MODIFICATION TO VIEWMATE SYSTEM

K073709 · Ep Medsystems · IYN · Mar 11, 2008 · Radiology

Device Facts

• Record ID: K073709
• Device Name: MODIFICATION TO VIEWMATE SYSTEM
• Applicant: Ep Medsystems
• Product Code: IYN · Radiology
• Decision Date: Mar 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ViewMate® System is intended to be used to visualize cardiac structures and blood flow within the heart.

Device Story

ViewMate System is a portable, computerized ultrasound imaging system for intracardiac echocardiography (ICE). It consists of a console, patient isolation module, and ViewFlex PLUS ultrasound catheter. The catheter is a single-use, 9 French, steerable device inserted via intravascular access. It utilizes a 64-element linear phased array transducer (4.5-8.5 MHz) to capture ultrasound signals. The console processes these signals to display B-mode, color Doppler, spectral Doppler, and M-mode images. Used by electrophysiologists and interventional cardiologists in EP labs to visualize cardiac structures, assess cardiac output, determine heart size, and guide placement of EP catheters, pacing leads, and PFO closure devices. The modification (ViewFlex PLUS) increases distal tip angulation (±30° to ±120°) and catheter stability via metal braiding and material changes. Output is displayed on the console for real-time clinical decision-making, enabling accurate device positioning and identification of physiologic or blood flow anomalies, potentially improving procedural outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation were performed on the mechanical design changes to ensure the catheter meets performance specifications for angulation and stability.

Technological Characteristics

System: Portable ultrasound console with PC, beam former, and digital frame grabber. Catheter: 9 French, 90 cm length, radio-opaque tubing. Transducer: 64-element linear phased array, 4.5-8.5 MHz. Materials: 35D PEBAX, metal braiding, Teflon tubing, FDA 2 epoxy. Connectivity: Standalone console. Sterilization: Not specified. Software: Controls imaging modes (B-mode, color/spectral/pulse wave Doppler, M-mode), image acquisition, storage, and retrieval.

Indications for Use

Indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

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.

Predicate Devices

• ViewMate System (K031066)
• ViewMate System (K071028)

Reference Devices

• Philips Medical Systems HD11 XE Ultrasound System (K062247)

Submission Summary (Full Text)

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# 510(k) Summary

# Summary preparation date: 12/28/07

### 1. Device Trade Name

| Device Trade Name | Device Classification | |
|--------------------------------------------------------------------------------------------------------|-----------------------|--|
| ViewMate® System | | |
| This application describes a modification to the<br>ViewMate® System's catheter called ViewFlex® PLUS. | | |

MAR 1 1 2008

# 2. Establishment Address and Registration

EP MedSystems Inc. Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 USA

Larry Picciano Telephone: [phone], x221 Fax: [phone] E-mail: [e-mail]

US Food and Drug Administration Establishment Registration No.: 2248049

| Classification | Product<br>Code | Device<br>Classification<br>Name | Regulation<br>Number | Classification<br>Number | Performance<br>Standard(s) |
|----------------|-----------------|------------------------------------------------------|----------------------|--------------------------|----------------------------|
| Primary | IYN | System,<br>Imaging, Pulsed<br>Doppler,<br>Ultrasonic | 892.1550 | II | None |
| Subsequent | ITX | Transducer,<br>Ultrasonic | 892.1570 | II | None |
| Subsequent | IYO | System,<br>Imaging, Pulsed<br>Echo, Ultrasonic | 892.1560 | II | None |

#### 3. Device Classification

# 4. Predicate Devices / Technology

| Product Description | 510 (k) No. | Date |
|---------------------|-------------|----------|
| ViewMate® System | 031066 | 10/17/03 |
| ViewMate® System | 071028 | 05/01/07 |

This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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# 5. Labeling and Intended Use

The following draft labeling is contained within Appendix 4.

- 5.1. Product Labeling
- 5.2. Marketing Literature
- 5.3. Instructions for Use

#### 6. Intended Use

The ViewMate® System is intended to be used to visualize cardiac structures and blood flow within the heart.

