The Sapheneia Clarity is intended for use by radiologists for transfer, storage, noise reduction, contrast enhancement and viewing of multi-modality images from a variety of diagnostic systems. The device is also intended to be used by trained/qualified technologists for installation and maintenance of the software. For your legal protection, it is strongly recommended that you backup your original data.

For digital mammography, only DICOM 'For Presentation' images should be displayed for primary image diagnosis

Device Description

The Sapheneia Clarity™ image processing software reduces noise and enhances contrast of relevant structures to increase image quality through structure adaptation, tissue adaptation, scale adaptation, and noise adaptation. Sapheneia Clarity™ employs a sophisticated statistical analysis of the image structure in the neighborhood of each pixel. Using robust estimation methods the dominant structures are separated from the embedding noise. Once the structure has been determined, it is possible to strengthen the interesting parts while simultaneously reducing the noise. The acquisition remains the same, i.e. the image processing can be generated from multiple modalities and with predefined or specific acquisition protocol settings.

The workflow of Sapheneia Clarity™ image enhancement system can be easily adapted to existing radiology departmental workflow. Sapheneia Clarity™ acts as a DICOM node that receives DICOM3.0 digital medical image data from the modality or another DICOM source, processes the data and then forwards the enhanced and/or original study to the selected destination. This destination can be any DICOM node, typically either the PACS system or a specific workstation.

AI/ML Overview

The provided text is a 510(k) summary for the Sapheneia Clarity™ image enhancement system. It does not contain a dedicated performance study with acceptance criteria and reported device performance to demonstrate clinical efficacy or equivalence beyond conformity to standards like DICOM3.0 and JPEG, and substantial equivalence to a predicate device.

Here's an analysis of what is and isn't provided:

1. Table of Acceptance Criteria and Reported Device Performance & 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance & 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not provided. The document states: "The Sapheneia Clarity™ will successfully complete integration testing, beta testing and verification prior to market release." and "Software development for the Sapheneia Clarity™ system follows documented processes for software design, verification and validation testing." However, details of these tests, specific acceptance criteria for image quality or diagnostic accuracy, and their quantitative results are not included in this 510(k) summary. There is no mention of an MRMC study or a standalone algorithm performance study. The focus is on demonstrating substantial equivalence to a predicate device primarily through intended use, design, and function, rather than through extensive clinical performance data with specific metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. No specific test set or clinical study data is detailed in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not provided. As there's no described performance study or test set with ground truth, this information is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not provided. No adjudication method is mentioned as there is no specific performance study detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not provided. No specific ground truth type is mentioned as there is no performance study detailed.

8. The sample size for the training set:

Not provided. No mention of a training set size, as the document focuses on the device's functionality rather than a machine learning model's training.

9. How the ground truth for the training set was established:

Not provided. As there's no mention of a training set, the method for establishing its ground truth is also absent.

Summary of Device and Evidence Presented:

The Sapheneia Clarity™ is an image processing software designed to reduce noise and enhance contrast in medical images from various modalities. It functions as a DICOM node, receiving, processing, and then forwarding images.

The submission primarily relies on demonstrating substantial equivalence to a predicate device, the ContextVision AB, SharpView Image Enhancement System (K024028). The argument for substantial equivalence is based on:

Intended Use: Both devices are for image transfer, storage, noise reduction, contrast enhancement, and viewing of multi-modality images.
Design and Function: Sapheneia Clarity™ is described as substantially identical in functionality to certain functions of the predicate, though acknowledging potential slight differences in underlying algorithms for image filtration.
Performance Standards: The device is designed to conform to DICOM3.0 and JPEG standards.

The document does not report on any specific clinical performance studies with quantitative results, acceptance criteria, test sets, or expert evaluations. It mentions that "The Sapheneia Clarity™ will successfully complete integration testing, beta testing and verification prior to market release," and that "Software development... follows documented processes for software design, verification and validation testing." However, the details and results of these internal tests are not provided in this 510(k) summary.

Therefore, the submission successfully obtained clearance based on substantial equivalence to an existing legally marketed device and compliance with relevant technical standards, rather than through a dedicated clinical study demonstrating specific performance metrics against defined acceptance criteria.

Summary

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Submission v1.2

ATTACHMENT 11

KO 63391.

510(k) Summary of Safety and Effectiveness

This 510(K) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart 807.87(h), 807.92(e).

1) Identification of Submitter

APR 2 6 2007

Sapheneia Commercial Products AB Teknikringen 8 SE-583 30 Linköping, Sweden

2) Official Correspondent

Hans Grahn, Ph.D.

