(232 days)
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used with selective catheter anglography procedures for the heart, chest abdomen, pelvis and brain.
The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System, Workstation and/or other PACS devices. The XIDF-AWS801 provides the image information and measurement results that are required when performing Angiography procedures.
Here's a breakdown of the acceptance criteria and study information for the XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3, based on the provided FDA 510(k) summary:
The provided document is a 510(k) summary for a software update to an existing device. As such, it primarily focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with explicit acceptance criteria for entirely new performance claims. The "acceptance criteria" in this context refer to demonstrating that the updated device performs at least as well as, or better than, the predicate device across various aspects, including safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a modification to a cleared device (software change from V8.0 to V9.3), the acceptance criteria are implicitly tied to demonstrating that the new version is substantially equivalent to the predicate device (XIDF-AWS801, V8.0, K181415) and does not raise new questions of safety or effectiveness. Explicit numerical performance metrics as "acceptance criteria" are not detailed in this summary for the updated software. Instead, the "performance" demonstrated is that the modifications maintain existing performance and potentially offer improvements without compromising safety.
| Aspect of Performance/Criteria | Reported Device Performance (XIDF-AWS801, V9.3) |
|---|---|
| Overall Performance | "Performance that is equal to or better than the predicate system." (Implies meeting or exceeding predicate's imaging capabilities, processing speed, accuracy etc. where applicable) |
| Safety | "Designed and manufactured under the Quality System Regulations (21 CFR § 820 and ISO 13485). Conforms to applicable parts of IEC60601-1 standards. Meets all requirements of the Federal Diagnostic Equipment Standard (21 CFR §1020)." |
| Software Validation/Integration | "Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform." |
| Risk Mitigation | "Design controls used for this device included risk management and all known risks were mitigated to an acceptable level." |
| Intended Use | "Performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not explicitly state a specific sample size used for a test set (e.g., number of images or cases) for clinical performance evaluation. The "testing" mentioned refers to verification and validation of software modules and the system's overall performance against the predicate.
The data provenance is not specified regarding country of origin or retrospective/prospective nature. Given the type of device (angiography workstation software), testing would likely involve technical performance and potentially review of existing clinical data/images for validation of new features or ensuring consistency with previous versions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The summary does not mention the use of experts to establish ground truth for a test set. This type of evaluation is not typically required for a software update to an angiography workstation that primarily processes and displays images, unless new diagnostic functions were introduced that required clinical validation against expert opinion.
4. Adjudication Method for the Test Set
As there's no mention of a clinical test set with expert ground truth, an adjudication method is not applicable or mentioned in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study was mentioned or performed. The device is an angiography workstation with various imaging and processing functionalities, not an AI-assisted diagnostic tool that directly impacts human reader interpretation in the context of an MRMC study. While it has improved "Dynamic Device Stabilization" and "Embolization Planning software," these are functional enhancements, not AI-driven diagnostic aids requiring MRMC studies to measure reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a workstation used to process and display images for clinical interpretation, inherently involving a "human-in-the-loop." Therefore, a standalone (algorithm only) performance evaluation in a purely diagnostic sense is not applicable or mentioned in this context for this type of device and submission. The "standalone" aspect applies more to specific AI algorithms making diagnostic predictions.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given the nature of the software update to an angiography workstation, the "ground truth" for its validation would primarily involve:
- Technical Specifications: Ensuring algorithms produce images and measurements according to predefined technical and mathematical standards.
- Predicate Device Performance: Comparing processed images and functionalities against the established performance of the cleared predicate device.
- Risk Analysis: Ensuring that the software changes do not introduce new, unmitigated risks.
Clinical ground truth from experts, pathology, or outcomes data is not mentioned as being used directly for this software update.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning. The improvements, such as "Dynamic Device Stabilization (DDS) software has been improved" or "Embolization Planning software has been migrated," indicate software engineering enhancements rather than a system trained on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of machine learning, the method for establishing ground truth for a training set is not applicable or mentioned.
