VIEWMATE SYSTEM

K071028 · Ep Medsystems · ITN · May 1, 2007 · Physical Medicine

Device Facts

• Record ID: K071028
• Device Name: VIEWMATE SYSTEM
• Applicant: Ep Medsystems
• Product Code: ITN · Physical Medicine
• Decision Date: May 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3675
• Device Class: Class 1
• 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 visualization. It consists of a console (PC, beam former, frame grabber), patient isolation module, and ViewFlex™ ultrasound catheter. The catheter is a single-use, 9 French, bi-directional steerable device with a 64-element linear phased array transducer (4.5–8.5 MHz). Used in interventional cardiology and EP labs, the system captures and displays 2D (B-mode, color Doppler) and time-motion (spectral/pulse wave Doppler, M-mode) images. Physicians use the system to assess cardiac performance/size, locate EP catheters, and identify blood flow anomalies. The modification adds Nitinol wire to the shaft and bending section, and replaces distal transfer section materials with silicone to improve production yield, curvature distribution, and steering stability. The system aids clinical decision-making by providing real-time visualization of cardiac structures and EP catheter placement.

Clinical Evidence

No clinical data provided. The submission relies on bench testing, design controls, and verification/validation of the mechanical modifications to the catheter.

Technological Characteristics

9 French, 110 cm long, single-use intracardiac ultrasound catheter. 64-element linear phased array transducer (4.5–8.5 MHz, 86° viewing angle). Materials include radio-opaque tubing, silicone (distal transfer section), silicone adhesive Med1511, and Nitinol wire (round 0.018 in. in shaft, flat 0.005 x 0.020 in. in bending section). Bi-directional steerability. Console includes PC, beam former, and digital frame grabber. Imaging modes: B-mode, color Doppler, spectral Doppler, pulse wave Doppler, M-mode.

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

A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.

Predicate Devices

• ViewMate® System (K031066)

Reference Devices

• Philips Medical Systems' (PMS) HD-11 Ultrasound System (K062247)

Submission Summary (Full Text)

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ViewFlex™Catheter Modification 510k Summary

# 510(k) Summary

K07/028

## Summary preparation date: 04/09/07

#### 1.0 Device Trade Name

MAY - 1 2007

| Alamo<br>BOUT | Carl States Carder<br>the productions of the entirements of the<br>:<br>necit<br>12 11<br>Cla<br>----------<br>"Device .<br>Sification<br>1-12-27 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| ViewMate® System | |

### Establishment Address and Registration 2.0

## 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 Code | Device Classification Name | Regulation Number | Classification Number | Performance 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 |

## 3.0 Device Classification

#### 4.0 *Predicate Devices / Technology

| Comments of the comments of the comments of the comments of the first of the first of the first of the first of the first of the first of the first of the first the first of<br>1 1 2 2 4 4 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------|
| ViewMate®<br>Svstem | 031066 | 10/17/03 |
| the will as a modification to the Viouslato" Cyctom's onthotar<br>1 | | |

* This application describes a modification to the ViewMate® System's catheter called ViewFlex™.

This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP mis document is the proporty of Er Meddycente, to only oblished or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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K071028

Image /page/1/Picture/1 description: The image shows the logo for EPMedSystems. The logo consists of a stylized graphic to the left of the text "EPMedSystems". The graphic is a series of curved lines that form a circular shape. The text is in a bold, sans-serif font.

ViewFlex™Catheter Modification 510k Summarv

## Labeling and Intended Use 5.0

The following labeling is contained within Appendix 4.

- Proposed Product Labeling 5.1
- Proposed Marketing Literature 5.2
- Proposed Instructions for Use 5.3
- 5.4 Intended Use

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

#### Indications for Use 6.0

Note: A copy of the original Diagnostic Ultrasound Indications for Use Form, which is not affected by this notification, is provided in Appendix 6-18.

## Indications for Use Statement

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

#### 7.0 Device Description

- Background of the ViewMate® System with the ViewFlex™ Catheter: 7.1 The ViewMate® cardiac ultrasound imaging console in combination with the ViewFlex™ ultrasound catheter was cleared for US marketing on October 17, 2003 (K031066). As of this writing, there have been no significant modifications to any element of the ViewMate® System; therefore, there have been no additional notifications to FDA (the agency). On August 18, 2006 EPMedSystems' ViewFlex™ catheter was cleared for US marketing with Philips Medical Systems' (PMS) HD-11 Ultrasound System (K062247). There have been no other US filings regarding the ViewMate® console or the ViewFlex™ catheter.
- Product Numbering Change Notice: In an effort to make it easier for 7.2 customers to order catheters and to clarify product identification, EPMedSystems, Inc., (the company) is modifying the way it refers to the ViewFlex™ catheter. This is strictly a nomenclature change. The company currently uses VF-PA9F64E2D to represent the ViewFlex™ catheter model number, the transducer (model) number, the product code and the part number. Moving forward EPMedSystems will refer to the ultrasound product as follows in Table 1.

This document is the property of EPMedSystems. Its' entire content is considered proprietary and confinential by End without 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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# Systems

ViewFlex TM Catheter Modification 510k Summary

| Number Description | Former Number | New Number |
|----------------------------------------|---------------|------------------|
| Catheter Model Number1 | VF-PA9F64E2D | VF-01 |
| Ultrasonic Transducer Model<br>Number2 | VF-PA9F64E2D | 204 |
| Catheter Part Number | VF-PA9F64E2D | VF-PA9F64E2DW3,4 |
| Product Code | VF-PA9F64E2D | VF-PA9F64E2DW3,4 |

## Table 1: Product Code Modification

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 cleared under K032066. (3) "W" indicates wire added as part of the redesign; this differentiates the product by design. (4) Units of former design will also be sold during a phase in period as VF-PA9F64E2D.

