VIEWPOINT

K961168 · Philips Medical Systems (Cleveland), Inc. · GAW · May 16, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961168
• Device Name: VIEWPOINT
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: May 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2

Intended Use

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).

Device Story

ViewPoint integrates 3D CT and MR diagnostic images with a non-mechanical 3D digitizer for surgical planning and intra-operative localization. System uses ultrasonic pulses emitted from a hand-held wand, detected by a microphone array mounted to the OR table, to track probe position. Operates on a DEC 3000 workstation; displays multiplanar reformatted images and surface renderings in 4 viewports. Used by surgeons in the OR to provide real-time orientation and reference information during intracranial procedures. Benefits include frame-less stereotactic accuracy, facilitating navigation of lesions or malformations without the limitations of traditional frame-based systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, system specifications, and intended use against predicate devices.

Technological Characteristics

System utilizes ultrasonic digitizer (hand-held wand with microphone array). Hardware: DEC 3000 Model 700 superscalar RISC microprocessor, 128MB RAM, 2.1GB disk storage. Display: 20-inch 1280x1024 color monitor. Connectivity: Ethernet, DICOM v3.0 support. Software: UNIX-based with X-windows/MOTIF. Sterilization: ETO for wand. Function: 3D image integration (CT/MR), multiplanar reformatting, surface rendering.

Indications for Use

Indicated for patients undergoing intracranial surgery for space-occupying lesions or malformations, including soft tissue, vascular, and osseous conditions.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• ISG Viewing Wand (K911783)
• SNT StealthStation (K954276)
• Picker ViStar (K905070)

Submission Summary (Full Text)

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K961168

SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 16 1996

## 1. General Information

Classification: Class II
Image Processing System (Accessory)

Common/Usual Name: Image assisted surgery device

Proprietary Name: ViewPoint™

Establishment Registration: Picker International, Inc.
World Headquarters
595 Miner Road
Cleveland, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965

Performance Standards: No Applicable Standards.

## 2. Intended Uses:

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).

## 3. Device Description:

This device integrates 3-D studies from computerized tomography (CT) and magnetic resonance (MR), and medical super-computers with image processing, analysis, and display functions already cleared by the FDA, with a non-mechanical 3-dimensional digitizer in order to provide pre-operative surgical planning and real-time intra-operative localization with accuracy similar to that of frame-stereotaxy without the limitations of frame-application.

## 4. Safety and Effectiveness

The ViewPoint is substantially equivalent to the Viewing Wand (K911783), the StealthStation (K954276) and the ViStar workstation (K905070) in safety and effectiveness. The following chart has been compiled to demonstrate ViewPoint's substantial equivalence to these devices.

PICKER INTERNATIONAL, INC. (VIEWHD) (3/21/96)

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# SUBSTANTIAL EQUIVALENCE CHART

| Parameter | ISG Viewing Wand (K911783) | SNT StealthStation (K954276) | Picker ViStar (K905070) | ViewPoint |
| --- | --- | --- | --- | --- |
| Type of Digitizer | A six-jointed, six degree of freedom electrogoniometer is mounted to the OR table t-rail or head holder and is used for position and angle measurement. The angular position of each joint is measured using proprietary potentiometer type sensors. | A manual surgical instrument that has been modified to incorporate low voltage LEDs onto the handle is used as a probe. The location of the probe is tracked by three optical cameras and is compared to the location of the reference system. | NA | Ultrasonic pulses emitted from two locations on hand-held wand are detected by 4 microphones in a detector array which is mounted to the OR table. |
| Registration Technique | Scanned Fiducials, Surface fitting, anatomical features. | Laitinen Stereo-adapter non-invasive stereotactic frame | NA | Scanned Fiducials |
| Type of Sterilization | Instrumented Arm: cleaned and draped. Probes: autoclaved or gas sterilized | Reference arc and Optical probe are auto-claved. | NA | Wand is ETO sterilizable. |