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September 27, 2022
Canon Medical Systems Corporation % Paul Biggins U.S. Agent/Senior Director Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780
Re: K220342
Trade/Device Name: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: August 25, 2022 Received: August 29, 2022
Dear Paul Biggins:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220342
Device Name
XIDF-AWS801, Angio Workstation, (Alphenix Workstation), V9.3
Indications for Use (Describe)
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used with selective catheter anglography procedures for the heart, chest abdomen, pelvis and brain.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K220342 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
1. CLASSIFICATION and DEVICE NAME
| Classification Name | Solid State X-ray System, Interventional |
|---|---|
| Regulation Number | 21 CFR 892.1650 (Class II) |
| Product Code | OWB, JAA |
| Trade Proprietary Name | XIDF-AWS801, Angio Workstation (Alphenix Workstation) |
| Model Number | XIDF-AWS801, V9.3 |
2. SUBMITTER'S NAME
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Fumiaki Teshima Senior Manager, Quality Assurance Department
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Paul Biggins Sr. Director, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7808 Fax: (714) 730-1310 pbiggins@us.medical.canon
5. MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED February 03, 2022
8. TRADE NAME(S) XIDF-AWS801, Angio Workstation, (Alphenix Workstation), V9.3
9. CLASSIFICATION PANEL Radiology
10. DEVICE CLASSIFICATION Class II (per 21 CFR 892.1650)
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Made For life
11. PRODUCT CODE / DESCRIPTION
Product Code: OWB, JAA
12. PERFORMANCE STANDARD
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].
13. PREDICATE DEVICE
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V8.0 (K181415)
| Product | XIDF-AWS801, Angio Workstation(Alphenix Workstation), V8.0 | XIDF-AWS801, Angio Workstation,(Alphenix Workstation), V9.3 |
|---|---|---|
| Marketed by | Canon Medical Systems USA | Canon Medical Systems USA |
| Indications ForUse | The Angio Workstation (XIDF-AWS801)is used in combination with aninterventional angiography system(Alphenix series systems, Infinix-iseries systems and INFX seriessystems) to provide 2D and 3Dimaging of selective catheterangiography procedures for the wholebody (includes heart, chest, abdomen,brain and extremity).When XIDF-AWS801 is combined withDose Tracking System (DTS), DTS isused with selective catheterangiography procedures for the heart,chest abdomen, pelvis and brain. | The Angio Workstation (XIDF-AWS801)is used in combination with aninterventional angiography system(Alphenix series systems, Infinix-iseries systems and INFX seriessystems) to provide 2D and 3Dimaging of selective catheterangiography procedures for the wholebody (includes heart, chest, abdomen,brain and extremity).When XIDF-AWS801 is combined withDose Tracking System (DTS), DTS isused with selective catheterangiography procedures for the heart,chest abdomen, pelvis and brain. |
| 510(k) Number | K181415 | K181415 |
| Clearance Date | September 10, 2018 | September 10, 2018 |
14. REASON FOR SUBMISSION
Modification of a cleared device
15. SUBMISSION TYPE
Traditional 510(k)
16. DEVICE DESCRIPTION
The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System, Workstation and/or other PACS devices. The XIDF-AWS801 provides the image information and measurement results that are required when performing Angiography procedures.
17. Indications for use
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body
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Made For life
(includes heart, chest, abdomen, brain and extremity).
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used with selective catheter angiography procedures for the heart, chest abdomen, pelvis and brain.
18. SUMMARY OF CHANGE(S)
This submission is to report the following items have been changed:
- . Dynamic Device Stabilization (DDS) software has been improved and new GPU for image processing is included.
- . Windows 10 new OS system is available
- Embolization Planning software has been migrated from the INFX platform ●
- . CAAS Workstation has been updated with vFFR application
- 3D Viewer Software has been updated to include new functions.
- 4D CT improvement was migrated from 4DCT that allows user to superimpose CT image on Angiographic image
- . Needle Guidance was improved which allows up to 5 needles
- Usability improvements are included in this software
19. SAFETY
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.
LIST OF APPLICABLE STANDARDS
- . IEC60601-1-2:2014
- IEC62304:2006 + A1:2015 .
- IEC62366-1:2015 + A1:2020 ●
- . IEC62368-1:2014
- ISO 14971:2007 ●
20. TESTING
This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
21. SUBSTANTIAL EQUIVALENCE
The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 is substantially equivalent to the XIDF-AWS801, Angio Workstation, V8.0, which received premarket clearance under K181415, marketed by Canon Medical Systems. XIDF-AWS801, Angio Workstation (Alphenix
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1EDICAL SYSTEMS USA, INC.
Made For life
Workstation), V9.3, includes modifications to the cleared device consisting of software change from V8.0 to V9.3.
The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device.
22. CONCLUSION
The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device.
§ 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.