(82 days)
Not Found
No
The summary describes image processing and guidance software, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as assisting in percutaneous interventions by providing planning and image guidance, which are diagnostic and procedural assistance functions, not therapies in themselves. It helps the physician with the procedure, but does not directly treat the condition.
No.
The device assists in percutaneous interventions, such as biopsies and drainages, by providing needle path planning and image guidance. It does not diagnose medical conditions but rather guides interventional procedures.
Yes
The device description explicitly states "XperGuide is a software medical device". While it integrates with imaging systems, the core device being described and submitted for 510(k) appears to be the software component providing the guidance and planning functionalities.
Based on the provided information, the XperGuide device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- XperGuide's Function: XperGuide is a software medical device that assists physicians during percutaneous interventions by providing image guidance and planning based on live fluoroscopic images and 3D anatomical reconstructions. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes assistance with procedures like biopsies and drainages, which are performed directly on the patient, not on in vitro samples.
Therefore, XperGuide falls under the category of medical imaging and guidance devices used during surgical or interventional procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
XperGuide is an extension of XperCT, which assists in percutaneous interventions, such as biopsies, drainages, etc., by providing needle path planning and image guidance by superimposing live fluoroscopic images of the needle on a cross sectional image of the targeted anatomy.
The XperGuide Ablation option assists with planning the position of multiple needles by visualizing the ablation coverage of the lesion.
Product codes
OWB, LLZ
Device Description
XperGuide is a software medical device intended to assist the physician during percutaneous interventions by providing live 3D needle image guidance. XperGuide overlays live 2D fluoroscopic images on a 3D reconstruction of the anatomy. XperGuide provides real-time feedback on needle position with respect to the planned path. In addition, the XperGuide has an ablation option, which visualizes the combined ablation zone of multiple planned needles.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopic images, 3D reconstruction (from XperCT, acquired CT or MR data)
Anatomical Site
targeted anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; control room and in the exam 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 have been performed with regards to the requirement specifications and the risk management results. These tests specifically include software verification and validation conformance testing, The test results demonstrate that XperGuide meets the acceptance criteria, and is adequate for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K131263
Page 1 og 3
| JUL 2 4 2013 | |
|---|---|
| This 510(k) Summary of Safety and Effectiveness has been prepared in accordance with Code of Federal Regulations, Title 21 CFR, Part 807.92. | |
| Date Prepared: | April 25, 2013 |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Veenpluis 4-6, 5684PC Best, The Netherlands | |
| Establishment registration number: 3003768277 | |
| Contact Person (Owner): | Dr. Jos van Vroonhoven |
| Phone: +31 40 2791111 Fax: +31 40 2769100 | |
| Proposed Device: | |
| Trade name: | XperGuide |
| Classification regulation: | 21 CFR, Part 892.1650 |
| Classification name: | Image-intensified fluoroscopic x-ray system |
| Classification panel: | Radiology |
| Device classification: | Class II |
| Primary Product Code: | OWB (interventional X-ray system) |
| Secondary Product Code: | LLZ (radiological image processing system) |
| Primary Predicate Device 1: | |
| Trade name: | Allura Xper FD20 X-Ray Imaging Systems |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| FDA clearance: | * K033737 (December 9. 2003) |
| Classification regulation: | 21 CFR. Part 892.1650 |
| Classification name: | Image-intensified fluoroscopic x-ray system |
| Classification panel: | Radiology |
| Device classification: | Class II |
| Product Code: | OWB (interventional X-ray system) |
| Primary Predicate Device 2: | |
| Trade name: | Allura Xper FD OR Table Series |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| FDA clearance: | K102005 (August 9, 2010) |
| Classification regulation: | 21 CFR. Part 892.1650 |
| Classification name: | Image-intensified fluoroscopic x-ray system |
| Classification panel: | Radiology |
| Device classification: | Class II |
| Product Code: | OWB (interventional X-ray system) |
1
K131263
page 2063
Note: The primary predicate devices 1 and 2 (Allura Xper FD20 X-Ray Imaging Systems and Allura Xper FD OR Table Series) are collectively referred to as "Philips Allura Xper FD X-Ray Imaging Systems" in this 510(k) Summary of Safety and Effectiveness.
