(168 days)
Not Found
No
The description focuses on statistical analysis and robust estimation methods for image processing, which are traditional image processing techniques and do not explicitly mention or imply the use of AI or ML.
No
This device is image processing software for radiologists to aid in viewing images; it does not directly treat or diagnose patients.
No
The device is an image processing software that enhances the quality of images from diagnostic systems. It does not perform a diagnosis itself but rather aids radiologists in viewing images and does not output any diagnostic results.
Yes
The device description explicitly states it is "image processing software" and describes its function as receiving, processing, and forwarding DICOM data. There is no mention of accompanying hardware components required for its primary function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The Sapheneia Clarity processes medical images, which are generated from diagnostic systems and represent the internal structures of the body, not biological specimens like blood, urine, or tissue samples.
- The intended use is for image processing and viewing. The description focuses on enhancing image quality for diagnostic interpretation by radiologists. This is a function related to medical imaging, not laboratory testing of biological samples.
- The device description details image processing techniques. The explanation of how the software works involves analyzing image structure and reducing noise, which are techniques applied to digital images, not biological samples.
Therefore, the Sapheneia Clarity falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
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.
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
radiologists
trained/qualified technologists
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)
The Sapheneia Clarity™ will successfully complete integration testing, beta testing and verification prior to market release.
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.
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
§ 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).
0
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 medical |
| image 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
1
. Premarket Notification 510(k) Sapheneia ClarityTM
Submission v1.2
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™
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
5) 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.
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.
2
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.
3
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
5
ATTACHMENT 12
Indication(s) for Use Statement
K063391 510(k) Number (if known):
Device Name:
Sapheneia ClarityTM
Indications for Use:
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
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)
1
(Optional Format 1-2-96)
Daniel A. Szyper
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devj 510(k) Number