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.

Device Description

Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart 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.

AI/ML Overview

I am sorry, but the provided text does not contain a study or specific acceptance criteria with reported device performance for the Steth IO device. The document is primarily a 510(k) premarket notification summary to the FDA, which focuses on establishing substantial equivalence to a predicate device.

It outlines:

Device Name: Steth IO
Regulation Number: 21 CFR 870.1875
Regulation Name: Stethoscope
Regulatory Class: Class II
Product Code: DQD
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."
Predicate Device: 3M Littmann Electronic Stethoscope, Model 3200 (K083903) used in conjunction with Zargis StethAssist phonocardiogram software.
Comparison to Predicate: A table (Table 2-1.1) highlighting differences in features and functionalities, but not specific performance metrics against acceptance criteria. It discusses how the differences do not affect safety or efficacy.
Compliance to Standards: A list of quality, risk management, process-related, technical/product-specific, labeling, and biocompatibility standards the device complies with.

The document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, or details about the study design (retrospective/prospective).
Number of experts, their qualifications, or adjudication methods for ground truth.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
Standalone (algorithm only) performance.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Therefore, I cannot provide the requested table and study details based on the given input.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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)

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."

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

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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: (425)876-4310 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:
1. 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: (913)845-3851 Establishment Registration Number: 3007124677
1. Classification Regulation, Class & Product Code & Panel:

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

1. 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-

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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 intendedfor medical diagnostic purposes only. It may be used for the detection and amplificationof sounds from the heart, and lungs with the use of selective frequency ranges. It hasbeen tested for use on adults undergoing a physical assessment.
Intended use:	The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intendedfor medical diagnostic purposes only. It may be used for the detection and amplificationof sounds from the heart, and lungs with the use of selective frequency ranges. It hasbeen tested for use on adults undergoing a physical assessment.
Intended User	Health Care Providers
Intended UseEnvironment:	Medical FacilitiesHospitalsOutpatient ClinicsPhysician Offices
Targeted PatientPopulation:	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:

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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 /Function	Steth IO(Subject Device)	3M Model 3200 with ZargisStethAssist (PredicateDevice)	Comments on Efficacy/Safety
DiaphragmMaterial	Fiberglass / Epoxy sheet	Polyurethane coated silicone	The reference device uses thefiberglass/epoxy interface for the diaphragm.This is equivalent for exempt device(Cardiology III).
Energy Source	Lithium Ion Batteryprovided by smartphone	Alkaline battery, Lithium Ionbattery, or NIMH battery.Lithium Ion used for belowfreezing temperatures	Specific energy power source in this casedoes not have a significant impact onefficacy or performance of the stethoscopedevice.
Signal InputMethod	Analog collection of soundwaves to smartphonemicrophone	Sound waves collected via atransducer	Both mechanisms convert sound waves intoa digital signal. They are functionallyequivalent.
Audio OutputMethod	Audio port and headphones	Earbuds	Both devices transmit sound energy into theear through devices inserted into the ear.While the mechanism is different the result isfunctionally equivalent.
Signal Storage	Dependant on capacity ofsmartphone. Eachrecording is last 1 minuteof evaluation	Limited to 12 – 30 secondrecordings	By using a smartphone operating platform,the Steth IO has a much greater capacity fordata storage, thus improving efficacy. Doesnot affect safety or efficacy.
SignalTransmission forVisualization	No transmission necessaryfor analysis and review,processed and displayed onsmartphone	Bluetooth transmission tocompatible PC	Improved efficacy as there is no need fordata transmission for processing, sodecreased opportunity for error. No safety orefficacy concerns.
Form Factor	Device that is held in thedoctors hand is the form ofthe smartphone	Similar to traditionalstethoscope	Because the stethoscope is built into the caseattached to the smartphone the handling ofthe device by the health care provider isslightly different. Usability validation hasshown that clinicians experience no difficultyin understanding how to use and operate thedevice and because the patient contactdiaphragm is very similar to traditionalstethoscopes there appear to be no challengesin understanding how the device is used.
DedicatedDevice vs.iPhone	Operates on iPhone 6smartphone using built inhardware and operatingsystem	Dedicated proprietaryhardware	The smartphone hardware and operatingsystem is fully capable of exceeding therequirements for an electronic stethoscope.The operating platform of the iPhone doesnot 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.

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.