(90 days)
The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body.
Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations.
This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance.
Exclusion: This system is not recommended for Mammography.
Contraindication: Exposure of X-Ray should be avoided during pregnancy.
The Cardiovascular Angiography system is designed to perform fluoroscopic & digital radiographic studies and are used in interventional examinations. This system covers the complete range of angiographic applications, cardiac angiography, neuroangiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and digital radiographic/ fluoroscopic procedures. The following components are configured to create the Cardiovascular Angiography system:
-
- Floor mounted C-arm (Altima FDX Adv) or Ceiling Mounted C-Arm (Proxima FDX) or Mobile C-Arm (Digiscan FDX-VXXYY), X-ray tube assembly and Solid State X-Ray image detector
-
- Patient Table
-
- Ceiling suspended display(s)
-
- Footswitch for releasing radiation
-
- Control console for controlling the stand, patient table, collimator and imaging system.
The provided FDA 510(k) summary for the "Cardiovascular Angiography System" focuses on demonstrating substantial equivalence to predicate and reference devices, rather than establishing acceptance criteria and providing detailed study results in the manner typically seen for novel AI/ML devices.
This submission is for an X-ray imaging system, not an AI/ML powered device, so the typical AI/ML-specific study components like "number of experts used to establish ground truth" or "MRMC comparative effectiveness study" are not applicable in this context. The evaluation here is based on technical specifications, non-clinical performance testing, and adherence to recognized industry standards.
Here's an analysis based on the provided document, framed within your request:
Acceptance Criteria and Device Performance (for an X-ray system)
The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to legally marketed predicate devices and compliance with established performance standards for X-ray systems. The "reported device performance" is primarily presented as meeting or being comparable to these standards and the predicate device's specifications.
Table of Acceptance Criteria and Reported Device Performance
Since this is a traditional 510(k) for an X-ray system, the "acceptance criteria" are not framed as specific performance metrics of an AI algorithm (e.g., AUC, sensitivity/specificity targets). Instead, they are based on established safety and performance characteristics of such medical devices as outlined in relevant standards and predicate device comparisons. The document indicates that the device meets these, making it "substantially equivalent."
| Category | Acceptance Criteria (Implied / Standard-Based) | Reported Device Performance (as stated in document) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate/reference devices. | "Essentially the same as the predicate with respect to indication and intended use." (Table 3) |
| X-Ray Generator Type | Microprocessor-controlled, high frequency converter generator, comparable to predicate/reference. | "Microprocessor-controlled, high frequency converter generator." (Table 3) "Same as Predicate device" (Table 3 justification) |
| X-Ray Generator Power Rating | Comparable performance to predicate (Allura Xper FD: 100KW) or sufficient to meet exposure requirements (Reference Ziehm Vision RFD: 30KW, 25KW). | Subject Device: XGEN-100CV: 100KW, XGEN-80CV: 80KW, XGEN-65CV: 65KW, XGEN-40CV: 40KW, XGEN-27CV: 27KW. "Similar (SE #1)" and "Sufficient to meet the fluoroscopic and digital radiographic exposure requirements and have higher maximum power output as compare to Reference device." (SE#1 & #2 Discussion) |
| Digital Radiographic Mode (mA & kV) | Comparable ranges to predicate/reference. | Subject Device: 1-1000 mA, 40-125 kV. "Same as Predicate device" (Table 3 justification) |
| Fluoroscopic Mode (mA, kV, fps) | Comparable ranges to predicate/reference, including pulsed fluoroscopy. | Subject Device: Pulsed 200 mA max, 40-125 kV, Up to 30 fps. "Same as Predicate device" (Table 3 justification) |
| Automatic Brightness Stabilization (ABS) Control | Presence of ABS. | "Yes" (Table 3) "Same" (Table 3 justification) |
| X-Ray Tube Features (Type, Heat Storage, Focal Spot, Anode Angle) | Comparable to predicate/reference, with differences not introducing new safety concerns. | "Rotating Anode." Various specific values for heat storage, focal spot size, and anode angle for different optional tubes. "Similar (SE #3)", with a note that differences "do not change or add new potential safety risks." (SE#3 Discussion) |
| Solid State X-Ray Image Detectors (Type, Active Area, Pixel Matrix, DQE, MTF, A/D Conversion, Pixel Pitch) | Detectors either previously cleared by FDA or technology comparable to predicate/reference and compliant with SSXI guidance. Differences should not raise safety/effectiveness concerns. | Various specific values for different optional detectors. "Same as Reference device," "Similar (SE #4)," or "Same as Predicate device," depending on the specific parameter and detector. Differences are not deemed to affect safety or effectiveness. (SE#4 Discussion) |
| Imaging Mode Functionality | Standard imaging modes (Pulsed Fluoroscopy, Digital Spot). | "Pulsed Fluoroscopy" and "Digital Spot." "Same" (Table 3 justification) |
| Video Storage Type & PACS Interface | Standard storage options (HDD, USB, CD/DVD-RW) and networking (DICOM conformance, Ethernet/WLAN). | "Internal HDD drive, USB, CD/DVD-RW drive," "Yes" for DICOM conformance, "Ethernet or WLAN" for PACS. "Same" (Table 3 justifications) |
| Safety Compliance | Conformance to relevant IEC standards (e.g., 60601-1, 60601-1-2, 60601-1-3, 60601-2-43, 60601-2-54, 62304, 62366-1, 14971, 60825-1) and 21 CFR Federal Performance Standards (1020.30, 1020.32, 1040.10). | Certified conformance explicitly stated. "Non-clinical verification test results demonstrate that the Cardiovascular Angiography system complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents." (Performance Testing, Section 13) |
Study Details (for an X-ray system, not AI/ML)
-
Sample Size Used for the Test Set and Data Provenance:
- This document describes "non-clinical performance testing" and "bench testing." It does not specify a "test set" in the context of patient data or images as would be seen for AI/ML validation.
