Cardiovascular Angiography System

• K Number: K220311
• Device Name: Cardiovascular Angiography System
• Manufacturer: Allengers Medical Systems Limited
• Date Cleared: 2022-05-03 ( 90 days)
• Product Code: OWB JAA OXO
• Regulation Number: 892.1650

Intended 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. Contraindication: Exposure of X-Ray should be avoided during pregnancy.

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: - 1. 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 - 2. Patient Table - 3. Ceiling suspended display(s) - 4. Footswitch for releasing radiation - 5. Control console for controlling the stand, patient table, collimator and imaging system.

Predicate Devices

K162859

Reference Devices

K203428

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and standard imaging functionalities.

Therapeutic

No
The device is used to visualize vascular structures through X-ray imaging, primarily for diagnostic and interventional guidance purposes, not for direct therapeutic treatment.

Diagnostic

Yes
The device is described as a "Cardiovascular Angiography System" that uses X-ray to "visualize the vascular structures of human body" and perform "fluoroscopic & digital radiographic studies." These are diagnostic imaging functions, clearly aiming to acquire information for diagnosis or to guide interventional procedures. The "Intended Use" explicitly mentions "high end investigations" and the "Device Description" states it covers "the complete range of angiographic applications," which are inherently diagnostic in nature for assessing vascular conditions. Furthermore, the performance studies mention compliance with "21 CFR Federal Performance Standards: 1020.30 Diagnostic X-Ray Systems and their major components," directly linking it to diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components, including a C-arm, patient table, display(s), footswitch, and control console, which are integral to the system's function.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
• Device Function: The Cardiovascular Angiography System is an imaging system that uses X-rays to visualize the vascular structures within the human body. It does not analyze samples taken from the body.
• Intended Use: The intended use clearly describes visualizing structures and performing procedures on the patient, not analyzing samples.
• Device Description: The components listed are all related to generating and detecting X-rays and positioning the patient, not to handling or analyzing biological specimens.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Contraindication: Exposure of X-Ray should be avoided during pregnancy.

Product codes

OWB, JAA, OXO

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:

• 1. 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
• 2. Patient Table
• 3. Ceiling suspended display(s)
• 4. Footswitch for releasing radiation
• 5. 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

vascular structures of human body, cardiovascular, Neurovascular

Indicated Patient Age Range

Not Found

Intended User / Care Setting

persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use.
Catheterization labs

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench testing was performed to assess the device safety and effectiveness. 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. No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device.

Key Metrics

Not Found

Predicate Device(s)

K162859

Reference Device(s)

K203428

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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 ([e-mail]) or phone [phone] 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)

K220311

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, Distt
Mohali-140507, India
Telephone No:	[phone]
[phone]
[e-mail]
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 Adv
Digiscan FDX-V8043, Digiscan FDX-V8030, Digiscan FDX-V8020
Digiscan FDX-V6543, Digiscan FDX-V6530, Digiscan FDX-V6520
Digiscan FDX-V4043, Digiscan FDX-V4030, Digiscan FDX-V4020
Digiscan 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 : OWB
Subsequent 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 : OWB
Subsequent 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 : OWB
Subsequent 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:

• 1. 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
• 2. Patient Table
• 3. Ceiling suspended display(s)

2 Where XX may be 80/65/40/27 and YY may be 43/30/20

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• 4. Footswitch for releasing radiation
• 5. 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 FDX
Altima FDX Adv	XGEN-100CV
		Proxima FDX
Altima FDX Adv
X-Ray Generator	Allengers	Digiscan FDX-V8043
Digiscan FDX-V8030
Digiscan FDX-V8020	XGEN-80CV
X-Ray Generator	Allengers	Digiscan FDX-V6543
Digiscan FDX-V6530
Digiscan FDX-V6520	XGEN-65CV
X-Ray Generator	Allengers	Digiscan FDX-V4043
Digiscan FDX-V4030
Digiscan FDX-V4020	XGEN-40CV
X-Ray Generator	Allengers	Digiscan FDX-V2743
Digiscan FDX-V2730
Digiscan FDX-V2720	XGEN-27CV
X-Ray Tube	Siemens
Healthcare
GmbH	Proxima FDX
Altima FDX Adv	Megalix CAT
125/35/80 125 GW
Megalix CAT
125/15/40/80122 GW
X-Ray Tube	Canon
Electron Tubes
and devices	Proxima FDX
Altima FDX Adv	E79039X
E79030X
E79016X
X-Ray Tube	Varex Imaging	Proxima FDX
Altima FDX Adv
Digiscan FDX-V8043
Digiscan FDX-V8030
Digiscan FDX-V8020
Digiscan FDX-V6543
Digiscan FDX-V6530
Digiscan FDX-V6520
Digiscan FDX-V4043
Digiscan FDX-V4030
Digiscan FDX-V4020	G1082, G-1582BI,
G2090, G1092

