SHARPVIEW IMAGE ENHANCEMENT SYSTEM

K993802 · Context Vision AB · LLZ · Jan 18, 2000 · Radiology

Device Facts

• Record ID: K993802
• Device Name: SHARPVIEW IMAGE ENHANCEMENT SYSTEM
• Applicant: Context Vision AB
• Product Code: LLZ · Radiology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images.

Device Story

SharpView is a software and hardware kit installed on a personal computer for MRI image processing. It receives MRI images in DICOM 3 format via network connection. The system utilizes a PCI graphics processor board and proprietary GOP enhancement software to process, enhance, and store images locally. The original image file remains unmodified. The device is operated by a qualified/trained technologist in a clinical setting. The enhanced images are viewed by healthcare providers to assist in clinical evaluation. The system benefits patients by providing enhanced visualization of MRI data.

Clinical Evidence

Bench testing and user testing were performed. No clinical trial data was required or provided. The device was evaluated for safety and effectiveness compared to the predicate system.

Technological Characteristics

Kit includes software and PCI graphics processor board (MIP-PCI) for installation on PC. Supports Windows 98/NT 4.0. Connectivity via network for DICOM 3 image input. Storage via hard disk or compatible PC media (optical, CDROM, tape). Uses GOP enhancement software core.

Indications for Use

Indicated for use by qualified/trained technologists for the transfer, storage, enhancement, and viewing of MRI images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• IES Image Enhancement System (K922470)

Submission Summary (Full Text)

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K993802

JAN 1 8 2000

## EXHIBIT 2

ContextVision AB Storgatan 24 SE-582 23 Linköping SWEDEN Phone: [phone] Fax: [phone] CONTACT: Magnus Aurell

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: SharpView Classification Name: Picture Archiving and Communications system Product Code LNH Common/Usual Name: MRI Image Enhancement System
- Equivalent legally marketed devices: This product is similar in design and function to 2. the IES Image Enhancement System, K922470
- Indications for Use (intended use) The SharpView Image Enhancement System is used 3. for the intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images.
- 4. Description of the Device: The product is a kit containing software and hardware (PCI graphics processor board) which is intended to be installed on a personal computer. Typically the personal computer receives MRI images in DICOM 3 format over a network connection. The received image is stored locally, then accessed, then enhanced by the software/hardware combination, then stored in the enhanced format. The original file can still be accessed and is not modified.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

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## 6. Substantial Equivalence Chart

| Characteristic | IES Image<br>Enhancement<br>System (K922470) | SharpView Image<br>Enhancement<br>System |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended Use: | The Image<br>Enhancement<br>System is intended<br>for use by a<br>qualified/trained<br>technologist for<br>transfer, storage,<br>enhancement, and<br>viewing of MRI<br>images. | SAME |
| Physical<br>characteristics: | | |
| Computer | Sun computer (MRI<br>console) | PC compatible |
| Operating<br>system | Unix | Windows 98, NT<br>4.0 |
| Storage | Hard disk or Optical<br>Disk | Hard disk or any<br>compatible PC<br>method: Optical,<br>CDROM, Tape |
| Image<br>processing<br>board | MIP-S | MIP-PCI |
| Software<br>core | GOP®<br>Enhancement<br>software | SAME |
| Image input | Direct from MRI<br>console (product is<br>installed in MRI<br>unit) | DICOM 3 |

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Contextvision AB SharpView Image Enhancement System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central graphic features three curved lines that resemble a bird in flight or a stylized representation of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

Constance Bundy ContextVision AB c/o C.G. Bundy Associates 6470 Riverview Terrace Minneapolis, MN 55432

Re:

K993802 SharpView Image Enhancement System Dated: November 1, 1999 Received: November 9, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Ms. Bundy:

We have reviewed your Section 510(k) 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.

If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number_K99 380 2

Device Name:

Indications for Use: The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Seggern.

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Kyaz807 510(k) Number

Prescription Use_ 1

OR Over the Counter Use (Per 21 CFR 801.109)