PREVIEW TREATMENT PLANNING SOFTWARE

K040852 · Medical Media Systems, Inc. · LLZ · Apr 23, 2004 · Radiology

Device Facts

• Record ID: K040852
• Device Name: PREVIEW TREATMENT PLANNING SOFTWARE
• Applicant: Medical Media Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Preview® Treatment Planning Software is intended to provide accurate, alternative two-dimensional images, as well as three-dimensional models, of patient specific anatomy from existing two-dimensional scan data of organs and tissues. The Preview® product offers the physician the capability to view existing scan data in a format that is more user friendly, and thus enhances the physician's capability to plan treatment. The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach.

Device Story

Software processes existing 2D scan data (CT, MRI) from multiple vendors; generates 2D reformatted images and 3D anatomical models using surface shaded display (SSD). Physician uses software to view, rotate, measure, and manipulate 3D models; features include transparency control, user-placed markers, and surgical plan saving. New features in this version include Manufacturer Specific Virtual Graft (MSVG), 'Click-Drag' manipulation, standardized marks/calculations, and centerline tensioning/morphing. Used in clinical settings to enhance treatment planning; does not provide diagnosis or treatment recommendations.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing comparisons.

Technological Characteristics

Software-based image processing system. Inputs: 2D scan data (CT, MRI). Outputs: 2D reformatted images, 3D models (SSD). Features: 2D/3D measurements, model rotation, transparency control, MSVG, centerline tensioning. Connectivity: Links to hospital networks. Operating platforms: Macintosh OS, DOS/Windows. Software-only device.

Indications for Use

Indicated for physicians to visualize and plan treatment using 2D and 3D anatomical models derived from existing 2D scan data (CT, MRI) of organs and tissues. Not for medical diagnosis or treatment recommendation.

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

• Preview™ Surgery Planning Software (K953616)

Submission Summary (Full Text)

{0}------------------------------------------------

| APR 2 3 2004 | Preview® Treatment Planning Software<br>Summary of Safety and Effectiveness |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | Medical Media Systems, Inc<br>K040852 |
| Submitter Address: | 12 Commerce Avenue<br>West Lebanon, NH 03784 |
| Contact Person: | William F. Greenrose<br>Senior Vice President |
| Phone Number:<br>Fax Number: | 603-298-5509 x 303<br>603-298-5055 |
| Date Prepared: | April 1, 2004 |
| Device Trade Name: | Preview® Treatment Planning Software |
| Classification Name,<br>Number & Pro Code: | System, Image Processing, Radiological (21 CFR 892.2050; LLZ) |
| Predicate Device: | Preview™ Surgery Planning Software, by Medical Media Systems, Inc. |
| Device Description<br>and Statement of<br>Intended Use | The Preview® Treatment Planning Software is intended to provide<br>accurate, alternative two-dimensional images, as well as three-<br>dimensional models, of patient specific anatomy from existing two-<br>dimensional scan data of organs and tissues. The Preview® product<br>offers the physician the capability to view existing scan data in a format<br>that is more user friendly, and thus enhances the physician's capability<br>to plan treatment. The Preview® product is not intended to provide<br>medical diagnosis or a recommended treatment approach. |
| Summary of<br>Technological<br>Characteristics | A table comparing the Preview® Treatment Planning Software to the<br>original Preview™ predicate device is attached. |

{1}------------------------------------------------

| K040852<br>Substantial Equivalence Comparison | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Viewing Software | Modified MMS Preview®<br>Treatment Planning<br>Software | Original MMS<br>Preview™ Surgery<br>Planning Software<br>(K# 953616) |
| Imaging technique | SSD | SSD |
| Reformatted 2D images from 2D axial<br>images | Yes | Yes |
| Sequential viewing of 2D images | Yes | Yes |
| Random viewing of 2D slices | Yes | Yes |
| Rendered 3D model | Yes | Yes |
| Multi-color objects in model | Yes | Yes |
| 2D measurements | Yes | Yes |
| 3D measurements | Yes, generated from 2D<br>images. | Yes, same |
| Interactive 3D model | Yes | Yes |
| Rotate model | Yes | Yes |
| Add 2D image to 3D model | Yes | Yes |
| Control transparency of objects in model | Yes | Yes |
| User placed markers in model | Yes. Marks placed in 2D<br>images appear in 3D<br>model. | Yes. Same |
| Color display, 256 colors from 16.7 million<br>Color | Yes | Yes |
| Accept input data from multiple formats<br>(e.g., CT, MRI) | Yes | Yes |
| Accept input data from multiple vendors | Yes | Yes |
| Create & save surgical plans | Yes | Yes |
| Supports mouse & keyboard interface | Yes | Yes |
| Operating platform | Modeling done at MMS on<br>UNIX. Viewing software<br>run on Macintosh OS or<br>DOS/Windows. | Modeling done on<br>Linux platform.<br>Viewing only on<br>Windows OS. |
| Capability to link to hospital computer<br>network | Yes | Yes |
| MSVG feature | Yes | No |
| 'Click-Drag' feature | Yes | No |
| Standardized Mark and Calculation types | Yes | No |
| Centerline Tensioning/morphing | Yes | No |

2D = 2-Dimensional; 3D = 3-Dimensional; SSD = Surface shaded display; MSVG = Manufacturer Specific Virtual Graft

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2004

Medical Media Systems, Inc. % Ms. Patsy J. Trisler, J.D., RAC Regulatory Consultant 5610 Wisconsin Avenue, #304 CHEVY CHASE MD 20815

Re: K040852

Trade/Device Name: Preview® Treatment Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communication system Regulatory Class: II Product Code: 90 LLZ Dated: March 30, 2004 Received: April 1, 2004

Dear Ms. Trisler:

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 I ou may, there controls 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, 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 r roas be a nood was a determination that your device complies with other requirements of the Act many liederal 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

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begit marketing your device of your device of your device to a legally
premarket notification. The FDA in a leasifies for your device and thus premarket notification. The FDA inding of substantial of 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 device on our laboling organized 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 Additionally, for questions on the promotion and the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note of tags of the general Office of Compliance at [phone]. Also, production of obtain. Other general
by reference to premarket notification" (21 CER Part 807.97) you may obtain of Sma by reference to premarket notification (21C. I i in 0017779 your de mail.
information on your responsibilities under the Act may be obtained from the Uiving [phone] information on your responsibilities under Asstance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free increasing Manufacturers, International and Colisumer / Esistance a creative and contributional dismamain.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

Page 2

{4}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known):

Ko40852

Device Name:

Preview® Treatment Planning Software

Indications for Use:

The Preview® Treatment Planning Software is intended to provide accurate, The Freviews Treatment Flanning on well as three-dimensional models, of allemative two-dimensional images, as wo-dimensional scan data of organs and patient Specific anatomy from oxisting the and offers the capability to view existing tissues. The i reviews prosunor prosunore user friendly, and thus enhances the SCan data in a formia that is more nent. The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach.

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

Concurrence of CDRH; Office of Device Evaluation (ODE) Over-The-Counter OR X Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510(k) Number _