(59 days)
No
The summary describes sound analysis for identification of sounds from targeted areas, but does not mention AI or ML. The performance studies focus on heart rate accuracy and frequency response, not classification or pattern recognition typically associated with AI/ML in this context.
No.
The device is an electronic stethoscope that amplifies, filters, and transmits auscultation sound data for diagnostic purposes (physical examination, monitoring medical conditions), not for therapy.
No
The device is an electronic stethoscope that amplifies and transmits auscultation sounds for a clinician to listen to, but it explicitly states that it is "not intended for self-diagnosis or emergency use." Its purpose is for sound collection and transmission, not for automated interpretation leading to a diagnosis.
No
The device description explicitly states that the Steth IO Spot has two main components: the Steth IO Spot device (hardware) and the Steth IO Spot Software (Telemedicine App). The hardware component is an acoustic device with an integrated microphone that collects biological sounds and connects to a smartphone. This is not a software-only device.
Based on the provided information, the Steth IO Spot is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Steth IO Spot's Function: The Steth IO Spot is an electronic stethoscope that collects and transmits biological sounds (heart, lung, etc.) from the patient's body. It does not analyze or examine specimens derived from the body.
- Intended Use: The intended use is for physical examination and auscultation, which involves listening to internal sounds of the body. This is a direct examination of the patient, not an in vitro test.
- Device Description: The device description focuses on the acoustic nature of the device, the microphone, and the transmission of sound data. There is no mention of handling or analyzing biological specimens.
Therefore, the Steth IO Spot falls under the category of a medical device used for physical examination and auscultation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Steth IO Spot is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data, whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Steth IO Spot is intended for use on individuals undergoing physical examination. The Steth IO Spot is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis or emergency use.
OTC use: Steth IO Spot can be used by a patient to be examined during a video call and to submit a non-emergent-examination for review by their healthcare provider.
Rx-only use: Steth IO Spot may be prescribed by a licensed medical provider to monitor medical conditions that require the use of a stethoscope.
Product codes (comma separated list FDA assigned to the subject device)
DQD
Device Description
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
The Steth IO Spot device has two main components:
- Steth IO Spot device: The Steth IO Spot device is capable of transmitting your heart, lung or other biological sounds to the mobile device. This device needs to be connected to the smartphone's lightning port/USB-Type C port.
- Steth IO Spot Software (Telemedicine App): The Steth IO smartphone application software performs real-time analysis to hear the sounds using headphones. The app is available for download from a designated software repository.
A chest piece, consisting of a bell and diaphragm, and an integrated microphone is placed on the patient and the sound is transmitted to a smartphone via lightning port/USB-C port. The device is capable of recording sound data, allowing the patient-user at one location to share audio data with their healthcare provider on site or at a different location on the network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional users in a clinical environment or by lay users in a nonclinical environment.
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)
Performance Testing
- Functional
- Heart Rate Accuracy Test, side-by-side comparison test with predicate device and FDA-cleared gold standard (EKG). The Steth IO Spot successfully met the acceptance criteria of a concordance correlation coefficient of substantial strength (0.95 – 0.99). The Steth IO Spot's method to evaluate heart rate had a high concordance correlation with the heart rate measured by the Eko CORE (predicate device) and EKG (gold standard). Thus, the Steth IO Spot is considered to be similar to the predicate device in terms of heart rate measurement performance.
- Frequency Audio Response Test, side-by-side comparison test with predicate device at a response beyond 2000 Hz. The Steth IO Spot performed better than the Eko CORE (predicate device) with an overall amplitude (dB) of the signal registered by the Steth IO Spot being higher than that registered by the Eko CORE. Moreover, Steth IO Spot's frequency response curve was smooth, and free of undesirable spikes and dips. The heart and lung sounds of clinical interest fall within the range for which testing was conducted. Therefore, the Steth IO Spot performs equivalently to the EKO Core device in regards to audio frequency response performance.
- Human factors usability testing was conducted per IEC 62366-1 to evaluate that the intended users of the Steth IO Spot device are able to achieve its intended use with the help of the instructions for use. Two separate studies were conducted. One study evaluated healthcare professional users in their intended use environment (e.g., hospital setting, office setting, etc.) and the other study evaluated patient-users (i.e., lay-users) in the home setting. Overall, the Steth IO Spot successfully met the acceptance criteria and all users were able to successfully achieve the intended use of the device when given the appropriate instructions for use.