- The "testing" refers to technical evaluations of the system's components and overall functionality against engineering specifications and industry standards.
- There is no mention of patient data (retrospective or prospective) for performance evaluation. The data provenance (country of origin) is not applicable or stated for this type of technical performance testing.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth for an AI/ML algorithm (e.g., disease presence) is not being established here. The "truth" is whether the system performs according to its design specifications and relevant safety/performance standards. This is determined through engineering and compliance testing.
-
Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Not applicable. Adjudication methods are relevant for human reader studies, particularly in AI/ML performance evaluation where ground truth might be derived from expert consensus.
-
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 applicable. This is an X-ray imaging device, not an AI-assisted diagnostic tool. No human reader studies are described.
-
If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
- Not applicable, as this is not an AI/ML algorithm.
-
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the adherence to established engineering specifications, safety standards (e.g., IEC 60601 series), and the functional equivalence to predicate devices, verified through non-clinical bench testing. There is no biological or clinical ground truth like pathology or outcomes data used to establish device performance in this type of submission.
-
The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable.
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May 3, 2022
Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall Unit-2, Bhankarpur, Mubarakpur Road, Derabassi. Distt. Mohali, Punjab 140507 INDIA
Re: K220311
Trade/Device Name: Cardiovascular Angiography System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: January 27, 2022 Received: February 2, 2022
Dear Sanjeev Marjara:
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
{1}------------------------------------------------
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 Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological 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)
Device Name
Cardiovascular Angiography System
Indications for Use (Describe)
The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body.
Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations.
This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance.
Exclusion: This system is not recommended for Mammography.
Contraindication: Exposure of X-Ray should be avoided during pregnancy.
Type of Use (Select one or both, as applicable)
7 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 summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Contact Person and Address
| Company Name: | Allengers Medical Systems Limited |
|---|---|
| Company Address: | FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi, DisttMohali-140507, India |
| Telephone No: | +91 1762-282600+919872980168rnd@allengers.net |
| Contact Person: | Sanjeev K. Marjara |
| Date Prepared: | 27.01.2022 |
2. Proposed Device:
| Device (trade) name: | Cardiovascular Angiography System | ||
|---|---|---|---|
| Model Name: | Proxima FDX, Altima FDX AdvDigiscan FDX-V8043, Digiscan FDX-V8030, Digiscan FDX-V8020Digiscan FDX-V6543, Digiscan FDX-V6530, Digiscan FDX-V6520Digiscan FDX-V4043, Digiscan FDX-V4030, Digiscan FDX-V4020Digiscan FDX-V2743, Digiscan FDX-V2730, Digiscan FDX-V2720 | ||
| Classification Name : | Image-Intensified Fluoroscopic X-Ray System | ||
| Classification Panel: | Radiology | ||
| Regulation Number : | 21 CFR 892.1650 | ||
| Device Class: | Class II | ||
| Product Code: | Primary Code : OWBSubsequent Code : JAA and OXO for 'Digiscan FDX-VXXYY |
3. Predicate Device:
| Device (trade) name: | Allura Xper FD Series and Allura Xper OR Table serie | |
|---|---|---|
| 510(K) Number: | K162859 | |
| Clearance Date: | December 2, 2016 | |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System, | |
| Classification Panel: | Radiology | |
| Regulation Number: | 21 CFR 892.1650 | |
| Device Class: | Class II | |
| Product Code: | Primary Code : OWBSubsequent Code : JAA |
¹ Where XX may be 80/65/40/27 and YY may be 43/30/20
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4. Reference devices:
| Device (trade) name: | Ziehim Vision RFD |
|---|---|
| 510(K) Number: | K203428 |
| Clearance Date: | March 17, 2021 |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1650 |
| Device Class: | Class II |
| Product Code: | Primary Code : OWBSubsequent Code : JAA, OXO |
Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have been previously cleared by FDA or tested and evaluated per quidance for submission of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state detectors used with device.
| Solid State Detectors | 510(K) Numbers |
|---|---|
| Varex Imaging corporation – Paxscan 2020 DXV | K200218 |
| Varex Imaging corporation – Paxscan 3030 DXV | K200218 |
| Varex Imaging corporation - Paxscan 4343DXV | -- |
| MX Imaging - CFP 2222 | K171755 |
| MX Imaging - CFP 3131 | K171755 |
| Thales Group – Pixium Surgical 2121S-A | K183040 |
| Thales Group - Pixium 2121S-AU | K200218 |
| Thales Group - Pixium Surgical 3030S-A | K172822 |
| Thales Group - Pixium 3030S-AU | K200218 |
| IRAY Technology - Mercu 0909F | K200218 |
| Allengers Medical Systems Ltd - FP 2121 RF | -- |
| Allengers Medical Systems Ltd - FP 2121 HR | -- |
| Allengers Medical Systems Ltd - FP 3030 HR | -- |
Table 1 List of Solid State X-Rav Image Detectors
5. Device description:
The Cardiovascular Angiography system is designed to perform fluoroscopic & digital radiographic studies and are used in interventional examinations. This system covers the complete range of angiographic applications, cardiac angiography, neuroangiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and digital radiographic/ fluoroscopic procedures. The following components are configured to create the Cardiovascular Angiography system:
-
- Floor mounted C-arm (Altima FDX Adv) or Ceiling Mounted C-Arm (Proxima FDX) or Mobile C-Arm (2Digiscan FDX-VXXYY), X-ray tube assembly and Solid State X-Ray image detector
-
- Patient Table
-
- Ceiling suspended display(s)
2 Where XX may be 80/65/40/27 and YY may be 43/30/20
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-
- Footswitch for releasing radiation
-
- Control console for controlling the stand, patient table, collimator and imaging system.
