(138 days)
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 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. 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 provided document is a 510(k) premarket notification for the doctorgram™ Stethoscope DES-I. It primarily focuses on demonstrating substantial equivalence to a predicate device (Eko CORE Electronic Stethoscope System).
Therefore, it does not contain the detailed acceptance criteria and study information (including sample sizes, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies) typically found in a clinical study report for a diagnostic AI device aiming to establish its own clinical performance or effectiveness against a control group.
Instead, the document relies on demonstrating that the new device has "similar overall operational and technological characteristics" to the predicate device and that performance testing showed it "functioned as intended" and has a "safety and effectiveness profile that is similar to the predicate device."
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document describes performance testing in a general sense ("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.").
However, it does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio requirements) or the actual numerical performance results of the doctorgram™ Stethoscope DES-I against those criteria. The primary performance claim is substantial equivalence to the predicate, which implies meeting general functional and safety standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any performance testing.
- Data Provenance: Not specified. The document mentions "usability testing with passing results" but offers no details about the participants or data sources.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The nature of the device (an electronic stethoscope for sound amplification, filtering, and transmission) suggests that "ground truth" might relate more to technical accuracy of sound reproduction and transmission rather than a diagnostic interpretation requiring expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as detailed clinical performance testing with "ground truth" adjudication is not described.
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:
- No MRMC comparative effectiveness study is mentioned. This device is an electronic stethoscope, not an AI-powered diagnostic algorithm designed to assist human readers in interpretation. Its function is to capture and transmit sounds.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the typical sense of an "algorithm-only" performance for diagnostic accuracy. The device's standalone performance would relate to its ability to amplify, filter, and transmit sounds accurately, which is covered by "bench verification" and "software verification and validation" but without specific metrics provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Based on the device type, "ground truth" for its performance testing would likely involve objective acoustic measurements and verification against known sound sources, rather than clinical diagnostic ground truth.
8. The sample size for the training set:
- Not applicable. The document does not describe any machine learning or AI algorithm development that would necessitate a "training set." The device's functionality is based on electronic amplification, filtering, and transmission, not on learning from a dataset.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 ChowPhone: (408) 781-3861Email: chingkay.chow@gvconcepts.com |
| Correspondence person: | Faye Liu, Ph.D., RACPhone: (408) 714-0188Email: faylee2009@gmail.com |
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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| Traditional 510(k) Premarket Notificationdoctorgram™ Stethoscope DES-I | SECTION 5510(k) SUMMARY OF SAFETY AND EFFECTIVENESS |
|---|---|
| -------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- |
Table 5-1, Substantial Equivalence Discussion
| Elements ofcomparison | doctorgram Stethoscope DES-I(Candidate Device) | Eko Electronic Stethoscope System (OTC)(Predicate device), K200776 | Comparison |
|---|---|---|---|
| Regulatory Data | |||
| Regulatory Class | Class II | Class II | Identical |
| Classificationname | Electronic Stethoscope | Electronic Stethoscope | Identical |
| RegulationNumber | 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 foruse | 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. logoTraditional 510(k) Premarket Notificationdoctorgram™ Stethoscope DES-I | SECTION 5510(k) SUMMARY OF SAFETY ANDEFFECTIVENESS | ||
| Characteristics | |||
| Principles of operation | The device consists of a handheld piece withbuilt-in stethoscope head. Acoustic sound canbe sent analoglly to the headphone or digitallyvia Bluetooth to compatible mobile phones ortablets.1. Dispositive introduced in an acousticstethoscope and gives sound amplification andaudio transmission to a smartphone viaBluetooth that allows the user to open andplayback sounds in a mobile application oncompatible iOS smartphones and tablets.2. Use it as standalone stethoscope byconnecting earbud headphone via 3.5mm jack | Dispositive introduced in an acoustic stethoscopeand gives sound amplification and audiotransmission to a smartphone via Bluetooth thatallows the user to open and playback sounds in amobile application on compatible iOSsmartphones and tablets. | Similar withminordifferences |
| Clinicalconditions | Human body sounds related | Human body sounds related | Identical |
| Clinical Use | Electronic stethoscope | Electronic stethoscope | Identical |
| StethoscopeType | Built-in stethoscope head | Attachment to an analog stethoscope; compatiblestethoscopes include:-Littmann 3M Cardiology II/III-WelchAllyn Harvey Elite-ADC601 lines of analog stethoscopes | Similar withminordifferences |
| Prescription/OTC | OTC use | OTC use | Identical |
| User Interface | On/Off Power button Volume adjustment LEDstatus indicator;Mobile App | On/Off Power button Volume adjustment LEDstatus indicator;Mobile App | Identical |
| SECTION 5510(k) SUMMARY OF SAFETY ANDEFFECTIVENESS | |||
| Technical equivalence | |||
| Analog/ DigitalInteroperability | Yes | Yes | Identical |
| SoundAmplification | Yes | Yes | Identical |
| Volume Control | Yes | Yes | Identical |
| Record andPlayback Sounds | Yes | Yes | Identical |
| Data Transfer toCompatibleComputingplatform | Yes | Yes | identical |
| Connectivity | Bluetooth® | Bluetooth® | Identical |
| Energy Source | Litium Ion Battery | Lithium Ion Battery | Identical |
| System required | iOS | Android and iOS | Similar withminordifferences |
| Hardware andsoftwareplatforms | Mobile and tablets (no computer software yet) | Mobile devices or tablets | Identical |
| Connections | Micro USB connector only for charginginternal battery of the device | Micro USB connector only to charge internalbattery of the device | Identical |
| Frequency range | 20 Hz to 2KHz | 20 Hz to 2 kHz | Identical |
| Signal InputMethod | Sound waves collected via a TransducerElectro Microphone | Sound waves collected via a Transducer Electromicro-phone | Identical |
| Audio OutputMethod | 3.5mm earbud headphone | Speakerphone | Similar withminordifferences |
| Image: Concepts, Inc. logoTraditional 510(k) Premarket Notificationdoctorgram™ Stethoscope DES-I | SECTION 5510(k) SUMMARY OF SAFETY ANDEFFECTIVENESS | ||
| SoftwareFunction | (1) Receive and store the data of sound tracks(2) Display the phonogram of the sound tracks(3) Replay the audio data in the connecteddevice installed with software; share the audiofile with physicians. | (1) Receive and store the data of sound tracks(2) Display the phonogram of the sound tracks(3) Replay the audio data in the connecteddevice installed with software; share the audiofile with physicians. | Identical |
| Performancerequirements | The operating range is - 10°C to 40°C, and 0%to 90% relative humidity | The operating range is - 10°C to 40°C, and 0% to90% relative humidity | Identical |
| Electrical SafetyStandards Met | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | Identical |
| Biological Equivalence | |||
| Materials | Body: ABS | Body: ABS (Acrylonitrile Butadiene Styrene). | Identical |
| Contact withhuman tissues orbody fluids | Attached stethoscope head comes in directcontact with patient's skin; the body doesn'tcontact patient's body. | The body does not contact patient's body.Attached stethoscope does. | Similar withminordifferences |
| 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.
§ 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.