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.

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:

AeviceMD Sensor – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth.
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.
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.
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.
AeviceMD Cloud Platform – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.

AI/ML Overview

The AeviceMD is a non-invasive, battery-operated device intended to acquire, record, and store lung sounds from adult patients for later review and analysis by a clinician.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical performance tests but does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance values in a table format for the device's primary function of acquiring and recording lung sounds.

However, based on the non-clinical performance data section, the device likely aims to perform "as well as" a legally marketed predicate device, implying equivalence in its core function. The "Stethoscope Performance Test against a 510(k) cleared reference stethoscope" suggests that the AeviceMD's acoustic performance was compared to an already cleared device.

Implicit Acceptance Criteria (inferred from the document):

Acceptance Criteria Category	Description (Inferred)	Reported Device Performance (Inferred)
Acoustic Performance	Functional equivalence to a 510(k) cleared reference stethoscope in recording and acquiring lung sounds. Frequency range similar to predicate/reference devices.	"The subject device performs as well as the legally marketed predicate device and is substantially equivalent." "All three devices have the same frequency range and can connect to mobile applications for recording and sharing data with HCP." (This implies the AeviceMD's frequency response is acceptable and comparable to cleared devices). A "Non-clinical Frequency Response Test" and "Stethoscope Performance Test against a 510(k) cleared reference stethoscope" were performed.
Biocompatibility	Silicone patch does not cause adverse biological reactions.	Biocompatibility testing was performed on the AeviceMD Silicone Patch (ISO 10993-5:2009 for in vitro cytotoxity, ISO 10993-10:2010 for irritation and skin sensitization). Results are implied to be acceptable as part of the overall conclusion of substantial equivalence.
Electrical Safety (Basic & Essential Performance)	Compliance with general requirements for basic safety and essential performance of medical electrical equipment.	Compliance with IEC 60601-1:2005+A1:2012 (or 2012 reprint). Results are implied to be acceptable.
Electromagnetic Compatibility (EMC)	Compliance with electromagnetic disturbance requirements.	Compliance with EN 60601-1-2:2015. Results are implied to be acceptable.
Usability	Device is safe and effective for users in the intended environments.	Compliance with IEC 60601-1-6:2010 and ANSI AAMI IEC 62366-1:2015+AMD1:2020. Human Factors Usability testing was performed. Results are implied to be acceptable.
Software Life Cycle Processes	Software development and maintenance meet medical device standards.	Compliance with ANSI AAMI IEC 62304:2006/A1:2016. Results are implied to be acceptable.
Risk Management	Risks associated with the device are identified and managed.	Compliance with ISO 14971:2019. Results are implied to be acceptable.
Shipping Validation	Device maintains integrity and functionality during shipping.	Shipping Validation Test according to ASTM D4169-16 was performed. Results are implied to be acceptable.
Cleaning Validation	Device can be effectively cleaned without compromising safety or performance.	Cleaning Validation Testing was performed. Results are implied to be acceptable.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any "test set" in the context of clinical or performance data for lung sound acquisition accuracy. The studies mentioned are primarily non-clinical validation tests (e.g., biocompatibility, electrical safety, usability, software, shipping, cleaning, frequency response, stethoscope performance comparison). These typically involve specific test conditions and components rather than human subject data sets in the way an AI algorithm test set would.

For the "Stethoscope Performance Test against a 510(k) cleared reference stethoscope", the exact number of data points or recordings used for comparison is not provided.

The data provenance for these non-clinical tests is not explicitly stated in terms of country of origin but would generally originate from the manufacturer's testing facilities or accredited third-party labs carrying out these standardized tests. The studies are described as "non-clinical performance data," implying laboratory or engineering testing rather than retrospective or prospective clinical human studies to evaluate diagnostic performance.

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 in the document. The document describes a device for acquiring, recording, and storing lung sounds for later playback, review, and analysis by a clinician. It does not mention any automated interpretation or diagnostic capabilities that would necessitate a ground truth established by experts interpreting sounds. Therefore, there's no mention of experts establishing a ground truth for diagnostic accuracy for the device itself.

4. Adjudication method for the test set

Not applicable, as no expert-adjudicated test set for diagnostic performance is mentioned.

