(24 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 contains a number of features to support a flexible and patient centric procedural workflow.
The Azurion R2.0 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion R2.0 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 Azurion R2.0 is available as a single monoplane (single C-arm) configuration of the currently marketed and predicate devices Azurion series R1.2 consisting of a FD20 (frontal channel) detector with a ceiling (Clea) geometry having a standard or OR compatible table. This can optionally be configured with a horizontal L-arm which provides an extra rotation axis, with re-designed motion control software providing patient and X-ray beam positioning movement and an improved 3D roll scan time. Additionally, identical to the predicate devices, Azurion R2.0 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.
The provided text describes the Philips Azurion R2.0, an interventional fluoroscopic X-ray system, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria with granular details like sample sizes for test and training sets, number and qualifications of experts, adjudication methods, or specific comparative effectiveness study results.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Azurion series R1.2) based on similarities in indications for use, technological characteristics, and non-clinical performance testing. It states that "the Azurion series R2.0 did not require clinical study data."
Therefore, I cannot provide a table of acceptance criteria with reported device performance, sample sizes, expert qualifications, or specific study design elements as these details are not present in the provided text.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that non-clinical performance testing "demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents" and "meets the acceptance criteria and is adequate for its intended use."
While specific numerical acceptance criteria (e.g., "accuracy > 95%") are not provided, the "acceptance criteria" implicitly refer to meeting the requirements of these standards and guidance documents. The "reported device performance" is that it complies with these standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Life Cycle Processes | Complies with IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). |
| Risk Management | Complies with ISO 14971 Medical devices Application of risk management to medical devices (Edition 2.0, 2007-03-01). |
| X-ray Tube Assemblies Safety & Performance | Complies with IEC 60601-2-28 - Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Edition 3.0, 2017-06). |
| X-Ray Equipment for Interventional Procedures Safety | Complies with IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.0, 2010-03). |
| Software in Medical Devices Premarket Submissions | Complies with Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005. |
| Substantial Equivalence Evaluation | Complies with Guidance for Industry and FDA Staff – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014. |
| Functional & Non-functional Software Requirements | Software verification testing demonstrated all executed verification tests were passed. |
| Performance, Reliability & Safety | Software verification testing demonstrated all executed verification tests were passed. |
| User Needs, Intended Use, Claims, Effectiveness of Safety Measures & Instructions for Use | Non-clinical validation testing (including usability and simulated use studies) demonstrated all executed validation protocols were passed. |
| Commercial Product Claims | Simulated use study with interventional physicians substantiated commercial product claims. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document refers to "non-clinical performance testing," "software verification testing," and "non-clinical validation testing," including "simulated use environment" studies. No specific number of test cases, images, or subjects for these evaluations is given.
- Data Provenance: The studies are described as "non-clinical" and "simulated use," suggesting they were conducted in a controlled environment, likely by Philips Medical Systems Nederland B.V. The document does not specify the country of origin of data or if it was retrospective or prospective in detail. It does state that usability was performed with "interventional validation radiologists/cardiologists (physicians) and nurse/technicians in a simulated use environment." This indicates prospective data collection within the simulated environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document mentions "interventional validation radiologists/cardiologists (physicians) and nurse/technicians" participated in usability and simulated use studies. However, it does not state how many of each were involved or if they established a formal "ground truth" for a test set in the traditional sense of diagnostic accuracy. Their role was to validate the device's usability and conformity to intended use.
- Qualifications of Experts: "Interventional validation radiologists/cardiologists (physicians) and nurse/technicians." Specific experience levels (e.g., "10 years of experience") are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. The description of validation activities indicates that "participants executed validation protocols," and "all executed validation protocols were passed." This suggests a pass/fail assessment based on predefined criteria during the simulated use, rather than a conflict resolution/adjudication process for diagnostic ground truth.
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:
- MRMC Comparative Effectiveness Study: No. The document explicitly states: "The Azurion series R2.0 did not require clinical study data since substantial equivalence to the currently marketed predicate device Azurion series R1.1 was demonstrated..." There is no mention of an MRMC study or an assessment of human reader improvement with or without AI assistance. The device is an imaging system, and while it mentions "ClarityIQ image processing algorithms" can optionally be equipped, the focus of this submission is on the hardware and core software updates, not on a specific AI assistance feature for diagnostic improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable in the context of diagnostic accuracy for an algorithm. The device is an interventional fluoroscopic X-ray system, not a standalone AI diagnostic algorithm. Its "performance" refers to its compliance with technical and safety standards in a system context. Software verification testing was performed on "functional and non-functional requirements," which is a form of standalone testing for the software components, but not in the sense of a diagnostic accuracy study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the "non-clinical validation testing," the "ground truth" was effectively established by adherence to predefined "user needs, intended use, claims, effectiveness of safety measures and instructions for use." This is not a diagnostic ground truth (like pathology or outcomes data) but rather a validation that the system functions as intended and meets safety and usability criteria within a simulated environment.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes a medical device (X-ray system) and its software updates, not a machine learning model that would typically have a distinct "training set." The software components are verified and validated against specifications.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as this is not a machine learning model.
