The Interventional Workspot has the following medical purpose:
· import, export and storage of digital clinical images,
· manage the patient information associated with those images.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Interventional Workspot." This device is a software platform intended to host interventional tools and provide common functionalities like importing, exporting, and managing digital clinical images and associated patient information.

Key takeaway: The document describes a "Picture archiving and communications system" that handles and displays medical images and associated patient information. It does not describe an AI medical device that provides diagnostic or prognostic insights, therefore, it does not have the kind of performance acceptance criteria typically seen for AI/ML devices.

The product is a software platform (21 CFR 892.2050 - Picture archiving and communications system) and functions primarily as a data handler and host for other interventional tools. It is an accessory to Philips Interventional X-ray systems.

Based on the provided information, the device is not an AI/ML diagnostic or prognostic device. It does not perform tasks such as detecting abnormalities, classifying diseases, or predicting outcomes based on image analysis. Therefore, the questions related to "acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this device.

The study referenced focuses on demonstrating substantial equivalence to a predicate device (Interventional Workspot Release 1.0, K121296) by showing that the new version (1.4.5.1) has similar indications for use, technological characteristics, and safety and effectiveness, despite some minor updates (e.g., operating system, hardware support, bug fixes, security features).

The acceptance criteria for this device are related to its functional performance, safety, and compliance with relevant standards, rather than diagnostic accuracy.

Here's a breakdown of the available information relevant to "acceptance criteria" and the "study" (non-clinical performance testing) conducted:

1. A table of acceptance criteria and the reported device performance:

The document does not present a formal table of quantitative acceptance criteria for diagnostic or prognostic performance, as it is not an AI/ML diagnosis/prognosis device. Instead, the acceptance criteria are implicitly tied to a series of verification and validation tests demonstrating the device's functional integrity, safety, and compliance with standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Device conforms to its intended use, claims, and user needs.	"Software validation testing has been performed to validate that Interventional Workspot conforms to its intended use, claims and user needs."
Compliance with predetermined System Requirements Specification and acceptance criteria.	"Software verification testing has been performed to verify the modifications as per predetermined System Requirements Specification and acceptance criteria. The verification tests and acceptance criteria were identified based on Risk Assessment." "Verification results demonstrated that all executed tests were passed."
Implementation of safety risk control measures from the Detailed Risk Management Matrix.	"Verification tests were performed to verify safety risk control measures from the Detailed Risk Management Matrix..."
Implementation of Privacy and Security requirements.	"...and to verify the Privacy and Security requirements for Interventional Workspot 1.4.5.1 have been implemented."
Effectiveness of safety measures and Instructions for Use.	"Non clinical software validation testing has been performed to validate the intended use, claims, user needs, service user needs, effectiveness of safety measures and Instructions for use."
Compliance with FDA recognized consensus standards and FDA guidance documents.	The device demonstrates compliance with: IEC 62304:2006, IEC 62366-1, ISO 14971, ISO15223-1, NEMA PS 3.1 - 3.20 (DICOM Set), and several FDA guidance documents (e.g., Content of Premarket Submissions for Software, Human Factors, Cybersecurity, 510(k) Program, Off-the-Shelf Software Use). "All these tests were used to support substantial equivalence of the subject device and demonstrate that Interventional Workspot: complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and meets the acceptance criteria and is adequate for its intended use." Verification and Validation tests were conducted... and conformance to international and FDA-recognized consensus standards and guidance documents were provided. These tests demonstrate that Interventional Workspot Release 1.4.5.1 is substantially equivalent to the predicate device and is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness concerns."
Substantial equivalence to predicate device in terms of indications for use and technological parameters.	"The Indications for use is same for both the predicate and proposed device." "The predicate and proposed device are same in design, function and application." (Applies to various parameters like OS change, hardware support, bug fixes, security features, feature enhancement, code refactoring, labeling changes, support for new tools). "Interventional Workspot Release 1.4.5.1 is substantially equivalent to the predicate device Interventional Workspot Release 1.0 (K121296) in terms of indications for use, technological characteristics and safety and effectiveness."

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. The "test set" here refers to the software verification and validation activities, which involve structured testing scenarios rather than a dataset of clinical cases for diagnostic performance evaluation. The document states: "Software verification testing has been performed to verify the modifications as per predetermined System Requirements Specification and acceptance criteria. The verification tests and acceptance criteria were identified based on Risk Assessent. Verification tests were performed to verify safety risk control measures from the Detailed Risk Management Matrix and to verify the Privacy and Security requirements for Interventional Workspot 1.4.5.1 have been implemented."
Data Provenance: Not applicable. No clinical image data or patient data was used for a performance study. "Clinical images are not necessary to establish substantial equivalence based on the modifications to the predicate device (note that the Interventional Workspot software is strongly based on the predicate). Non-clinical performance data provides sufficient evidence that the subject device works as intended."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "ground truth" in the clinical diagnostic sense for this device. The testing involved verifying that the software performs its intended functions (e.g., import/export images, manage patient info) correctly and securely, and complies with engineering and quality standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No diagnostic "test set" requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a software platform, not an algorithm that performs a standalone clinical task.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this device's validation is adherence to functional requirements, safety specifications, and recognized industry standards (e.g., DICOM compatibility, cybersecurity, usability engineering).