Secondary Predicate Device:
| Trade name: | Innova Vision Applications |
|---|---|
| Manufacturer: | GE Healthcare |
| FDA clearance: | K092639 (December 2, 2009) |
| Classification regulation: | 21 CFR, Part 892.2050 |
| Classification name: | Picture archiving and communications system |
| Classification panel: | Radiology |
| Device classification: | Class II |
| Product Code: | LLZ (radiological image processing system) |
XperGuide is a software medical device intended to assist the physician during Device Description: percutaneous interventions by providing live 3D needle image guidance. XperGuide overlays live 2D fluoroscopic images on a 3D reconstruction of the anatomy. XperGuide provides real-time feedback on needle position with respect to the planned path. In addition, the XperGuide has an ablation option, which visualizes the combined ablation zone of multiple planned needles.
XperGuide is an extension of XperCT, which assists in percutaneous Intended Use: interventions, such as biopsies, drainages, etc., by providing needle path planning and image guidance by superimposing live fluoroscopic images of the needle on a cross sectional image of the targeted anatomy. The XperGuide Ablation option assists with planning the position of multiple needles by visualizing the ablation coverage of the lesion.
- Technology: XperGuide is provided on the independent hosting software functionality platform of the currently marketed Philips Interventional Workspot (K121296, January 2. 2013). Live 2D fluoroscopy images and exam data are transmitted from the currently marketed and predicate Philips Allura Xper FD X-Ray Imaging Systems (K033737. K102005) to Interventional Workspot through a dedicated real-time link and are overlaid on a slab of the 3D planning volume. either created by the currently marketed XperCT (K060749. April 4. 2006) or from a previously acquired CT or MR data set. Live 2D/3D fluoroscopic overlay runs, together with planning information. snapshots and movies. can be stored in a local database for use in XperGuide and can be reviewed at any time. Live 2D/3D overlay images and the XperGuide user interface are shown on monitors in the control room and in the exam room with use of a video splitter. XperGuide can be operated from the control room (via keyboard and mouse) as well as in the exam room (via the Xper module of the currently marketed and predicate Philips Allura Xper FD X-Ray Imaging Systems).
2
The technology utilized in both XperGuide and the currently marketed and predicate Innova Vision Applications with TrackVision option (GE Healthcare, K092639) includes:
- · Execution on and connection to an independent software hosting platform;
- · Transmission of live 2D fluoroscopy images and exam data from a digital X-ray imaging system to the software hosting platform (workstation) through a dedicated real-time link;
- · Loading of previously acquired 3D data sets from the software hosting platform (workstation);
- · Fusion or superimposing live 2D fluoroscopy images on top of selected 3D cross-sectional images of the targeted anatomy;
- . Storage of live 2D/3D overlay runs and of fused photos and video clips in a local database;
- · Display of overlay images and user interface in the control room and in the exam room;
- · Operation of the software medical device from the control room and in the exam room.
Based on the information provided above, XperGuide is considered substantially equivalent to the currently marketed and predicate Innova Vision Applications with Track Vision option (GE Healthcare. K 092639) in terms of technology.
Non-clinical Performance Data:
The proposed XperGuide software medical device complies with the following international FDA-recognized consensus standards:
- · IEC 62304 Medical device software Software life cycle processes (2006);
- IEC 62366 Application of usability engineering to medical devices (2007);
- · ISO 14971 Application of risk management to medical devices (2007).
Non-clinical verification and validation tests have been performed with regards to the requirement specifications and the risk management results. These tests specifically include software verification and validation conformance testing, The test results demonstrate that XperGuide meets the acceptance criteria, and is adequate for its intended use. Therefore, the XperGuide software medical device is substantially equivalent to the currently marketed and predicate Innova Vision Applications with Track Vision option (GE Healthcare, K092639) in terms of safety and effectiveness.
- XperGuide is substantially equivalent to the currently marketed and predicate Conclusion: Innova Vision Applications with Track Vision option (GE Healthcare, K092639) in terms of design features. fundamental scientific technology, indications for use. and safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
f
July 24, 2013
Philips Medical Systems Nederland B.V. % Dr. Jos van Vroonhoven Standardization Manager Veenpluis 4-6 5684 PC Best NETHERLANDS
Re: K131263
Trade/Device Name: XperGuide Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: April 25, 2013 Received: May 03, 2013
Dear Dr. Vroonhoven:
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
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.
4
Page 2 - Dr. Vroonhoven
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDcvices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K131263 510(k) Number (if known):
Device Name: XperGuide
Indications for Use:
XperGuide is an extension of XperCT, which assists in percutaneous interventions, such as biopsies, drainages, etc.. by providing needle path planning and image guidance by superimposing live fluoroscopic images of the needle on a cross sectional image of the targeted anatomy.
The XperGuide Ablation option assists with planning the position of multiple needles by visualizing the ablation coverage of the lesion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
$m(h,7)$
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) ======================================================================================================================================================================= K131263
Page 1 of 1