ECHO SOUNDER EX-101EX 8 MHZ

K031931 · Koven Technology, Inc. · DPW · Feb 13, 2004 · Cardiovascular

Device Facts

• Record ID: K031931
• Device Name: ECHO SOUNDER EX-101EX 8 MHZ
• Applicant: Koven Technology, Inc.
• Product Code: DPW · Cardiovascular
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

Evaluation of blood flow in patients with peripheral vascular disease, heart sounds and rates. Prescription Device. Federal Law (US) restricts this device to sale, distribution, and use by or on the order of a physician.

Device Story

The Echo Sounder ES-101EX 8M is a handheld vascular Doppler system used by clinicians to assess blood flow. It utilizes ultrasound transducers to transmit high-frequency signals into tissue; reflected signals from moving objects (e.g., blood, fetal heart) are received and converted into electronic signals. The device amplifies these signals, filters noise, and converts Doppler shifts into audible sound via speaker or headset. Simultaneously, it calculates and displays heart rate and blood velocity metrics on an integrated LCD. The device assists physicians in diagnosing peripheral vascular conditions by providing real-time auditory and visual feedback on blood flow dynamics.

Clinical Evidence

No clinical data provided. The device underwent bench testing, including performance and safety validation, to ensure compliance with functional requirements and industry safety standards.

Technological Characteristics

Handheld vascular Doppler system; ultrasound transducer-based sensing; electronic signal amplification and filtering; LCD display for heart rate and velocity; battery-operated; standalone device.

Indications for Use

Indicated for patients with peripheral vascular disease requiring evaluation of blood flow, heart sounds, and heart rates.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Predicate Devices

• Mini-Doppler II ES-100V (K915550)

Submission Summary (Full Text)

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# Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92

#### Company making the submission: 1.

| | Company making submission: | or | Correspondent (contract): |
|------------|-------------------------------------------------------------------|----|-------------------------------------------------------|
| Name: | Koven Technology, Inc. | | Delphi Consulting Group |
| Address: | 12125 Woodcrest Executive Dr.<br>Suite 220<br>St. Louis, MO 63141 | | 11874 South Evelyn Circle<br>Houston, Texas 770713404 |
| Telephone: | 1-314-542-2101 | | 1-832-285-9423 |
| Fax: | 1-314-542-6020 | | 1-775-429-9524 |
| Contact: | Paul G. Koven<br>President | | J. Harvey Knauss<br>Consultant |
| E-mail: | [e-mail] | | [e-mail] |

#### 2. Device:

Proprietary Name: Common Name: Classification Name: Manufactured by:

Echo Sounder ES-101EX 8M Vascular Doppler Cardiovascular blood flowmeter Cardiovascular blood flowmeter Hayashi Denki Co., Ltd., Japan

#### ന് Predicate Device(s):

K915550, Mini-Doppler II ES-100V, Koven Technology, Inc.

#### 4. Classifications Names & Citations:

Class II per 21 CFR 2100, Cardiovascular blood flowmeter,

#### ഗ് Description:

The Echo Sounder ES-101EX 8M is a single-handed vascular Doppler system that utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within arteries and display heart rate.

The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again.

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The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.

#### Indications for use: 6.

Detection and displays blood velocity motion, peak velocity, mean velocity and heart rate.

#### Contra-indications: 7.

None known at this time.

#### 8. Comparison:

The Echo Sounder ES-101EX 8M Doppler has the same device basic characteristics as the predicate device.

#### Test Data: ರು.

The Echo Sounder ES-101EX 8M Doppler device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.

The Echo Sounder ES-101EX 8M Doppler device labeling includes instructions for safe and effective use. It includes Warning, Cautions, and guidance for use.

#### 10. Literature Review:

A review of literature pertaining to the safety of Doppler Blood Flowmeters has been conducted. Appropriate safeguards have been incorporated in the design of the Echo Sounder ES-101EX 8M Doppler.

#### 11. Conclusions:

The conclusion drawn from these tests is that the Echo Sounder ES-101EX 8M Doppler device is equivalent in safety and efficacy to its predicated device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

FEB 1 3 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Koven Technology, Inc. c/o Mr. J. Harvey Knauss Adelphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071

Re: K031931

Echo Sounder ES-101EX 8M Vascular Doppler Regulation Number: 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: June 22, 2003 Received: June 26, 2003

Dear Mr. Knauss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Bi-Directional Doppler Volume Flowmeter, as described in your premarket notification:

Model ES-101EX

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### Page 2 - Mr. J. Harvey Knauss

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.

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 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, 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" (21 CFR 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 at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". If you have any questions regarding the content of this letter, please contact Kachi Enyinna at [phone].

Sincerely yours,

R. Lochner

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

Enclosures

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510(k) Number K_319 3)

#### Echo Sounder ES-101EX 8M Vascular Doppler Device Name:

### Indications for use:

Evaluation of blood flow in patients with peripheral vascular disease, heart sounds and rates.

### Prescription Device.

Federal Law (US) restricts this device to sale, distribution, and use by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <b>YES</b> | OR | Over-The-Counter Use |
|------------------|------------|----|----------------------|
|------------------|------------|----|----------------------|

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | k031931 |
|---------------|---------|
| Section 4 | Page 2 |

indications for use tab 4
510(k) Submission Page #