(76 days)
Yes
The device name and description explicitly state "eMurmur Heart AI" and refer to "automated analysis by eMurmur Heart AI".
No
The device is a decision support system for evaluating recorded heart sounds and does not provide therapy. It is used for diagnosis, not treatment.
Yes
The software is described as a "decision support system in the evaluation of recorded patient heart sounds" and identifies heart sounds, including physiological and pathological heart murmurs. While it explicitly states it is "not intended as a sole means of diagnosis," it provides analyses that directly support the diagnostic process undertaken by a healthcare provider.
Yes
The device is described as "eMurmur Heart AI software" and its function is the analysis of recorded heart sounds. While it requires a digital stethoscope for input and a platform for display, the regulated component is explicitly the "eMurmur Heart AI" software itself, which performs the analysis. The description clarifies that the platform and stethoscope are separate components, with the software being the subject of the 510(k).
Based on the provided text, the eMurmur Heart AI software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- eMurmur Heart AI's function: The eMurmur Heart AI analyzes recorded patient heart sounds, which are physiological signals obtained externally from the body using a stethoscope. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "decision support system in the evaluation of recorded patient heart sounds." This aligns with analyzing external physiological data, not in vitro samples.
Therefore, while it's a medical device software that is subject to FDA review, it falls under a different regulatory category than IVDs.
No
The letter does not mention that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur.
eMurmur Heart AI is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.
Product codes
DQD, DQC
Device Description
To analyze heart sounds via the eMurmur Heart AI, a digital recording of a patient's heart sounds is required. Recordings are made using a supported digital stethoscope, connected to a front-end client like, e.g., the eMurmur app or the eMurmur web portal. The recorded auscultation data are transmitted from the front-end client to the eMurmur backend, which hosts the eMurmur Heart Al. After analysis by the eMurmur Heart Al, the results of the analysis are returned to the front-end client where they are displayed to the user. The user can utilize the eMurmur Heart AI results to support their decision-making process regarding the potential presence and type of a heart murmur.
eMurmur is a non-medical device software platform which includes the eMurmur backend, eMurmur apps and eMurmur web portal. The platform is used to stream, record, display. replay, and store auscultation data, recorded by means of supported digital stethoscopes.
The eMurmur software platform has functions subject to FDA premarket review, i.e., eMurmur Heart AI, as well as functions that are not subject to FDA premarket review. For this application. FDA assessed those functions only to the extent that they could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
eMurmur Heart AI
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
The document mentions "the patient's age as input" but does not specify an indicated patient age range.
Intended User / Care Setting
Setting where auscultation would typically be performed by a healthcare provider.
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)
eMurmur Heart AI and the predicate, eMurmur ID (K181988), utilize the same heart sound analysis algorithm, hence no new performance data is required.
All applicable verification measures (unit tests, system tests, inspections) that were performed for the predicate were also performed for the current device, using the same pass/fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 85.0% (72.9%-92.5%)
Specificity: 86.7% (74.9%-93.7%)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
May 31, 2022
CSD Labs GmbH % Allison Komiyama Principal Consultant Ram+ 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K220766
Trade/Device Name: eMurmur Heart AI Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DQC Dated: May 6, 2022 Received: May 9, 2022
Dear Allison Komiyama:
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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2023 |
See PRA Statement below.
510(k) Number (if known)
Device Name
eMurmur Heart Al
Indications for Use (Describe)
The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur.
eMurmur Heart Al is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.
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) |
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
CSD Labs' eMurmur Heart Al
SPONSOR
| Company name: | CSD Labs GmbH |
|---|---|
| Company address: | Nikolaiplatz 4 |
| 8020 Graz | |
| Austria | |
| Phone: | +43 650 5272666 |
| Contact Person: | Andreas Reinisch |
| Date Prepared: | March 14, 2022 |
CONSULTANT
| Company name: | RQM+ |
|---|---|
| Company address: | 2251 San Diego Ave. Ste B-257 |
| San Diego, CA 92110 | |
| Phone: | (412) 816-8253 |
| Contact Person: | Allison Komiyama, PhD, RAC |
| Anike Freeman, MEng, PMP |
DEVICE
| Trade Name: | eMurmur Heart Al |
|---|---|
| Common or usual name: | Computer Aided Auscultation, Heart Sounds Analyzer |
| Classification name: | Electronic Stethoscope; Phonocardiograph; |
| Regulation number: | 21 CFR 870.1875, 870.2390 |
| Product code: | DQD, DQC |
| Device class: | Class II |
| Reviewing panel: | Cardiology |
PREDICATE DEVICE
| Company | CSD Labs GmbH |
|---|---|
| Product | eMurmur ID |
| 510(k) | K181988 |
INDICATIONS FOR USE
The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur.
eMurmur Heart AI is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.
4
DEVICE DESCRIPTION
To analyze heart sounds via the eMurmur Heart AI, a digital recording of a patient's heart sounds is required. Recordings are made using a supported digital stethoscope, connected to a front-end client like, e.g., the eMurmur app or the eMurmur web portal. The recorded auscultation data are transmitted from the front-end client to the eMurmur backend, which hosts the eMurmur Heart Al. After analysis by the eMurmur Heart Al, the results of the analysis are returned to the front-end client where they are displayed to the user. The user can utilize the eMurmur Heart AI results to support their decision-making process regarding the potential presence and type of a heart murmur.
eMurmur is a non-medical device software platform which includes the eMurmur backend, eMurmur apps and eMurmur web portal. The platform is used to stream, record, display. replay, and store auscultation data, recorded by means of supported digital stethoscopes.
