HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE

K021087 · Erecords Limited · DQD · Oct 11, 2002 · Cardiovascular

Device Facts

• Record ID: K021087
• Device Name: HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE
• Applicant: Erecords Limited
• Product Code: DQD · Cardiovascular
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The Hippocrat is an electronically amplified device intended for use in projecting the sounds associated with the heart and other internal organs. The Hippocrat records, stores, plays back, and electronically transmits these sounds.

Device Story

Hippocrat Model DR300 is an electronic stethoscope system. Input: acoustic signals from heart, arteries, veins, and internal organs. Processing: device amplifies, records, and stores audio data via a control unit and installation software. Output: playback of recorded sounds and electronic transmission via email. Operational context: requires user-supplied PC (Windows 98, NT 4.0, 2000, or XP), CD-ROM drive, and Infrared Port. Used by clinicians as a diagnostic aid to assist in patient diagnosis, treatment, and monitoring. Benefits include enhanced sound projection and ability to share/store diagnostic audio data.

Clinical Evidence

No clinical data submitted. Substantial equivalence demonstrated via nonclinical testing, including environmental and electromagnetic compatibility (EMC) testing against international standards.

Technological Characteristics

Electronic stethoscope system comprising a control unit, installation software, and power supply/charger. Requires PC connectivity via Infrared Port. Operates as an electronic amplifier for physiological sounds. Complies with international standards for environmental and electromagnetic compatibility (EMC).

Indications for Use

Indicated for use as a diagnostic aid in patient diagnosis, treatment, and monitoring by projecting, recording, storing, playing back, and transmitting sounds associated with the heart, arteries, veins, and other internal organs.

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 Littmann Electronic Stethoscope - Model 4000

Submission Summary (Full Text)

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## OCT 11 2002

## 510(k) Summary

- 1. Name/Address of Submitter:
eRecords Limited 314-801 York Mills Road Toronto, Ontario M3B 1X7 Canada

- Edward A. Goss 2. Contact Person: General Manager 416) 383-0046
- 3. Date Summary Prepared: March 26, 2002

4. Device Name: Hippocrat Model DR300 Electronic Stethoscope

- 5. Predicate Devices: Meditron Electronic Stethoscope, 3M Littmann Electronic Stethoscope - Model 4000
- 6. Device Description and Intended Use:

The Hippocrat 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, arteries, and veins and other internal organs. Significant components include a control unit, installation software; and power supply/charger. The user must supply a personal computer with a Microsoft Windows 98, NT 4.0, 2000, or XP operating system, CD-ROM drive, and Infrared Port. The stored sounds can be transmitted via e-mail.

- 7. Brief Description of Nonclinical Testing:
The specifications for the environmental and electromagnetic compatibility (EMC) testing of the Hippocrat reference appropriate international standards. All product specifications were met.

- 8. Brief Description of Clinical Testing:
Clinical study information was not submitted for the purpose of demonstrating Substantial equivalence to legally marketed electronic stethoscopes.

- 9. Conclusions Drawn:
The indications for use are consistent with those for legally marketed electronic Stethoscopes and in the applicable FDA classification regulation. Differences in technological characteristics from those of the cited predicate devices do not raise new issues of safety or effectiveness and are addressed in the submission.

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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes above its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 11 2002

eRecords Limited c/o Mr. Edward A. Goss Vice President Business Development 801 York Mills Road, Suite 314 Toronto, Ontario M3B 1X7 Canada

Re: K021087

Trade Name: Hippocrat Model DR300 Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: August 20, 2002 Received: August 21, 2002

Dear Mr. Goss:

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. Edward A. Goss

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,

Oelartu
Lito R. P. Zaluar, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

510(k) Number (if known): __ Ko2|087

Device Name: Hippocrat Model DR300 Electronic Stethoscope

Indication for Use:

The Hippocrat is an electronically amplified device intended for use in projecting the sounds associated with the heart and other internal organs. The Hippocrat records, stores, plays back, and electronically transmits these sounds.

Concurrence of CDRH Office of Device Evaluation

Prescription Use (per 21 CFR 801.109)

OR

Over-the-counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K021087