Steth IO

K160016 · Stratoscientific, Inc. · DQD · Jul 15, 2016 · Cardiovascular

Device Facts

• Record ID: K160016
• Device Name: Steth IO
• Applicant: Stratoscientific, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Jul 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.

Device Story

Steth IO is an acoustic device attaching to a smartphone; functions as a protective case and acoustic waveguide. It channels heart and lung sounds from a chest piece to the smartphone microphone. The smartphone application performs real-time analysis, allowing clinicians to hear sounds via headphones and visualize them as a phonocardiogram on the screen. Used in hospitals, clinics, and physician offices by healthcare providers. The device records sound and phonocardiogram data for immediate review or transmission to other providers. By leveraging smartphone processing and storage, it enables diagnostic aid for identifying abnormalities. Benefits include enhanced data capture, storage capacity, and visualization compared to traditional stethoscopes.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1, ISO 10993, and ISO 14971 standards was declared. Usability validation was performed to confirm clinician proficiency with the smartphone-integrated form factor.

Technological Characteristics

Acoustic stethoscope with fiberglass/epoxy diaphragm. Powered by smartphone lithium-ion battery. Connectivity via smartphone hardware/operating system. Software-based phonocardiogram visualization. Biocompatibility per ISO 10993. Safety per IEC 60601-1. Risk management per ISO 14971.

Indications for Use

Indicated for adults undergoing physical assessment for the detection and amplification of heart and lung sounds. Contraindicated for patients with open skin lesions at the site of examination.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• 3M Littmann Electronic Stethoscope, Model 3200 (K083903)

Reference Devices

• ViScope Electronic Stethoscope (K100531)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2016

Stratoscientific, Inc. % Jim West Principal Consultant Biomedical Devices Of Kansas 1205 E Us 24-40 Highway Tonganoxie, Kansas 66086

Re: K160016

Trade/Device Name: Steth IO Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: May 27, 2016 Received: June 7, 2016

Dear Jim West:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mude Yellm
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

510(k) Number (if known) K160016

Device Name Steth IO

#### Indications for Use (Describe)

The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the text 'K160016' at the top left. Below that is the logo for StratoScientific Inc. The logo features a stylized blue graphic to the left of the company name, which is also in blue. A horizontal line underlines the company name, and the abbreviation 'Inc' is located at the bottom right of the logo.

SECTION 4

# Traditional 510(k) Summary

# Update for Addendum 2

- 1. Summary Date: 27 May 2016
- Applicant Name: StratoScientific, Inc. 2. 1574 Northwest 190th Street Shoreline, WA 98177 USA Ph: [phone] Establishment Registration Number: Pending FDA Registration is pending.
- 1. Submission Correspondent: On behalf of StratoScientific Inc., the following consultant is assigned the responsibility of submission correspondence:

Jim West, Principal Consultant Biomedical Devices of Kansas, LLC 1205 E US 24-40 Highway Tonganoxie, KS 66086 Ph: 913.845.3851 ext. 106

- Steth IO® 2. Trade Name:
- 3. Common Name: Smartphone Stethoscope and Phonocardiogram

Description: Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart 4. and lung sounds. Steth IO attaches to the back of the smartphone and contains an acoustic wave guide that channels sound from the Steth IO chest piece to the smartphone's microphone, while also acting as a protective covering for the phone. The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram. The device is capable of recording sound and phonocardiogram data, allowing healthcare providers to capture biological sounds and send the data to other healthcare providers or for review at a later time. Steth IO is intended for use as a diagnostic aid, enabling the healthcare provider to identify sounds and any abnormalities that may be present.

- న. Biomedical Devices of Kansas Manufacturing Site: 1205 E. US 24-40 Highway 6. (Hardware) Tonganoxie, KS 66086 USA Ph: [phone] Establishment Registration Number: 3007124677
- 7. Classification Regulation, Class & Product Code & Panel:

21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular

- 8. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:
## Quality, Risk Management & Process related Standards.

CFR 21CFR820: Part 820 - QUALITY SYSTEM REGULATION, IEC 62304:2006 Medical device software - Software life cycle processes, ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 14971:2012 Medical devices - Application of risk management to medical devices,

## Technical/ Product Specific Standards

ASTM D 4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems, IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential

| Steth IO® | ADDENDUM 2 VOL_006/004_Traditional 510(k) Summary.doc |
|-----------------------------------------|-------------------------------------------------------|
| Model 1.0 Traditional 510(k) Submission | Page 006/004- |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the text "K160016" at the top. Below that is the logo for StratoScientific Inc. The logo includes a stylized blue graphic to the left of the company name, which is also in blue. A thin gray line runs beneath the company name, and the abbreviation "Inc" is in smaller font to the right.