The following in Table 2 are the specific components for various configurations of the system. A complete system will consist of a selection of one of the devices in each category.
| Component | Manufacture | Model | |
|---|---|---|---|
| X-Ray Generator | Allengers | Proxima FDXAltima FDX Adv | XGEN-100CV |
| Proxima FDXAltima FDX Adv | |||
| X-Ray Generator | Allengers | Digiscan FDX-V8043Digiscan FDX-V8030Digiscan FDX-V8020 | XGEN-80CV |
| X-Ray Generator | Allengers | Digiscan FDX-V6543Digiscan FDX-V6530Digiscan FDX-V6520 | XGEN-65CV |
| X-Ray Generator | Allengers | Digiscan FDX-V4043Digiscan FDX-V4030Digiscan FDX-V4020 | XGEN-40CV |
| X-Ray Generator | Allengers | Digiscan FDX-V2743Digiscan FDX-V2730Digiscan FDX-V2720 | XGEN-27CV |
| X-Ray Tube | SiemensHealthcareGmbH | Proxima FDXAltima FDX Adv | Megalix CAT125/35/80 125 GWMegalix CAT125/15/40/80122 GW |
| X-Ray Tube | CanonElectron Tubesand devices | Proxima FDXAltima FDX Adv | E79039XE79030XE79016X |
| X-Ray Tube | Varex Imaging | Proxima FDXAltima FDX AdvDigiscan FDX-V8043Digiscan FDX-V8030Digiscan FDX-V8020Digiscan FDX-V6543Digiscan FDX-V6530Digiscan FDX-V6520Digiscan FDX-V4043Digiscan FDX-V4030Digiscan FDX-V4020 | G1082, G-1582BI,G2090, G1092 |
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| X-Ray Tube | Varex Imaging | Digiscan FDX-V2743Digiscan FDX-V2730Digiscan FDX-V2720 | A-145, RAD-99,RAD-99B, RAD-15 |
|---|---|---|---|
| Solid State X-Ray ImageDetectors | Varex Imaging | Proxima FDXAltima FDX AdvDigiscan FDX-V8020Digiscan FDX-V6520Digiscan FDX-V4020Digiscan FDX-V2720 | Paxscan 2020 DXV |
| Solid State X-Ray ImageDetectors | Varex Imaging | Proxima FDXAltima FDX AdvDigiscan FDX-V8030Digiscan FDX-V6530Digiscan FDX-V4030Digiscan FDX-V2730 | Paxscan 3030 DXV |
| Solid State X-Ray ImageDetectors | Varex Imaging | Proxima FDXAltima FDX AdvDigiscan FDX-V8043Digiscan FDX-V6543Digiscan FDX-V4043Digiscan FDX-V2743 | Paxscan 4343DXV |
| Solid State X-Ray ImageDetectors | IRAYTechnology | Proxima FDXAltima FDX AdvDigiscan FDX-V8020Digiscan FDX-V6520Digiscan FDX-V4020Digiscan FDX-V2720 | Mercu 0909F |
| Solid State X-Ray ImageDetectors | Thales Group | Proxima FDXAltima FDX AdvDigiscan FDX-V8020Digiscan FDX-V6520Digiscan FDX-V4020Digiscan FDX-V2720 | Pixium 2121S-AUPixium Surgical2121S-A |
| Solid State X-Ray ImageDetectors | Thales Group | Proxima FDXAltima FDX AdvDigiscan FDX-V8030Digiscan FDX-V6530Digiscan FDX-V4030Digiscan FDX-V2730 | Pixium 3030S-AUPixium Surgical3030S-A |
| Solid State X-Ray ImageDetectors | MX Imaging | Proxima FDXAltima FDX AdvDigiscan FDX-V8020 | CFP 2222 |
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| Solid State X-Ray ImageDetectors | MX Imaging | Digiscan FDX-V6520Digiscan FDX-V4020Digiscan FDX-V2720 | |
|---|---|---|---|
| Digiscan FDX-V8030Digiscan FDX-V6530Digiscan FDX-V4030Digiscan FDX-V2730 | CFP 3131 | ||
| Solid State X-Ray ImageDetectors | Allengers | Proxima FDXAltima FDX AdvDigiscan FDX-V8020Digiscan FDX-V6520Digiscan FDX-V4020Digiscan FDX-V2720 | FP 2121 RFFP 2121 HR |
| Solid State X-Ray ImageDetectors | Allengers | Proxima FDXAltima FDX AdvDigiscan FDX-V8030Digiscan FDX-V6530Digiscan FDX-V4030Digiscan FDX-V2730 | FP 3030 HR |
| Patient Table | Allengers | Proxima FDXAltima FDX Adv | C Tab F FDXC Tab FXL FDXC Tab FCV FDX |
| Patient Table | Allengers | Digiscan FDX-V8043Digiscan FDX-V8030Digiscan FDX-V8020Digiscan FDX-V6543Digiscan FDX-V6530Digiscan FDX-V6520Digiscan FDX-V4043Digiscan FDX-V4030Digiscan FDX-V4020Digiscan FDX-V2743Digiscan FDX-V2730 | C Tab M FDXVascu Tab FDX |
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6. Indications for Use:
The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body.
Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations.
This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance.
Exclusion: This system is not recommended for Mammography.
Contraindications: Exposure of X-Ray should be avoided during pregnancy.
7. Technological Characteristics Comparison to Predicate & Reference Devices:
The Cardiovascular Angiography Systems having set of components similar to the Allura Xper FD Series and Allura Xper OR Table series (K162859) and Ziehm Vision RFD (K203428) as compared in Table 3 found below in this Section. This table below shows that the systems are either similar, or the same, as the predicate & reference device.
8. Software Feature
Synergy FP FDX & Synergy FDX-CR imaging software is a Digital Imaging System (DIS) provides useful functions to manage X-Ray images obtained from Cardiovascular Anqiography System.
The software feature set and functions is essentially the same as the device, with the system complying with DICOM 3.0 specifications .Refer to section 9 Image processing and storage of the table 3 for a list of top level functions
9. Substantial Equivalence:
The Cardiovascular Angiography system are substantially equivalent to the commercially available Allura Xper FD series and Allura Xper OR Table series (K162859) & Ziehm Vision RFD (K203428). Functional and specification differences are identifying in the following table.
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| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
|---|---|---|---|---|---|
| 1. 510(k) | This submission | K162859 | K203428 | ||
| 2. Product Code | |||||
| ProductClassificationCode | OWB, JAA &OXO for 'Digiscan FDX-VXXYY' | OWB and JAA | OWB , JAA & OXO | Same | |
| 3. Product Classification | |||||
| Classification | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | Same | |
| 4. Indication for Use | |||||
| Indications forUse | The CardiovascularAngiography system isdigital system with highfrequency X-Ray generatorfor application incardiovascular procedures.This system used incatheterization labs useshigh power x-ray pulses anddigital imaging system tovisualize the vascularstructures of human body.Clinical applications mayinclude (but not limited to)interventional cardiovascularprocedures, Neurovascularprocedures, pacemakerimplantable and high endinvestigations.This system should behandled by persons whohave been briefed in itsprofessional handling andwho have familiarizedthemselves with the productby means of instructions foruse. Intended use alsomeans following the usermanual and observing theconditions for inspection andmaintenance.Exclusion: This system isnot recommended forMammography.Contraindications:Exposure of X-Ray shouldbe avoided duringpregnancy. | The Allura Xper series andthe Allura Xper OR Tableseries (within the limits ofthe used OR table) areintended for useon human patients toperform:• Vascular, cardiovascularand neurovascular imagingapplications, includingdiagnostic, interventionaland minimallyinvasive procedures. Thisincludes, e.g., peripheral,cerebral, thoracic andabdominal angiography, aswell as PTAs, stentplacements, embolisationsand thrombolysis.• Cardiac imagingapplications includingdiagnostics, interventionaland minimally invasiveprocedures (such asPTCA, stent placing,atherectomies),pacemaker implantations,and electrophysiology(EP). • Non-vascularinterventions such asdrainages, biopsies andvertebroplastiesprocedures.Additionally:• The Allura Xper andAllura Xper OR Tableseries is compatible with ahybrid Operating Room.• Allura Xper FD10 iscompatible with specifiedmagnetic navigationsystems.• Combined with a | The Ziehm Vision RFDis intended for use inproviding medicalimaging for adult andpediatric populations,using pulsed andcontinuous fluoroscopicdigital imaging, as wellas digital subtractionand cine image captureduring diagnosticinterventional andsurgical procedureswhere intra-operativeimaging andvisualization ofcomplex anatomicalstructures of both lowerand higher contrastdensity are required.Such procedures mayinclude but are notlimited to those ofinterventionalcardiology, heartsurgery, hybridprocedures,interventionalradiology,interventionalangiography,electrophysiology,pediatrics, endoscopic,urological,gastroenterology,orthopedic,maxillofacial surgery,neurology,neurosurgery, criticalcare, emergency roomprocedures, and thoseprocedures visualizingstructures of the | Essentiallythe sameNote: Thereare nodifferencesbetweenthe subjectdevice andthe predicatewith respectto indicationand intendeduse. | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| qualified, compatible ORtable, the Allura Xper ORTable series can be usedfor imaging in the HybridOR within the applicationsdomains Neuro, Vascular,Non Vascular and Cardiac.The OR table can also beused standalone forsurgical use in the OR. | cervical, thoracic, andlumber regions of thespine, and jointfractures of the upperand lower extremities,and where digitalimage data is requiredfor computer aidedsurgery proceduresand whenever theclinician benefits fromthe high degree ofgeometric imagingaccuracy, and wheresuch fluoroscopic, cineand DSA imaging isrequired. Thevisualization of suchanatomical structuresassists the clinician inthe clinical outcome.This device does notsupport directradiographic filmexposures and is notintended for use inperformingmammography. Thesystem is not intendedfor use near MRIsystems. | ||||
| 5. X-Ray Generator | |||||
