KINETDX

K041029 · Siemens Medi Cal Solutions, Inc. · LLZ · Jul 8, 2004 · Radiology

Device Facts

• Record ID: K041029
• Device Name: KINETDX
• Applicant: Siemens Medi Cal Solutions, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the KinetDx system is for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification.

Device Story

KinetDx is a digital image management system (PACS) receiving, storing, distributing, and archiving images from acquisition devices like ultrasound and x-ray angiography machines. System includes server and workstations; clinicians use workstations to review, edit, and manipulate image data; generate quantitative/qualitative data; and produce diagnostic reports. Upgrade from K023772 adds advanced reporting, cardiology-specific analysis features for x-ray angiographic images, standalone DVD archiving, and support for 3rd party software applications. Operates in clinical settings; used by healthcare professionals to facilitate diagnostic decision-making through image visualization and analysis.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by risk analysis, software development processes, and verification and validation testing adhering to established industry standards.

Technological Characteristics

PACS utilizing standard computer hardware from qualified vendors. Server runs Windows 2000; workstations run Windows XP. Proprietary software manages image acceptance, transfer, display, storage, and post-processing. Supports connectivity for digital image acquisition devices (ultrasound, x-ray angiography) and 3rd party software integration. Archiving via standalone DVD.

Indications for Use

Indicated for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification, in a clinical environment.

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

• KinetDx Picture Archiving Communication System (K023772)
• Camtronics Echocardiography System Series 95000 (K992259)

Submission Summary (Full Text)

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K041029

## 510(k) Summary

# JUL - 8 2004

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

### 8.2 GENERAL INFORMATION

| Establishment:<br>• Address: | Siemens Medical Solutions, Inc<br>400 W Morgan Road<br>Ann Arbor, MI 48108 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------|
| • Registration Number: | 1836549 |
| • Contact Person: | Ana Ladino<br>Technical Specialist Regulatory Submissions<br>Telephone: [phone]<br>Telefax: [phone] |
| Device Name:<br>• Trade Name: | KinetDx |

- Picture Archiving and Communications System (PACS) . Classification:
- Classification Panel: Radiology .
- . CFR Section: 21 CFR §892.2050
- . Device Class: Class II
- . Product Code: LLZ

Date of Preparation of Summary: April 16th, 2004

### 8.3 SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

#### . Intended Use

The intended use of the KinetDx system is for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification.

#### . Device Description

The KinetDx system is a digital image management system that includes a server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. The system has workstations that can be used to review, edit, and manipulate image data; as well as review, generate quantitative data, qualitative data, and diagnostic reports.

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This premarket notification addresses an upgrade and modification of the KinetDx Picture Archival and Communications System as described in K023772 (cleared on 11/22/02). KinetDx in addition provides advanced reporting features, cardiology features for review and analysis of x-ray angiographic images, a new archiving option of standalone DVD and capability to host additional 3rd party software applications

#### . Technological Characteristics

Similar to the predicate devices, the computer hardware components used for the KinetDx server and workstations are standard computer hardware procured from qualified vendors. The KinetDx server and workstations use proprietary software to accomplish their functions. KinetDx Servers use the Windows 2000 operating system and KinetDx Workstations use the Windows XP operating system

#### . General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device.

Risk management is ensured via a risk analysis, which is used to identify potential These potential hazards are controlled via software development, hazards. verification and validation testing. To minimize electrical, mechanical and radiation hazards, Siemens Medical Solutions adheres to recognized and established industry practices and standards.

#### . Substantial Equivalence

The KinetDx system described in this premarket notification has the same intended use and similar technical characteristics as the device listed below

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|----------------------------------------------------|----------------------|--------------------|
| KinetDx Picture Archiving<br>Communication System | K023772 | 11/22/02 |
| Camtronics Echocardiography System<br>Series 95000 | K992259 | 09/08/99 |

In summary, Siemens is of the opinion that KinetDx does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

•

JUL - 8 2004

Ms. Ana Ladino Technical Specialist, Regulatory Submissions Siemens Medical Solutions, Inc. 400 W. Morgan Road ANN ARBOR MI 48108

Re: K041029 Trade/Device Name: KinetDx Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: April 16, 2004 Received: April 21, 2004

Dear Ms. Ladino:

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, 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) 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 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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. Brydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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## Indications for Use

510(k) Number (if known): K041029
Device Name: KinetDx

### Indications for Use

The intended use of the KinetDx system is for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification.

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

V Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

David h. Legron

(Division Sign-Off) (Division Sign Sign Sign of Reproductive, Abdominal, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ്വ എന്നതല