VIEWMATE ULTRASOUND IMAGING SYSTEM

K031066 · Ep Medsystems · IYN · Oct 17, 2003 · Radiology

Device Facts

• Record ID: K031066
• Device Name: VIEWMATE ULTRASOUND IMAGING SYSTEM
• Applicant: Ep Medsystems
• Product Code: IYN · Radiology
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ViewMate System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

Device Story

The ViewMate System, including the ViewFlex Ultrasound Catheter (Model VF-PA9F64E2D), is a diagnostic ultrasound imaging system. It utilizes an ultrasound catheter to acquire images of cardiac structures and blood flow. The system processes these signals to provide real-time visualization for clinicians. It is intended for use in clinical settings by healthcare professionals to assist in the assessment of cardiac anatomy and hemodynamics. The output is displayed for the physician to aid in clinical decision-making during cardiac procedures. The device benefits patients by providing high-resolution, localized imaging of the heart, facilitating diagnostic or interventional guidance.

Clinical Evidence

No clinical data provided. The clearance is based on the demonstration of substantial equivalence and the requirement for post-clearance submission of acoustic output measurements.

Technological Characteristics

Diagnostic ultrasound imaging system utilizing pulsed Doppler and pulsed echo imaging. Includes the ViewFlex Ultrasound Catheter (Model VF-PA9F64E2D). Operates under 21 CFR 892.1550, 892.1560, and 892.1570. Product codes: IYN, IYO, ITX. Class II device.

Indications for Use

Indicated for adult and adolescent pediatric patients for visualization of cardiac structures and blood flow within the heart, specifically for intracardiac applications.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2003

EP MedSystems c/o Mr. John J. Talarico VP of QA/Regulatory Affairs Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NY 08091

Re: K031066

Trade Name: ViewMate® System Regulation Number: 21 CFR 892.1550, 892.1560, and 892.1570 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer Regulatory Class: Class II (two) Product Code: IYN, IYO, and ITX Dated: July 28, 2003 Received: July 29, 2003

Dear Mr. Talarico:

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 ViewMate® System, as described in your premarket notification:

### Transducer Model Number VF-PA9F64E2D

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. John J. Talarico

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 (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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".

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Page 3 - Mr. John J. Talarico

If you have any questions regarding the content of this letter, please contact Sharon Lappalainen at [phone].

Sincerely yours,

Megus Mayal

toy

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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# Diagnostic Ultrasound Indications for Use Form

# ViewMate (Console) Ultrasound Imaging System (Model #VM-01)

Intended Use:

The ViewMate System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|-------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity | Combined<br>(specify) | Other<br>(Specify) |
| Ophthalmic | - | | | ー | - | | | l | | |
| Fetal | l | l | l | • | י | - | l | 1 | | |
| Abdominal | - | - | - | - | l | - | | | | |
| Intraoperative (specify) | l | l | l | l | । | - | | | | |
| Intraoperative Neurological | - | | | - | ー | | - | 1 | | |
| Pediatric | - | l | | | r | | | - | | |
| Small Organ (specify) | l | - | - | - | t | - | ﻪ | - | | |
| Neonatal Cephalic | - | l | - | - | ー | - | u | - | | |
| Adult Cephalic | l | - | - | - | 1 | | - | - | | |
| Cardiac | - | - | - | - | - | - | - | - | | |
| Tranesphageal | l | l | ﺎ | - | l | | ﮯ | ー | | |
| Transrectal | | - | | | | | - | | | |
| Transvaginal | l | l | - | - | ー | - | | - | | |
| Transurethral | l | - | ー | ﮯ | l | - | - | ﻪ | | |
| Intravascular | l | ー | l | - | - | - | | י | - | |
| Periphereral Vascular | - | l | t | l | l | - | - | * | | |
| Laparoscopic | l | l | l | - | • | - | - | - | 1 | |
| Musculo-skeletal Conventional | l | t | r | l | l | - | - | - | | |
| Musculo-skeletal Superfical | t | 1 | - | - | - | - | ﺖ | - | ﺳ | |
| Other- Intracardiac | - | N | N | N | - | ಗ | | | | |

N= new indication; P= previously cleared by FDA: E= added under Appendix E

Additional Comments:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

C. Me Me May for BDZ
(Division Sign-Off)

**Division of Cardiovascular Devices**

File 3283a-ViewMate

510(k) Number K031066

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#### Diagnostic Ultrasound Indications for Use Form

### ViewFlex™ Ultrasound Catheter (Model # VF-PA9F64E2D)

The ViewMate System is indicated for use in adult and adolescent pediatric patients to Intended Use: visualize cardiac structures and blood flow within the heart.

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|-------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity | Combined<br>(specify) | Other<br>(Specify) |
| Ophthalmic | - | - | - | - | - | - | - | - | - | - |
| Fetal | - | - | - | - | - | - | - | - | - | - |
| Abdominal | - | - | - | - | - | - | - | - | - | - |
| Intraoperative (specify) | - | - | - | - | - | - | - | - | - | - |
| Intraoperative Neurological | - | - | - | - | - | - | - | - | - | - |
| Pediatric | - | - | - | - | - | - | - | - | - | - |
| Small Organ (specify) | - | - | - | - | - | - | - | - | - | - |
| Neonatal Cephalic | - | - | - | - | - | - | - | - | - | - |
| Adult Cephalic | - | - | - | - | - | - | - | - | - | - |
| Cardiac | - | - | - | - | - | - | - | - | - | - |
| Tranesphageal | - | - | - | - | - | - | - | - | - | - |
| Transrectal | - | - | - | - | - | - | - | - | - | - |
| Transvaginal | - | - | - | - | - | - | - | - | - | - |
| Transurethral | - | - | - | - | - | - | - | - | - | - |
| Intravascular | - | - | - | - | - | - | - | - | - | - |
| Periphereral Vascular | - | - | - | - | - | - | - | - | - | - |
| Laparoscopic | - | - | - | - | - | - | - | - | - | - |
| Musculo-skeletal Conventional | - | - | - | - | - | - | - | - | - | - |
| Musculo-skeletal Superfical | - | - | - | - | - | - | - | - | - | - |
| Other- Intracardiac | - | N | N | N | - | N | - | - | - | - |

N= new indication; P= previously cleared by FDA: E= added under Appendix E

Additional Comments: ____________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

Megan May for BOZ
(Division Sign-Off)

diovascular Devicesile 3283a-ViewFlexCatheter

510 k) N