Who is the manufacturer of DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI?

Dexela, Ltd. filed the 510(k) submission for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI (K080351).

What is the FDA product code for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI

K080351 · Dexela, Ltd. · LLZ · Apr 22, 2008 · Radiology

Device Facts

Record ID	K080351
Device Name	DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
Applicant	Dexela, Ltd.
Product Code	LLZ · Radiology
Decision Date	Apr 22, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data. The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images with special emphasis and optimization for mammography. When interpreted by a skilled physician, this software provides information that may be useful in screening and diagnosis. However, the final judgment must rely on the knowledge and skill of the physician.

Device Story

DexTop Mammography Workstation is a software-based PACS review system running on a high-end PC. It ingests digital medical images (MG, MR, CR, US) via DICOM 3.0/TCP/IP from hospital PACS, diagnostic systems, or local media. The system provides tools for image hanging, viewing, and manipulation (window/level, zoom, pan, tiling, CLAHE, unsharp mask). It supports multi-monitor configurations (typically two high-resolution 5MP monitors for mammography). Operated by radiologists in clinical settings, the software assists in screening and primary diagnosis. It does not perform proprietary image processing of FFDM manufacturers, maintaining full-fidelity DICOM 'For Presentation' images. The system uses a centralized configuration store for satellite workstations. Output is visual display for physician interpretation; clinical decisions remain the responsibility of the physician.

Clinical Evidence

Bench testing only. No clinical data provided. The device underwent system requirements testing according to a defined Software Testing Strategy and Software Requirements Test Specification Document. Development followed a formal design control process including product risk analysis and architecture documentation.

Technological Characteristics

Software-based PACS running on 64-bit Windows XP Professional. Hardware requirements: multi-core processor, 2GB RAM, 80GB storage, HIPAA-approved monitors (min 5MP for mammography). Connectivity: 10/100/1000 Base-T Ethernet, DICOM 3.0, TCP/IP. Image processing: CLAHE, unsharp mask, window/level, LUT adjustments. Architecture: Centralized configuration store with satellite workstations.

Indications for Use

Indicated for use by radiologists for screening and primary diagnosis of multimodality medical images (MG, MR, CR, US), with optimization for mammography. Requires interpretation by a skilled physician. Lossy compressed mammography images and digitized film screen images are contraindicated for primary diagnosis.

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

Seno Advantage (K033400)

