VINGMED SOUND COLOR FLOW MAPPING SYSTEM

K962662 · Diasonics, Inc. · IYO · Jan 2, 1997 · Radiology

Device Facts

• Record ID: K962662
• Device Name: VINGMED SOUND COLOR FLOW MAPPING SYSTEM
• Applicant: Diasonics, Inc.
• Product Code: IYO · Radiology
• Decision Date: Jan 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on these. The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device. As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices. The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to: - Produce 2D images that can be used to detect abnormalities. - Store images in the CFM system or via the CFM system to other storage media. Images can be retrieved from the CFM system or storage media for measurement and analysis.

Device Story

IVUS option integrates into Vingmed CFM 775/800 ultrasound systems; utilizes external off-the-shelf motor pods and ultrasound catheters. System processes ultrasound signals to generate 2D, 360-degree images of vessels. Operated by trained physicians in clinical settings. Includes EchoPac computer for video grabbing, archival, and measurement (distance, area, % stenosis). Provides picture-in-picture display (angio and ultrasound). Benefits include visualization of vascular abnormalities to aid clinical diagnosis and procedural decision-making.

Clinical Evidence

Bench testing only. Acoustic output measured per FDA 1985 guidance. Electrical safety and EMC testing performed per IEC 601-1, EN 60601-1-2, EN 55011, and IEC 801-2/-3/-4/-5.

Technological Characteristics

Integrated scanner card rack and video switch board for CFM 775/800 systems. Supports single-element rotating transducers or fixed transducers with rotating mirrors. Imaging mode: B-mode. Connectivity: EchoPac for archival, video output, magneto-optical disc. Safety standards: IEC 601-1, EN 60601-1-2, EN 55011, IEC 801. Software level of concern: moderate.

Indications for Use

Indicated for intravascular applications including intra-cardiac, coronary vessel, and peripheral vessel imaging in patients requiring ultrasound visualization of vascular structures.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• CVIS Insight III (K921750)

Submission Summary (Full Text)

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VINGMED SOUND

K962662

# 510(k) Summary PER 21 CFR 807.92

1: Submitted by:
Vingmed Sound A/S
P.O. Box 141,
N-3191 Horten, Norway
Contact person: Einar Korn Heide Aas, Director, Regulatory Affairs
Summary prepared: 19. June 1996

JAN - 2 1997

2: Device Name:
Intra Vascular Ultrasound System (IVUS) option for Vingmed Sound Color Flow Mapping System

3: Predicate Device:
CVIS Insight III, K921750

4: Device Description:
The IVUS consists of a basic scanner unit integrated into the CFM 775/800 ultrasound system. The basic scanner unit consists of a card rack mounted into the CFM 775/800; a video switch board mounted into the CFM 775/800 card rack; cables for interconnections; a connector for the motor drive and components that are common with the CFM 775/800. These common components include the keyboard and display, connectors for ECG and AUX, power supply, and internal computer (EchoPac) for video grabbing and archival (CFM 800 only), and peripherals such as a VCR printer. The system is used with specified off-the-shelf motor pod and ultrasound catheters not manufactured by Vingmed Sound A/S.

5: Intended Use:
The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on these.

The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device.

As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices.

The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to:

- Produce 2D images that can be used to detect abnormalities.
- Store images in the CFM system or via the CFM system to other storage media.

Images can be retrieved from the CFM system or storage media for measurement and analysis.

510(k) summary, IVUS option for CFM

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VINGMED SOUND

# 6: Comparison With Predicate Device

The following table depicts the similarities and differences between the Vingmed Sound IVUS System and the CVIS Insight III.

Table 1: General system comparison table

| | New device | Predicate device |
| --- | --- | --- |
| | IVUS | CVIS Insight III |
| 510(k) number | | K921750 |
| Indications for use | Intra cardiac | Intra cardiac |
| | Coronary vessel | Coronary vessel |
| | Peripheral vessel | Peripheral vessel |
| General device description | Embedded processor for system control | Embedded processor for system control |
| | Operator interface with imaging controls, alphanumeric keyboard, trackball, TGC controls, software menu controls | Operator interface with alphanumeric keyboard, remote control, trackball, software menu controls |
| | B&W - or colour monitor | B&W monitor |
| | Picture-in-picture (angio and ultrasound on one screen) | Picture-in-picture (angio and ultrasound on one screen) |
| | Two traces | Two traces |
| Imaging modes | B-mode | B-mode |
| | 360 degree image format | 360 degree image format |
| Catheters | Single element rotating transducer | Single element rotating transducer |
| | Single element fixed transducer with rotating mirror | Single element fixed transducer with rotating mirror |
| Measurements | General (distance, area and % stenosis) | General (distance, area and %s tenosis) |
| Acoustic output and device settings used | Track 1 | Track 1 |
| Image archiving and communications | EchoPAC, magneto-optical disc, video | Video, digital raw-data transfer, research option (RF output) |
| General safety and effectiveness | Conforms to IEC601-1, EN60601-1-2 | - |

# 7: Nonclinical tests:

The product has been designed for electrical patient safety by complying with IEC 601-1 and EN 60601-1-2, EN 55011 and IEC 801-2/-3/-4/-5 for EMC protections. Other tests performed have included measurements of acoustic output in accordance with the FDA

510(k) summary, IVUS option for CFM

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VINGMED SOUND

guidance document of December 1985 for measuring and reporting acoustic output of diagnostic ultrasound medical devices. The software is developed in accordance with a software development plan and the software level of concern, as described in the document "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) review" dated August 29,1991, is moderate.

8: Conclusion:

Based on the analysis of the comparison matrix described in 6 above and the results of the nonclinical testing described in 7 above, Vingmed Sound A/S has concluded that the Intra Vascular Ultrasound System (IVUS) option for Vingmed Sound Color Flow Mapping System is safe, effective, ad performs as well as or better than the legally marketed device in 3 above.

510(k) summary, IVUS option for CFM
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