#### 7. Indications for Use

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

Note: A copy of the original Diagnostic Ultrasound Indications for Use Form (K031066), which is not affected by this notification, is provided in Appendix 5.

#### 8. Device Description

- 8.1. The purpose of this submission is to provide premarket notifications to the mechanical design of the ViewFlex® catheter; the modified device will be marketed as ViewFlex® PLUS catheter (model VF-PM). The intended use and indications for use of the ViewFiex® catheter are not affected. No changes have been made to the ultrasound or electronics design of the catheter; the ultrasound transducer and its performance is not affected by the proposed changes. Similarly, no changes have been made to the ViewMate® or the ViewMate® II (PMS HD11 XE) console.
- 8.2. Background of the ViewMate® System with the ViewFlex® Catheter: The ViewFlex® ultrasound catheter in combination with the ViewMate® cardiac ultrasound imaging console was first cleared for US marketing on October 17, 2003 (K031066). Clearance to market a modification to the ViewFlex® catheter was received on May 1, 2007 (K071028). On August 18, 2006 EPMedSystems' ViewFlex® catheter was cleared for US marketing with Philips Medical Systems' (PMS) HD11 XE Ultrasound System (K062247). On January 9, 2007 EPMedSystems (the company) entered into a contractual agreement with PMS to market the HD11 XE under the EPMedSystems trade name ViewMate® II. As a US registered medical device distributor, re-packager and re-labeler, EPMedSystems has been distributing the ViewMate® II console. The company plans to continue distributing the ViewMate® II console for use with ViewFlex® catheters.
- 8.3. General Description of the ViewMate® System with the ViewFlex® PLUS Catheter: The ViewMate® cardiac ultrasound imaging system (K031066 and K071028) is intended to be used to visualize cardiac structures and blood flow within the heart; it is indicated for use in adult and adolescent pediatric patients. The ViewMate® system's intracardiac imaging capability is used by Electrophysiologists and Interventional Cardiologists in a number of ways, including

but not limited to, assessing cardiac output, determining the size of the heart and This document is the property of EPMedSystems. Its' entire considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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ViewFlex TMCatheter Modification VF-PM :510k Summary

locating its structures, determining device location (e.g., electrophysiology catheters, pacing leads, PFO closure devices), positioning of devices, and visualizing blood flow through cardiac arteries. Cardiac electrophysiology (EP) procedures are complex diagnostic tests during which physicians look at electrical signals from the heart to determine if an abnormality (arrhythmia) exists. Use of the ViewMate® system in EP studies offers significant advantages in that it enables physicians to accurately place EP catheters and to identify physiologic and blood flow anomalies. Interventional Cardiologists have recently begun using ViewMate® to view structures and devices during interventional cardiac procedures as well.

- 8.4. The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System illustrated in Figure 1 is comprised of three components. ViewMate® console, patient isolation module and the ViewFlex® PLUS ultrasound catheter.
Image /page/2/Figure/5 description: The image shows a diagram of a medical system. The system includes a monitor, a ViewMate console, an isolation module, a 12-lead ECG cable, and a ViewFlex catheter. The system is used by a physician to monitor and treat a patient.

Figure 1: ViewMate® System

*Note: ViewMate II ECG connects directly to console with internal isolation.

- 8.5. The ViewMate® ultrasound console comprises a personal computer (PC), ultrasound imaging beam former and a digital frame grabber with storage. The system software is used to control imaging modes, image quality, image acquisition, storage, and retrieval of patient records (i.e., images, ECG, and notes). The system software enables multiple imaging modes: two dimensional (B mode and color Doppler) and time-motion mode (spectral Doppler/puise wave Doppler and M Mode) Additional software functionality includes zoom, labeling, image storage, retrieval and review. ViewMate® may be used in interventional cardiology, specifically in the interventional EP laboratory.
- 8.6. Description of ViewFlex® PLUS Catheter: The ViewMate® connects with an ultrasound catheter called ViewFlex® PLUS that is inserted into the heart via intravascular access. The ViewFlex® PLUS catheter, illustrated in Figure 2, is a single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. ViewFlex® PLUS mechanical properties are as follows: The catheter shaft is 9 French, approximately 90 cm long, constructed of radio-opaque tubing. The catheter offers bi-directional steerability that can be A minimum of a 10 French introducer is manipulated with one hand.

