The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software earphones, and a communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner.

Device Description

The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software; earphones, and communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner.

AI/ML Overview

This 510(k) summary for the E-Steth Electronic Stethoscope (K011898) explicitly states that clinical study information was not submitted for the purpose of demonstrating substantial equivalence. Therefore, the device's acceptance criteria were not established through a clinical study as typically understood for AI-powered diagnostic devices.

Instead, substantial equivalence relied on:

Nonclinical Testing: Specifications for environmental and electromagnetic compatibility (EMC) testing.
Predicate Devices: Comparison to legally marketed electronic stethoscopes (Meditron Electronic Stethoscope and 3M Littman Electronic Stethoscope).
Prior Certification: The product had been tested and certified by France and the European Union.

Given the information provided, it's not possible to populate a table of acceptance criteria and reported device performance derived from a clinical study for this specific device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for Clinical Performance)	Reported Device Performance (as per 510(k))
Clinical Performance: Not evaluated through a substantial equivalence clinical study.	Not applicable. Device was not validated via a specific clinical study for this 510(k).
Environmental & EMC: Met specifications referencing appropriate voluntary standards.	All product specifications were met.
Functional Equivalence: Amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs, similar to predicate devices.	The E-Steth performs these functions.
Safety & Effectiveness: Indications for use are consistent with legally marketed electronic stethoscopes and do not raise new issues of safety or effectiveness.	Determined to be substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not applicable. No clinical testing was submitted for the purpose of demonstrating substantial equivalence.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical testing was submitted.

4. Adjudication method for the test set

Not applicable. No clinical testing was submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is an electronic stethoscope, not an AI-powered diagnostic tool in the sense of modern deep learning algorithms for image or signal interpretation. No MRMC study was mentioned or required.

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

This device is an electronic stethoscope that amplifies and records sounds for human interpretation. It is not an "algorithm" in the context of standalone AI performance. The device itself operates as a standalone unit for recording heartbeats analogically, but its ultimate use is in conjunction with a human diagnostician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No specific ground truth for diagnostic performance was established through a clinical study for this premarket notification. Substantial equivalence was based on nonclinical testing and comparison to predicate devices.

8. The sample size for the training set

Not applicable. This device is an electronic stethoscope and does not involve AI/machine learning models that require a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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K -011898

510(k) Summary

e-Med Innovations, Inc. Name/Address of Submitter: 1. 5001 LBJ Freeway, Suite 930A Dallas, Texas 75244

Pierre Laute Contact Person: 2. Vice President Engineering (469) 374-0123
Date Summary Prepared: June 11, 2001 3.
Device Name: E-Steth Electronic Stethoscope 4.
Meditron Electronic Stethoscope, Predicate Devices: ડ. 3M Littman Electronic Stethoscope

Device Description and Intended Use: 6.

The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software; earphones, and communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner."

Brief Description of Nonclinical Testing: 7.

The specifications for the environmental and electromagnetic compatibility (EMC) testing of the E-Steth reference appropriate voluntary standards. All products specifications were met.

Brief Description of Clinical Testing: 8.

Clinical study information was not submitted for the purpose of demonstrating substantial equivalence to legally marketed electronic stethoscopes. The product was tested and certified by France and the European Union. See Exhibits A, B and C.

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K011898 p.2/2

Conclusions Drawn: 9.

The indications for use are consistent with those for legally marketed electronic stethoscopes. The indications for ase are consistent these of the cited predicate devices do not raise new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting hair or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2001

e-Med Innovations, Inc. c/o Mr. Hugh E. Hackney Locke Liddell & Sapp LLP 2200 Ross Avenue, Suite 2200 Dallas, TX 75201-6776

Re: K011898

Trade Name: E-Steth Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: June 14, 2001 Received: June 18, 2001

Dear Mr. Hackney:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Hugh E. Hackney

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Decker Tiller

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO11898

INDICATIONS FOR USE

"The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software earphones, and a communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner."

Division of Cardiovascular & Respiratory Devices
510(k) Number K011898

Prescription Use ✓

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.