The CliniCloud Stethoscope is a digital stethoscope intended for periodic recording of lung and heart sounds to a smartphone device, via the CliniCloud app. It is intended to be used for persons of all ages. The device is for medical diagnostic purposes only.

Device Description

The CliniCloud stethoscope is a battery powered electronic stethoscope intended for the periodic recording of lung and heart sounds to a smartphone via a CliniCloud micro-USB to 4-pole audio cable. The CliniCloud Stethoscope features no user interface or speaker and must be used in conjunction with the CliniCloud app on a compatible smartphone. It is intended to be used for persons of all ages.

AI/ML Overview

This is a 510(k) premarket notification for the CliniCloud Stethoscope. The document indicates that no clinical performance data was required for this submission. Therefore, it does not contain a study proving the device meets specific acceptance criteria through clinical trials or human-in-the-loop performance. The approval is based on non-clinical testing demonstrating substantial equivalence to a predicate device.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since no clinical study was conducted with specific acceptance criteria for a human user or algorithm performance, a traditional table comparing acceptance criteria to reported device performance from such a study cannot be generated. However, the non-clinical tests conducted aimed to prove the device met design specifications and was substantially equivalent to the predicate. The performance aspects assessed are listed:

Acceptance Criteria (Implied from Non-Clinical Testing)	Reported Device Performance (Summary from Non-Clinical Testing)
Compliance with general safety and essential performance standards (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11)	Device complies with all relevant standards.
Compliance with usability engineering standards (IEC 62366)	Device complies with usability engineering standards.
Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10)	All biocompatibility requirements were met.
Equivalence of frequency response (20 to 2000Hz) to a reference 510(k) cleared stethoscope	Demonstrated frequency response equivalence.
Accuracy of heart rate estimation benchmarked with a 510(k) cleared pulse oximeter	Heart rate estimation accuracy validated against a cleared pulse oximeter.
Validation of device cleaning instructions	Cleaning instructions validated.
Validation that frequencies across entire functional range can be reproduced on the smartphone and transmitted remotely	Frequencies reproduced on smartphone and transmitted remotely across full functional range validated.
Software contained in medical devices guidance compliance	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Home use design considerations guidance compliance	Compliance with "Design Considerations for Devices Intended for Home Use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. No human test set for performance evaluation was used. The non-clinical tests involved laboratory-based evaluations of the device's physical and functional characteristics.
Data Provenance: Not applicable for a human test set. The non-clinical testing was conducted to verify design specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No human test set requiring expert ground truth establishment was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human test set requiring adjudication was used.

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. An MRMC comparative effectiveness study was not performed. The device is a digital stethoscope, not an AI diagnostic algorithm for image or signal interpretation by human readers.

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

Yes, in a way. The performance tests for the device itself (e.g., frequency response, heart rate estimation accuracy, signal transmission) can be considered "standalone" evaluations of the device's technical capabilities, without direct human intervention in the performance measurement. However, it's not a standalone AI algorithm performance evaluation in the typical sense.

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

For the non-clinical performance evaluations:

Heart rate estimation: Ground truth was established by comparison to a "510(k) cleared pulse oximeter."
Frequency response: Ground truth was established by comparison against a "reference 510(k) cleared stethoscope."
Other tests relied on engineering specifications and compliance with established standards (e.g., for safety, EMC, biocompatibility).

8. The sample size for the training set

Not applicable. This device is a digital stethoscope, not an AI algorithm that requires a training set for machine learning.

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

Not applicable. This device is a digital stethoscope, not an AI algorithm that requires a training set.

Summary

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January 25, 2018

StethoCloud Pty. Ltd (CliniCloud) % Dave Yungvirt Senior RA/QA Consultant Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K173448

Trade/Device Name: CliniCloud Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: November 2, 2017 Received: November 6, 2017

Dear Dave Yungvirt:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, M& Hillele

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K173448

Device Name

CliniCloud Stethoscope

Indications for Use (Describe)

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

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K173448

1. Submission Sponsor

StethoCloud Pty. Ltd (CliniCloud)

Level 5, 141 Flinders Lane

Melbourne VIC, 3000

Australia

Contact: Andrew Lin

Title: CEO

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327.9997

Contact: Diane Sudduth

Title: Senior Consultant, RA

3. Date Prepared

1/15/2018

4. Device IDentification

Trade/Proprietary Name:	CliniCloud Stethoscope
-------------------------	------------------------

Common/Usual Name:	Electronic Stethoscope
--------------------	------------------------

Classification Name: Electronic Stethoscope
Regulation Number: 870.1875

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DQD Product Code: Device Class: Class II Classification Panel: Cardiovascular

5. Legally Marketed Predicate Device:

K050159, 3M™ Littmann® Electronic Stethoscope, 3M Health Care. Primary Predicate.

