AeviceMD

K223382 · Aevice Health Pte. , Ltd. · DSH · Jul 7, 2023 · Cardiovascular

Device Facts

• Record ID: K223382
• Device Name: AeviceMD
• Applicant: Aevice Health Pte. , Ltd.
• Product Code: DSH · Cardiovascular
• Decision Date: Jul 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from adult patients in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

Device Story

AeviceMD is a wearable electronic stethoscope system for adult patients. It consists of a sensor, silicone patch, docking station, mobile/web apps, and cloud platform. The sensor detects lung sounds and transmits data via Bluetooth to a gateway (docking station), which uploads to the cloud. Healthcare professionals (HCP) use the AeviceMD HCP Web App to review, playback, and analyze recorded lung sounds to support clinical decision-making. Patients use the mobile app to view recorded sounds for sharing with HCPs. The device is intended for longitudinal monitoring; it does not provide alarms, is not for emergency use, is not for sleep apnea, and is not for self-diagnosis. It facilitates remote or in-clinic auscultation, allowing clinicians to compare current lung sounds with historical data to track patient status.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included frequency response, stethoscope performance against a cleared reference device, human factors usability, shipping validation (ASTM D4169-16), cleaning validation, and biocompatibility (ISO 10993-5, ISO 10993-10). Electrical safety and electromagnetic compatibility verified per IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.

Technological Characteristics

Wearable electronic stethoscope. Materials: Silicone patch (biocompatible). Connectivity: Bluetooth (sensor to gateway), Cloud-based platform. Software: Embedded firmware and mobile/web applications. Standards: ISO 10993-5/10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, ANSI AAMI IEC 62366-1, ANSI AAMI IEC 62304, ISO 14971. Power: Battery-operated.

Indications for Use

Indicated for longitudinal acquisition, recording, and storage of lung sounds in adult patients in clinical or non-clinical settings for clinician review and comparison.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Strados Remote Electronic Stethoscope Platform (RESP) (K220893)

Reference Devices

• Eko CORE (K200776)

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). 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 7, 2023

Aevice Health Pte. Ltd. Adrian Ang CEO 18 Howard Road, #06-11 Novelty Bizcentre Singapore, Singapore 369585 Singapore

Re: K223382

Trade/Device Name: AeviceMD Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, DOD Dated: November 7, 2022 Received: November 7, 2022

Dear Adrian Ang:

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

{1}------------------------------------------------

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 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 medical devices and radiation-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,

# Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K223382

Device Name AeviceMD

Indications for Use (Describe)

The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from adult patients in a clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

Type of Use (Select one or both, as applicable)

| <span></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|--------------------------------------------------------------------------------------|
| <span></span> | <input type="checkbox"/> 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}------------------------------------------------

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

## I. SUBMITTER

Aevice Health Pte. Ltd. 18 Howard Road, #06-11 Novelty Bizcentre Singapore 369585 Tel: [phone] Fax: N/A

Company Contact: Adrian Ang Chief Executive Officer

- Contact Person: Adrian Ang Chief Executive Officer
- Contact Email: [e-mail]
- Date Prepared: 9 June 2023

| II. DEVICE | |
|----------------------|--------------------------------|
| Name of Device: | AeviceMD |
| Classification Name: | Medical Magnetic Tape Recorder |
| Regulation: | 21 CFR §870.2800 |
| Regulatory Class: | Class II |
| Product Code: | DSH; DQD |

## III. PREDICATE AND REFERENCE DEVICES

Predicate Manufacturer: Strados Labs, Inc. Predicate Trade Name: Strados Remote Electronic Stethoscope Platform (RESP) Predicate 510(k): K220893

Reference Device Manufacturer: Eko Devices, Inc. Reference Device Trade Name: Eko CORE Reference Device 510(k): K200776

{4}------------------------------------------------

## IV. DEVICE DESCRIPTION

The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis.

The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components:

1. AeviceMD Sensor – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth.

2. AeviceMD Silicone Patch - silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin.

3. AeviceMD Docking Station - gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charqer for the Sensor.

4. AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals in a clinical setting) - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting.

5. AeviceMD Cloud Platform – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.

## V. INTENDED USE/ INDICATIONS FOR USE

The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from adult patients in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

# VI. COMPARISON OF DEVICE CLASSIFICATION CHARACTERISTICS WITH PREDICATE AND REFERENCE DEVICES

The table below includes a comparison of the product code, regulation number, device classification name, intended user (including which data or measurements), and intended use environment among the subject device, the predicate device and the reference device.