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set for an AI/ML model.

Summary

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May 31, 2018

Philips Medical Systems Nederland BV % Chandrika Srinivasan Senior Regulatory Affairs Specialist Veenpluis 4-6 5684PC Best, THE NETHERLANDS

Re: K181177

Trade/Device Name: Interventional Workspot Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, OWB Dated: April 30, 2018 Received: May 2, 2018

Dear Chandrika Srinivasan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Chandrika Srinivasan

K181177

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Molds

Robert Ochs, Ph.D. 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

510(k) Number (if known) K181177

Device Name Interventional Workspot

Indications for Use (Describe)

The Interventional Workspot has the following medical purpose:

· import, export and storage of digital clinical images,

· manage the patient information associated with those images.

Patient Population:

Not applicable because Interventional Workspot is only a hosting platform.

Operating Profile:

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

Clinical Environment:

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

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	May 24, 2018
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Chandrika SrinivasanRegulatory Affairs OfficerPhone: +9180 41894132E-mail: chandrika.s@philips.com
Secondary ContactPerson:	Marta WalkerHead of Regulatory Affairs IGT SystemsPhone: +31 631978546E-mail: marta.walker@philips.com
Device:	Trade Name: Interventional WorkspotRelease Number: Version 1.4.5.1Classification Name: Picture archiving and communications systemClassification Regulation: 21 CFR, Part 892.2050Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: LLZ (System, Image Processing, Radiological)Secondary Product Code: OWB (Interventional Fluoroscopic X-Ray system)
Predicate Device:	Trade Name: Interventional Workspot Release 1Manufacturer: Philips Medical Systems Nederland B.V510(k) Clearance: K121296 (Jan 02, 2013)Classification Name: Picture archiving and communications systemClassification Regulation: 21 CFR, Part 892.2050Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: LLZ (System, Image Processing, Radiological)Secondary Product Code: OWB (Interventional Fluoroscopic X-Ray system)

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The Interventional Workspot is a software platform to host Interventional Tools. Device description: 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.

The images made with the Interventional Tools use X-ray imaging and CT/MR imaging as the source data, acquired on compatible equipment. The Interventional Workspot acts as a data handler for Interventional tools.

Interventional Workspot can be used with compatible Philips interventional Xray systems that is equipped with appropriate options. Interventional Workspot is only intended to be used with the PC hardware configuration on which it is initially installed by the manufacturer.

Indications for Use: Interventional Workspot is provided as accessory to the Philips Interventional X-ray system, has the following indications for use:

Indications for use/ Medical Purpose:

The Interventional Workspot has the following medical purpose:

· import, export and storage of digital clinical images,
· manage the patient information associated with those images.

Patient Population:

Not applicable because Interventional Workspot is only a hosting platform.

Operating Profile:

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

Clinical Environment:

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

Interventional WorkspotR1.0 (predicate device)(K121296)	Interventional WorkspotR1.4.5.1(proposed device)	Comparison
The InterventionalWorkspot has thefollowing medical purpose:• import, export and storageofdigital clinical images,• manage the patientInformation associated withthose images	The Interventional Workspothas thefollowing medical purpose:• import, export and storageofdigital clinical images,• manage the patientinformationassociated with those images	Same

Table 1: Indications for Use comparison with predicate device

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The Indications for use is same for both the predicate and proposed device.

Technological Interventional Workspot software is executed on a PC based hardware platform. characteristics: There is no difference is Technological characteristics between the Interventional Workspot Rel. 1.0 and the proposed Interventional Workspot IW1.4.5.1.