Related Devices

K062107 — SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 · Hologic, Inc. · Aug 18, 2006
K083740 — MAMMODIAGNOST VU · Philips Medical Systems Nederland B.V. · Feb 13, 2009
K103385 — SECURVIEW DX DIAGNOSTIC WORKSTATION · Hologic, Inc. · Feb 2, 2011
K112439 — SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 · Fujifilm Medical System U.S.A., Inc. · Oct 17, 2011
K041555 — SECURVIEW DX SOFTCOPY WORKSTATION · Hologic, Inc. · Aug 9, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ ### 5 510(k) Summary of Safety and Effectiveness Ko80351 | SUBMITTER: | Dexela Limited | |----------------------|------------------------------------------------------------| | CONTACT PERSON: | Michael Henry | | | APR 22 2008 | | DATE PREPARED: | 31 January, 2008 | | DEVICE TRADE NAME: | DexTop Mammography Workstation | | COMMON NAME: | DexTop Mammography Workstation | | CLASSIFICATION NAME: | Picture Archiving and Communication System | | PREDICATE DEVICE(S): | General Electric Medical Systems: Seno Advantage (K033400) | #### DEVICE DESCRIPTION: The DexTop Mammography Workstation is a software product, which runs on a high end personal computer, for the purpose of non-invasive multi-modality review. It provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar medical image data. The DexTop Mammography Workstation receives digital image data from various sources including a variety of diagnostic imaging systems, Hospital PACS, Electronic media and local file systems. The architecture of the DexTop Workstation means that it can be deployed as a central base station with satellite workstations all using the same user configuration store and image data. The Dexela DexTop Mammography Workstation supports the following image network communications: - Standard 10/100/1000 Base-T Ethernet protocols . - . DICOM 3.0 Storage SCP and Query/Retrieve SCU. - . TCP/IP network layer The hardware configuration used with the software typically will include a PC, a single standard color monitor, a multi-function keypad (for increased productivity), and two high resolution monitors for mammographic Image review. See the following table. {1}------------------------------------------------ | Component | Quantity | |----------------------------------------------------------------------------------|-----------------------------------| | SYSTEM: Multi-core (>2) 64-bit processor | 1 | | Memory: Minimum 2GB RAM | NA | | STORAGE: DVD Drive SONY DDU1615 or equivalent | 1 | | RAM: Minimum 80 GB (MAXTOR ATLAS SCSI drive or equiv) | NA | | DISPLAYS: Any HIPAA approved display monitors | 1 or 2 depending on configuration | | PERIPHERALS: Standard keyboard Standard mouse X-KEYS SE USB - LCD keypad | 1 each | | SOFTWARE: Windows XP Professional X64 Dexela Mammography Workstation Software | 1 each | #### INDICATION FOR USE: The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data. The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality softcopy images with special emphasis and optimization for mammography. When interpreted by a skilled physician, this software provides information that may be useful in screening and diagnosis. However, the final judgment must rely on the knowledge and skill of the physician. | Hardware | | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 64 bit Windows Operating System | More memory for larger data sets and increase speed of workflow | | Multi-core processor | Makes full use of new multi core CPUs to maximize throughput | | Remote workstation configuration | Multiple workstations can view the same data. | | Easy to use shortcut keypad | Shortcut keys to often used functions are presented on a separate keypad for ease of use | | Communications | | | DICOM | DICOM compliant communications | | Software | | | Modalities | MG,MR,CR,US | | Multi-vendor imaging | Fully IHE and DICOM compliant image display allows any vendor image to be displayed correctly | | Window centre and width adjustment | Window centre and width can be freely adjusted | | Hardware | | | | for any image maintaining the predefined curve if it exists | | Use of imbedded VOI LUTs | Correct implementation of the DICOM LUTS imbedded in the image file, including the ability for the user to adjust the image maintain the | | Linear and Sigmoid LUTs | same curve Switch between the use of a linear or a sigmoid | | Pull-scale function | curve for the display of gray scale images Function allowing the user to focus on a specific area with regard to window centre and width | | User specific window center and width | The system can remember the individual's preference for an image with regard to changes made to its default window centre and width | | Highly flexible patient and technical information display | The user can specify which pieces of patient and technical information should appear on which screen | | XML based annotation | Allows the radiologist to annotate the images in a very flexible way. The annotation can be hidden and deleted as required | | Flip, Zoom, Invert and Pan | The images can be manipulated on screen in all the usual ways | | Tiling | Images series or planar images can be tiled to the screen allowing some or all of the frames to viewed at the same time. | | Shutter-View | A type of shutter view of the image where two synchronized images have a mask overlaid so only the same small portion of each image is visible. | | 1:1 view | Display of the image data at one pixel per image data. | | Life-size view | Display of the image at life size | | Magnifying glass | A zoomed in portion of the image at the current cursor position | | Hot lamp / Bright Light | A portion of the image is displayed as if a brighter light had been applied to that area of the screen. | | CLAHE and Un-sharp Mask | Image processing techniques can be applied to sharpen and equalize the images | | Highly configurable hanging | Hanging protocols are designed per user with unlimited categories and limitless flexibility with respect to screen use and positioning | | Smart-Merge Protocol | Specific technology that brings together user preferences from different aspects of film type and screen use and combines them to form a new hanging from images that are only loosely specified. | | DICOM printing | DICOM printing | | Data export | Export data to CD or for presentations | ## TECHNOLOGICAL CHARACTERISTICS: {2}------------------------------------------------ : · : · : . · · {3}------------------------------------------------ #### NON-CLINICAL REQUIREMENTS TEST: The non-clinical testing for the DexTop Workstation includes performance of system requirements testing according to the Software Testing Strategy and following the test cases as defined in the Software Requirements Test Specification Document. #### CONCLUSIONS: Software Development for the DexTop workstation has been performed in accordance with the Software Development Plan and following the guidance of the Dexela Design and Development Procedures, and which includes, in addition to other documents, a Product Risk Analysis, Software Requirements, Design and Development Plan, detailed Architecture documents , Testing Strategy, and Software Requirements Test Specification. Therefore Dexela is confident that the system as developed will perform according to the specifications detailed in the User Requirements Specification and System Requirements Specification. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 22 2008 Dexela, Ltd. % Mr. Barry Sall, RAC Principal Consultant Parexel Consulting 200 West St. WALTHAM MA 02451 Re: K080351 Trade/Device Name: Dexela DexTop Mammography Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 28, 2008 Received: March 31, 2008 Dear Mr. Sall: 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 such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Rarts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter, | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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 {6}------------------------------------------------ 510(k) Number (if known): K080351 #### Device Name: Dexela DexTop Mammography Workstation The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data. The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images with special emphasis and optimization for mammography. Dexela DexTop Mammography Workstation will display the full fidelity DICOM image in a non-compressed format. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 megapixel resolution and meets other technical specifications reviewed and accepted by the FDA When interpreted by a skilled physician, this software provides information that may be useful in screening and diagnosis. However, the final judgment must rely on the knowledge and skill of the physician. The device will display only DICOM "For Presentation" images for primary image diagnosis. The device does not perform any image processing (except simple manipulation such as gray scale changes by window level and window width) of the proprietary image processing algorithm of the FFDM manufacturers. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-the-Counter Use (21 CFR 807 Subpart C) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number K080351