(65 days)
The Azurion series (within the limits of the used Operation 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 Azurion series can be used in a hybrid Operation Room.
· The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
The Azurion series R1.2 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion series R1.2 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 o
- Storage of reference/control images for patient records ●
- Compatibility to images of other modalities via DICOM o
- Built in radiation safety controls ●
This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures.
The Azurion series R1.2 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) and biplane (dual 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 Azurion series R1.2 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.
Here's an analysis of the provided text regarding the Azurion series R1.2 device, focusing on acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes the Azurion series R1.2 as an interventional fluoroscopic X-ray system intended for image guidance and cardiac imaging applications. It indicates that the device's performance is demonstrated through its compliance with various international and FDA-recognized consensus standards and guidance documents, as well as software verification and non-clinical validation testing. However, the document does not explicitly state specific, quantifiable acceptance criteria (e.g., "minimum resolution of X lp/mm," "contrast-to-noise ratio of Y"). Instead, it focuses on demonstrating equivalence to a predicate device and compliance with established standards.
Therefore, the "acceptance criteria" can be inferred as successful completion of the listed tests and compliance with the relevant standards, aiming for performance that is "substantially equivalent" to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated) |
|---|---|
| Compliance with IEC 62304 (Medical device software – Software life cycle processes) | Demonstrated compliance. |
| Compliance with ISO 14971 (Medical devices – Application of risk management to medical devices) | Demonstrated compliance. |
| Compliance with IEC 60601-2-28 (Basic safety and essential performance of X-ray tube assemblies for medical diagnosis) | Demonstrated compliance. |
| Compliance with IEC 60601-2-43 (Safety of X-Ray equipment for interventional procedures) | Demonstrated compliance. |
| Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Demonstrated compliance. |
| Compliance with FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices | Demonstrated compliance. |
| Successful Software verification testing (functional, non-functional requirements, performance, reliability, safety, risk control measures) | "Results demonstrated that all executed tests were passed." |
| Successful Non-clinical validation testing (intended use, commercial claims, service, user needs, effectiveness of safety measures, instructions for use) | "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." (Implies successful completion, as the conclusion is substantial equivalence) |
| Substantial Equivalence to predicate device Allura Xper R9 in terms of Indications for Use, Technological Characteristics, Non-clinical performance testing, and Safety and Effectiveness. | "The Azurion series R1.2 is substantially equivalent to the currently marketed predicate device Allura Xper R9 in terms of indications for use, technological characteristics and safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or image datasets. The performance validation is based on:
- Software verification testing: Performed to cover system-level requirements and risk control measures. The "sample size" here would refer to the number of software test cases, which is not provided.
- Non-clinical validation testing: Performed to cover intended use, claims, user needs, etc. The "sample size" is not specified here either, as this refers to device-level validation activities rather than a dataset.
- Lack of clinical study data: The document explicitly states: "The Azurion series R1.2 did not require clinical study data since substantial equivalence to the currently marketed predicate device Allura Xper R9 was demonstrated..."
Therefore, there is no information about a "test set" sample size or data provenance in the sense of patient data or images used for algorithmic performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical study data or image-based test set with ground truth is mentioned for the Azurion series R1.2 in this document, there is no information regarding experts used to establish ground truth or their qualifications. The device is evaluated for substantial equivalence based on technical specifications and non-clinical testing.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set or human interpretation of images requiring ground truth adjudication, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission explicitly states that clinical study data was not required.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is an X-ray imaging system, not an AI algorithm designed for standalone diagnostic interpretation. Its "performance" is inherently tied to producing images for human interpretation and guiding procedures. Therefore, the concept of a "standalone" algorithmic performance study as typically understood for AI/CAD devices does not directly apply here. The software verification and non-clinical validation assess the system's operational integrity and image generation capabilities.
7. Type of Ground Truth Used
Given the nature of the device (an X-ray imaging system) and the emphasis on non-clinical testing and substantial equivalence, the "ground truth" for its evaluation would primarily involve:
- Technical specifications and engineering standards: Compliance with IEC, ISO, and FDA guidance documents serves as a form of "ground truth" that the device meets defined safety and performance benchmarks.
- Predicate device features and performance: The Allura Xper R9 serves as the primary "ground truth" reference for substantial equivalence, meaning the Azurion series R1.2 is evaluated against the established and cleared performance and safety profile of the predicate device.
- Internal functional requirements: Software verification tests against defined functional and non-functional requirements.
There is no mention of pathology, expert consensus on patient images, or outcomes data being used as ground truth in this 510(k) summary.
