MMS VIDEO OPTION

K050993 · Medical Measurement Systems B.V. · LLZ · May 26, 2005 · Radiology

Device Facts

• Record ID: K050993
• Device Name: MMS VIDEO OPTION
• Applicant: Medical Measurement Systems B.V.
• Product Code: LLZ · Radiology
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The MMS Video option is intended to acquire, view, record, process, print, archive and retrieve video images such as of gastroenterology and urology procedures.

Device Story

MMS Video Option is a software-based system designed to integrate with gastroenterology and urology diagnostic equipment. It captures, processes, records, and archives video signals generated during clinical procedures. The device allows clinicians to view live video, print images, and retrieve stored data for review. Used in clinical settings, it assists physicians in documenting and analyzing procedural findings. By providing a centralized platform for image management, the device facilitates clinical decision-making and patient record-keeping.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device functions as a Picture Archiving and Communications System (PACS) under 21 CFR 892.2050. It is designed for the acquisition, processing, and storage of video data. Connectivity is provided for integration with gastroenterology and urology procedural equipment.

Indications for Use

Indicated for use in acquiring, viewing, recording, processing, printing, archiving, and retrieving video images during gastroenterology and urology procedures.

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).

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows a circular logo with a stylized bird in the center. The bird is depicted with three curved lines suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper half of the circle, following its curvature. The logo appears to be a simplified representation of a government agency, likely related to health and human services.

MAY 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karin Ogink-Somhorst Quality Assurance and Regulatory Affairs Manager Medical Measurement Systems B.V. Colosseum 25 7521 PV Enschede THE NETHERLANDS

Re: K050993 Trade/Device Name: MMS Video Option Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 29, 2005 Received: April 19, 2005

Dear Ms. Ogink-Somhorst:

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 proor 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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notheation. The I DA miding of bassification 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 If you desire specific advice for your dovies on our line 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 premated notification the Also, please note the regulation entined, "Thisoration on your responsibilities under the Act from the 807.97). You may outer general mional and Consumer Assistance at its toll-free number (800) Division of Small Manufacturers, Internet address http://www.fda.gov/cdrb/dsmadsmamain.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

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## Indications for Use

510(k) Number (if known):

0 50993

MMS Video option Device Name:

Indications For Use:

The MMS Video option is intended to acquire, view, record, process, print, archive and retrieve video images such as of gastroenterology and urology procedures.

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Yes Prescription Use (Part 21 CFR 801 Subpert D)

AND/OR

No

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jancic Bladon

(Division Sign-Off) Division of Reproductive, Abdominat, and Radiological Devices 2050993 510(k) Number _

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