The eMurmur software platform has functions subject to FDA premarket review, i.e., eMurmur Heart AI, as well as functions that are not subject to FDA premarket review. For this application. FDA assessed those functions only to the extent that they could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.
TECHNOLOGICAL CHARACTERISTICS
The eMurmur Heart Al has the same technological characteristics as the predicate device eMurmur ID. It can be accessed via the eMurmur backend, which in turn communicates with the front-end clients, e.g., the eMurmur app and eMurmur web portal.
- Both systems use the same heart sound analysis algorithm, hosted on a server, requiring 1. a 20 second digital heart sound recording and the patient's age as input.
-
- Both systems provide heart sound analysis outputs and additional supporting information to the user.
-
- Both systems provide the transfer of auscultation data and the analysis results through a secure connection.
-
- Both systems employ equivalent usability and cybersecurity features.
-
- Both systems use the electronic stethoscope Littmann 3200 by 3M (MN, USA) (K083903) for the acquisition of the heart sounds that are to be analyzed.
PERFORMANCE DATA
eMurmur Heart AI and the predicate, eMurmur ID (K181988), utilize the same heart sound analysis algorithm, hence no new performance data is required.
All applicable verification measures (unit tests, system tests, inspections) that were performed for the predicate were also performed for the current device, using the same pass/fail criteria.
SUBSTANTIAL EQUIVALENCE
eMurmur Heart AI and eMurmur ID differ only in scope. For the previously cleared device eMurmur ID, all components of the software system (mobile app, web portal, backend, etc.) were treated as a medical device. For eMurmur Heart AI, only the relevant component, i.e., the algorithm analyzing heart sounds, is treated as a medical device. The other components which are solely intended to transfer, store, convert and display medical data or results are excluded from the scope of the medical device.
Thus, eMurmur Heart AI is substantially equivalent to eMurmur ID, see the table below.
5
| eMurmur Heart Al | eMurmur ID | |
|---|---|---|
| Indications for | ||
| Use | The 'eMurmur Heart Al' software is a | |
| decision support system in the evaluation | ||
| of recorded patient heart sounds. The | ||
| automated analysis by eMurmur Heart | ||
| Al identifies specific heart sounds that | ||
| may be present, including S1, S2, | ||
| physiological heart murmurs, pathological | ||
| heart murmurs and the absence of a | ||
| heart murmur. |
eMurmur Heart Al is indicated for use in
a setting where auscultation would
typically be performed by a healthcare
provider. It is not intended as a sole
means of diagnosis. The heart sound
interpretations offered by eMurmur Heart
Al are only significant when considered in
conjunction with healthcare provider over-
read and including all other relevant
patient data.
'eMurmur' is a non-medical device
software platform which includes the
eMurmur apps and eMurmur web portal.
The platform is used to stream, record,
display, replay, and store auscultation
data, recorded by means of supported
digital stethoscopes. eMurmur Heart Al
interacts with the 'eMurmur' software
platform. | The eMurmur ID software system is a
decision support device for the healthcare
provider (the user) in the evaluation of
patient heart sounds. eMurmur ID is used
to record, display, analyze, and store the
acoustic signal of the heart, recorded by
means of an electronic stethoscope. The
automated analysis will identify specific
heart sounds that may be present,
including S1, S2, physiological heart
murmurs, pathological heart murmurs and
absence of a heart murmur.
eMurmur ID is indicated for use in a
setting where auscultation would typically
be performed by a healthcare provider. It
is not intended as a sole means of
diagnosis. The heart sound interpretations
offered by eMurmur ID are only significant
when considered in conjunction with
healthcare provider over-read and
including all other relevant patient data. |
| User Population | Identical | Healthcare provider licensed or authorized
to perform auscultation |
| Acquires and
Records Heart
Sounds | Identical | Acquires acoustic signals of the heart by
means of electronic stethoscope and
mobile app |
| Analyzes Heart
Sounds | Identical | Distinguishes between
normal/physiological and pathological
heart murmurs |
| User Interface | The user interface is not a part of
eMurmur Heart Al (medical device);
the user interface is part of 'eMurmur',
a non-medical device. | Android app for recording heart sounds,
sending analysis requests and receiving
analysis results. Web portal for reviewing
and editing user and patient data, OS
independent. |
| Backend | The backend is not a part of eMurmur
Heart AI (medical device); the backend
is part of 'eMurmur', a non-medical
device. | Server analyzes (algorithm) and stores
(database) patient-related data and
communicates with the other components
of eMurmur ID. The interface to the other
components is a REST/JSON web API. |
| Accessories | Identical | Electronic stethoscope Littmann 3200 |
| Safety Features | Identical | Encrypted internet traffic, data stored in
the database on the backend is
encrypted, data in the database is
duplicated to another database in a
different datacenter, no protected health
information is stored on the user's
devices, user needs to authenticate, user
can only access authorized data |
| Clinical
Performance | Identical | Sensitivity: 85.0% (72.9%-92.5%)
Specificity: 86.7% (74.9%-93.7%) |
Table 1. Substantial Equivalence Summary Comparison Table
6
CONCLUSIONS
The medical device eMurmur Heart Al has the same intended use, similar indications for use, and the same technological characteristics, and principles of operation as eMurmur ID. Thus, eMurmur Heart AI is substantially equivalent to eMurmur ID.
eMurmur Heart AI consists of the same heart sound analysis algorithm as eMurmur ID. Other components that were part of the eMurmur ID medical device (e.g., the app and web portal) have been excluded from the eMurmur Heart Al medical device, since these components are software solely intended to transfer, store, convert and display medical data or results.