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August 2, 2018
Philips Medical Systems Nederland BV % Mr. Owen Callaghan Regulatory Affairs Manager Veenpluis 4-6 Best, 5684PC NETHERLANDS
Re: K181830
Trade/Device Name: Azurion R2.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: July 6, 2018 Received: July 9, 2018
Dear Mr. Callaghan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Hsl 2. Nils
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)
K181830
Device Name Azurion R2.0
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 contains 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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PHILIPS
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | July 6th 2018 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277 |
| Primary ContactPerson: | Owen CallaghanRegulatory Affairs ManagerPhone: +31 621394159E-mail: owen.callaghan@philips.com |
| Secondary ContactPerson: | Marta WalkerHead of Regulatory Affairs IGT SystemsPhone: +31 631978546E-mail: marta.walker@philips.com |
| Device: | |
| Trade Name: Azurion R2.0 | |
| 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: OWBSecondary product code: JAA | |
| Predicate Device: | |
| Trade Name: Azurion series R1.2 | |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K172822 (November 22, 2017) | |
| 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: OWBSecondary product code: JAA |
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Device description: The Azurion R2.0 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion R2.0 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 Azurion R2.0 is available as a single monoplane (single C-arm) configuration of the currently marketed and predicate devices Azurion series R1.2 consisting of a FD20 (frontal channel) detector with a ceiling (Clea) geometry having a standard or OR compatible table. This can optionally be configured with a horizontal L-arm which provides an extra rotation axis, with re-designed motion control software providing patient and X-ray beam positioning movement and an improved 3D roll scan time. Additionally, identical to the predicate devices, Azurion R2.0 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 (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 Azurion series can be used in a hybrid Operating 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.
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PHILIPS
Based on the information provided above, the Azurion R2.0 is considered substantially equivalent to the currently marketed and predicate device Azurion series R1.2 in terms of Indications for Use.
The Azurion R2.0 has similar technological characteristics compared to the Technological characteristics: 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 R2.0:
- Introduction of:
- Modified Horizontal L-arm with additional rotational axis O
- Rotatable Collimator O
- New Roll Drive o
- o New motion control software for patient and X-ray beam positioning, giving an improved roll scan time
- Automatic Image Beam Rotation O
- O 2D image overlay on 3D model for additional C-arm positions (±45° and ±135°)
- Additional monitor ceiling suspension boom O
- Re-design of X-ray tube, Collimator
- Removal of X-ray tube side BodyGuard, replace with extended (3D) ● intelligent collision protection
- More consistent BodyGuard collision prevention (software update)
- Update of software to maintain Maquet table compatibility .
The differences between the Azurion R2.0 and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, Azurion R2.0 is considered substantially equivalent to the currently marketed predicate Azurion series R1.2 in terms of fundamental scientific technology.
Non-clinical performance testing has been performed on the Azurion R2.0 and Summary of Non-Clinical Performance demonstrates compliance with the following International and FDA-recognized Data: consensus standards and FDA guidance documents:
- . IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79.
- ISO 14971 Medical devices Application of risk management to medical ● devices (Edition 2.0, 2007-03-01). 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 3.0, 2017-06). FDA/CDRH recognition number 12-309.
- IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.0, 2010-03).
- . 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).
- "Guidance for Industry and FDA Staff – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
Software verification testing of the functional and non-functional requirements as well as performance, reliability and safety has been performed to verify that all
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the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements have been implemented. Results demonstrated that all executed verification tests were passed.
Non-clinical validation testing has been performed to validate that Azurion R2.0 conforms to the intended use, claims, user and service needs, effectiveness of safety measures and instructions for use. The validation consisted of the following activities:
Usability was performed with both interventional validation radiologists/cardiologists (physicians) and nurse/technicians in a simulated use environment. Azurion R2.0 was found to be safe and effective for the intended use, users and use environment.
A simulated use design validation was performed with users that fulfill the intended user profile. The participants executed validation protocols in the form of a clinical workflow to validate user needs, intended use, claims and effectiveness of the safety and instructions for use. Results demonstrated that all executed validation protocols were passed.
Additionally, a simulated use study was conducted with interventional physicians to substantiate commercial product claims.
All these tests were used to support substantial equivalence of the subject device and demonstrate that Azurion R2.0:
- . complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and
- meets the acceptance criteria and is adequate for its intended use.
Therefore, Azurion R2.0 is substantially equivalent to the currently marketed Azurion series R1.2 in terms of safety and effectiveness.
Summary of Clinical The Azurion series R2.0 did not require clinical study data since substantial Performance Data: equivalence to the currently marketed predicate device Azurion series R1.2 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.
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Substantial Equivalence Conclusion:
The Azurion R2.0 is substantially equivalent to the currently marketed predicate device Azurion series R1.2 in terms of indications for use, technological characteristics and safety and effectiveness.
The modification of the Azurion R2.0 is within the controls and predetermined specifications. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that Azurion R2.0 complies with the user need requirements as well as the requirements specified in the FDA-recognized consensus standards and guidance documents.
Therefore Azurion R2.0 is as safe and effective as its predicate device and does not raise 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.