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| X-Ray Tube | Varex Imaging | Digiscan FDX-V2743
Digiscan FDX-V2730
Digiscan FDX-V2720 | A-145, RAD-99,
RAD-99B, RAD-15 |
|------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Solid State X-
Ray Image
Detectors | Varex Imaging | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8020
Digiscan FDX-V6520
Digiscan FDX-V4020
Digiscan FDX-V2720 | Paxscan 2020 DXV |
| Solid State X-
Ray Image
Detectors | Varex Imaging | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8030
Digiscan FDX-V6530
Digiscan FDX-V4030
Digiscan FDX-V2730 | Paxscan 3030 DXV |
| Solid State X-
Ray Image
Detectors | Varex Imaging | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8043
Digiscan FDX-V6543
Digiscan FDX-V4043
Digiscan FDX-V2743 | Paxscan 4343DXV |
| Solid State X-
Ray Image
Detectors | IRAY
Technology | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8020
Digiscan FDX-V6520
Digiscan FDX-V4020
Digiscan FDX-V2720 | Mercu 0909F |
| Solid State X-
Ray Image
Detectors | Thales Group | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8020
Digiscan FDX-V6520
Digiscan FDX-V4020
Digiscan FDX-V2720 | Pixium 2121S-AU
Pixium Surgical
2121S-A |
| Solid State X-
Ray Image
Detectors | Thales Group | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8030
Digiscan FDX-V6530
Digiscan FDX-V4030
Digiscan FDX-V2730 | Pixium 3030S-AU
Pixium Surgical
3030S-A |
| Solid State X-
Ray Image
Detectors | MX Imaging | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8020 | CFP 2222 |

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| Solid State X-
Ray Image
Detectors | MX Imaging | Digiscan FDX-V6520
Digiscan FDX-V4020
Digiscan FDX-V2720 | |
|------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| | | Digiscan FDX-V8030
Digiscan FDX-V6530
Digiscan FDX-V4030
Digiscan FDX-V2730 | CFP 3131 |
| Solid State X-
Ray Image
Detectors | Allengers | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8020
Digiscan FDX-V6520
Digiscan FDX-V4020
Digiscan FDX-V2720 | FP 2121 RF
FP 2121 HR |
| | | | |
| Solid State X-
Ray Image
Detectors | Allengers | Proxima FDX
Altima FDX Adv
Digiscan FDX-V8030
Digiscan FDX-V6530
Digiscan FDX-V4030
Digiscan FDX-V2730 | FP 3030 HR |
| | | | |
| Patient Table | Allengers | Proxima FDX
Altima FDX Adv | C Tab F FDX
C Tab FXL FDX
C Tab FCV FDX |
| Patient Table | Allengers | Digiscan FDX-V8043
Digiscan FDX-V8030
Digiscan FDX-V8020
Digiscan FDX-V6543
Digiscan FDX-V6530
Digiscan FDX-V6520
Digiscan FDX-V4043
Digiscan FDX-V4030
Digiscan FDX-V4020
Digiscan FDX-V2743
Digiscan FDX-V2730 | C Tab M FDX
Vascu 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 | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| 1. 510(k) | This submission | K162859 | K203428 | | |
| 2. Product Code | | | | | |
| Product
Classification
Code | 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 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. | The Allura Xper series and
the Allura Xper OR Table
series (within the limits of
the used OR table) are
intended for use
on human patients to
perform:
• Vascular, cardiovascular
and neurovascular imaging
applications, including
diagnostic, interventional
and minimally
invasive procedures. This
includes, e.g., peripheral,
cerebral, thoracic and
abdominal angiography, as
well as PTAs, stent
placements, embolisations
and thrombolysis.
• Cardiac imaging
applications including
diagnostics, interventional
and minimally invasive
procedures (such as
PTCA, stent placing,
atherectomies),
pacemaker implantations,
and electrophysiology
(EP). • Non-vascular
interventions such as
drainages, biopsies and
vertebroplasties
procedures.
Additionally:
• The Allura Xper and
Allura Xper OR Table
series is compatible with a
hybrid Operating Room.
• Allura Xper FD10 is
compatible with specified
magnetic navigation
systems.
• Combined with a | The Ziehm Vision RFD
is intended for use in
providing medical
imaging for adult and
pediatric populations,
using pulsed and
continuous fluoroscopic
digital imaging, as well
as digital subtraction
and cine image capture
during diagnostic
interventional and
surgical procedures
where intra-operative
imaging and
visualization of
complex anatomical
structures of both lower
and higher contrast
density are required.
Such procedures may
include but are not
limited to those of
interventional
cardiology, heart
surgery, hybrid
procedures,
interventional
radiology,
interventional
angiography,
electrophysiology,
pediatrics, endoscopic,
urological,
gastroenterology,
orthopedic,
maxillofacial surgery,
neurology,
neurosurgery, critical
care, emergency room
procedures, and those
procedures visualizing
structures of the | Essentially
the same

