(29 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on basic software functionalities for hosting other tools. There is no mention of AI/ML in the intended use, device description, performance studies, or key metrics.
No
The device is described as a software platform for handling digital clinical images and patient information, acting as a host for 'Interventional Tools' but not performing or directly supporting a therapeutic action itself.
No
The device is a software platform for importing, exporting, and storing digital clinical images and managing associated patient information. It functions as a hosting platform for "Interventional Tools" and provides common functionalities like data handling, but it does not perform diagnostic functions itself. Its primary purpose is data management and support for other tools, not disease diagnosis or detection.
Yes
The device description explicitly states it is a "software platform" and provides "common functionalities" for "Interventional Tools," indicating it is a software-only component designed to host other software tools. The testing described focuses on software verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on the management of digital clinical images and associated patient information for use in interventional procedures. This is related to medical imaging and procedural support, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as a software platform to host Interventional Tools and provide common functionalities for supporting interventional procedures. This aligns with medical imaging and procedural support, not IVD activities.
- Lack of IVD Specifics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
- Focus on Imaging: The document explicitly mentions "digital clinical images," "X-ray imaging," and "CT/MR imaging," which are modalities used for in vivo imaging, not in vitro diagnostics.
Therefore, the Interventional Workspot, as described, falls under the category of medical imaging software and is not an IVD.
N/A
Intended Use / Indications for Use
The Interventional Workspot has the following medical purpose:
- · import, export and storage of digital clinical images,
- · manage the patient information associated with those images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, OWB
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray imaging and CT/MR imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not applicable because Interventional Workspot is only a hosting platform.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on the modified Interventional Workspot R1.4.5.1 and demonstrates compliance with the 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 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 the intended use, claims, user needs, service user needs, effectiveness of safety measures and Instructions for use. Software validation testing has been performed to validate that Interventional Workspot conforms to its intended use, claims and user needs.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
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);
1
Page 2 - Chandrika Srinivasan
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
2
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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3
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 4-6 | |
| 5684 PC Best | |
| The Netherlands | |
| Establishment Registration Number: 3003768277 | |
| Primary Contact | |
| Person: | Chandrika Srinivasan |
| Regulatory Affairs Officer | |
| Phone: +9180 41894132 | |
| E-mail: chandrika.s@philips.com | |
| Secondary Contact | |
| Person: | Marta Walker |
| Head of Regulatory Affairs IGT Systems | |
| Phone: +31 631978546 | |
| E-mail: marta.walker@philips.com | |
| Device: | Trade Name: Interventional Workspot |
| Release Number: Version 1.4.5.1 | |
| Classification Name: Picture archiving and communications system | |
| Classification Regulation: 21 CFR, Part 892.2050 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product Code: LLZ (System, Image Processing, Radiological) | |
| Secondary Product Code: OWB (Interventional Fluoroscopic X-Ray system) | |
| Predicate Device: | Trade Name: Interventional Workspot Release 1 |
| Manufacturer: Philips Medical Systems Nederland B.V | |
| 510(k) Clearance: K121296 (Jan 02, 2013) | |
| Classification Name: Picture archiving and communications system | |
| Classification Regulation: 21 CFR, Part 892.2050 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product Code: LLZ (System, Image Processing, Radiological) | |
| Secondary Product Code: OWB (Interventional Fluoroscopic X-Ray system) |
4
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 Workspot
R1.0 (predicate device)
(K121296) | Interventional Workspot
R1.4.5.1
(proposed device) | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| The Interventional
Workspot has the
following medical purpose:
• import, export and storage
of
digital clinical images,
• manage the patient
Information associated with
those images | The Interventional Workspot
has the
following medical purpose:
• import, export and storage
of
digital clinical images,
• manage the patient
information
associated with those images | Same |
Table 1: Indications for Use comparison with predicate device
5
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 Workspot
R1
(K121296) 21 CFR
sec.892.2050 | Interventional
Workspot R1.4.5.1
(proposed device) 21
CFR sec.892.2050 | Comparison |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | 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. | 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. | Same |
| Operating
System | Windows XP professional | Windows 7 | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design.
function and
application. |
| DICOM | DICOM compatible | DICOM compatible | Same |
| Compatibility
with currently
marketed
Philips
Interventional
X-ray systems. | Compatible with currently
marketed Philips
Interventional X-ray
systems- Allura Series. | Compatible with
currently marketed
Philips Interventional
X-ray systems- Allura
Series & Azurion
series. | Substantially
equivalent.
Note: for ease of
review, the
differences have
been underlined.
SE analysis:
Both the
predicate and
proposed device
are accessories
to the Philips |
| | | Interventional
X-ray systems. | |
| Hardware
obsolescences | - | Changes to support
different hardware
such as: PC Dell
T3600, Haswell PC,
Radysis 7 &8 | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design,
function and
application. |
| Bug fixes | - | Minor bug fixes | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design,
function and
application. |
| OS & network
security
features | - | Changes to support
network security
features like
whitelisting, and
technology to protect
malware. | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design,
function and
application. |
| Feature
enhancement | - | Changes to support
resizing larger data
sets;
Support for direct
upgrade from older
versions, software
installer | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design,
function and
application. |
| Code
refactoring | - | Code refactoring to
improve software
maintenance. | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design,
function and
application. |
| Labeling
changes | - | Adapting the labeling
to include the minor
changes implemented. | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design, |
| | | function and
application. | |
| Support for
new
Interventional
tools | - | Hosting platform
when new
Interventional tools
are released. | Substantially
equivalent.
SE analysis:
The predicate
and proposed
device are same
in design,
function and
application. |
Table 2: Technological characteristics comparison-Classification & Design attributes and functionality
6
7
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
8
| | 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 the
intended use, claims, user needs, service user needs, effectiveness of safety
measures and Instructions for use. |
| | Software validation testing has been performed to validate that Interventional
Workspot conforms to its intended use, claims and user needs. |
| | 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, andmeets the acceptance criteria and is adequate for its intended use. |
| | Based on the information provided above, Interventional Workspot Release
1.4.5.1 is substantially equivalent to the predicate device Interventional Workspot
Release 1.0 (K121296) in terms of safety and effectiveness. |
| Summary of Clinical
Performance Data: | 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. |
| Substantial
Equivalence
Conclusion: | 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.
The modifications made in the proposed device Interventional Workspot
Release 1.4.5.1 are within the controls and predetermined specifications.
Additionally, non-clinical performance tests provided in this 510(k) premarket
notification demonstrated substantial equivalence to the predicate device and
ensured that the modifications are implemented successfully. Verification and
Validation tests were conducted to verify the modifications listed 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. |