(192 days)
No
The description focuses on acoustic signal processing and visualization (phonocardiogram) without mentioning AI/ML algorithms for analysis or interpretation.
No
The device is described as being for "medical diagnostic purposes only" and as a "diagnostic aid," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only." Additionally, the "Device Description" section notes that "Steth IO is intended for use as a diagnostic aid."
No
The device description explicitly states that Steth IO is an acoustic device that attaches to the back of a smartphone and contains an acoustic wave guide and chest piece, indicating it includes physical hardware components beyond just software.
Based on the provided information, the StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body. The Steth IO device is used to directly listen to and visualize sounds from the heart and lungs within the patient's body. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for medical diagnostic purposes based on acoustic signals. The device collects and analyzes sounds, not biological specimens.
The description clearly indicates that the device is an acoustic stethoscope and phonocardiogram used for physical assessment of the heart and lungs. This falls under the category of medical devices used for direct patient examination, not in vitro diagnostics.
N/A
Intended Use / Indications for 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 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.
Product codes
DQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, and lungs
Indicated Patient Age Range
Adults undergoing a physical assessment.
Intended User / Care Setting
Health Care Providers / Medical Facilities, Hospitals, Outpatient Clinics, Physician Offices
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/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 (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
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.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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
-
- 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.
-
- 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:
-
- 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
-
- Classification Regulation, Class & Product Code & Panel:
21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular
-
- 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 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. | |
| 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. | |
| Intended User | Health Care Providers |
| Intended Use | |
| Environment: | Medical Facilities |
| Hospitals | |
| Outpatient Clinics | |
| Physician Offices | |
| Targeted Patient | |
| 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:
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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 Zargis
StethAssist (Predicate
Device) | Comments on Efficacy/Safety |
|---------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diaphragm
Material | Fiberglass / Epoxy sheet | Polyurethane coated silicone | The reference device uses the
fiberglass/epoxy interface for the diaphragm.
This is equivalent for exempt device
(Cardiology III). |
| Energy Source | Lithium Ion Battery
provided by smartphone | Alkaline battery, Lithium Ion
battery, or NIMH battery.
Lithium Ion used for below
freezing temperatures | Specific energy power source in this case
does not have a significant impact on
efficacy or performance of the stethoscope
device. |
| Signal Input
Method | Analog collection of sound
waves to smartphone
microphone | Sound waves collected via a
transducer | Both mechanisms convert sound waves into
a digital signal. They are functionally
equivalent. |
| Audio Output
Method | Audio port and headphones | Earbuds | Both devices transmit sound energy into the
ear through devices inserted into the ear.
While the mechanism is different the result is
functionally equivalent. |
| Signal Storage | Dependant on capacity of
smartphone. Each
recording is last 1 minute
of evaluation | Limited to 12 – 30 second
recordings | By using a smartphone operating platform,
the Steth IO has a much greater capacity for
data storage, thus improving efficacy. Does
not affect safety or efficacy. |
| Signal
Transmission for
Visualization | No transmission necessary
for analysis and review,
processed and displayed on
smartphone | Bluetooth transmission to
compatible PC | Improved efficacy as there is no need for
data transmission for processing, so
decreased opportunity for error. No safety or
efficacy concerns. |
| Form Factor | Device that is held in the
doctors hand is the form of
the smartphone | Similar to traditional
stethoscope | Because the stethoscope is built into the case
attached to the smartphone the handling of
the device by the health care provider is
slightly different. Usability validation has
shown that clinicians experience no difficulty
in understanding how to use and operate the
device and because the patient contact
diaphragm is very similar to traditional
stethoscopes there appear to be no challenges
in understanding how the device is used. |
| Dedicated
Device vs.
iPhone | Operates on iPhone 6
smartphone using built in
hardware and operating
system | Dedicated proprietary
hardware | The smartphone hardware and operating
system is fully capable of exceeding the
requirements for an electronic stethoscope.
The operating platform of the iPhone does
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.