Note: There
are no
differences
between
the subject
device and
the predicate
with respect
to indication
and intended
use. | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| | | qualified, compatible OR
table, the Allura Xper OR
Table series can be used
for imaging in the Hybrid
OR within the applications
domains Neuro, Vascular,
Non Vascular and Cardiac.
The OR table can also be
used standalone for
surgical use in the OR. | cervical, thoracic, and
lumber regions of the
spine, and joint
fractures of the upper
and lower extremities,
and where digital
image data is required
for computer aided
surgery procedures
and whenever the
clinician benefits from
the high degree of
geometric imaging
accuracy, and where
such fluoroscopic, cine
and DSA imaging is
required. The
visualization of such
anatomical structures
assists the clinician in
the clinical outcome.
This device does not
support direct
radiographic film
exposures and is not
intended for use in
performing
mammography. The
system is not intended
for use near MRI
systems. | | |
| 5. X-Ray Generator | | | | | |
| Type | Microprocessor-controlled,
high frequency converter
generator | Microprocessor-controlled,
high frequency converter
generator | Monoblock and High
Frequency Generator | Same as
Predicate
device | |
| 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
(highest
electrical
power) | 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 100
kV) | 30 kW(300mA at 100
kV)
25 KW(250mA at 100
kV) | Similar
(SE #2 ) | |
| Digital Radiographic Mode | | | | | |
| Radiographic
mA (Max.) | 1-1000 mA | 1-1000 mA | 1-300 mA | Same as
predicate
device | |
| Radiographic
KV | 40-125 | 40-125 | 40-120 | Same as
Predicate
Device | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| Fluoroscopic Mode | | | | | |
| Fluoroscopic
mA | Pulsed 200 mA max | Pulsed 200 mA max | Pulsed 300 mA max | Same as
Predicate
Device | |
| Fluoroscopic
KV | 40-125 | 40-125 | 40-120 | Same as
Predicate
Device | |
| Pulsed
fluoroscopy | Upto 30 fps | upto 30 fps | upto 25 fps | Same as
Predicate
Device | |
| ABS Control | Yes | Yes | Yes | Same | |
| 6. X-Ray Tube | | | | | |
| Model | Megalix CAT 125/35/80 125
GW | MRC-GS 0508 | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anode
heat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, 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 CAT125/15/40/80
122 GW | MRC-GS 0508 | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anode
heat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, 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. anode
heat storage | 2.1 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, 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. anode
heat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, mm | Dual Focus 0.6/1.0 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Similar
(SE #3) | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| 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. anode
heat storage | 3 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, 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. anode
heat storage | 2 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, 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. anode
heat storage | 1.5 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, 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. anode
heat storage | 1 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, 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. anode
heat storage | 1 MHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| Focal Spot
Size, 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. anode
heat storage | 365 KHU | 2.4 MHU | 365 KHU | Same as
Reference
Device | |
| Focal Spot
Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Same as
