TECHNO-SCOPE VISUAL STETHOSCOPE

K050097 · Techtrade, LLC · DQD · Sep 30, 2005 · Cardiovascular

Device Facts

• Record ID: K050097
• Device Name: TECHNO-SCOPE VISUAL STETHOSCOPE
• Applicant: Techtrade, LLC
• Product Code: DQD · Cardiovascular
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate. The Techno-Scope is not intended to be used as a diagnostic device.

Device Story

Techno-Scope combines manual stethoscope with integrated ECG display unit; features 3 leadless nondisposable electrodes on chestpiece opposite diaphragm. Device captures acoustic organ sounds and electrical cardiac signals simultaneously. High-resolution LCD displays real-time ECG waveform and calculated heart rate. Operated by healthcare professionals in clinical settings to augment auscultation with visual cardiac biopotentials. Provides real-time monitoring; not intended for diagnostic purposes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison.

Technological Characteristics

Manual stethoscope with integrated ECG module; 3 leadless nondisposable electrodes; high-resolution LCD display for ECG and heart rate; electronic signal processing for biopotentials.

Indications for Use

Indicated for healthcare professionals to project internal organ sounds (heart, arteries, veins) and display real-time ECG signals and heart rate. Not intended for diagnostic use.

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

• CADISCOPE ELECTRONIC STETHOSCOPE (K990809)

Submission Summary (Full Text)

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510(k) Addendum, K050097 Techno-Scope

## TECHTRADE

## 274 MADISON AVE. S-1001 NEW YORK, NY 10016 TEL: [phone] FAX: [phone] EMAIL: [e-mail] Toll Free: 1-866-491-TECH

510(k) SUMMARY

| 510(k) Owner's name:<br>Address: | TechTrade<br>274 Madison Ave. S-1001<br>New York, NY 10016 |
|----------------------------------|-----------------------------------------------------------------------------------------|
| Phone: | 212-481-2515 |
| Fax number: | 212-481-2487 |
| Name of contact person: | Grace Holland<br>Regulatory Specialists, Inc<br>3722 Ave. Sausalito<br>Irvine, CA 92606 |
| | Phone: [phone] |
| | Fax: [phone] |
| Date the summary was prepared: | September 26, 2005 |
| Name of the device: | Techno-Scope™ Visual Stethoscope |
| Trade or proprietary name: | Techno-Scope™ Visual Stethoscope |
| Common or usual name: | Stethoscope |
| Classification name: | Electronic Stethoscope (21 CFR |

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

| Applicant | Device | 510(k) |
|------------|----------------------------------|---------|
| CADITEC AG | CADISCOPE ELECTRONIC STETHOSCOPE | K990809 |

870.1875, Product Code DQD)

Description of the device:

The Techno-Scope™ Visual Stethoscope is comprised of a manual stethoscope which can project sounds associated with the heart, arteries, veins and other internal organs. It also has

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an electrocardiograph (ECG) display unit. The electrocardiograph consists of 3 leadless nondisposable electrodes. It is placed on the chestpiece of the stethoscope, opposite the diaphragm. It can display real time ECG through high resolution LCD. It also calculates and displays the heart rate according to the ECG. The healthcare professional can listen to internal organ sounds simultaneously while seeing the ECG signals.

Indications for Use:

The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate.

The Techno-Scope is not intended to be used as a diagnostic device.

Summary of the technological characteristics of the Techno-Scope

The predicate was compared in the following areas and, with the except that the predicate device is an electronic stethoscope and the Techno-Scope is a manual stethoscope, found to have similar technological characteristics and to be equivalent to the CADIscope.

- Biocompatibility Display of cardiac biopotentials Environment Indications Intended Use LCD Display On/Off Controls Patient Contacting Materials Power Supply Signal Storage Sound Amplification Sound Pickup Target Population

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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

SEP 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TechTrade LLC c/o Ms. Grace Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606

Re: K050097

Trade Name: Techno-Scope™ Visual Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: August 31, 2005 Received: August 31, 2005

Dear Ms. Holland:

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 10 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 - Ms. Grace Holland

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. production of the more to begin marketing your device as described in your Section 510(k) I mo lotter with cation. 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), pleasc contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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,

Blumenafer

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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## Indications for Use Statement

510(k) Number (if known): K050097

Device Name: Techno-Scope

Indications For Use:

The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate.

The Techno-Scope is not intended to be used as a diagnostic device.

Prescription Use __ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimima

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