| Type | Microprocessor-controlled,high frequency convertergenerator | Microprocessor-controlled,high frequency convertergenerator | Monoblock and HighFrequency Generator | Same asPredicatedevice | |
| Power Rating | XGEN-100CV | 100KW | 100 KW | 30 KW | Similar(SE #1) |
| XGEN-80CV | 80KW | ||||
| XGEN-65CV | 65KW | ||||
| XGEN-40CV | 40KW | 25 KW | |||
| XGEN-27CV | 27KW | ||||
| Nominal power(highestelectricalpower) | 100 kW(1000mA at 100kV)80 KW(800 mA at 100 KV)65 KW(650 mA at 100 KV)40 KW(400 mA at 100 KV)27 KW(270 mA at 100 KV) | 100 kW (1000 mA at 100kV) | 30 kW(300mA at 100kV)25 KW(250mA at 100kV) | Similar(SE #2 ) | |
| Digital Radiographic Mode | |||||
| RadiographicmA (Max.) | 1-1000 mA | 1-1000 mA | 1-300 mA | Same aspredicatedevice | |
| RadiographicKV | 40-125 | 40-125 | 40-120 | Same asPredicateDevice | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| Fluoroscopic Mode | |||||
| FluoroscopicmA | Pulsed 200 mA max | Pulsed 200 mA max | Pulsed 300 mA max | Same asPredicateDevice | |
| FluoroscopicKV | 40-125 | 40-125 | 40-120 | Same asPredicateDevice | |
| Pulsedfluoroscopy | Upto 30 fps | upto 30 fps | upto 25 fps | Same asPredicateDevice | |
| ABS Control | Yes | Yes | Yes | Same | |
| 6. X-Ray Tube | |||||
| Model | Megalix CAT 125/35/80 125GW | MRC-GS 0508 | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Dual Focus 0.4/0.8 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 8.5° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | Megalix CAT125/15/40/80122 GW | MRC-GS 0508 | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Triple Focus 0.3/0.6/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 12.5° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | E79039X | MRC-GS 0508 | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 2.1 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Dual Focus 0.6/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 11° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | E79030X | MRC-GS 0508 | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Dual Focus 0.6/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Table series(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| Size, mm | -- | (SE #3) | |||
| Anode Angle | 11° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | E79016X | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Triple Focus 0.3/ 0.6/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 11° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | G2090TRI | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 2 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Triple Focus 0.3/ 0.6/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 12° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | G1582BI | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 1.5 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Triple Focus 0.3/ 0.6/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 10° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | G1082 | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 1 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Dual Focus 0.3/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 10° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | G1092 | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 1 MHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| Focal SpotSize, mm | Dual Focus 0.6/1.2 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar(SE #3) | |
| Anode Angle | 12° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | RAD-15 | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 365 KHU | 2.4 MHU | 365 KHU | Same asReferenceDevice | |
| Focal SpotSize, mm | Dual Focus 0.3/0.6 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Same asReferenceDevice | |
| Anode Angle | 10° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | RAD-99 / RAD-99B | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 300 KHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Dual Focus 0.3/0.6 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Same asReferenceDevice | |
| Anode Angle | 10° | 9° | -- | Similar(SE #3) | |
| Optional | |||||
| Model | A-145 | MRC-GS 0508 | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anodeheat storage | 300 KHU | 2.4 MHU | 365 KHU | Similar(SE #3) | |
| Focal SpotSize, mm | Dual Focus 0.3/0.6 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Same asReferenceDevice | |
| Anode Angle | 10° | 9° | -- | Similar(SE #3) | |
| 7. Solid State X-Ray Image Detectors | |||||
| Make | Thales, Pixium Surgical2121S-A | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same asReferencedevice | |
| Active Area | 21 cm x 21 cm | 21 cm x21 cm | 19.9 cm x 19.9 cm | Same aspredicatedevice | |
| Pixel Matrix | 1,344 x 1,344 | 1,344 x 1,344 | 1,024 x 1,024 | Same aspredicate | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| DQE | 77 % at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Same aspredicatedevice | |
| ModulationTransferFunction (MTF)at 1lp/mm | 59% | 59% | 55% | Same aspredicatedevice | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 154 μm | 154 μm | 194 μm | Same aspredicatedevice | |
| Optional | |||||
| Make | Varex's, Paxscan 4343DXV | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same asReferencedevice | |
| Active Area | 42.7cm x 42.7cm | 38 cm x 30 cm | 29.8 cm x 29.8 cm | Similar(SE #4) | |
| Pixel Matrix | 3,072 x 3,072 | 2,480 x 1,920 | 1,536 x 1,536 | Similar(SE #4) | |
| DQE | 78% at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 54% | 60% | 55% | Similar(SE #4) | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 139μm | 154 μm | 194 μm | Similar(SE #4) | |