This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published to others, in whole or in part, without express written consent of EPMedSystems' executive management.

File: VF-PM Sp510(k) Summary

Page 3 of 6

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ViewFlex™Catheter Modification VF-PM 510k Summary

recommended for use with this catheter for insertion into the femoral or jugular veins. ViewFlex® PLUS imaging properties are as follows: The catheter consists of a 64-element linear phased array, wideband transducer with an imaging frequency range of 4.5 MHz to 8.5 MHz, user-selectable magnification, 86° viewing angle on the ViewMate® I system and a viewing angle of 90° on the ViewMate® II system.

Image /page/3/Figure/4 description: The image shows a device with several labeled parts and measurements. The device includes a "CARD EDGE CONNECTOR" on the left, followed by a section measuring "115cm". Further along, there's a "HANDLE", a "9FR SHAFT", and a "DEFLECTION AREA" leading to a "TRANSDUCER" on the right, which is measured at "90cm".

Figure 2: ViewFlex® PLUS Catheter

- 8.7. Change Scope and Description: The intent of this submission is to provide premarket notification of modifications to the mechanical design of the ViewFlex® catheter; the modified device will be marketed as ViewFlex® PLUS catheter (model VF-PM). The intended use and indications for use of the ViewFlex® catheter are not affected. No changes have been made to the ultrasound or electronics design of the catheter; the ultrasound transducer and its performance is not affected by the proposed changes. Similarly, no changes have been made to the ViewMate® The catheter modification is or the ViewMate® II (PMS HD11 XE) console. intended to satisfy the broadening range of ICE (IntraCardiac Echo) user needs that have been realized since the product's original release (K031066). Specifically, the modification increases the range of angulation (i.e., bending of the distal tip measured in degrees) and increases the stability (i.e., firmness) of the positioned catheter. In addition to meeting a broader range of user needs, these changes position the product more competitively in the market place. EPMedSystems employed design controls, including verification and validation in the design change process. The changes are detailed in Appendix 6 and in the supporting documentation provided. The following table summarizes the changes.
This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP Mis document is the proporty of an insural, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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K73702

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ViewFlex™Catheter Modification VF-PM 510k Summary

| Change<br># | Change<br>Classification | Change Description | Reason |
|-------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 1 | Finished product,<br>external<br>modification | Reduce usable length from<br>110cm to 90 cm | Extra 20cm is not used<br>in right heart<br>catheterizations.<br>Competitive product is<br>90cm. |
| 2 | Finished product,<br>external material<br>change and<br>performance<br>change | Replace covering of distal<br>transfer section with 35D<br>PEBAX® with metal braiding | Extending the braiding<br>to the transducer<br>increases catheter<br>stability |
| 3 | Finished product,<br>internal material<br>change | Replace steering wires with<br>0.003" x 0.010" stainless<br>steel wire | Satisfy broadened user<br>requirements -- increase<br>deflection range |
| 4 | Finished product,<br>internal material<br>change | Add one Teflon® tube over<br>individual steering wires | Satisfy broadened user<br>requirements - increase<br>deflection range |
| 5 | Finished product,<br>internal material<br>change | Replace adhesive bonding<br>shaft to the transducer with<br>FDA 2 epoxy. | Increase production<br>yield |
| 6 | Finished product,<br>internal material<br>change | Replace wire post (0.062"<br>OD) pin with (0.220" OD)<br>tube | Satisfy broadened user<br>requirements - increase<br>deflection range |
| 7 | Finished product,<br>internal material<br>change | Add Advanced Polymer heat<br>shrink 140250 at proximal<br>joint | Satisfy broadened user<br>requirements - increase<br>deflection range |
| 8 | Production process<br>change | Eliminate gluing of transfer<br>section cover, employ heat<br>fusing and continuous<br>braiding | Increase production<br>yield |
| 9 | Performance<br>change | Increased angulation from<br>±30° to ±120° | Satisfy broadened user<br>requirements - increase<br>deflection range |

| Table 1: ViewFlex® Catheter Change Summary | | |
|--------------------------------------------|--|--|
|--------------------------------------------|--|--|