8. Sample Size for the Training Set
No information is provided about a training set. This device is an imaging system, not an AI/ML algorithm that would typically require a training set of data. While the device may incorporate image processing algorithms (like ClarityIQ), the document doesn't detail their development or any associated training sets.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of this device's submission, there is no information on how its ground truth would have been established.
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November 22, 2017
Image /page/0/Picture/1 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 and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems Nederland BV % Ms. Jeanette Becker Senior Regulatory Affairs Manager Veenpluis 4-6 Best, 5684PC THE NETHERLANDS
Re: K172822
Trade/Device Name: Azurion series R1.2 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: November 3, 2017 Received: November 6, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
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 mediation-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,
Michael D. O'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) K172822
Device Name Azurion series R1.2
Indications for Use (Describe)
The Azurion series (within the limits of the used Operation 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 Azurion series can be used in a hybrid Operation Room.
· The Azurion 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: | September 13, 2017 | |
|---|---|---|
| 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 611386380/ +31 621823383E-mail: jeanette.becker@philips.com | |
| Secondary ContactPerson: | Ms. Marta WalkerSenior Regulatory Affairs ManagerPhone: +31 631978546E-mail: marta.walker@philips.com | |
| Device: | Trade Name: | Azurion series R1.2 |
| 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: | K163715 (January 26, 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: | Allura Xper R8.2.1 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K141979 (August 19, 2014) | |
| 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: IAA |
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Device description: The Azurion series R1.2 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion series R1.2 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 o
- Storage of reference/control images for patient records ●
- Compatibility to images of other modalities via DICOM o
- Built in radiation safety controls ●
This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures.
The Azurion series R1.2 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) and biplane (dual 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 Azurion series R1.2 can be used 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 Azurion series R1.2 (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 Azurion series R1.2 can be used in a hybrid Operating Room.
• The Azurion series R1.2 contain a number of features to support a flexible and patient centric procedural workflow.
Patient Population:
{5}------------------------------------------------
All human patients of all ages. Patient weight is limited to the specification of the patient table.
Based on the information provided above, the Azurion series R1.2 is considered substantially equivalent to the currently marketed and predicate device Allura Xper R9 in terms of Indications for Use.
Technological The Azurion series R1.2 has similar technological characteristics compared to characteristics: the predicate device. The same hardware and software is used in the predicate and subject device. With exception of the following modifications implemented in the Azurion series R1.2:
- . Commercial introduction of monoplane configurations with
- o 12" flat detector
- 15" flat detector o
- Flat detector controller and System interface box integrated in 1 (one) unit (FDC-SIB)
- Redesign of Power Distribution Unit (PDU)
- System Software with Support of new HW components mentioned ● above, FDCSIB and PDU. Support of new labeling.
- New Product name Azurion
- System software product maintenance
- Commercial introduction of bi-plane configurations ●
- o frontal 12" and lateral 12" flat detector
- frontal 20" and lateral 12" flat detector O
- O frontal 20" and lateral 15" flat detector
The differences between the Azurion series R1.2 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 Azurion series R1.2 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 Azurion series R1.2 Clinical Performance and demonstrates compliance with the following International and FDA-Data: recognized consensus standards and FDA guidance documents:
- . 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).
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| FDA Guidance for Industry and/or for FDA Reviewers/Staff and/orCompliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (document number 644). | |
|---|---|
| Software verification testing of the functional and non-functional requirements aswell as performance, reliability and safety has been performed to cover systemlevel requirements as well as risk control measures. Results demonstrated that allexecuted tests were passed. | |
| Non-clinical validation testing has been performed to cover the intended use,commercial claims, service, user needs, effectiveness of safety measures andinstructions for use. | |
| Therefore, Azurion series R1.2 is substantially equivalent to the currentlymarketed Allura Xper R9 in terms of safety and effectiveness. | |
| Summary of ClinicalPerformance Data: | The Azurion series R1.2 did not require clinical study data since substantialequivalence to the currently marketed predicate device Allura Xper R9 wasdemonstrated 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 modifieddevice is substantially equivalent to the predicate device. | |
| SubstantialEquivalenceConclusion: | The Azurion series R1.2 is substantially equivalent to the currently marketedpredicate device Allura Xper R9 in terms of indications for use, technologicalcharacteristics and safety and effectiveness. |
| The modification of the Azurion series R1.2 is within the controls andpredetermined specifications. Additionally, non-clinical performance testsprovided in this 510(k) premarket notification demonstrated substantialequivalence to the predicate device and ensured that the modification is properlyintroduced; verification and validation testing was conducted to ensure the properintroduction of the modifications listed; conformance to IEC standards andguidance documents were provided. All of these components and tests were usedto support substantial equivalence of the subject device and demonstrate that theAzurion series R1.2 is as safe and effective as its predicate device without raisingany 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.