- Biocompatibility Testing
The main patient-contacting components of this device are the diaphragm and retainer ring, which are off-the-shelf components that are identical to the ones used in the previously-cleared reference device (K160016) as well as other stethoscopes in the market. No biocompatibility testing was required to demonstrate substantial equivalence. - Electrical safety and electromagnetic compatibility (EMC)
The Steth IO Spot is an active device used in conjunction with the user's own smartphone. The following ES/EMC tests were conducted per the respective international standards:- IEC 60601-1:2005/A1:2012/A2:2020 General electrical safety testing
- IEC 60601-1-2 Edition 4.0 2014-02 EMC testing
- IEC 60601-1-11: 2015 Requirements for medical devices in home healthcare environment
- Software Verification and Validation Testing
The Steth IO Spot Software is developed and tested in compliance with IEC 62304.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 24, 2022
StratoScientific % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220196
Trade/Device Name: Steth IO Spot Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: March 21, 2022 Received: March 22, 2022
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220196
Device Name Steth IO Spot
Indications for Use (Describe)
The Steth IO Spot is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data, whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Steth IO Spot is intended for use on individuals undergoing physical examination. The Steth IO Spot is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis or emergency use.
OTC use: Steth IO Spot can be used by a patient to be examined during a video call and to submit a non-emergentexamination for review by their healthcare provider.
Rx-only use: Steth IO Spot may be prescribed by a licensed medical provider to monitor medical conditions that require the use of a stethoscope.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- I. SUBMITTER StratoScientific, Inc. 19125 North Creek Pkwy. #120 Bothell, WA 98011 Tel: +1.425.260.0729
| Company Contact: | Mahesh Mulumudi
CEO and President |
|------------------|-------------------------------------------------------|
| Contact Person: | Meritxell Martinez
Associate Regulatory Consultant |
| Contact Email: | meri@fdaecopy.com |
| Date Prepared: | March 1st, 2022 |
II. DEVICE
| Name of Device: | Steth IO Spot |
|---|---|
| Classification Name: | Electronic Stethoscope |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR §870.1875 |
| Regulatory Class: | Class II |
| Product Classification Code: | DQD |
III. PREDICATE AND REFERENCE DEVICE
| Primary Predicate Manufacturer: | Eko Device, Inc. |
|---|---|
| Primary Predicate Trade Name: | Eko CORE |
| Primary Predicate 510(k): | K200776 |
| Reference Device Manufacturer: | StratoScientific, Inc. |
| Reference Device Trade Name: | Steth IO |
| Reference Device 510(k): | K160016 |
IV. DEVICE DESCRIPTION
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
The Steth IO Spot device has two main components:
- Steth IO Spot device: The Steth IO Spot device is capable of transmitting your heart, lung or other ● biological sounds to the mobile device. This device needs to be connected to the smartphone's lightning port/USB-Type C port.
- Steth IO Spot Software (Telemedicine App): The Steth IO smartphone application software ●
4
performs real-time analysis to hear the sounds using headphones. The app is available for download from a designated software repository.
A chest piece, consisting of a bell and diaphragm, and an integrated microphone is placed on the patient and the sound is transmitted to a smartphone via lightning port/USB-C port. The device is capable of recording sound data, allowing the patient-user at one location to share audio data with their healthcare provider on site or at a different location on the network.
V. INDICATIONS FOR USE
The Steth IO Spot is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data, whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Steth IO Spot is intended for use on individuals undergoing physical examination. The Steth IO Spot is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis or emergency use.
OTC use: Steth IO Spot can be used by a patient to be examined during a video call and to submit a non-emergent-examination for review by their healthcare provider.