| Optional | |||||
| Make | Varex's, Paxscan 3030 DXV | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same asReferencedevice | |
| Active Area | 29.8 cm x 29.8 cm | 29 cm x26 cm | 29.8 cm x 29.8 cm | Same asReferencedevice | |
| Pixel Matrix | 1,536 x 1,536 | 1,560 x 1,440 | 1,536 x 1,536 | Same asReferencedevice | |
| DQE | 80% at 0lp/mm | 70% at 0lp/mm | 80% at 0lp/mm | Same asReferencedevice | |
| ModulationTransfer | 55% | 59% | 55% | Same asReference | |
| Feature | Cardiova scularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableserie s(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| Function (MTF)at 11p/mm | device | ||||
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 194 µm | 184 µm | 194 µm | Same asReferencedevice | |
| Optional | |||||
| Make | Varex's , Paxscan 2020 DXV | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same asReferencedevice | |
| Active Area | 19.9 cm x 19.9 cm | 21 cm x 21 cm | 19.9 cm x 19.9 cm | Same asReferencedevice | |
| Pixel Matrix | 1,024 x 1,024 | 1,344 x 1,344 | 1,024 x 1,024 | Same asReferencedevice | |
| DQE | 80% at 0lp/mm | 77% at 01p/mm | 80% at 01p/mm | Same asReferencedevice | |
| ModulationTransferFunction (MTF)at 1lp/mm | 55% | 59% | 55% | Same asReferencedevice | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 194 µm | 154 µm | 194 µm | Same asReferencedevice | |
| Optional | |||||
| Make | IRAY 's, Mercu 0909F | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | -- | |
| Active Area | 22.9 cm x 22.9 cm | 21 cm x 21 cm | 19.9 cm x 19.9 cm | Similar(SE #4) | |
| Pixel Matrix | 1,024 x 1,024 | 1,344 x 1,344 | 1,024 x 1,024 | Same asReferenceDevice | |
| DQE | 77% at 01p/mm | 77% at 0lp/mm | 80% at 0lp/mm | Same asPredicatedevice | |
| ModulationTransferFunction (MTF)at 1lp/mm | 61% | 59% | 55% | Similar(SE #4) | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 205 um | 154 µm | 194 µm | Similar | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| (SE #4) | |||||
| Optional | |||||
| Make | Thales, Pixium 2121S-AU | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same asReferencedevice | |
| Active Area | 20.5 cm x 20.5 cm | 21 cm x 21 cm | 19.9 cm x 19.9 cm | Similar(SE #4) | |
| Pixel Matrix | 1,024 x 1,024 | 1,344 x 1,344 | 1,024 x 1,024 | Same asReferenceDevice | |
| DQE | 78 % at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 53 % | 59% | 55% | Similar(SE #4) | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 200 μm | 154 μm | 194 μm | Similar(SE #4) | |
| Optional | |||||
| Make | MX CFP 2222 | -- | -- | -- | |
| Type | CMOS | -- | Amorphous Silicon | Similar(SE #4) | |
| Active Area | 21.7 cm x 21.7 cm | 21 cm x 21 cm | 29.8 cm x 29.8 cm | Similar(SE #4) | |
| Pixel Matrix | 2,170 x 2,170 | 1,344 x 1,344 | 1,536 x 1,536 | Similar(SE #4) | |
| DQE | 72% at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 60% | 59% | 55% | Similar(SE #4) | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 100 μm | 154 μm | 194 μm | Similar(SE #4) | |
| Optional | |||||
| Make | MX CFP 3131 | -- | -- | -- | |
| Type | CMOS | -- | Amorphous Silicon | Similar(SE #4) | |
| Active Area | 30.9 cm x 30.7 cm | 29 cm x 26 cm | 29.8 cm x 29.8 cm | Similar(SE #4) | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| DQE | 72% at 0lp/mm | 70% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 60% | 59% | 55% | Similar(SE #4) | |
| A/DConversion | 14 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 99 µm | 184 µm | 194 µm | Similar(SE #4) | |
| Optional | |||||
| Make | Thales, Pixium Surgical3030S-A | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same asReferenceDevice | |
| Active Area | 30.1 cm x 30.1 cm | 29 cm x 26 cm | 29.8 cm x 29.8 cm | Similar(SE #4) | |
| Pixel Matrix | 1,956 x 1,956 | 1,560 x 1,440 | 1,536 x 1,536 | Similar(SE #4) | |
| DQE | 75 % at 0lp/mm | 70% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 59% | 59% | 55% | Same asPredicateDevice | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 154 µm | 184 µm | 194 µm | Similar(SE #4) | |
| Optional | |||||
| Make | Thales, Pixium 3030S-AU | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same asReferenceDevice | |
| Active Area | 30 cm x 30 cm | 29 cm x 26 cm | 19.9 cm x 19.9 cm | Similar(SE #4) | |
| Pixel Matrix | 1,536 x 1,536 | 1,560 x 1,440 | 1,024 x 1,024 | Similar(SE #4) | |
| DQE | 78 % at 0lp/mm | 70% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 59% | 59% | 55% | Same asPredicatedevice | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 200 µm | 184 µm | 194 µm | Similar | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| (SE #4) | |||||
| Optional | |||||
| Make | Allengers, FP 2121RF | -- | -- | -- | |
| Type | Amorphous Silicon TFT/PDmatrix panel | -- | Amorphous Silicon | -- | |
| Active Area | 21 cm x 21 cm | 21 cm x 21 cm | 19.9 cm x 19.9 cm | Same asPredicateDevice | |
| Pixel Matrix | 1,024 x 1,024 | 1,344 x 1,344 | 1,024 x 1,024 | Same asReferenceDevice | |
| DQE | 77% at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Same asPredicatedevice | |
| ModulationTransferFunction (MTF)at 1lp/mm | 61% | 59% | 55% | Similar(SE #4) | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 205 μm | 154 μm | 194 μm | Similar(SE #4) | |
| Optional | |||||
| Make | Allengers, FP 2121HR | -- | -- | -- | |
| Type | Amorphous Silicon TFT/PDmatrix panel | -- | Amorphous Silicon | -- | |
| Active Area | 21.3 cm x 21.3 cm | 21 cm x 21 cm | 19.9 cm x 19.9 cm | Similar(SE #4) | |
