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.

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.

AI/ML Overview

The provided document describes the Steth IO Spot, an electronic stethoscope. While it details various performance tests (functional, biocompatibility, electrical safety, EMC, software verification and validation), it focuses on demonstrating substantial equivalence to a predicate device (Eko CORE) rather than proving the device meets specific acceptance criteria based on clinical efficacy or diagnostic accuracy.

Therefore, the information required to construct the comprehensive table of acceptance criteria and a study proving those criteria (especially regarding diagnostic performance, human reader improvement with AI, standalone AI performance, and detailed ground truth establishment), as typically seen for AI-driven diagnostic devices, is not fully available in this regulatory submission document. This document is for a medical device that amplifies, filters, and transmits sounds, which is different from an AI-driven diagnostic tool that analyzes sounds for specific medical conditions.

However, I can extract the available information and highlight what is missing based on your request.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance studies for the Steth IO Spot:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Eko CORE) by comparing technological characteristics and showing that the device performs comparably or better in functional aspects relevant to its core purpose (amplifying, filtering, and transmitting sounds). It does not describe a study that validates a diagnostic AI model's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device as an electronic stethoscope for sound data acquisition and transmission, the "acceptance criteria" presented are primarily functional and safety-related, rather than diagnostic performance metrics (e.g., sensitivity, specificity for disease detection).

Acceptance Criteria Type	Acceptance Criteria	Reported Device Performance
Functional Testing
Heart Rate Accuracy	Concordance correlation coefficient of substantial strength (0.95 – 0.99) with predicate device (Eko CORE) and gold standard (EKG).	The Steth IO Spot successfully met the acceptance criteria of a concordance correlation coefficient of substantial strength (0.95 – 0.99). Its 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). The Steth IO Spot is considered to be similar to the predicate device in terms of heart rate measurement performance.
Frequency Audio Response	Perform equivalently to the predicate device (Eko CORE) with an overall amplitude (dB) and smooth frequency response curve beyond 2000 Hz, free of undesirable spikes and dips.	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.
Usability Testing	Intended users (healthcare professionals and lay users) are able to achieve its intended use with the help of the instructions for use.	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	No biocompatibility testing required.	The main patient-contacting components (diaphragm and retainer ring) are off-the-shelf components identical to those in previously-cleared predicate (K160016) and other market stethoscopes. No biocompatibility testing was required to demonstrate substantial equivalence.
Electrical Safety / EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.	Tests were conducted per the respective international standards, indicating compliance: IEC 60601-1:2005/A1:2012/A2:2020 (General electrical safety), IEC 60601-1-2 Edition 4.0 2014-02 (EMC testing), and IEC 60601-1-11: 2015 (Requirements for medical devices in home healthcare environment).
Software V&V	Software developed and tested in compliance with IEC 62304.	The Steth IO Spot Software is developed and tested in compliance with IEC 62304.

2. Sample Size Used for the Test Set and Data Provenance

Heart Rate Accuracy Test: Not explicitly stated, but "side-by-side comparison test" implies a test set was used. The provenance (country, retrospective/prospective) is not mentioned.
Frequency Audio Response Test: Not explicitly stated.
Human Factors Usability Testing: "Two separate studies were conducted." Sample size (number of participants) is not explicitly stated. Provenance (country, retrospective/prospective) is not mentioned beyond the "intended use environment (e.g., hospital setting, office setting, etc.)" for professionals and "home setting" for lay users.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Heart Rate Accuracy Test: The ground truth was established using an "EKG (gold standard)." This implies an objective measurement rather than expert interpretation of the device's output. The expertise for establishing the EKG ground truth itself is not detailed.
Frequency Audio Response Test: No mention of experts; this is an engineering performance test against specifications and a predicate device.
Human Factors Usability Testing: Evaluated "intended users" (healthcare professionals and patient-users/lay-users), but it's about usability, not a diagnostic ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable for the described tests, as they are primarily technical performance or usability assessments rather than diagnostic accuracy studies requiring adjudication of discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done according to the provided text. This document describes a device for sound acquisition and transmission, not an AI that interprets or aids in diagnosis. Therefore, there's no discussion of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not explicitly applicable in the context of diagnostic AI. The "Steth IO Spot Software (Telemedicine App)" performs "real-time analysis to hear the sounds," but the document does not state that this analysis includes automated diagnostic interpretations. Its role is primarily for amplification, filtering, transmission, and recording of sounds for human clinicians to interpret. The "analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present," implying it's an aid for the human, not a standalone diagnostic algorithm being evaluated for accuracy.

7. The Type of Ground Truth Used

Heart Rate Accuracy Test: "EKG (gold standard)" for heart rate.
Frequency Audio Response Test: Objective measurements against a predicate device and engineering specifications.
Human Factors Usability Testing: User task completion and satisfaction (functional ground truth).

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device, not an AI model trained on sound data for diagnostic purposes. The software mentioned (Steth IO Spot Software) primarily handles real-time audio processing for listening and transmission, not deep learning for diagnosis.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K220196

Device Name Steth IO Spot

Indications for Use (Describe)

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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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 MulumudiCEO and President
Contact Person:	Meritxell MartinezAssociate 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 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 ●

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performs real-time analysis to hear the sounds using headphones. The app is available for download from a designated software repository.

V. INDICATIONS FOR 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 electronicstethoscope that enablesamplification, filtering, andtransmission of auscultation sounddata, whereby a clinician at onelocation on network can listen to theauscultation sounds of a patient onsite or at a different location on thenetwork. Steth IO Spot is intended foruse on individuals undergoingphysical examination. The Steth IOSpot is intended to be used byprofessional users in a clinicalenvironment or by lay users in anonclinical environment. The deviceis not intended for self-diagnosis oremergency use.	The Eko CORE is an electronicstethoscope that enables amplification,filtering, and transmission ofauscultation sound data (heart, lungs,bowel, arteries, and veins), whereby aclinician at one location on network canlisten to the auscultation sounds of apatient on site or at a different locationon the network. Eko CORE is intendedfor use on pediatric and adultpatients. The Eko CORE is intended tobe used by professional users in aclinical environment or by lay users in anonclinical environment. The device isnot intended for self-diagnosis.
	OTC use: Steth IO Spot can be usedby a patient to be examined during avideo call and to submit a non-emergent-examination for review bytheir healthcare provider.

	Rx-only use: Steth IO Spot may beprescribed by a licensed medicalprovider to monitor medicalconditions that require the use of astethoscope.
Standards Met	IEC 60601-1:2005/A1:2012/A2:2020IEC 60601-1-2:2015IEC 60601-1-11:2015IEC 62304:2006/A1:2016ISO 14971:2019ASTM D 4169-16ISO 15223-1:2016IEC 62366-1:2015	IEC 60601-1IEC 60601-1-2IEC 60601-1-11
DeviceClassification	DQD: Electronic stethoscope	DQD: Electronic stethoscope
PrescribedClassification	Rx and OTC	Rx and OTC
Classification	Class II	Class II
StethoscopeType	Electronic stethoscope withattachment to smartphone vialightning port/USB-C port	Attachment to an analog stethoscope(Core)
User Interface	Steth IO Spot hardware deviceMobile App/Web Portal	On/Off Power buttonVolume adjustmentLED status indicatorMobile App
Analog/DigitalInteroperability	Not applicable	Yes
Connectivity tomobile phone	Wired connection via lightningport/USB-C port	Bluetooth
SoundAmplification	Yes	Yes
Record andPlaybackSounds	Yes	Yes
Data Transferto CompatibleComputingPlatform	Yes	Yes

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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

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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.

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.