(82 days)
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.
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.
Here's an analysis of the provided text regarding the XperGuide device, focusing on acceptance criteria and supporting studies:
This document ([K131263](https://510k.innolitics.com/device/K131263)) is a 510(k) Summary of Safety and Effectiveness, not a detailed study report. Therefore, it provides a high-level overview and states that tests were performed, but does not provide specific numerical acceptance criteria or detailed study results. It mainly focuses on substantiating equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
The document states generally that "The test results demonstrate that XperGuide meets the acceptance criteria, and is adequate for its intended use." However, no specific quantitative acceptance criteria or corresponding device performance values are reported in the provided text.
The acceptance criteria are implicitly related to the device successfully performing its intended functions (live 3D needle image guidance, overlay of live 2D fluoroscopic images on 3D anatomy, real-time feedback on needle position, ablation option visualization) and complying with relevant standards and risk management results.
The key acceptance criteria, while not quantified in a table, can be inferred as:
- Compliance with IEC 62304 (Medical device software Software life cycle processes)
- Compliance with IEC 62366 (Application of usability engineering to medical devices)
- Compliance with ISO 14971 (Application of risk management to medical devices)
- Successful software verification and validation conformance testing.
- Demonstration of substantial equivalence to predicate devices (Innova Vision Applications with TrackVision option).
The "reported device performance" is summarized as having met these implied criteria.
Study Information
The document describes "Non-clinical verification and validation tests" that were performed. This is a general statement about the type of study conducted rather than a specific clinical trial.
-
A table of acceptance criteria and the reported device performance:
As explained above, this information is not provided in the requested tabular format with specific numerical criteria. The document broadly states that tests demonstrated the device meets acceptance criteria and is adequate for its intended use and is substantially equivalent to a predicate device. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not specified. The document mentions "non-clinical verification and validation tests" but does not detail any specific test sets, their sizes, or data provenance. Given the focus on substantial equivalence to a software product, these tests likely involved software testing environments rather than patient data in the sense of a clinical study. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not specified. This type of detail is typical for clinical performance studies, which this document does not describe. The "ground truth" for software verification would involve adherence to functional specifications and usability standards, likely evaluated by software engineers / quality assurance personnel and usability experts. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified. As there is no mention of a formal clinical test set requiring expert adjudication, this information is not relevant to the described non-clinical tests. -
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 MRMC study was done or reported. This device is an image guidance system, not an AI diagnostic tool for interpreting images. Its purpose is to assist interventional procedures by overlaying images and providing real-time feedback, rather than to improve reader diagnostic accuracy. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document describes "software verification and validation conformance testing." This type of testing would assess the algorithm's standalone functionality against its design specifications. However, the device itself is explicitly intended to be human-in-the-loop ("intended to assist the physician during percutaneous interventions"). Therefore, while individual software modules would undergo standalone testing, the performance of the device as a whole is inherently linked to human interaction. The document does not isolate "algorithm only" performance explicitly separate from the system's intended interactive use. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For "non-clinical verification and validation tests," the ground truth would primarily be the functional specifications, design documents, and relevant international standards (IEC 62304, IEC 62366, ISO 14971). For aspects related to image overlay accuracy, the "ground truth" would be established by comparing the device's output to known anatomical models or precisely calibrated phantom setups. -
The sample size for the training set:
Not applicable / Not specified. This document describes a software medical device, XperGuide, an image guidance system. It is not presented as a machine learning or deep learning device that requires a "training set" in the conventional AI sense. The software's functionality is based on algorithms that perform image fusion, overlay, and tracking, not on learning from a large dataset to make predictions. -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" described for this device in the context of machine learning.
{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 NetherlandsEstablishment registration number: 3003768277 |
| Contact Person (Owner): | Dr. Jos van VroonhovenPhone: +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
§ 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.