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.

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.

AI/ML Overview

This 510(k) summary describes Philips Interventional Workspot, a software platform intended to host other interventional tools, providing functionalities such as import, export, and data handling of digital clinical images and patient information.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the device underwent non-clinical verification and validation tests.

Acceptance Criteria Category	Reported Device Performance
Functional Verification	Interventional Workspot met the acceptance criteria.
Validation	Interventional Workspot met the acceptance criteria.
DICOM Conformance	Interventional Workspot met the acceptance criteria.
Compliance with Standards	Complies with international recognized standards.
Risk Management Results	Performed as part of non-clinical verification and validation tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is "non-clinical verification and validation tests," implying software-based evaluations rather than studies involving patient data. Therefore, details regarding test set sample size and data provenance (country of origin, retrospective/prospective) are not provided and do not appear to be relevant to the type of testing performed for this device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. As the testing was non-clinical verification and validation of software functionalities, there was no "ground truth" related to medical diagnoses or human interpretation that would require expert adjudication.

4. Adjudication Method

Not applicable. No expert adjudication process is described for non-clinical software testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a multi-reader, multi-case comparative effectiveness study involving human readers or the effect size of AI assistance. This device is a software platform, not an AI-powered diagnostic tool, so such a study would not typically be conducted.

6. Standalone (Algorithm Only) Performance Study

Yes, in the sense that the "Summary of testing" details non-clinical verification and validation tests indicating the algorithm/software's standalone performance in meeting its functional requirements and regulatory standards. However, it's not a standalone clinical performance study as might be conducted for a diagnostic algorithm. The statement "The results of these tests demonstrate that Interventional Workspot met the acceptance criteria" refers to the software's performance in isolation from clinical application.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical verification and validation tests would be the pre-defined requirement specifications and expected behavior of the software functionalities (e.g., successful import/export, correct data handling, DICOM compliance). It does not involve expert consensus, pathology, or outcomes data, as these are related to clinical efficacy or diagnostic accuracy, which are not the focus of this device's testing.

8. Sample Size for the Training Set

Not applicable. This device is described as a software platform providing functionalities like import, export, and data handling. It is not an AI/ML algorithm that requires a "training set" of data in the conventional sense to learn patterns or make predictions. Its development would involve software engineering and testing against functional specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of software platform. The "ground truth" for its development and testing would be derived from its design specifications and compliance with relevant industry standards (e.g., DICOM for image handling).

Summary

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Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters. The characters appear to be handwritten and include the letter 'K' followed by the numbers '12', a forward slash '/', '29', and the number '6'. The writing style is somewhat stylized, with variations in stroke thickness and character formation.

510(k) Summary of Safety and Effectiveness

JAN 2 2013

ldentification of manufacturer

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

Identification of U.S. designated agent

Company:	Philips Medical Systems
Address:	22100 Bothell Everett HighwayBothell, WA 98021-8431, U.S.A.
Registration number:	1217116

Identification of official correspondent

Name:	Frans Jacobs
Position:	Regulatory Affairs Manager
Telephone:	+31-40-27-99709
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

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 (800) 638 2041 or (301) 796-7100 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

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 x	AND/OR	Over-The-Counter Use
(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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Regulation Number and Section

§ 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).