SECTION 4

performance, 3rd

#### Labeling Standards

EN 1041:2008 The system labelling shall comply with BS EN 1041:2008 Information supplied by the manufacturer of medical devices,

ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirement,

#### Biocompatibility standards

ISO 10993:2010 The parts of the system that come into contact with humans shall comply with AAM / ANSI / ISO 10993:2010 (Biological evaluation of medical devices),

- Intended Use of Device 9.

| | PRODUCT REQUIREMENTS DOCUMENT - Novilase Model LTS-2 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use: | The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended<br>for medical diagnostic purposes only. It may be used for the detection and amplification<br>of sounds from the heart, and lungs with the use of selective frequency ranges. It has<br>been tested for use on adults undergoing a physical assessment. |
| Intended use: | The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended<br>for medical diagnostic purposes only. It may be used for the detection and amplification<br>of sounds from the heart, and lungs with the use of selective frequency ranges. It has<br>been tested for use on adults undergoing a physical assessment. |
| Intended User | Health Care Providers |
| Intended Use<br>Environment: | Medical Facilities<br>Hospitals<br>Outpatient Clinics<br>Physician Offices |
| Targeted Patient<br>Population: | Adults undergoing a physical assessment. |
| Contraindications: | Open skin lesions at site of examination |
| 10. Predicate Device(s): 510(k) Number: | K083903 |

| 10. Predicate Device(s): | 510(k) Number: | K083903 |
|--------------------------|-----------------|------------------------------------------------|
| | Manufacturer: | 3M Company |
| | Trade Name: | 3M Littmann Electronic Stethoscope, Model 3200 |
| | Product Code: | DQD |
| | Classification: | 870.1875 |

## 11. Comparison to Predicates

The proposed device and the predicate device have the same/equivalent intended user, intended use environment and targeted patient population. The predicate device chosen to establish substantial equivalence is the 3M Littmann Electronic Stethoscope, Model 3200, cleared under 510(k) K083903; used in conjunction with the Zargis StethAssist phonocardiogram software. It should be noted that phonocardiograms are 510(k) exempt devices per 870.2390. This predicate was selected based on a reference product, the ViScope Electronic Stethoscope (K100531) which used the same principal predicate in their 510(k) for an electronic stethoscope.

The main differences between Steth IO, Model 1.0 Smartphone Stethoscope and Phonocardiogram and the Predicate 3M Littmann Electronic Stethoscope, Model 3200 are included in the Executive Summary VOL_002/001 Table 2-1.1, copied here for reader convenience:

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the identifier "K160016" at the top left. Below that is the logo for StratoScientific Inc. The logo features a stylized blue graphic to the left of the company name, with "StratoScientific" in a bold, dark blue font and "Inc" in a smaller, lighter font to the right.

# Steth 10® Model 1.0 Traditional 510(k) Summary

SECTION 4

| | Table 2-1.1 Differences between Steth IO and Predicate Efficacy/Safety Concerns | |
|--|---------------------------------------------------------------------------------|--|
| | | |

| Feature /<br>Function | Steth IO<br>(Subject Device) | 3M Model 3200 with Zargis<br>StethAssist (Predicate<br>Device) | Comments on Efficacy/Safety |
|---------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diaphragm<br>Material | Fiberglass / Epoxy sheet | Polyurethane coated silicone | The reference device uses the<br>fiberglass/epoxy interface for the diaphragm.<br>This is equivalent for exempt device<br>(Cardiology III). |
| Energy Source | Lithium Ion Battery<br>provided by smartphone | Alkaline battery, Lithium Ion<br>battery, or NIMH battery.<br>Lithium Ion used for below<br>freezing temperatures | Specific energy power source in this case<br>does not have a significant impact on<br>efficacy or performance of the stethoscope<br>device. |
| Signal Input<br>Method | Analog collection of sound<br>waves to smartphone<br>microphone | Sound waves collected via a<br>transducer | Both mechanisms convert sound waves into<br>a digital signal. They are functionally<br>equivalent. |
| Audio Output<br>Method | Audio port and headphones | Earbuds | Both devices transmit sound energy into the<br>ear through devices inserted into the ear.<br>While the mechanism is different the result is<br>functionally equivalent. |
| Signal Storage | Dependant on capacity of<br>smartphone. Each<br>recording is last 1 minute<br>of evaluation | Limited to 12 – 30 second<br>recordings | By using a smartphone operating platform,<br>the Steth IO has a much greater capacity for<br>data storage, thus improving efficacy. Does<br>not affect safety or efficacy. |
| Signal<br>Transmission for<br>Visualization | No transmission necessary<br>for analysis and review,<br>processed and displayed on<br>smartphone | Bluetooth transmission to<br>compatible PC | Improved efficacy as there is no need for<br>data transmission for processing, so<br>decreased opportunity for error. No safety or<br>efficacy concerns. |
| Form Factor | Device that is held in the<br>doctors hand is the form of<br>the smartphone | Similar to traditional<br>stethoscope | Because the stethoscope is built into the case<br>attached to the smartphone the handling of<br>the device by the health care provider is<br>slightly different. Usability validation has<br>shown that clinicians experience no difficulty<br>in understanding how to use and operate the<br>device and because the patient contact<br>diaphragm is very similar to traditional<br>stethoscopes there appear to be no challenges<br>in understanding how the device is used. |
| Dedicated<br>Device vs.<br>iPhone | Operates on iPhone 6<br>smartphone using built in<br>hardware and operating<br>system | Dedicated proprietary<br>hardware | The smartphone hardware and operating<br>system is fully capable of exceeding the<br>requirements for an electronic stethoscope.<br>The operating platform of the iPhone does<br>not introduce any safety or efficacy concerns. |

## 12. Conclusions

StratoScientific believes the proposed Steth IO (Model 1.0) and its predicates the 3M Littmann Electronic Stethoscope, Model 3200 used in conjunction with the Zargis StethAssist phonocardiogram software, are substantially equivalent in their intended users, intended use environment and indications for use. They share similar design and technology characteristics as well as the same fundamental scientific operational technology. The differences that exist between the devices do not affect the relative safety and/or effectiveness.