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 study is mentioned. The device's indications for use emphasize acquisition, recording, storage, playback, and review by a clinician, not AI-assisted interpretation or diagnosis. There is no mention of AI features intended to improve human reader performance.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

No standalone algorithm performance study is mentioned. The device is a "Medical Magnetic Tape Recorder" and "Stethoscope, Electronic" intended for clinicians to interpret the recorded sounds, not for an algorithm to provide a standalone diagnosis. The device's cloud platform "analyzes user's data using meaningful output information," but the nature of this "meaningful output" is not specified to be diagnostic or requiring standalone performance evaluation in the context of this 510(k) summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as the device doesn't have a stated diagnostic function that requires ground truth for clinical accuracy. The "Stethoscope Performance Test" would likely use a reference cleared stethoscope as its "ground truth" for acoustic fidelity, rather than clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable. The document does not describe the development or evaluation of a machine learning algorithm for diagnostic purposes that would require a "training set." The "AeviceMD Cloud Platform" is mentioned to "analyze user's data using meaningful output information," but the details of this analysis, particularly if it involves machine learning and a corresponding training set, are not provided or assessed in this 510(k) summary for substantial equivalence.

9. How the ground truth for the training set was established

Not applicable, as no training set for a diagnostic algorithm is mentioned.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K223382

Device Name AeviceMD

Indications for Use (Describe)

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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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: +65 90058825 Fax: N/A

Company Contact: Adrian Ang Chief Executive Officer

Contact Person: Adrian Ang Chief Executive Officer
Contact Email: adrian@aevice.com
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

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IV. DEVICE DESCRIPTION

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

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

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Parameter:	Subject Device:AeviceMD	Predicate Device:Strados RESP(K220893)	Reference Device:Eko CORE(K200776)
Product Code	DSH; DQD	DSH	DQD
Regulation Number	21 CFR 870.2800;	21 CFR 870.2800	21 CFR 870.1875
DeviceClassification Name	Recorder, MagneticTape, Medical;Stethoscope,Electronic	Recorder, MagneticTape, Medical	Stethoscope, Electronic
Indications for Use	The AeviceMD is anon-invasivebattery-operateddevice, including awearable component,intended tolongitudinally acquire,record and store lungsound from adultpatients in a clinical ornon-clinical setting.The device stores thedata forlater playback, review,and analysis by aclinician andcomparison withearlier data from thesame patient.	The Strados RemoteElectronicStethoscopePlatform (RESP) is anon-invasivebattery-operateddevice, including awearablecomponent, intendedto longitudinallyacquire, record, andstore lung soundsfrom adult patients ina healthcare oroutpatient settingincluding transitionfrom healthcaresetting to outpatientcare withoutinterruption. Thedevice stores thedata for laterplayback, review,and analysis by aclinician andcomparison withearlier data from thesame patient.	The Eko CORE is anelectronic stethoscopethat enablesamplification, filtering,and transmission ofauscultation sound data(heart, lungs, bowel,arteries, and veins),whereby a clinician atone location on networkcan listen to theauscultation sounds ofa patient on site or at adifferent location on thenetwork. Eko CORE isintended for use onpediatric and adultpatients. The EkoCORE is intended to beused by professionalusers in a clinicalenvironment or by layusers in a nonclinicalenvironment. Thedevice is not intendedfor self-diagnosis.
Intended User	Adults only	Adults only	Adults and pediatrics
Intended UseEnvironment	Clinical andNon-clinical Setting	Clinical andNon-clinical Setting	Clinical and Non-clinicalSetting
User Interface	Mobile AppWeb Portal (For HCP)	Mobile AppWeb Portal (ForHCP)	Mobile AppWeb Portal (Mentionedon their website for
			HCP)
Record andPlayback Sounds	Yes	Yes	Yes
Data Transfer toCompatibleComputing platform	Yes	Yes	Yes
Condition of Use	Reusable	Reusable	Reusable
Rx or OTC	Prescription Only	Prescription Only	Over-the-Counter
Wearable	Yes	Yes	No

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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

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. 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.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
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.(b)
Classification. Class II (performance standards).