(27 days)
The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform: · Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. · Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: · The Allura Xper R9 series can be used in a hybrid Operating Room. • The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.
The Allura Xper R9 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Allura Xper R9 interventional fluoroscopic X-ray system include: - Real-time image visualization of patient anatomy during procedures ● - Imaging techniques and tools to assist interventional procedures - Post processing functions after interventional procedures ● - Storage of reference/control images for patient records ● - . Compatibility to images of other modalities via DICOM - Built in radiation safety controls ● This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Allura Xper R9 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper R9. Configurations are composed of detector type. (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features: - . 12 inch Flat detector (FD12) - 15 inch Flat detector (FD15) - 20 inch Flat detector (FD20) . Additionally, identical to the predicate devices, all configurations of the Allura Xper R9 are compatible for use in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.
The provided document is a 510(k) premarket notification for the Philips Medical Systems Nederland B.V. Allura Xper R9, an image-intensified fluoroscopic x-ray system. It describes the device, its indications for use, and a comparison to a predicate device.
However, the document states explicitly that "The Allura Xper R9 did not require clinical study data" (Page 7). This means the submission does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them from this document. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technological similarity rather than a clinical study.
Here's a breakdown of why the requested information cannot be fully provided:
1. A table of acceptance criteria and the reported device performance
- Not available in the document. The document states that clinical study data was not required. It relies on non-clinical performance testing and compliance with standards. No specific acceptance criteria or reported device performance from a clinical study are presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set or data provenance is mentioned as no clinical study was performed.
3. 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 applicable. No clinical study was performed requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical study was performed requiring 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
- Not available. The device is an X-ray system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware imaging system, not an algorithm being assessed for standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical study was performed requiring ground truth.
8. The sample size for the training set
- Not available/Applicable. The document does not describe a machine learning model or an algorithm that requires a training set in the context of clinical performance. The "2D Quantitative Analysis software" is mentioned as unchanged from a reference device and its details are not provided in terms of training.
9. How the ground truth for the training set was established
- Not available/Applicable. As no training set or clinical ground truth is described, this information cannot be provided.
In summary: The provided FDA 510(k) clearance letter and summary for the Allura Xper R9 demonstrate substantial equivalence based on non-clinical performance testing, technological characteristics, and compliance with recognized standards. It explicitly states that "The Allura Xper R9 did not require clinical study data." Therefore, the detailed information requested about acceptance criteria and clinical study results is not present in this document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Philips Medical Systems Nederland B.V. % Ms. Jeanette Becker Senior Regulatory Affairs Manager Veenpluis 4-6 5684 PC Best THE NETHERLANDS
Re: K163715
Trade/Device Name: Allura Xper R9 Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: December 23, 2016 Received: December 30, 2016
Dear Ms. Becker:
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Michael D'Hara
For
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)
Device Name Allura Xper R9
Indications for Use (Describe)
The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform: · Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
· Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
· The Allura Xper R9 series can be used in a hybrid Operating Room.
• The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.
Patient Population:
All human patients of all ages. Patient weight is limited to the specification of the patient table.
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: | December 22, 2016 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277 | |
| Primary ContactPerson: | Ms. Jeanette BeckerSenior Regulatory Affairs ManagerPhone: +31 611386380E-mail: jeanette.becker@philips.com | |
| Secondary ContactPerson: | Ms. Liselotte Kornmann, PhDSenior Manager Regulatory AffairsPhone: +31 611621238E-mail: liselotte.kornmann@philips.com | |
| Device: | Trade Name: | Allura Xper R9 |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21 CFR, Part 892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | Primary Code: OWBSubsequent Code: JAA | |
| Predicate Device: | Trade Name: | Allura Xper R9 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K162148 (November 23, 2016) | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21 CFR, Part 892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | Primary Code: OWBSubsequent Code: JAA | |
| Reference Device: | Trade Name: | 2D Quantitative Analysis |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K161839 (July 29, 2016) | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21 CFR, Part 892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | Primary Code: OWB | |
| Subsequent Code: LLZ |
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Device description: The Allura Xper R9 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Allura Xper R9 interventional fluoroscopic X-ray system include:
- Real-time image visualization of patient anatomy during procedures ●
- Imaging techniques and tools to assist interventional procedures
- Post processing functions after interventional procedures ●
- Storage of reference/control images for patient records ●
- . Compatibility to images of other modalities via DICOM
- Built in radiation safety controls ●
This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures.
