SHARP VIEW IMAGE ENHANCEMENT SYSTEM

• K Number: K024028
• Device Name: SHARP VIEW IMAGE ENHANCEMENT SYSTEM
• Manufacturer: CONTEXT VISION AB
• Date Cleared: 2003-01-24 ( 49 days)
• Product Code: LLZ 90L
• Regulation Number: 892.2050

Intended Use

The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.

Device Description

The product is a software or a kit containing software and hardware (Image processing board), which is intended to be installed on a personal computer. Typically the personal computer receives digital medical images in DICOM 3 format over a network connection. The enhanced and original image can be sent in DICOM 3 format over the network connection. The original file and the enhanced file can be kept locally if selected.

Predicate Devices

K993802

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary mentions "image enhancement" and "image processing" but does not explicitly mention AI, ML, deep learning, or any related terms. The description of the device and its function aligns with traditional image processing techniques.

Therapeutic

No
The device is used for image enhancement and viewing, which assists in diagnosis rather than directly treating a condition.

Diagnostic

No
The device is intended for image enhancement and viewing, not for making a diagnosis itself. It processes images from diagnostic systems, but the diagnostic function remains with the original imaging system and the interpreting technologist/physician.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is "a software or a kit containing software and hardware (Image processing board)". This indicates the device can include hardware components, making it not solely a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the transfer, storage, enhancement, and viewing of multi-modality images from diagnostic imaging systems. This is related to medical imaging, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
• Device Description: The device processes and enhances medical images. It does not interact with biological samples or reagents.
• No mention of biological samples or testing: The description focuses entirely on image processing and handling. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device operates on medical images, which are generated by imaging equipment, not directly from biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.

Product codes (comma separated list FDA assigned to the subject device)

90LLZ

Device Description

The product is a software or a kit containing software and hardware (Image processing board), which is intended to be installed on a personal computer. Typically the personal computer receives digital medical images in DICOM 3 format over a network connection. The enhanced and original image can be sent in DICOM 3 format over the network connection. The original file and the enhanced file can be kept locally if selected.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

multi-modality images

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified/trained technologist

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)

Bench and user testing indicates that the modified device is as safe and effective as the predicate device.

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.

K993802

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.

Not Found

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

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

0

EXHIBIT 2

JAN 2 4 2003

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

November 29, 2002

510(k) Summary of Safety and Effectiveness

• 1. Identification of the device: Proprietary-Trade Name: SharpView Classification Name: Image Processing, System Product code: 90LLZ Common/Usual name: SharpView Image Enhancement System
• Equivalent legally marketed devices: This product is similar in design and function to 2. the ContextVision SharpView Image Enhancement System, K993802
• Indications for Use (intended use); The SharpView Image Enhancement System is 3. intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.
• 4. Description of the device: The product is a software or a kit containing software and hardware (Image processing board), which is intended to be installed on a personal computer. Typically the personal computer receives digital medical images in DICOM 3 format over a network connection. The enhanced and original image can be sent in DICOM 3 format over the network connection. The original file and the enhanced file can be kept locally if selected.
• 5. Safety and Effectiveness, comparison to predicate device. The result of bench and user testing indicates that the modified device is as safe and effective as the predicate device.

1

• 6. Substantial Equivalence Chart

| Characteristics: | SharpView Image
Enhancement System | SharpView Image
Enhancement System, modified |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: | The Image
Enhancement System is
intended for use by a
qualified/trained
technologist for transfer,
storage, enhancement,
and viewing of MRI
images. | The Image
Enhancement System is
intended for use by a
qualified/trained
technologist for transfer,
storage, enhancement,
and viewing of multi-
modality images. |
| Physical
characteristics: | | |
| Computer | PC compatible | Same |
| Operating system | Windows 98, NT 4.0 | Windows 98, NT 4.0,
2000 and XP |
| Storage | Hard disk or any
compatible PC method:
Optical, CDROM, Tape | Same |
| Image processing
board | MIP-PCI | Javelin (PCI-bus) |
| Software core | GOP® Enhancement
software | Same
(Trademark is the
property of
ContextVision) |
| Image input | DICOM 3 | Same |

7. Conclusion

After analysing both bench and user testing data, it is the conclusion of ContextVision AB that the multi-modality SharpView Image Enhancement System is as safe and effective as the predicate device, has few technological differences, and only a minor change to the indications for use compared with the predicate device, thus rendering it substantially equivalent to the predicate device.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kent Strandlund Quality & Regulatory Affairs ContextVision AB Storgatan 24 SE-582 23 Linköping SWEDEN

Re: K024028 Trade/Device Name: SharpView Image Enhancement System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 29, 2002 Received: December 6, 2002

Dear Mr. Strandlund:

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 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

3

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 one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

j) Indications for Use

510(k) Number_Ko24028

Device Name: SharpView Image Enhancement System

Indications for Use: The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over the Counter Use_ (Per 21 CFR801.109)

Nancy C. Brogdon
(Division Sign-Off)

Division of Rons and Radiologi 510(k) Nul