- 8.8. Product Numbering Change Notice: In an effort to make it easier for customers to order catheters and to clarify product identification, EPMedSystems is modifying the way it refers to its ViewFlex® catheters. This is strictly a nomenclature change. The company currently uses VF-01 to represent the ViewFlex® catheter model number. Moving forward EPMedSystems will refer to the ultrasound products as follows in Table 2.
This document is the property of EPMedSystems. Its' entire content is considered proprietery within and with and with with with with with with with with with with with with w mis document is the propery of Er modeled, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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c73709

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ViewFlex TMCatheter Modification VF-PM 510k Summary

| Number Description | Former Number | New Number |
|----------------------------------------|------------------|------------|
| Catheter Model Number1 | VF-01 | VF-PM |
| Ultrasonic Transducer Model<br>Number2 | 204 | PA 6.5/64 |
| Catheter Part Number | VF-PA9F64E2DW3,4 | 09-20055 |
| Product Code6 | VF-PA9F64E2DW3,4 | NA6 |

#### Table 2: Product Identification Change

Notes:

(1) "Catheter" and "Transducer" are not used synonymously.

(2) "Transducer" model refers to the active ultrasonic element commonly referred to as a piezoelectric crystal contained within the catheter - there is no change to this component, it is the same as that first cleared under K031066.

(3) "W" indicates wire added as part of the redesign (K071028); this differentiates the product by design.

(4) Units of former design (K031066) may also be sold as VF-PA9F64E2D.

(5) Part number is redesigned to accommodate additional curve sizes as the product line expands (e.g., 09-2003 for size 3, 09-2005 for size 5, 09-2007 for size 7).

(6) The company will no longer refer to the VF-PM by a numeric product code; company's internal device identification will be the part number. Note, this product code is not the same as the three digit FDA alpha product code used for device description/classification.

#### End of document

This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published to others, in whole or in part, without express written consent of EPMedSystems' executive management.

File: VF-PM Sp510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2008

EP MedSystems, Inc. c/o Mr. Larry Picciano Director of Regulatory Systems Cooper Run Executive Park 575 Route 73 North, Unit D West Berlin, NJ 08091

Re: K073709

ViewMate® System with ViewFlex® PLUS Catheter Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II (two) Product Code: IYN, IYO, ITX, OBJ Dated: February 15, 2008 Received: February 19, 2008

Dear Mr. Picciano:

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:

ViewFlex® PLUS Catheter, Model VF-PM

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. Larry Picciano

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]. 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 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/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lisa E. Leveille at [phone].

Sincerely yours,

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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Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, New Jersey 08091 [phone] Tel: [phone] Fax:

# Indications for Use

Device Name: ViewMate® System (K073709)

Indications for Use: The ViewMate® System is indicated for use in adult and adolescent pediatric

patients to visualize cardiac structures and blood flow within the heart.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-O
Division of Cardio
510(k) Number K073 Page 1 of 1

le: VF-PM Sp 510(k) Indcations for Use 122707

File: VF-PM Sp 510(k) Indcations for Use 122707

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Re: K∅737∅9

Attachment: 4.2

Appendix F

# Diagnostic Ultrasound Indications for Use Form

# Fill out one form for each ultrasound system and each transducer.

intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | P | p | p | | ρ | | | | |

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

Additional Comments:
Cathete, Model: View Flex® PLUS
Ultrasound Element: PA 6.5/64
Catheter Model Number: VF-PM
Catheter Part Number: 09-2005

(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)