INTERVENTIONAL WORKSPOT

K121296 · Philips Medical Systems Nederland B.V. · LLZ · Jan 2, 2013 · Radiology

Device Facts

• Record ID: K121296
• Device Name: INTERVENTIONAL WORKSPOT
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LLZ · Radiology
• Decision Date: Jan 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

import, export, and store digital clinical images. manage the patient information associated with those images.

Device Story

Interventional Workspot is a software platform designed to host various interventional medical tools. It functions as a centralized environment for importing, exporting, and storing digital clinical images, as well as managing associated patient information. The device is intended for use in interventional suites or operating rooms by clinicians who possess a basic understanding of medical software operation. By providing common data handling functionalities, it supports physicians during interventional procedures. It does not perform clinical analysis itself but acts as a hosting infrastructure for other software medical devices.

Clinical Evidence

Bench testing only. Non-clinical verification and validation tests were performed, including software verification, validation, and DICOM conformance testing, confirming the device met all acceptance criteria.

Technological Characteristics

PC-based hardware platform; software-only medical device; supports DICOM standard for image handling; functions as a hosting platform for interventional software tools.

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

• Fresco (K031836)
• Allura 3D-RA (K040254)
• Allura 3D-CA (K042334)
• Xper CT (K060749)
• HeartNavigator Release 1 (K111245)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

JAN 2 2013

# ldentification of manufacturer

| Company: | Philips Medical Systems Nederland B.V |
|----------------------|--------------------------------------------------|
| Address: | Veenpluis 4-6,<br>5684-PC, Best, The Netherlands |
| Registration number: | 3003768277 |

# Identification of U.S. designated agent

| Company: | Philips Medical Systems |
|----------------------|-----------------------------------------------------------------|
| Address: | 22100 Bothell Everett Highway<br>Bothell, WA 98021-8431, U.S.A. |
| Registration number: | 1217116 |

# Identification of official correspondent

| Name: | Frans Jacobs |
|----------------|----------------------------|
| Position: | Regulatory Affairs Manager |
| Telephone: | [phone] |
| Date prepared: | February 3, 2012 |

# Device identification

| Trade name: | Interventional Workspot |
|-------------------------|---------------------------------------------|
| Device name: | Interventional Workspot Release 1 |
| Regulation description: | Picture archiving and communications system |
| Regulation number: | 21CFR 892.2050 |
| Class: | II |
| Product code: | 90LLZ |

# Legally marketed devices

Trade names: Manufacturer: 510(k) numbers:

Fresco Philips K031836 - Aug 14, 2003

Trade names: Manufacturer: 510(k) numbers:

Trade names: Manufacturer: . 510(k) numbers:

Trade names: Manufacturer: 510(k) numbers: Allura 3D-RA Philips K040254 - Feb 19, 2004

Allura 3D-CA Philips K042334 - Sep 27, 2004

Xper CT Philips K060749 – Apr 4, 2006

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| Trade names: | HeartNavigator Release 1 |
|-----------------|--------------------------|
| Manufacturer: | Philips |
| 510(k) numbers: | K111245 - Jul 29, 20 |

## Device description

The Interventional Workspot software medical device is a software platform for hosting the aforementioned currently marketed and predicate software medical devices. It provides the same functionalities (for example, import, export, and data handling) that are required by the aforementioned currently marketed and predicate software medical devices to support the physician with performing interventional procedures.

### Indications for Use:

### Medical purpose / Intended Use:

Interventional Workspot has the following medical purpose:

- import, export, and store digital clinical images. -
- manage the patient information associated with those images. -

### Patient population:

Not applicable because Interventional Workspot is only a hosting platform.

#### Operator profile:

The operator of Interventional Workspot has basic understanding of the operating principle of medical computer software.

### Technological characteristics

Interventional Workspot software is executed on a PC based hardware platform

## Summary of testing

The Interventional Workspot software medical device complies with international recognized standards as detailed in this premarket submission. Non-clinical verification and validation tests were performed with regards to the requirement specifications and risk management results, specifically including software verification, validation and DICOM conformance testing. The results of these tests demonstrate that Interventional Workspot met the acceptance criteria.

### Conclusion:

The Interventional Workspot software medical device is substantially equivalent to the currently marketed and predicate Philips Fresco, Allura 3D-RA, Allura 3D-CA, Xper CT, and HeartNavigator software medical devices based on the same indications for use, intended use and software requirements.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 2, 2013

Philips Medical Systems Nederland B.V. c/o Frans Jacobs Regulatory Affairs Manager Veenpluis 4-6 BEST, 5684 PC THE NETHERLANDS

Re: K121296

Trade/Device Name: Philips Interventional Workspot Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 13, 2012 Received: December 26, 2012

Dear Mr. Jacobs:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

> Sincerely yours, Janine M. Morris -1 201

ડ .
ળ

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K121296 510(k) Number (if known):

Device Name:

Interventional Workspot

Indications for Use:

The indications for use statement for the proposed Interventional Workspot software medical device, as presented in the IFU, are as follows:

#### 1.1 Device Description

The interventional workspot is a software platform to host Interventional Tools. It provides common functionalities (e.g. import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the interventional procedure.

#### 1.2 Medical Purpose

The Interventional Workspot has the following medical purpose:

- import, export, and store digital clinical images. ?
- manage the patient information associated with those images. ▼

#### Patient Population 1.3

Not applicable because Interventional Workspot is only a hosting platform.

#### Intended Operator Profile 1.4

The operator of Interventional Workspot has basic understanding of the operating principle of medical computer software.

#### 1.5 Clinical Environment

The software can be used in the control room and in the exam room of an interventional suite and/or operating room.

| Prescription Use <span style="text-decoration:underline">x</span> | AND/OR | Over-The-Counter Use <span style="text-decoration:underline"></span> |
|-------------------------------------------------------------------|--------|----------------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine M. Morris -S 2013.01.02 ,16:10:12 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

#### 510(k) K121296

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