(247 days)
No
The description focuses on basic image handling and platform hosting functionalities, with no mention of AI/ML terms or performance metrics typically associated with such technologies.
No
The device is described as a software platform for importing, exporting, and storing digital clinical images and managing patient information associated with those images. It provides common functionalities for other medical devices but does not directly diagnose, treat, mitigate, or prevent disease.
No
The device is described as a software platform for importing, exporting, and storing digital clinical images and managing patient information. Its primary function is to host other medical devices ("Interventional Tools") and provide common functionalities, not to perform diagnostic analysis of images.
Yes
The device description explicitly states it is a "software medical device" and a "software platform." The functionalities described (import, export, storage, data handling) are software-based operations. There is no mention of accompanying hardware components that are part of the device itself.
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 importing, exporting, and storing digital clinical images and managing associated patient information. This is related to handling and managing medical imaging data, not performing tests on biological samples to diagnose or monitor a condition.
- Device Description: The device is described as a software platform for hosting other software medical devices that support interventional procedures. Its core functionalities are data handling (import, export, storage). This aligns with image management and workflow support, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic devices.
The device's purpose is to facilitate the use of other medical devices that are likely used in interventional procedures, which are performed in vivo (within the body).
N/A
Intended Use / Indications for Use
The indications for use statement for the proposed Interventional Workspot software medical device, as presented in the IFU, are as follows:
The Interventional Workspot has the following medical purpose:
- import, export, and store digital clinical images.
- manage the patient information associated with those images.
Product codes
90LLZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital clinical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not applicable because Interventional Workspot is only a hosting platform.
Intended User / Care Setting
The operator of Interventional Workspot has basic understanding of the operating principle of medical computer software.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031836, K040254, K042334, K060749, K111245
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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 Highway |
| Bothell, 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
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 (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
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 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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