- General Description of the ViewMate® System with the ViewFlex™ 7.3 Catheter: The ViewMate® cardiac ultrasound imaging system (K031066) 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 imaging capability can be used by physicians to: assess overall cardiac performance and size, determine the presence and location of electrophysiology catheters, aid in electrophysiology procedures, and visualize blood flow through cardiac arteries. Cardiac electrophysiology (EP) procedures are complex diagnostic tests that enable physicians to look at electrical signals from within 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 locate and accurately place EP catheters and to identify physiologic and blood flow anomalies.
- The ViewMate® System is a portable, computerized, ultrasound imaging 7.4 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™ ultrasound catheter.

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.

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K07 i02 e

# EPMedSystems

ViewFlex™Catheter Modification 510k Summary

Image /page/3/Figure/3 description: The image shows a diagram of a medical system. The diagram includes components such as a monitor, a physician's keyboard/trackball, a ViewMate console, an isolation module, a 12-lead ECG cable, a ViewFlex catheter, and a patient. The diagram illustrates the connections and interactions between these components in a medical setting.

## Figure 1: ViewMate® System

- The ViewMate® console comprises a personal computer (PC), ultrasound 7.5 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/pulse 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.
- Description of ViewFlex™ Catheter: ViewMate® employs an ultrasound 7.6 catheter called ViewFlex™ inserted into the heart though intravascular access. The ViewFlex™ catheter, illustrated in Figure 2, is a single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. ViewFlex™ mechanical properties are as follows: The catheter shaft is 9 French, approximately 110 cm long, The catheter offers bi-directional constructed of radio-opaque tubing. steerability that can easily be manipulated with one hand. A minimum of a 10 French introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. ViewFlex™ 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, 86° viewing angle, and user-selectable magnification.

This document is the property of EPMedSystems. Its' entire content is considered proprietery and onlines in whole or in whole or in whole or in whole or in whole or in whole This document is the property of EPMedically. Reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

File: ViewFlex 01 Sp510(k) Summary 040907

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K071028

Image /page/4/Figure/1 description: The image shows a diagram of the ViewFlex Catheter Modification. The diagram includes labels for different parts of the catheter, such as the card edge connector, handle, 9FR shaft, transducer, and transfer section. The diagram also includes measurements of 95cm and 110cm.

Figure 2: ViewFlex™ Catheter

- Change Scope and Description: The intent of this submission is to provide 7.7 premarket notification of modifications to the mechanical design of the ViewFlex™ catheter; intended use and indications for use 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® console. The modification is intended to improve production yield and throughput, to improve curvature distribution and bond strength of the transfer (bending) section, and to stabilize the steering (deflection) range. EPMedSystems employed design controls, verification and validation in the design change process. The changes are explained in Engineering Change Request - Change Description (ECRCD) 004 located in Appendix The following table 6 and in the supporting documentation provided. summarizes the changes.
This document is the property of EPMedSystems. Its' entire content is considered proprieters in white any and without mil the the property of the copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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## dSystems EPMe

ViewFlex™Catheter Modification 510k Summary

| ECR 004<br>Change # | Change Classification | Change Description |
|---------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 1 | Finished product, external<br>material change | Replace PEBAX® with silicone in distal<br>transfer section |
| 1 | Finished product, internal<br>material change | Change transfer section adhesive to<br>silicone adhesive Med1511 |
| 1 | Production process, material<br>change | Add silicone expander OS-10 for<br>assembly with silicone |
| 1 | Finished product, internal<br>material change | Addition of Nitinol round wire (0.018<br>in.) in main shaft to maintain length and<br>avoid kinking |
| 1 | Production process change | Modify manufacturing steps to add and<br>secure Nitinol wire; included is<br>disassembly and assembly of catheters |
| 2 | Finished product, internal<br>material change | Addition of Nitinol flat wire (0.005 x<br>0.020 in.) in distal bending section to<br>maintain curvature after many<br>deflections |
| 2 | Production process change | Modify manufacturing steps to add and<br>secure Nitinol wire; included is<br>disassembly and assembly of catheters |

Table 2:ViewFlex™ Catheter Change Summary

End of document

This document is the property of EPMedSystems. Its' entire content is considered propriefary and confidential by EP
MedSystems. This document may not be copied, reproduced, p express written consent of EPMedSystems' executive management.

File: ViewFlex 01 Sp510(k) Summary 040907

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02006

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2007

EPMedSystems c/o Larry Picciano Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293

Re: K071028

Trade/Device Name: ViewMate® System Regulation Numbers: 21 CFR 892.1550; 21 CFR 892.1560; and, 21 CFR 892.1570 Regulation Names: Ultrasonic pulsed doppler imaging system; Ultrasonic pulsed echo imaging system; and, Diagnostic ultrasonic transducer; Regulatory Class: Class II Product Codes: IYN; IYO; and, ITX Dated: April 10, 2007 Received: April 11, 2007

Dear Mr. Picciano:

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. 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 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), 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.

Sincerely yours,

Blsimmimafor

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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Image /page/8/Picture/0 description: The image shows the logo for EPMedSystems. The logo consists of a stylized graphic to the left of the text "EPMedSystems". The graphic is a black, abstract design. The text is in a bold, serif font.

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

K071028

## Indications for Use

Device Name: ViewMate® System (K031066)

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 V (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumemmer

Page 1 of 1 (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KO3/066

File: VF-01 Sp 510(k) Indcations for Use 040907

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