(80 days)
No
The summary describes a digital stethoscope that records sounds to a smartphone app but does not mention any analysis or processing of these sounds using AI or ML. The performance studies focus on basic device functionality and equivalence to a predicate device.
No
Explanation: The device is intended for medical diagnostic purposes only, specifically for recording lung and heart sounds to a smartphone, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states: "The device is for medical diagnostic purposes only."
No
The device description explicitly states it is a "battery powered electronic stethoscope" and requires a "micro-USB to 4-pole audio cable," indicating it includes hardware components beyond just software.
No, the CliniCloud Stethoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This typically involves analyzing blood, urine, tissue, or other bodily fluids outside of the body to diagnose diseases or conditions.
- The CliniCloud Stethoscope is used to record sounds from the human body. It listens to lung and heart sounds directly from the patient.
The intended use and device description clearly state that the CliniCloud Stethoscope is for recording lung and heart sounds from a person. This is a form of in vivo (within the living body) diagnostic tool, not an in vitro diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
DQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung and heart
Indicated Patient Age Range
persons of all ages
Intended User / Care Setting
Not Found
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
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:
- 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
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.
Key Metrics
Not Found
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
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);
1
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
2
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)
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.
Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
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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
4
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
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.
7. 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.
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 Model |
| 3000 | ||
| 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 MoDeL |
| 3000 | ||
| ReguLation | ||
| Number | 870.1875 | 870.1875 |
| ReguLation Name | Electronic Stethoscope | Electronic Stethoscope |
| InDications for Use | 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. | The 3M™ Littmann® Electronic Stethoscope | |
| Model 3000 is intended for medical diagnostic | ||
| purposes only. It may be used for the | ||
| amplification of heart, lung, arteries, veins, and | ||
| other internal organs with the use of selective | ||
| frequency. It can be used on any person | ||
| undergoing a physical assessment. | ||
| Prescription use | No | No |
| Measurement | ||
| frequency range | 20 - 22050 Hz | 20 - 500 Hz |
| DispLay Heart Rate | Yes | No |
| Permits Data | ||
| transfer of storeD | ||
| DigitaL 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 compatible | |
| smartphone | No signal transmission capabilities | |
| Diaphragm | ||
| Diameter | 34 mm | 29 mm |
| Chestpiece | ||
| technoLogy | Single sided | Single sided |
| User interface | Smartphone device | |
| display | No display, 4-button keypad | |
| LoW battery | ||
| inDication | 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 MoDeL |
| 3000 | ||
| Patient contacting | ||
| material | Plastic | Plastic |
5
6
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:
7
- 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).