| Pixel Matrix | 1,536 x 1,536 | 1,344 x 1,344 | 1,024 x 1,024 | Similar(SE #4) | |
| DQE | 73% at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 61% | 59% | 55% | Similar(SE #4) | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 139 μm | 154 μm | 194 μm | Similar(SE #4) | |
| Optional | |||||
| Make | Allengers, FP 3030 HR | -- | -- | -- | |
| Type | Amorphous Silicon TFT/PDmatrix panel | -- | Amorphous Silicon | Same asReferencedevice | |
| Feature | CardiovascularAngiography System(Subject Device) | Allura Xper FD Seriesand Allura Xper OR Tableseries(Predicate Device) | Ziehm Vision RFD(Reference Device) | Justificationfordifferences | |
| Pixel Matrix | 2,048 x 2,048 | 1,560 x 1,440 | 1,536 x 1,536 | Similar(SE #4) | |
| DQE | 67% at 0lp/mm | 70% at 0lp/mm | 80% at 0lp/mm | Similar(SE #4) | |
| ModulationTransferFunction (MTF)at 1lp/mm | 55% | 59% | 55% | Same asReferencedevice | |
| A/DConversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 150 μm | 184 μm | 194 μm | Similar(SE #4) | |
| 8. | Ceiling Suspension Viewing Monitors | ||||
| Size, in (Min)(ExaminationRoom) | 55" | 58" | N/A | Similar(SE #5) | |
| Size, in (Min)(ConsoleRoom) | 19" | 18" | N/A | Similar(SE #5) | |
| Touch Screen | Yes | Yes | N/A | Same asPredicatedevice | |
| 9. | Image Processing and storage | ||||
| Imaging Mode | • Pulsed Fluoroscopy• Digital Spot | • Pulsed Fluoroscopy• Digital Spot | • PulsedFluoroscopy• Digital Spot | Same | |
| Video storagetype | Internal HDD drive, USB,CD/DV D-RW drive | Internal HDD drive, USB,CD/DV D-RW drive | Internal HDD drive,USB,CD/DV D-RW drive | Same | |
| ImageInterference | Detector Dependant | Detector Dependant | Detector Dependant | Same | |
| LIH | Yes | Yes | Yes | Same | |
| Dicomconformance | Yes | Yes | Yes | Same | |
| PACSInterfaces | Ethernet or WLAN | Ethernet or WLAN | Ethernet or WLAN | Same | |
| Hard copydevices | Printer and DICOM print | Printer and DICOM print | Printer and DICOMprint | Same | |
| 10. Power Requirement | |||||
| PowerRequirement | 400 VAC, (±10%) 50/60 Hz(Except 40KW & 27KW machines )110/230 VAC, (±10%) ,50/60 Hz(For 40KW & 27KW machines ) | 400 VAC, (±10%) 50/60Hz | 110/240 VAC, (±10%)50/60 Hz | Essentiallythe Same aspredicate &referencedevice |
Table 3: Functional and specification differences
3 Where XX may be 80/65/40/27 and YY may be 43/30/20
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Difference Discussion
| SE-# | Substantial Equivalence discussion |
|---|---|
| SE#1& #2 | #1 & #2The subject device provides with different X-Ray Generators perform similar orbetter compared to predicate and Reference device in terms of performancespecification. For XGEN-100CV, the performance specification is almost identical topredicate device in terms of kV and tube current. For XGEN-80CV, XGEN-65CV,XGEN-40CV & XGEN-27CV, the generator capacity is sufficient to meet thefluoroscopic and digital radiographic exposure requirements and have highermaximum power output as compare to Reference device. Such differences inperformance do not raise additional risk concerns. |
| SE#3 | #3There are many X-Ray tubes available due to equipment design considerations. Thetubes were tested and information is included in the Operator and Service Manuals.Any differences between the subject device and predicate & reference device do notchange or add new potential safety risks. Therefore, it is our determination thatthere is "No impact on safety or efficacy" and there are no new potential orincreased safety risks concerning this difference. |
| SE#4 | #4The Subject device utilized different Solid State X-Ray Image Detectors (FPD) ascompare to predicate device Allura Xper FD Series and Allura Xper OR Table series(K162859) & reference device Ziehm Vision RFD (K203428), however Detectortechnology is comparable to predicate device and reference device as per the SSXIGuidance document .The FPD used along with subject device are already clearedby FDA and does not raise the level of safety concern and affect any effectiveness.The relevant 510(k) approval numbers are K171755, K183040 K172822 andK200218. |
| SE #5 | #5The Cardiovascular Angiography System utilized monitors with same resolution asthe predicate device Allura Xper FD Series and Allura Xper OR Table series(K162859) and Reference device Ziehm Vision RFD (K203428), however the screensize is slightly bigger. Therefore it is our determination that there is "No impact onsafety or efficacy" and there are no new potential or increased safety risksconcerning this difference. |
10. Technological characteristics comparison to predicate & Reference device:
The indications for use, operating principle, technical specifications such as X-Rav tube head and generator as well as safety characteristics of Cardiovascular Angiography system models are identical to those of the predicate & reference device. This System is designed as a set of components (X-Ray tube and housing, detector, digital imaging system, collimator, generator etc.) similar to the predicate device Allura Xper FD Series and Allura Xper OR Table series (K162859) and Reference device Ziehm Vision RFD (K203428). Based on the recognized standard conformity evidences related to electro-mechanical, software-, and risk management, Allengers Medical Systems certifies that technological characteristics of Cardiovascular Angiography system models are substantially equivalent to Allura Xper FD Series and Allura Xper OR Table series (K162859), the predicate device and Ziehm Vision RFD (K203428) the reference device.