Reference
Device | |
| 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. anode
heat storage | 300 KHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Same as
Reference
Device | |
| Anode Angle | 10° | 9° | -- | Similar
(SE #3) | |
| Optional | | | | | |
| Model | A-145 | MRC-GS 0508 | -- | | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Same | |
| Max. anode
heat storage | 300 KHU | 2.4 MHU | 365 KHU | Similar
(SE #3) | |
| Focal Spot
Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.5/0.8 | Dual Focus 0.3/0.6 | Same as
Reference
Device | |
| Anode Angle | 10° | 9° | -- | Similar
(SE #3) | |
| 7. Solid State X-Ray Image Detectors | | | | | |
| Make | Thales, Pixium Surgical
2121S-A | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same as
Reference
device | |
| Active Area | 21 cm x 21 cm | 21 cm x21 cm | 19.9 cm x 19.9 cm | Same as
predicate
device | |
| Pixel Matrix | 1,344 x 1,344 | 1,344 x 1,344 | 1,024 x 1,024 | Same as
predicate | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| DQE | 77 % at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Same as
predicate
device | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 59% | 59% | 55% | Same as
predicate
device | |
| A/D
Conversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 154 μm | 154 μm | 194 μm | Same as
predicate
device | |
| Optional | | | | | |
| Make | Varex's, Paxscan 4343DXV | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same as
Reference
device | |
| 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) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 54% | 60% | 55% | Similar
(SE #4) | |
| A/D
Conversion | 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 as
Reference
device | |
| Active Area | 29.8 cm x 29.8 cm | 29 cm x26 cm | 29.8 cm x 29.8 cm | Same as
Reference
device | |
| Pixel Matrix | 1,536 x 1,536 | 1,560 x 1,440 | 1,536 x 1,536 | Same as
Reference
device | |
| DQE | 80% at 0lp/mm | 70% at 0lp/mm | 80% at 0lp/mm | Same as
Reference
device | |
| Modulation
Transfer | 55% | 59% | 55% | Same as
Reference | |
| Feature | Cardiova scular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
serie s
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| Function (MTF)
at 11p/mm | | | | device | |
| A/D
Conversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 194 µm | 184 µm | 194 µm | Same as
Reference
device | |
| Optional | | | | | |
| Make | Varex's , Paxscan 2020 DXV | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same as
Reference
device | |
| Active Area | 19.9 cm x 19.9 cm | 21 cm x 21 cm | 19.9 cm x 19.9 cm | Same as
Reference
device | |
| Pixel Matrix | 1,024 x 1,024 | 1,344 x 1,344 | 1,024 x 1,024 | Same as
Reference
device | |
| DQE | 80% at 0lp/mm | 77% at 01p/mm | 80% at 01p/mm | Same as
Reference
device | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 55% | 59% | 55% | Same as
Reference
device | |
| A/D
Conversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 194 µm | 154 µm | 194 µm | Same as
Reference
device | |
| 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 as
Reference
Device | |
| DQE | 77% at 01p/mm | 77% at 0lp/mm | 80% at 0lp/mm | Same as
Predicate
device | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 61% | 59% | 55% | Similar
(SE #4) | |
| A/D
Conversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 205 um | 154 µm | 194 µm | Similar | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| | | | | (SE #4) | |
| Optional | | | | | |
| Make | Thales, Pixium 2121S-AU | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same as
Reference
device | |
| 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 as
Reference
Device | |
| DQE | 78 % at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Similar
(SE #4) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 53 % | 59% | 55% | Similar
