(242 days)
Unknown
The summary mentions the Cloud Platform "analyzes user's data using meaningful output information," but it does not explicitly state that this analysis uses AI or ML. The lack of mention of AI/ML terms, training/test sets, or performance metrics typically associated with AI/ML models makes it difficult to confirm its presence.
No
The device is intended for data acquisition, recording, storage, and playback of lung sounds for analysis by a clinician, not for providing therapy or treatment.
Yes
The device is intended to acquire, record, and store lung sounds for later playback, review, and analysis by a clinician, which directly supports the process of forming a diagnosis. It is described as an "electronic stethoscope" which is inherently a diagnostic tool.
No
The device description explicitly states that the AeviceMD consists of "hardware and embedded software" and lists multiple hardware components (Sensor, Silicone Patch, Docking Station).
Based on the provided information, the AeviceMD is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The AeviceMD acquires and records lung sounds from the body, but it doesn't analyze biological samples like blood, urine, or tissue.
- The intended use is to acquire, record, and store lung sounds for clinician review and analysis. This is a diagnostic aid based on physical sounds, not an analysis of biological material.
- The device description focuses on electronic stethoscope functionality. It's designed to capture acoustic data, not perform laboratory-style tests on samples.
The AeviceMD falls under the category of a medical device, specifically one that aids in diagnosis by providing physiological data (lung sounds) for a clinician to interpret. It's more akin to an electronic stethoscope with recording and data management capabilities.
N/A
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 setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Product codes
DSH, DOD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung sounds from adult patients
Indicated Patient Age Range
Adults only
Intended User / Care Setting
Clinician; clinical setting / non-clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The device was subject to non-clinical performance testing including: 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.
Key results: The conclusions drawn from the non-clinical tests demonstrate that the proposed subject device performs as well as the legally marketed predicate device and is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 (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
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +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
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:
-
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 |
| Device
Classification Name | Recorder, Magnetic
Tape, Medical;
Stethoscope,
Electronic | Recorder, Magnetic
Tape, Medical | Stethoscope, Electronic |
| Indications for Use | The AeviceMD is a
non-invasive
battery-operated
device, including a
wearable component,
intended to
longitudinally acquire,
record and store lung
sound 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. | The Strados Remote
Electronic
Stethoscope
Platform (RESP) 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 healthcare or
outpatient setting
including transition
from healthcare
setting to outpatient
care without
interruption. The
device stores the
data for later
playback, review,
and analysis by a
clinician and
comparison with
earlier data from the
same patient. | 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. |
| Intended User | Adults only | Adults only | Adults and pediatrics |
| Intended Use
Environment | Clinical and
Non-clinical Setting | Clinical and
Non-clinical Setting | Clinical and Non-clinical
Setting |
| User Interface | Mobile App
Web Portal (For HCP) | Mobile App
Web Portal (For
HCP) | Mobile App
Web Portal (Mentioned
on their website for |
| | | | HCP) |
| Record and
Playback Sounds | Yes | Yes | Yes |
| Data Transfer to
Compatible
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 |
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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
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.