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11. Performance Testing
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. Performance testing included functional testing of all motions systems with respect to design specifications. Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k) for Solid state X-Ray imaging devices (SSXI); Demonstration of system performance and an Imaging performance evaluation. Safety compliance checking was evaluated according to IEC 60601-1: 2005/ A1:2012. Allengers Medical Systems Ltd certifies conformance to Voluntary standards covering electrical and Mechanical safety.
In conclusion, the identified risk of electrical hazards was mitigated and it is the Allengers opinion that Cardiovascular Angiography system appears to be as safe and effective as predicate & reference device.
12. Software Features and Testing:
Software Documentation for a Moderate Level of concern software per FDA's Guidance document "Guidance for the Content of Premarket Submission for software contained in Medical Device" is also included as part of this submission.
13. Description of Non Clinical & Clinical testing
Non Clinical performance testing has been performed on the Cardiovascular Angiography system and it demonstrates compliance with the following 21 CFR Federal Performance Standards:
- . 1020.30 Diagnostic X-Ray Systems and their major components
- 1020.32 Fluoroscopic equipment ●
- 1040.10 Laser products
and with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| RecognitionNumber | ProductArea | Title of standard | ReferenceNumber anddate | StandardDevelopmentorganization |
|---|---|---|---|---|
| 19-4 | General | Medical Electrical Equipment -Part 1: General requirements forbasic safety and essentialperformance | 60601-1:2012,ed. 3.1 | IEC |
| 19-8 | General | Medical electrical equipment - Part1-2: General requirements for basicsafety and essential performance -Collateral Standard:Electromagnetic Compatibility -Requirements and tests | 60601-1-2Edition 4.02014-02 | IEC |
| 12-269 | Radiology | Medical Electrical Equipment Part1-3: General Requirements forBasic Safety and EssentialPerformance. -Collateral Standard:Radiation Protection in DiagnosticX-Ray Equipment. | 60601-1-3Edition 2.12013-04 | IEC |
| 12-308 | Radiology | Particular requirements for thesafety of X-Ray equipment forinterventional procedures | 60601-2-43Edition 2.1,2017 | IEC |
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| 12-296 | Radiology | Medical Electrical Equipment- Part2-54: Particular Requirements forthe Basic Safety and EssentialPerformance of X-Ray Equipmentfor Radiography and Radioscopy | 60601-2-54,(Edition 1.12015). | IEC |
|---|---|---|---|---|
| 13-79 | General | Medical device software - Softwarelife cycle processes | 62304 (Edition1.1, 2015) | IEC |
| 5-89 | General | Medical Electrical Equipment Part1-6: General Requirements• forBasic Safety and EssentialPerformance- Collateral Standard:Usability | 60601-1-6,(Edition 3.12013). | IEC |
| 5-114 | General | Application of Usability Engineeringto Medical Devices | 62366-1 Edition1.0 2015-02 | IEC |
| 5-40 | General I(QS/RM) | Medical devices – application ofrisk management to medicaldevices | 14971 SecondEdition 2007-03 | ISO |
| 12-273 | Radiology | Safety of laser products - Part 1:Equipment classification, andrequirements | 60825-1 Edition2.02007-03 | IEC |
Table 4: FDA Guidance Documents
| FDA Guidance Documents and Effective Date | |
|---|---|
| 1 | Guidance for Industry and FDA Staff – User Fees and Refunds for PremarketNotification Submissions 510(k)Document issued on October 2, 2017 |
| 2 | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policyfor 510(k)sDocument issued on September 13, 2019. |
| 3 | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s -Guidance for Industry and FDA StaffDocument issued on September 13, 2019. |
| 4 | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications [510(k)]Document Issued on July 28, 2014 |
| 5 | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for SolidState X-ray Imaging DevicesDocument issued on September 1, 2016 |
| 6 | Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical DevicesDocument issued on May 11, 2005 |
| 7 | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use inMedical DevicesDocument issued on September 27, 2019. |
| 8 | Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016 |
| 9 | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging DevicePremarket Notifications.Document issued on November 28, 2017 |
| 10 | Guidance for Industry and FDA Staff: Content of Premarket Submissions formanagement of Cybersecurity in Medical devices.Document issued on October 2, 2014. |
| 11 | Guidance for Industry and FDA Staff: Information to Support a Claim of ElectromagneticCompatibility (EMC) of Electrically-Powered Medical DevicesDocument issued on July 11, 2016 |
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Non-clinical verification test results demonstrate that the Cardiovascular Angiography system complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents. Also No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Bench testing was performed to assess the device safety and effectiveness.
14. Substantial Equivalence Conclusion:
Cardiovascular Angiography system does not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The subject device is substantially equivalent to the Allura Xper FD Series and Allura Xper OR Table series (K162859). The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate & reference device. Some characteristics, for example, their appearance, the user interfaces and the physical dimensions are different. However, the performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the Allengers opinion that the subject device appears to be as safe and effective as the predicate & reference 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.