(SE #4) | |
| A/D
Conversion | 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) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 60% | 59% | 55% | Similar
(SE #4) | |
| A/D
Conversion | 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 | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| DQE | 72% at 0lp/mm | 70% at 0lp/mm | 80% at 0lp/mm | Similar
(SE #4) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 60% | 59% | 55% | Similar
(SE #4) | |
| A/D
Conversion | 14 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 99 µm | 184 µm | 194 µm | Similar
(SE #4) | |
| Optional | | | | | |
| Make | Thales, Pixium Surgical
3030S-A | -- | -- | -- | |
| Type | Amorphous Silicon | -- | Amorphous Silicon | Same as
Reference
Device | |
| 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) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 59% | 59% | 55% | Same as
Predicate
Device | |
| A/D
Conversion | 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 as
Reference
Device | |
| 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) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 59% | 59% | 55% | Same as
Predicate
device | |
| A/D
Conversion | 16 bit | 16 bit | 16 bit | Same | |
| Pixel Pitch | 200 µm | 184 µm | 194 µm | Similar | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| | | | | (SE #4) | |
| Optional | | | | | |
| Make | Allengers, FP 2121RF | -- | -- | -- | |
| Type | Amorphous Silicon TFT/PD
matrix panel | -- | Amorphous Silicon | -- | |
| Active Area | 21 cm x 21 cm | 21 cm x 21 cm | 19.9 cm x 19.9 cm | Same as
Predicate
Device | |
| Pixel Matrix | 1,024 x 1,024 | 1,344 x 1,344 | 1,024 x 1,024 | Same as
Reference
Device | |
| DQE | 77% at 0lp/mm | 77% at 0lp/mm | 80% at 0lp/mm | Same as
Predicate
device | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 61% | 59% | 55% | Similar
(SE #4) | |
| A/D
Conversion | 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/PD
matrix 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) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 61% | 59% | 55% | Similar
(SE #4) | |
| A/D
Conversion | 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/PD
matrix panel | -- | Amorphous Silicon | Same as
Reference
device | |
| Feature | Cardiovascular
Angiography System
(Subject Device) | Allura Xper FD Series
and Allura Xper OR Table
series
(Predicate Device) | Ziehm Vision RFD
(Reference Device) | Justification
for
differences | |
| 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) | |
| Modulation
Transfer
Function (MTF)
at 1lp/mm | 55% | 59% | 55% | Same as
Reference
device | |
| A/D
Conversion | 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)
(Examination
Room) | 55" | 58" | N/A | Similar
(SE #5) | |
| Size, in (Min)
(Console
Room) | 19" | 18" | N/A | Similar
(SE #5) | |
| Touch Screen | Yes | Yes | N/A | Same as
Predicate
device | |
| 9. | Image Processing and storage | | | | |
| Imaging Mode | • Pulsed Fluoroscopy
• Digital Spot | • Pulsed Fluoroscopy
• Digital Spot | • Pulsed
Fluoroscopy
• Digital Spot | Same | |
| Video storage
type | 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 | |
| Image
Interference | Detector Dependant | Detector Dependant | Detector Dependant | Same | |
| LIH | Yes | Yes | Yes | Same | |
| Dicom
conformance | Yes | Yes | Yes | Same | |
| PACS
Interfaces | Ethernet or WLAN | Ethernet or WLAN | Ethernet or WLAN | Same | |
| Hard copy
devices | Printer and DICOM print | Printer and DICOM print | Printer and DICOM
print | Same | |
| 10. Power Requirement | | | | | |
| Power
Requirement | 400 VAC, (±10%) 50/60 Hz
(Except 40KW & 27KW machines )
110/230 VAC, (±10%) ,
50/60 Hz
(For 40KW & 27KW machines ) | 400 VAC, (±10%) 50/60
Hz | 110/240 VAC, (±10%)
50/60 Hz | Essentially
the Same as
predicate &
reference
device | |