{5}------------------------------------------------

-

| Parameter: | Subject Device:<br>AeviceMD | Predicate Device:<br>Strados RESP<br>(K220893) | Reference Device:<br>Eko CORE<br>(K200776) |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DSH; DQD | DSH | DQD |
| Regulation Number | 21 CFR 870.2800; | 21 CFR 870.2800 | 21 CFR 870.1875 |
| Device<br>Classification Name | Recorder, Magnetic<br>Tape, Medical;<br>Stethoscope,<br>Electronic | Recorder, Magnetic<br>Tape, Medical | Stethoscope, Electronic |
| Indications for Use | The AeviceMD is a<br>non-invasive<br>battery-operated<br>device, including a<br>wearable component,<br>intended to<br>longitudinally acquire,<br>record and store lung<br>sound from adult<br>patients in a clinical or<br>non-clinical setting.<br>The device stores the<br>data for<br>later playback, review,<br>and analysis by a<br>clinician and<br>comparison with<br>earlier data from the<br>same patient. | The Strados Remote<br>Electronic<br>Stethoscope<br>Platform (RESP) is a<br>non-invasive<br>battery-operated<br>device, including a<br>wearable<br>component, intended<br>to longitudinally<br>acquire, record, and<br>store lung sounds<br>from adult patients in<br>a healthcare or<br>outpatient setting<br>including transition<br>from healthcare<br>setting to outpatient<br>care without<br>interruption. The<br>device stores the<br>data for later<br>playback, review,<br>and analysis by a<br>clinician and<br>comparison with<br>earlier data from the<br>same patient. | The Eko CORE is an<br>electronic stethoscope<br>that enables<br>amplification, filtering,<br>and transmission of<br>auscultation sound data<br>(heart, lungs, bowel,<br>arteries, and veins),<br>whereby a clinician at<br>one location on network<br>can listen to the<br>auscultation sounds of<br>a patient on site or at a<br>different location on the<br>network. Eko CORE is<br>intended for use on<br>pediatric and adult<br>patients. The Eko<br>CORE is intended to be<br>used by professional<br>users in a clinical<br>environment or by lay<br>users in a nonclinical<br>environment. The<br>device is not intended<br>for self-diagnosis. |
| Intended User | Adults only | Adults only | Adults and pediatrics |
| Intended Use<br>Environment | Clinical and<br>Non-clinical Setting | Clinical and<br>Non-clinical Setting | Clinical and Non-clinical<br>Setting |
| User Interface | Mobile App<br>Web Portal (For HCP) | Mobile App<br>Web Portal (For<br>HCP) | Mobile App<br>Web Portal (Mentioned<br>on their website for |
| | | | HCP) |
| Record and<br>Playback Sounds | Yes | Yes | Yes |
| Data Transfer to<br>Compatible<br>Computing platform | Yes | Yes | Yes |
| Condition of Use | Reusable | Reusable | Reusable |
| Rx or OTC | Prescription Only | Prescription Only | Over-the-Counter |
| Wearable | Yes | Yes | No |

{6}------------------------------------------------

Table 1. Comparison of Device Classification Characteristics with Predicate and Reference Devices

#### Summary of Subject Device Comparison to predicate and reference device

The subject device as it longitudinally acquires sounds and allows recording and playback. The subject device identifies as an electronic stethoscope as the auscultation locations consist of the anterior body where a manual stethoscope would be placed during a consultation. These locations are supported by the cleared reference device.

#### Summary of Technological Characteristics

The AeviceMD has very similar technological characteristics compared to predicate and reference devices. All three devices have the same frequency range and can connect to mobile applications for recording and sharing data with HCP.

#### Non-Clinical Performance Data

The subject device was subject to non-clinical performance testing. There are no device-specific special control documents/ regulations that apply to the subject device. A list of the standards, guidance and additional testings for the device is listed below:

- . ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cvtotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012 (or IEC . 60601-1: 2012 reprint)
- EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-11: 2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

{7}------------------------------------------------

- . IEC 60601-1-6:2010- Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ANSI AAMI IEC 62366- 1:2015+AMD1:2020(Consolidated Text) Medical devices Part ● 1: Application of usability engineering to medical devices
- . ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)] ISO 14971:2019 Medical devices -Applications of risk management to medical devices
- Additional testing: - Non-clinical Frequency Response Test
- Stethoscope Performance Test against a 510(k) cleared reference stethoscope
- Human Factors Usability
- Shipping Validation Test according to ASTM D4169-16
- Cleaning Validation Testing

# VII. CONCLUSIONS

The conclusions drawn from the non-clinical tests demonstrate that the proposed subject device performs as well as the leqally marketed predicate device and is substantially equivalent. The minor differences in the indications for use do not introduce a new intended use and do not raise any new issues of safety and effectiveness.