(22 days)
K# 953616
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not contain any language suggesting the use of AI or ML for image processing or model generation. The description focuses on providing alternative views and models from existing scan data for treatment planning, which is a common function of traditional medical imaging software.
No.
The software is explicitly stated to enhance the physician's capability to plan treatment but is "not intended to provide medical diagnosis or a recommended treatment approach," indicating it is a planning tool, not a therapeutic one.
No
The "Intended Use / Indications for Use" section explicitly states, "The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach."
Yes
The device description explicitly states "The Preview® Treatment Planning Software" and describes its function as processing existing scan data to create images and models. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the software is for providing alternative images and models for treatment planning and enhancing the physician's capability to plan treatment. It specifically states it is not intended to provide medical diagnosis or a recommended treatment approach. IVDs are typically used to diagnose diseases or conditions.
- Device Description: The description reiterates the purpose of providing images and models for treatment planning, again emphasizing that it's not for diagnosis or recommending treatment.
- Mentions image processing: While it mentions image processing, this is a common function in many medical devices that are not IVDs, such as imaging systems themselves or treatment planning software.
- Input Imaging Modality: Accepting data from CT and MRI scans is consistent with a device used for visualizing anatomical structures, which is relevant for treatment planning but not necessarily for in vitro diagnostic testing.
- Anatomical Site: Focusing on organs and tissues is also consistent with visualization for treatment planning.
- Lack of Diagnostic Claims: There are no claims or indications that the software analyzes biological samples (like blood, urine, or tissue) or provides information about a patient's health status based on such analysis, which is a hallmark of IVDs.
In summary, the Preview® Treatment Planning Software is designed to assist physicians in visualizing patient anatomy for treatment planning purposes, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
Device Description
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.
Mentions image processing
System, Image Processing, Radiological (21 CFR 892.2050; LLZ)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Organs and tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Preview™ Surgery Planning Software, by Medical Media Systems, Inc. K# 953616
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| APR 2 3 2004 | Preview® Treatment Planning Software
Summary of Safety and Effectiveness |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | Medical Media Systems, Inc
K040852 |
| Submitter Address: | 12 Commerce Avenue
West Lebanon, NH 03784 |
| Contact Person: | William F. Greenrose
Senior Vice President |
| Phone Number:
Fax Number: | 603-298-5509 x 303
603-298-5055 |
| Date Prepared: | April 1, 2004 |
| Device Trade Name: | Preview® Treatment Planning Software |
| Classification Name,
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
and Statement of
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. |
| Summary of
Technological
Characteristics | A table comparing the Preview® Treatment Planning Software to the
original Preview™ predicate device is attached. |
1
| K040852
| Substantial Equivalence Comparison | ||
|---|---|---|
| Viewing Software | Modified MMS Preview® | |
| Treatment Planning | ||
| Software | Original MMS | |
| Preview™ Surgery | ||
| Planning Software | ||
| (K# 953616) | ||
| Imaging technique | SSD | SSD |
| Reformatted 2D images from 2D axial | ||
| 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 | |
| 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 | |
| images appear in 3D | ||
| model. | Yes. Same | |
| Color display, 256 colors from 16.7 million | ||
| Color | Yes | Yes |
| Accept input data from multiple formats | ||
| (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 | |
| UNIX. Viewing software | ||
| run on Macintosh OS or | ||
| DOS/Windows. | Modeling done on | |
| Linux platform. | ||
| Viewing only on | ||
| Windows OS. | ||
| Capability to link to hospital computer | ||
| 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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (301) 594-4639. Also, please note of tags of the general Office of Compliance at (301) 394-4037. 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 (800) 638-2041 information on your responsibilities under Asstance at its toll-free number (800) 638-2041 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 _