Table 3: Functional and specification differences

3 Where XX may be 80/65/40/27 and YY may be 43/30/20

10

11

12

13

14

15

16

17

18

19

20

Difference Discussion

SE-#	Substantial Equivalence discussion
SE#1
& #2	#1 & #2
The subject device provides with different X-Ray Generators perform similar or
better compared to predicate and Reference device in terms of performance
specification. For XGEN-100CV, the performance specification is almost identical to
predicate device in terms of kV and tube current. For XGEN-80CV, XGEN-65CV,
XGEN-40CV & XGEN-27CV, the generator capacity is sufficient to meet the
fluoroscopic and digital radiographic exposure requirements and have higher
maximum power output as compare to Reference device. Such differences in
performance do not raise additional risk concerns.
SE#3	#3
There are many X-Ray tubes available due to equipment design considerations. The
tubes were tested and information is included in the Operator and Service Manuals.
Any differences between the subject device and predicate & reference device do not
change or add new potential safety risks. Therefore, it is our determination that
there is "No impact on safety or efficacy" and there are no new potential or
increased safety risks concerning this difference.
SE#4	#4
The Subject device utilized different Solid State X-Ray Image Detectors (FPD) as
compare to predicate device Allura Xper FD Series and Allura Xper OR Table series
(K162859) & reference device Ziehm Vision RFD (K203428), however Detector
technology is comparable to predicate device and reference device as per the SSXI
Guidance document .The FPD used along with subject device are already cleared
by FDA and does not raise the level of safety concern and affect any effectiveness.
The relevant 510(k) approval numbers are K171755, K183040 K172822 and
K200218.
SE #5	#5
The Cardiovascular Angiography System utilized monitors with same resolution as
the predicate device Allura Xper FD Series and Allura Xper OR Table series
(K162859) and Reference device Ziehm Vision RFD (K203428), however the screen
size is slightly bigger. Therefore it is our determination that there is "No impact on
safety or efficacy" and there are no new potential or increased safety risks
concerning 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:

| Recognition
Number | Product
Area | Title of standard | Reference
Number and
date | Standard
Development
organization |
|-----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------|
| 19-4 | General | Medical Electrical Equipment -
Part 1: General requirements for
basic safety and essential
performance | 60601-1:2012,
ed. 3.1 | IEC |
| 19-8 | General | Medical electrical equipment - Part
1-2: General requirements for basic
safety and essential performance -
Collateral Standard:
Electromagnetic Compatibility -
Requirements and tests | 60601-1-2
Edition 4.0
2014-02 | IEC |
| 12-269 | Radiology | Medical Electrical Equipment Part
1-3: General Requirements for
Basic Safety and Essential
Performance. -Collateral Standard:
Radiation Protection in Diagnostic
X-Ray Equipment. | 60601-1-3
Edition 2.1
2013-04 | IEC |
| 12-308 | Radiology | Particular requirements for the
safety of X-Ray equipment for
interventional procedures | 60601-2-43
Edition 2.1,
2017 | IEC |

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| 12-296 | Radiology | Medical Electrical Equipment- Part
2-54: Particular Requirements for
the Basic Safety and Essential
Performance of X-Ray Equipment
for Radiography and Radioscopy | 60601-2-54,
(Edition 1.1
2015). | IEC |
|--------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----|
| 13-79 | General | Medical device software - Software
life cycle processes | 62304 (Edition
1.1, 2015) | IEC |
| 5-89 | General | Medical Electrical Equipment Part
1-6: General Requirements• for
Basic Safety and Essential
Performance- Collateral Standard:
Usability | 60601-1-6,
(Edition 3.1
2013). | IEC |
| 5-114 | General | Application of Usability Engineering
to Medical Devices | 62366-1 Edition
1.0 2015-02 | IEC |
| 5-40 | General I
(QS/RM) | Medical devices – application of
risk management to medical
devices | 14971 Second
Edition 2007-03 | ISO |
| 12-273 | Radiology | Safety of laser products - Part 1:
Equipment classification, and
requirements | 60825-1 Edition
2.0
2007-03 | IEC |

Table 4: FDA Guidance Documents

	FDA Guidance Documents and Effective Date
1	Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket
Notification Submissions 510(k)
Document issued on October 2, 2017
2	Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy
for 510(k)s
Document 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 Staff
Document 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 Solid
State X-ray Imaging Devices
Document issued on September 1, 2016
6	Guidance for Industry and FDA Staff: Guidance for the Content of Premarket
Submission for Software in Medical Devices
Document issued on May 11, 2005
7	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in
Medical Devices
Document issued on September 27, 2019.
8	Guidance for Industry and FDA Staff: Applying Human Factors and Usability
Engineering to Medical Devices.
Document issued February 3, 2016
9	Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device
Premarket Notifications.
Document issued on November 28, 2017
10	Guidance for Industry and FDA Staff: Content of Premarket Submissions for
management of Cybersecurity in Medical devices.
Document issued on October 2, 2014.
11	Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic
Compatibility (EMC) of Electrically-Powered Medical Devices
Document 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.