E-STETH ELECTRONIC STETHOSCOPE

K011898 · E-Med Innovations, Inc. · DQD · Sep 14, 2001 · Cardiovascular

Device Facts

• Record ID: K011898
• Device Name: E-STETH ELECTRONIC STETHOSCOPE
• Applicant: E-Med Innovations, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Sep 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended 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.

Device Story

E-Steth Electronic Stethoscope functions as diagnostic aid for heart/internal organ auscultation; amplifies, records, stores, plays back, and transmits acoustic signals. Device comprises control unit, earphones, and communication cable; operates as stand-alone analog system. Optional PC connectivity via sound card allows recording/transmission of audio files via e-mail. Used by clinicians in diagnostic settings. Device does not utilize active software for stethoscope operation; PC software serves only for data storage/management. Benefits include broader frequency range than traditional diaphragm stethoscopes and ability to share diagnostic audio data.

Clinical Evidence

No clinical data submitted. Substantial equivalence demonstrated via bench testing, including environmental and electromagnetic compatibility (EMC) testing per voluntary standards.

Technological Characteristics

Analog electronic stethoscope; control unit with earphones and communication cable. Operates via analog amplification; frequency range exceeds traditional diaphragm stethoscopes. Connectivity: optional PC interface via sound card for data recording/transmission. Power: not specified. Sterilization: not specified.

Indications for Use

Indicated for use as a diagnostic aid in patient diagnosis, treatment, and monitoring by amplifying, recording, storing, playing back, and transmitting heart and internal organ sounds.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• Meditron Electronic Stethoscope
• 3M Littman Electronic Stethoscope

Submission Summary (Full Text)

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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 [phone]
- 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 ✓