PICKER INTERNATIONAL, INC. (VIEWHD) (3/21/96) I-2

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PICKER INTERNATIONAL, INC. (VIEWHD) (3/21/96) I-3

| Parameter | ISG Viewing Wand (K911783) | SNT StealthStation (K954276) | Picker ViStar (K905070) | ViewPoint |
| --- | --- | --- | --- | --- |
| Computer | Hewlett Packard Apollo Series 700, Unix System 5 Operating System, X-Windows/MOTIF | Silicon Graphics Indy workstation with a minimal configuration of a UNIX/X-windows operating system. | Stardent 3000 supercomputer using parallel RISC architecture. | DEC 3000 Model 700 superscalar RISC microprocessor with 64 bit word. UNIX System with X-windows/MOTIF. |
| RAM Memory | 64 MBytes. | 64 MBytes. | 64 MBytes. Expandable to 128 MBytes. | 128 MBytes. Expandable to 256 MBytes. |
| Image Storage Capabilities | 1.0 GByte disk storage. DAT drive and QIC tape. | 500 MBytes of hard disk space and a DAT archive/backup device | 760 MBytes disk storage, 1/4" cartridge tape drive, magnetic tape drive. Optional optical disk drive. | 2.1 GBytes of disk storage. Optional 1.3 GByte optical disk drive. 1/2" 9-track tape system. |
| Monitor | 19 inch, 1280 x 1024 high resolution color monitor, 72 Hz, non-interlaced | High-resolution monitor capable of displaying 256 grey levels | 19 inch, 1280 x 1024 high resolution color monitor, 60 Hz, non-interlaced. | 20 inch, 1280 x 1024 high resolution color monitor, 72 Hz, non-interlaced. |
| Networking | Ethernet networking capabilities. | Supports the DICOM v3.0 imaging / networking protocol. | Ethernet TCP/IP. | Networking software for direct link to MR and CT systems. Supports the DICOM v3.0 imaging / networking protocol. |

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| Parameter | ISG Viewing Wand (K911783) | SNT StealthStation (K954276) | Picker ViStar (K905070) | ViewPoint |
| --- | --- | --- | --- | --- |
| Graphical Interface | 4 viewports with control panel.
Standard viewports: coronal view, sagittal view, axial view and 3D view. | 4 viewports with control panel.
Standard viewports: coronal view, sagittal view, axial view and navigational view.
Probe position indicated by cross-hairs. | 1 to 256 individual viewports, image sizes from 64 x 64 to 1024 x 1024 pixels, ability to window, level, zoom, pan, apply filters and draw. | 4 viewports with 512 x 512 resolution.
Control panel with status information and menu selections.
Ability for graphical overlays. Layout of viewports depends on mode of operation. |
| Image Manipulation & Reformatting Capabilities | Multiplanar Reformatting, Surface Rendering. Able to show diagnostic images at the location of the articulated arm. | Multiplanar Reformatting, Surface Rendering. Able to show diagnostic images at any Laitinen coordinate in surgical space as identified by the probe. | Multiplanar Reformatting, Angiographic Rendering, Surface Rendering, Cubeview, Cine Display. | Multiplanar Reformatting, Surface Rendering. Able to show diagnostic images at the location of the probe tip. |

PICKER INTERNATIONAL, INC. (VIEWHD) (3/21/96)

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| Parameter | ISG Viewing Wand (K911783) | SNT StealthStation (K954276) | Picker ViStar (K905070) | ViewPoint |
| --- | --- | --- | --- | --- |
| Intended Use | The Viewing Wand is intended for use with patients who have imaged space occupying lesions or malformations (both soft tissue and osseous) such as: intra-cerebral tumors and cysts, skull-based tumors and cysts, vascular malformations such as cavernous malformations and arterio-venous malformations, epilepsy, acute sinusitis with complications, chronic sinusitis and cerebrospinal fluid leaks. There are no known restrictions on patient population other than patients with Creutzfeld-Jakob's disease. The Wand is intended for use during planning and surgery provided the attainable correlation accuracy is adequate for the intended use.

The StealthStation is intended for use for precise stereotactic determination of cranial and neurological targets and is suitable for locating tumors during open surgery, and for percutaneous tumor biopsy and ventriculostomy.

The ViStar systems used with HPQ and 2055HP systems do not change the existing indications which are: The Picker International Vista HPQ and 2055 HP systems are indicated for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous). | | | |

PICKER INTERNATIONAL, INC. (VIEWHD) (3/21/96)