PATXFER

K021583 · Brainlab AG · LLZ · Aug 12, 2002 · Radiology

Device Facts

• Record ID: K021583
• Device Name: PATXFER
• Applicant: Brainlab AG
• Product Code: LLZ · Radiology
• Decision Date: Aug 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

PatXfer provides capabilities for the acceptance, transfer, display, storage and digital processing of medical images including functions for performing operations related to image manipulation, enhancement, compression and quantification.

Device Story

PatXfer is a Picture Archiving and Communication System (PACS) designed to interface between medical devices and provide patient data for treatment planning. It accepts medical images from various digital storage media (network archive, optical disk, tape, CD-ROM, hardcopy) and supports DICOM protocols for communication with other medical systems. The device enables image manipulation, enhancement, compression, and quantification. Operated by trained professionals (physicians, nurses, technicians) via mouse or touch screen, the system displays patient data and image series. It maintains a history log-file of all data import actions. By facilitating efficient image management and processing, the device assists clinicians in reviewing diagnostic information, thereby supporting clinical decision-making and treatment planning.

Clinical Evidence

No clinical data. Bench testing and validation performed according to manufacturer's design and development procedures.

Technological Characteristics

PACS software; supports DICOM format and protocol; compatible with network, optical, tape, CD-ROM, and hardcopy media; user interface via mouse or touch screen; includes image manipulation, enhancement, compression, and quantification tools; maintains history log-files.

Indications for Use

Indicated for use by trained professionals, including physicians, nurses, and technicians, for the acceptance, transfer, display, storage, and digital processing of medical images.

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

• VectorVision2 (K983831)

Submission Summary (Full Text)

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AUG 1 2 2002

## 510 (k) Summary of Safety and Effectiveness for PatXfer

#### Manufacturer:

| Address: | BrainLAB AG<br>Ammerthalstraße 8<br>85551 Heimstetten<br>Germany |
|-----------------|------------------------------------------------------------------|
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Mr. Stefan Vilsmeier |
| Summary Date: | May 6. 2002 |

#### Device Name:

| Trade name: | PatXfer |
|-----------------------------|------------------------------------------------------|
| Common/Classification Name: | PatXfer / Picture Archiving and Communication System |

#### Predicate Device: VectorVision

Device Classification Name: Picture Archiving and Communication System Regulatory Class: Class II

#### Intended Use:

PatXfer provides capabilities for the acceptance, transfer, display, storage and digital processing of medical images including functions for performing operations related to image manipulation, enhancement, compression and quantification.

#### Device Description:

PatXfer intends to interface between medical devices and provide the patient data for treatment plan. The application provides capabilities for the transfer, display, storage and digital images. PatXfer supports scanner specific and standard data formats from digital storage media, such as network archive, optical disk, tape, CD-ROM or hardcopy. To facilitate the imaging and communication with other medical systems the DICOM format and protocol is supported.

To keep the application as user-friendly as possible only the necessary information for the intended procedures are displayed. The patient, image series and images will be displayed and can be selected and processed. PatXfer creates a history log-file including all the software actions to import the data and can be controlled with the mouse or by touch screen monitor.

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Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.

### Substantial equivalence:

PatXfer has been verified and validated according to BrainLAB's procedures for product design and development and found to be substantially equivalent with BrainLAB medical devices such as VectorVision2 (K 983831). The validation proves the safety and effectiveness of the system.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 2 2002

Re: K021583

Mr. Stefan Vilsmeier President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten GERMANY

Trade/Device Name: PatXfer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: May 6, 2002 Received: May 14, 2002

Dear Mr. Vilsmeier:

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird. The text is in all capital letters.

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This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snigdon

Nancv 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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| 510(k) Number (if known): | K02 158 3 |
|---------------------------|-----------|
|---------------------------|-----------|

Device Name:

PatXfer

Indications For Use:

PatXfer provides capabilities for the acceptance, transfer, display, storage and digital processing of medical images including functions for performing operations related to image manipulation, enhancement, compression and quantification.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format I-2-96)

David G. Legrom

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number