Rx-only use: Steth IO Spot may be prescribed by a licensed medical provider to monitor medical conditions that require the use of a stethoscope.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device:
| Steth IO Spot | Eko CORE – K200776 | |
|---|---|---|
| Indications for Use | The Steth IO Spot is an electronic | |
| stethoscope that enables | ||
| amplification, filtering, and | ||
| transmission of auscultation sound | ||
| data, whereby a clinician at one | ||
| location on network can listen to the | ||
| auscultation sounds of a patient on | ||
| site or at a different location on the | ||
| network. Steth IO Spot is intended for | ||
| use on individuals undergoing | ||
| physical examination. The Steth IO | ||
| Spot is intended to be used by | ||
| professional users in a clinical | ||
| environment or by lay users in a | ||
| nonclinical environment. The device | ||
| is not intended for self-diagnosis or | ||
| emergency use. | The Eko CORE is an electronic | |
| stethoscope that enables amplification, | ||
| filtering, and transmission of | ||
| auscultation sound data (heart, lungs, | ||
| bowel, arteries, and veins), whereby a | ||
| clinician at one location on network can | ||
| listen to the auscultation sounds of a | ||
| patient on site or at a different location | ||
| on the network. Eko CORE is intended | ||
| for use on pediatric and adult | ||
| patients. The Eko CORE is intended to | ||
| be used by professional users in a | ||
| clinical environment or by lay users in a | ||
| nonclinical environment. The device is | ||
| not intended for self-diagnosis. | ||
| OTC use: Steth IO Spot can be used | ||
| by a patient to be examined during a | ||
| video call and to submit a non- | ||
| emergent-examination for review by | ||
| their healthcare provider. | ||
| Rx-only use: Steth IO Spot may be | ||
| prescribed by a licensed medical | ||
| provider to monitor medical | ||
| conditions that require the use of a | ||
| stethoscope. | ||
| Standards Met | IEC 60601-1:2005/A1:2012/A2:2020 | |
| IEC 60601-1-2:2015 | ||
| IEC 60601-1-11:2015 | ||
| IEC 62304:2006/A1:2016 | ||
| ISO 14971:2019 | ||
| ASTM D 4169-16 | ||
| ISO 15223-1:2016 | ||
| IEC 62366-1:2015 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-1-11 | ||
| Device | ||
| Classification | DQD: Electronic stethoscope | DQD: Electronic stethoscope |
| Prescribed | ||
| Classification | Rx and OTC | Rx and OTC |
| Classification | Class II | Class II |
| Stethoscope | ||
| Type | Electronic stethoscope with | |
| attachment to smartphone via | ||
| lightning port/USB-C port | Attachment to an analog stethoscope | |
| (Core) | ||
| User Interface | Steth IO Spot hardware device | |
| Mobile App/Web Portal | On/Off Power button | |
| Volume adjustment | ||
| LED status indicator | ||
| Mobile App | ||
| Analog/Digital | ||
| Interoperability | Not applicable | Yes |
| Connectivity to | ||
| mobile phone | Wired connection via lightning | |
| port/USB-C port | Bluetooth | |
| Sound | ||
| Amplification | Yes | Yes |
| Record and | ||
| Playback | ||
| Sounds | Yes | Yes |
| Data Transfer | ||
| to Compatible | ||
| Computing | ||
| Platform | Yes | Yes |
5
VII. PERFORMANCE DATA
The following performance data were provided in the support of this submission:
Performance Testing
- Functional
- Heart Rate Accuracy Test, side-by-side comparison test with predicate device and FDA- O cleared gold standard (EKG). The Steth IO Spot successfully met the acceptance criteria of a concordance correlation coefficient of substantial strength (0.95 – 0.99). The Steth IO Spot's method to evaluate heart rate had a high concordance correlation with the heart rate measured by the Eko CORE (predicate device) and EKG (gold standard). Thus, the Steth IO Spot is considered to be similar to the predicate device in terms of heart rate
6
measurement performance.
- O Frequency Audio Response Test, side-by-side comparison test with predicate device at a response beyond 2000 Hz. The Steth IO Spot performed better than the Eko CORE (predicate device) with an overall amplitude (dB) of the signal registered by the Steth IO Spot being higher than that registered by the Eko CORE. Moreover, Steth IO Spot's frequency response curve was smooth, and free of undesirable spikes and dips. The heart and lung sounds of clinical interest fall within the range for which testing was conducted. Therefore, the Steth IO Spot performs equivalently to the EKO Core device in regards to audio frequency response performance.
- Human factors usability testing was conducted per IEC 62366-1 to evaluate that the intended users of the Steth IO Spot device are able to achieve its intended use with the help of the instructions for use. Two separate studies were conducted. One study evaluated healthcare professional users in their intended use environment (e.g., hospital setting, office setting, etc.) and the other study evaluated patient-users (i.e., lay-users) in the home setting. Overall, the Steth IO Spot successfully met the acceptance criteria and all users were able to successfully achieve the intended use of the device when given the appropriate instructions for use.
Biocompatibility Testing
The main patient-contacting components of this device are the diaphragm and retainer ring, which are off-the-shelf components that are identical to the ones used in the previously-cleared reference device (K160016) as well as other stethoscopes in the market. No biocompatibility testing was required to demonstrate substantial equivalence.
Electrical safety and electromagnetic compatibility (EMC)
The Steth IO Spot is an active device used in conjunction with the user's own smartphone. The following ES/EMC tests were conducted per the respective international standards:
- IEC 60601-1:2005/A1:2012/A2:2020 General electrical safety testing
- IEC 60601-1-2 Edition 4.0 2014-02 EMC testing
- . IEC 60601-1-11: 2015 Requirements for medical devices in home healthcare environment
Software Verification and Validation Testing
The Steth IO Spot Software is developed and tested in compliance with IEC 62304.
VIII. CONCLUSIONS
Based on a comparison of technological characteristics, indications for use, and performance data, it can be concluded that the proposed Steth IO Spot is substantially equivalent to the predicate device.