(20 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as an ultrasound imaging system used to visualize cardiac structures, indicating a diagnostic rather than a therapeutic function.
Yes
The device is used to visualize cardiac structures and blood flow, which is a key step in diagnosing cardiac conditions. While it doesn't explicitly state "diagnosis," visualization for the purpose of understanding the state of internal structures is inherently diagnostic.
No
The device description explicitly states it is comprised of three hardware components: a console, a patient isolation module, and an ultrasound catheter. This indicates it is a hardware-based system, not software-only.
Based on the provided information, the ViewMate® System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize cardiac structures and blood flow within the heart." This is a diagnostic imaging procedure performed in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
- Device Description: The description details an ultrasound imaging system with a console, isolation module, and catheter. This is consistent with an imaging device used directly on a patient.
- Anatomical Site: The anatomical site is "Cardiac structures and blood flow within the heart," which is an internal part of the body.
- Input Imaging Modality: The input modality is "Ultrasonic," which is a common imaging technique used in vivo.
IVD devices are typically used to examine biological samples (like blood, urine, tissue) to diagnose diseases or conditions. The ViewMate® System is used to directly image the heart within a patient.
N/A
Intended Use / Indications for Use
The ViewMate® System is intended to be used to visualize cardiac structures and blood flow within the heart.
The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
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.
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 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.
The ViewMate® 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/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.
ViewMate® employs an ultrasound 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, constructed of radio-opaque tubing. The catheter offers bi-directional 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac structures within the heart
Indicated Patient Age Range
Adult and adolescent pediatric patients
Intended User / Care Setting
Physicians in interventional cardiology, specifically in the interventional EP laboratory.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3675 Denis Brown splint.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
Image /page/0/Picture/0 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract graphic to the left of the text "EPMedSystems". The graphic is a black, swirling shape. The text is in a bold, serif font.
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
BOUT | Carl States Carder
the productions of the entirements of the
:
necit
12 11
Cla
"Device .
Sification
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: 856-753-8533, x221 Fax: 856-753-8544 E-mail: Ipicciano@epmedsystems.com
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, | |||
| Imaging, Pulsed | |||||
| Doppler, | |||||
| Ultrasonic | 892.1550 | II | None | ||
| Subsequent | ITX | Transducer, | |||
| Ultrasonic | 892.1570 | II | None | ||
| Subsequent | IYO | System, | |||
| Imaging, Pulsed | |||||
| 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
| 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® | ||
| Svstem | 031066 | 10/17/03 |
| the will as a modification to the Viouslato" Cyctom's onthotar | ||
| 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.
1
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.
2
Systems
ViewFlex TM Catheter Modification 510k Summary
| Number Description | Former Number | New Number |
|---|---|---|
| Catheter Model Number1 | VF-PA9F64E2D | VF-01 |
| Ultrasonic Transducer Model | ||
| 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.
020003
3
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
Page 4 of 6
4
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.
5
dSystems EPMe
ViewFlex™Catheter Modification 510k Summary
| ECR 004
| Change # | Change Classification | Change Description |
|---|---|---|
| 1 | Finished product, external | |
| material change | Replace PEBAX® with silicone in distal | |
| transfer section | ||
| 1 | Finished product, internal | |
| material change | Change transfer section adhesive to | |
| silicone adhesive Med1511 | ||
| 1 | Production process, material | |
| change | Add silicone expander OS-10 for | |
| assembly with silicone | ||
| 1 | Finished product, internal | |
| material change | Addition of Nitinol round wire (0.018 | |
| in.) in main shaft to maintain length and | ||
| avoid kinking | ||
| 1 | Production process change | Modify manufacturing steps to add and |
| secure Nitinol wire; included is | ||
| disassembly and assembly of catheters | ||
| 2 | Finished product, internal | |
| material change | Addition of Nitinol flat wire (0.005 x | |
| 0.020 in.) in distal bending section to | ||
| maintain curvature after many | ||
| deflections | ||
| 2 | Production process change | Modify manufacturing steps to add and |
| secure Nitinol wire; included is | ||
| 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
Page 6 of 6
02006
6
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.
7
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
8
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 (856)753-8533 Tel: (856)753-8544 Fax:
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
050001