | GV Concepts, Inc. | Eko Devices, Inc. | NA |
| Indications for Use | | | |
| Indications for<br>use | The doctorgram™ Stethoscope DES-I is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The doctorgram™ Stethoscope DES-I is intended for use on pediatric and adult patients. The doctorgram™ Stethoscope DES-I is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis. | The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on pediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis. | Identical |
| Image: Concepts, Inc. logo<br>Traditional 510(k) Premarket Notification<br>doctorgram™ Stethoscope DES-I | SECTION 5<br>510(k) SUMMARY OF SAFETY AND<br>EFFECTIVENESS | | |
| <b>Characteristics</b> | | | |
| Principles of operation | The device consists of a handheld piece with<br>built-in stethoscope head. Acoustic sound can<br>be sent analoglly to the headphone or digitally<br>via Bluetooth to compatible mobile phones or<br>tablets.<br><br>1. Dispositive introduced in an acoustic<br>stethoscope and gives sound amplification and<br>audio transmission to a smartphone via<br>Bluetooth that allows the user to open and<br>playback sounds in a mobile application on<br>compatible iOS smartphones and tablets.<br><br>2. Use it as standalone stethoscope by<br>connecting earbud headphone via 3.5mm jack | Dispositive introduced in an acoustic stethoscope<br>and gives sound amplification and audio<br>transmission to a smartphone via Bluetooth that<br>allows the user to open and playback sounds in a<br>mobile application on compatible iOS<br>smartphones and tablets. | Similar with<br>minor<br>differences |
| Clinical<br>conditions | Human body sounds related | Human body sounds related | Identical |
| Clinical Use | Electronic stethoscope | Electronic stethoscope | Identical |
| Stethoscope<br>Type | Built-in stethoscope head | Attachment to an analog stethoscope; compatible<br>stethoscopes include:<br>-Littmann 3M Cardiology II/III<br>-WelchAllyn Harvey Elite<br>-ADC601 lines of analog stethoscopes | Similar with<br>minor<br>differences |
| Prescription/OTC | OTC use | OTC use | Identical |
| User Interface | On/Off Power button Volume adjustment LED<br>status indicator;<br>Mobile App | On/Off Power button Volume adjustment LED<br>status indicator;<br>Mobile App | Identical |
| SECTION 5<br>510(k) SUMMARY OF SAFETY AND<br>EFFECTIVENESS | | | |
| Technical equivalence | | | |
| Analog/ Digital<br>Interoperability | Yes | Yes | Identical |
| Sound<br>Amplification | Yes | Yes | Identical |
| Volume Control | Yes | Yes | Identical |
| Record and<br>Playback Sounds | Yes | Yes | Identical |
| Data Transfer to<br>Compatible<br>Computing<br>platform | Yes | Yes | identical |
| Connectivity | Bluetooth® | Bluetooth® | Identical |
| Energy Source | Litium Ion Battery | Lithium Ion Battery | Identical |
| System required | iOS | Android and iOS | Similar with<br>minor<br>differences |
| Hardware and<br>software<br>platforms | Mobile and tablets (no computer software yet) | Mobile devices or tablets | Identical |
| Connections | Micro USB connector only for charging<br>internal battery of the device | Micro USB connector only to charge internal<br>battery of the device | Identical |
| Frequency range | 20 Hz to 2KHz | 20 Hz to 2 kHz | Identical |
| Signal Input<br>Method | Sound waves collected via a Transducer<br>Electro Microphone | Sound waves collected via a Transducer Electro<br>micro-phone | Identical |
| Audio Output<br>Method | 3.5mm earbud headphone | Speakerphone | Similar with<br>minor<br>differences |
| Image: Concepts, Inc. logo<br>Traditional 510(k) Premarket Notification<br>doctorgram™ Stethoscope DES-I | SECTION 5<br>510(k) SUMMARY OF SAFETY AND<br>EFFECTIVENESS | | |
| Software<br>Function | (1) Receive and store the data of sound tracks<br>(2) Display the phonogram of the sound tracks<br>(3) Replay the audio data in the connected<br>device installed with software; share the audio<br>file with physicians. | (1) Receive and store the data of sound tracks<br>(2) Display the phonogram of the sound tracks<br>(3) Replay the audio data in the connected<br>device installed with software; share the audio<br>file with physicians. | Identical |
| Performance<br>requirements | The operating range is - 10°C to 40°C, and 0%<br>to 90% relative humidity | The operating range is - 10°C to 40°C, and 0% to<br>90% relative humidity | Identical |
| Electrical Safety<br>Standards Met | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 | Identical |
| Biological Equivalence | | | |
| Materials | Body: ABS | Body: ABS (Acrylonitrile Butadiene Styrene). | Identical |
| Contact with<br>human tissues or<br>body fluids | Attached stethoscope head comes in direct<br>contact with patient's skin; the body doesn't<br>contact patient's body. | The body does not contact patient's body.<br>Attached stethoscope does. | Similar with<br>minor<br>differences |
| Sterility | Not intended to be sterilized | Not intended to be sterilized | Identical |

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Image /page/10/Picture/1 description: The image shows the logo for G Concepts, Inc. with the text "Traditional 510(k) Premarket Notification" below it. The text "doctorgram™ Stethoscope DES-I" is below the title. The logo features a stylized red letter G with a red line through it.

510(k) SUMMARY OF SAFETY AI EFFECTIVENESS

## 6. Performance Testing

The DES-I stethoscope has undergone extensive bench verification, as well as software verification and validation. Electrical safety and EMC were successfully conducted, and Bluetooth SIG Qualification were obtained. The OTC use of the device was assessed in usability testing with passing results.

In all instances, the device functioned as intended. Based on the testing results, the device has a safety and effectiveness profile that is similar to the predicate device.

### 7. Conclusion

The DES-I stethoscope has the same intended use and indications, technological characteristics, and principles of operation as its predicate device.

The minor differences in product design do not raise different questions of safety and effectiveness when used as labeled. Performance data demonstrate that the DES-I stethoscope is as safe and effective as the predicate device.