Parameter	Interventional WorkspotR1(K121296) 21 CFRsec.892.2050	InterventionalWorkspot R1.4.5.1(proposed device) 21CFR sec.892.2050	Comparison
Technologicalcharacteristics	The interventionalworkspot is a softwareplatform to hostInterventional Tools. Itprovides commonfunctionalities (e.g. import/ export and data handlingfunctions) that are requiredby the Interventional Toolstosupport the physician withperforming theinterventional procedure.	The interventionalworkspot is a softwareplatform to hostInterventional Tools.It provides commonfunctionalities (e.g.import / export anddata handlingfunctions) that arerequired by theInterventional Tools tosupport the physicianwith performing theinterventionalprocedure.	Same
OperatingSystem	Windows XP professional	Windows 7	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design.function andapplication.
DICOM	DICOM compatible	DICOM compatible	Same
Compatibilitywith currentlymarketedPhilipsInterventionalX-ray systems.	Compatible with currentlymarketed PhilipsInterventional X-raysystems- Allura Series.	Compatible withcurrently marketedPhilips InterventionalX-ray systems- AlluraSeries & Azurionseries.	Substantiallyequivalent.Note: for ease ofreview, thedifferences havebeen underlined.SE analysis:Both thepredicate andproposed deviceare accessoriesto the Philips
		InterventionalX-ray systems.
Hardwareobsolescences	-	Changes to supportdifferent hardwaresuch as: PC DellT3600, Haswell PC,Radysis 7 &8	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design,function andapplication.
Bug fixes	-	Minor bug fixes	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design,function andapplication.
OS & networksecurityfeatures	-	Changes to supportnetwork securityfeatures likewhitelisting, andtechnology to protectmalware.	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design,function andapplication.
Featureenhancement	-	Changes to supportresizing larger datasets;Support for directupgrade from olderversions, softwareinstaller	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design,function andapplication.
Coderefactoring	-	Code refactoring toimprove softwaremaintenance.	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design,function andapplication.
Labelingchanges	-	Adapting the labelingto include the minorchanges implemented.	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design,
		function andapplication.
Support fornewInterventionaltools	-	Hosting platformwhen newInterventional toolsare released.	Substantiallyequivalent.SE analysis:The predicateand proposeddevice are samein design,function andapplication.

Table 2: Technological characteristics comparison-Classification & Design attributes and functionality

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Summary of Non-Non-clinical performance testing has been performed on the modified Clinical Performance Interventional Workspot R1.4.5.1 and demonstrates compliance with the Data: following FDA recognized consensus standards and FDA guidance documents:

IEC 62304:2006 Medical device software Software life cycle processes. ● FDA/CDRH recognition number 13-32;
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0 including corrigendum, 2015). FDA/CDRH recognition number 5-114;
ISO 14971 Medical devices Application of risk management to medical . devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40;
ISO15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Second edition, 2012). FDA/CDRH recognition number 5-90:
NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016). FDA/CDRH recognition number 12-300
. "Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005 (document number 337);
. "Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices", February 3, 2016 (document number 1757);
. "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014 (document number 1825);
"Guidance for Industry and FDA Staff The 510(k) Program: ● Evaluating Substantial Equivalence in Premarket Notifications [510(k)] ", July 28, 2014 (document number 1766).
. Guidance for Industry, FDA Reviewers and Compliance on "Guidance for Off-the-Shelf Software Use in Medical Devices, September 1999"

Software verification testing has been performed to verify the modifications as per predetermined System Requirements Specification and acceptance critera. The verification tests and acceptance criteria were identified based on Risk Assessent. Verification tests were performed to verify safety risk control measures from the Detailed Risk Management Matrix and to verify the Privacy and Security

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	requirements for Interventional Workspot 1.4.5.1 . have been implemented.Verification results demonstrated that all executed tests were passed.
	Non clinical software validation testing has been performed to validate theintended use, claims, user needs, service user needs, effectiveness of safetymeasures and Instructions for use.
	Software validation testing has been performed to validate that InterventionalWorkspot conforms to its intended use, claims and user needs.
	All these tests were used to support substantial equivalence of the subject deviceand demonstrate that Interventional Workspot :complies with the aforementioned international and FDA-recognizedconsensus standards and FDA guidance documents, andmeets the acceptance criteria and is adequate for its intended use.
	Based on the information provided above, Interventional Workspot Release1.4.5.1 is substantially equivalent to the predicate device Interventional WorkspotRelease 1.0 (K121296) in terms of safety and effectiveness.
Summary of ClinicalPerformance Data:	Clinical images are not necessary to establish substantial equivalence based onthe modifications to the predicate device (note that the Interventional Workspotsoftware is strongly based on the predicate). Non-clinical performance dataprovides sufficient evidence that the subject device works as intended.
SubstantialEquivalenceConclusion:	Interventional Workspot Release 1.4.5.1 is substantially equivalent to thepredicate device Interventional Workspot Release 1.0 (K121296) in terms ofindications for use, technological characteristics and safety and effectiveness.The modifications made in the proposed device Interventional WorkspotRelease 1.4.5.1 are within the controls and predetermined specifications.Additionally, non-clinical performance tests provided in this 510(k) premarketnotification demonstrated substantial equivalence to the predicate device andensured that the modifications are implemented successfully. Verification andValidation tests were conducted to verify the modifications listed andconformance to international and FDA-recognized consensus standards andguidance documents were provided. These tests demonstrate that InterventionalWorkspot Release 1.4.5.1 is substantially equivalent to the predicate device andis as safe and effective as its predicate device and does not raise any new safetyand/or effectiveness concerns.

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).