The Allura Xper R9 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper R9.
Configurations are composed of detector type. (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features:
- . 12 inch Flat detector (FD12)
- 15 inch Flat detector (FD15)
- 20 inch Flat detector (FD20) .
Additionally, identical to the predicate devices, all configurations of the Allura Xper R9 are compatible for use in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.
Indications for Use: The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform:
• Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, cardiovascular and neuro procedures.
· Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
- The Allura Xper R9 series can be used in a hybrid Operating Room.
• The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.
Patient Population:
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All human patients of all ages. Patient weight is limited to the specification of the patient table.
Based on the information provided above, the Allura Xper R9 is considered substantially equivalent to the currently marketed and predicate device Allura Xper R9 in terms of Indications for Use.
Technological characteristics: The Allura Xper R9 has similar technological characteristics compared to the predicate device. The same hardware and software is used in the predicate and subject device. The only exception is the modification implemented in the Allura Xper R9 which is:
- Addition of (optional) Quantitative Analysis feature by implementing ● 2D Quantitative Analysis software.
The 2D Quantitative Analysis software is unchanged from the reference device (clearance K161839 (July 29, 2016)).
See also table below:
| Main system modulesand components | Proposed Allura Xper R9 systems comparedwith the predicate device. |
|---|---|
| Acquisition | |
| X-ray generator | No change |
| Digital Flat Detector | No change |
| Flat Detector Controller | No change |
| X-Ray tube | No change |
| Beam limiting device | No change |
| Anti-scatter grid | No change |
| Patient & Beam Positioning | |
| Patient support | No change |
| Frontal stand | No change |
| Lateral stand | No change |
| User interfaces | |
| User interface modules | No change |
| Graphical user interfaces(GUI) | No change |
| Monitors | No change |
| Monitor ceilingsuspension | No change |
| Infrastructure | |
| Cabinets | No change |
| PC's | No change |
| Power distribution | No change |
| Video distribution | No change |
| Network | No change |
| System software | |
| System software | No change |
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| Quantitative analysis | |
|---|---|
| Quantitative Analysisfunctionality | Implementation of 2D Quantitative Analysis SW |
The differences between the Allura Xper R9 and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the Allura Xper R9 is considered substantially equivalent to the currently marketed predicate Allura Xper R9 in terms of fundamental scientific technology.
Summary of Non-Non-clinical performance testing has been performed on the Allura Xper R9 and Clinical Performance demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents: Data:
- IEC 62304 Medical device software – Software life cycle processes (Edition 1.0, 2006). FDA/CDRH recognition number 13-32.
- ISO 14971 Medical devices Application of risk management to medical ● devices (Edition 2.0. corrected version, 2007). FDA/CDRH recognition number 5-40.
- . IEC 60601-2-28 - Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Edition 2.0, 2010). FDA/CDRH recognition number 12-204
- IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.0, 2010). FDA/CDRH recognition number 12-202.
- . 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).
- FDA Guidance for Industry and/or for FDA Reviewers/Staff and/or . Compliance: Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices (document number 644).
Software verification testing of the functional and non-functional requirements as well as performance, reliability and safety has been performed to cover system level requirements as well as risk control measures. Results demonstrated that all executed tests were passed.
Non-clinical validation testing has been performed to cover the intended use, commercial claims, service, user needs, effectiveness of safety measures and instructions for use.
Therefore, Allura Xper R9 is substantially equivalent to the currently marketed Allura Xper R9 in terms of safety and effectiveness.
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Performance Data:
Summary of Clinical The Allura Xper R9 did not require clinical study data since substantial equivalence to the currently marketed predicate device Allura Xper R9 was demonstrated with the following attributes:
- Indication for use;
- . Technological characteristics;
- . Non-clinical performance testing; and
- . Safety and effectiveness.
These attributes demonstrated that the clinical performance of the modified device is substantially equivalent to the predicate device.
Substantial Equivalence Conclusion:
The Allura Xper R9 is substantially equivalent to the currently marketed predicate device Allura Xper R9 in terms of indications for use, technological characteristics and safety and effectiveness.
The modification of the Allura Xper R9 is 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 modification is properly introduced; verification and validation testing was conducted to ensure the proper introduction of the modification listed; conformance to IEC standards and guidance documents were provided. All of these components and tests were used to support substantial equivalence of the subject device and demonstrate that the Allura Xper R9 is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.
§ 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.