We have identified "K083903, 3M™ Littmann® Electronic Stethoscope, 3M Health Care" as a Reference Device. The reference device is used to support the heart rate estimation technology available in the subject device and the data transfer ability of its digital signals to an auxiliary device (which was needed to directly assess the frequency response of the subject device).

6. Indications for Use Statement

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the CliniCloud Stethoscope to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

TabLe 5A - Comparison of Characteristics for Primary Predicate

Manufacturer	StethoCLouD Pty LtD (CLiniCLouD)	3M Health Care
Trade Name	CliniClouD Stethoscope (SPL-999)	3M Littmann Electronic Stethoscope Model3000
510(k) Number	K173448	K050159
ProDuct CoDe	DQD	DQD
Manufacturer	StethoCLouD Pty LtD (CLiniCLouD)	3M Health Care
TraDe Name	CLiniCLouD Stethoscope SPL-999	3M Littmann Electronic Stethoscope MoDeL3000
ReguLationNumber	870.1875	870.1875
ReguLation Name	Electronic Stethoscope	Electronic Stethoscope
InDications for Use	The CliniCloud Stethoscope is adigital stethoscope intended forperiodic recording of lung and heartsounds to a smartphone device, viathe CliniCloud app. It is intended tobe used for persons of all ages. Thedevice is for medical diagnosticpurposes only.	The 3M™ Littmann® Electronic StethoscopeModel 3000 is intended for medical diagnosticpurposes only. It may be used for theamplification of heart, lung, arteries, veins, andother internal organs with the use of selectivefrequency. It can be used on any personundergoing a physical assessment.
Prescription use	No	No
Measurementfrequency range	20 - 22050 Hz	20 - 500 Hz
DispLay Heart Rate	Yes	No
Permits Datatransfer of storeDDigitaL signaLs	Yes	No
PoWer source	1 x CR2032 coin battery	1 x AA battery
	(maximum 3.0 V)	(maximum 1.5 V)
SignaL transmission	Wired connection to a compatiblesmartphone	No signal transmission capabilities
DiaphragmDiameter	34 mm	29 mm
ChestpiecetechnoLogy	Single sided	Single sided
User interface	Smartphone devicedisplay	No display, 4-button keypad
LoW batteryinDication	Yes	Yes
AmpLification	N/A	Up to 18 Times amplification
Waterproof	No	No
Manufacturer	StethoCLouD Pty LtD (CLiniCLouD)	3M Health Care
TraDe Name	CLiniClouD Stethoscope SPL-999	3M Littmann Electronic Stethoscope MoDeL3000
Patient contactingmaterial	Plastic	Plastic

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Note on the "InDications for Use": Both stethoscopes are indicated for medical diagnostic purposes only. The CliniCloud Stethoscope is not indicated for use to amplify sounds from arteries, veins and other internal organs. This does not affect the safety or effectiveness of the CliniCloud Stethoscope within its intended use of recording heart and lung sounds.

9. Non-CLinicaL Data

Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

AAMI ANSI ES 60601-1:2005/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
IEC 60601-1-11:2010 Radiators 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 [Including: Technical Corrigendum 1 (2011)]
. IEC 62366:2007 Medical devices - Application of usability engineering to medical devices.
. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005"
ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a . Risk Management Process; all requirements were met.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity; all requirements were met.
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin ● Sensitization; all requirements were met.
FDA Guidance "Design Considerations for Devices Intended for Home Use (November, 24, 2014)" ●

Other performance testing conducted include:

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Frequency response equivalence testing from 20 to 2000Hz against a reference 510k cleared . stethoscope
Accuracy testing of heart rate estimation benchmarked with a 510k cleared pulse oximeter
· Validation of device cleaning instructions considering likely use
Validation that frequencies across entire functional range can be reproduced on the smartphone and when transmitted remotely

10. CLinicaL Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial EquivaLence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics, but can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The CliniCloud Stethoscope, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).

Regulation Number and Section

§ 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.