Vice President of International Growth & Development Sapheneia Commercial Products AB Teknikringen 8 SE-583 30 Linköping, Sweden Phone: +46-8-6072417 Cell: +46 73 801 1995 Fax: +46-8-6072417 hgrahn@saphenia.org

Date of Submission

01/24/07

3) Identification of Product

Device Trade Name:	Sapheneia Clarity™
Release Version:	1.1
Common Name:	Image Enhancement System
Classification Name:	Picture Archiving and Communications System
Reference:	Per 21 CFR 892.2050
Class:	II
Review Panel:	Radiology
Product Classification:	90 LLZ, Picture Archiving and Communications System
Guidance document:	Guidance for the submission of Premarket notifications for medicalimage management system (issued on July 2000)
Manufactured by:	Sapheneia Commercial Products AB
Distributed by:	Sapheneia Commercial Products AB

"I certify that, in my capacity as President, of Sapheneia Commercial Products AB, I will make available all information included in this Premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the Premarket notification is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the Premarket notification submission, including any adverse safety and effectiveness information, but excluding all

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. Premarket Notification 510(k) Sapheneia ClarityTM

Submission v1.2

patient identifiers, and trade secret and confidential information, as defined in 21 CFR 20.61."

4) Indications for Use:

04/20/2007 12:23 FAX

2003

Premarket Notification 510(k) Sapheneia Clarity™

For digital mammography, only DICOM 'For Presentation' images should be displayed for primary image diagnosis

5) Device Description

6) Marketing History

The software has not yet been marketed.

7) Marketed Devices - Predicate Devices

Insofar as it relates to safety, the Sapheneia Clarity™ is substantially equivalent to the currently marketed and to other legally marketed post-processing software products that analyzes data from medical images. Specifically, intended use, design, and function and performance characteristics for Sapheneia Clarity™ are substantially equivalent to the predicate device named ContextVision AB, SharpView Image Enhancement System (K024028).

ContextVision AB, SharpView Image Enhancement System (K024028) is an inage transfer, enhancement, and viewing analysis package intended for use for the visualization and enhancement of medical images. Thus, insofar as DICOM images are concerned, ContextVision AB SharpView Image Enhancement System is substantially identical to the Sapheneia Clarity™. Safety and effectiveness, comparison to predicate device, thus far the functionality of the Sapheneia Clarity™ is substantially identical to certain of the functions provided by ContextVision AB SharpView Image Enhancement System, though again, there may be slight difference in image filtration as a result of differences in the underlying It is the opinion of Sapheneia Commercial Products AB, that Sapheneia algorithms. Clarity™ raises no new issues of safety and effectiveness as compared to the predicate devices.

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Premarket Notification 510(k) Sapheneia Clarity™

raises no new issues of safety and effectiveness as compared to the predicate devices.

The Sapheneia Clarity™ provides image enhancement, and in the opinion of Sapheneia Commercial Products AB, this medical device is substantially equivalent to the SharpView Image Enhancement System (K024028), ContextVision AB, Storgatan 24, SE-582 23 Linköping, Sweden.

8) Performance Testing

The Sapheneia Clarity™ will successfully complete integration testing, beta testing and verification prior to market release.

9) Performance Standards

The Sapheneia Clarity has been designed to conform to the DICOM3.0 standard and the JPEG standard. The use of the Sapheneia Clarity™ is compatible with various off-the-shelf hardware components. Those monitors recommended by the Company will meet the SMPTE test pattern standard.

10) Software

Software development for the Sapheneia Clarity™ system follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the qualification results. Appropriate steps have been taken to control all identified risks for this type of image display and qualification product.

11) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the Sapheneia ClarityTM software in the "Operator's Manual".

12) Conclusion

The Sapheneia Clarity™ software is designed and manufactured to meet United States and international standards for the post processing and image enhancement system of images acquired from multi modality devices.

The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verifications and validation testing processes. The system has been shown to be substantially equivalent to the predicate devices, and no new issues of safety or effectiveness are raised.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Rick Mancilla CEO Sapheneia LLC 932 North State Street JACKSON MS 39202-2613

APR 2 6 2007

Re: K063391

Trade/Device Name: Sapheneia Clarity™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 3, 2007 Received: April 9, 2007

Dear Mr. Mancilla:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image shows a logo for the FDA Centennial, which took place from 1906 to 2006. The logo is circular and contains the letters "FDA" in a stylized font. Below the letters, the word "Centennial" is written in a smaller font. The text "Protecting and Promoting Public Health" is written below the logo.

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Page 2 -

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 producted 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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other	()	240-276-0100

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

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ATTACHMENT 12

Indication(s) for Use Statement

K063391 510(k) Number (if known):

Device Name:

Sapheneia ClarityTM

Indications for Use:

For digital mammography, only DICOM 'For Presentation' images should be displayed for primary image diagnosis

Prescription Use

AND/OR

Over-The-Counter Use_

(21 CFR 807 Subpart C)

(Per 21 C.F.R. 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

Daniel A. Szyper

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devj 510(k) Number

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).