(167 days)
No
The document describes a standard digital fluoroscopic imaging system and its software, focusing on hardware components, movements, and basic image management. There is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies.
No.
The device is used for diagnostic visualization and recording of images, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures" and the "Device Description" states it is "used in diagnostic."
No
The device description explicitly states that the Digiscan FDX Family is a mobile X-Ray C-Arm fluoroscopic device composed of hardware components including a C-Arm, X-Ray generating equipment, FPD, and workstation. While it includes imaging software, it is not solely software.
Based on the provided information, the Digiscan FDX Family is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing Fluoroscopic images of the patient during diagnostic and surgical procedures. This involves imaging the patient's internal structures using X-rays.
- Device Description: The description details a Mobile C-Arm X-Ray System with components like an X-Ray generator, FPD (Flat Panel Detector), and workstation. These are all components of an imaging system that interacts directly with the patient.
- IVD Definition: In Vitro Diagnostic devices are defined as those intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
The Digiscan FDX Family operates by generating X-rays that pass through the patient's body and are detected to create images. It does not analyze specimens taken from the patient.
Therefore, the Digiscan FDX Family is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures.
Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), GI procedures like endoscopy, neurology, urology, critical care and emergency room procedures.
Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique.
Exclusion: Digiscan FDX Family is not recommended for Mammography.
Contraindications: Exposure of X-Ray should be avoided during pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, OXO
Device Description
The Digiscan FDX Family (Digiscan FDX-V, Digiscan FDX-R and Digiscan FDX-S) are mobile X-Ray C-Arm fluoroscopic device used by radiation experts. Digiscan FDX family is a digital fluoroscopic imaging system with Solid State X-Ray Image Detetors (FPD) used in diagnostic. The device is designed in such a way that it can moved around and can be positioned for the required anatomical/clinical/procedural position.
Digiscan FDX family composed of C-Arm, X-Ray generating equipment (X-Ray controller, high voltage generator, X-Ray tube), FPD, and workstation (Console computer and Monitor(s)). C-Arm unit with generator is capable of movements which are essential for patient positioning, like horizontal travel, orbital movement, vertical movement, wig-wag movement and C rotation. The X-Ray generator, X-Ray control system and collimator controls are housed in the C-Arm unit.
Synergy FDX-CR imaging software is a Digital Imaging System (DIS) designed for C-arm Fluoroscopic Mobile X-Ray System. Synergy FDX-CR imaging software provides useful functions to manage X-Ray images obtained from Digiscan FDX family FPD Fluoroscopic Mobile X-Ray System.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
Surgical region of interest and anatomy. Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), GI procedures like endoscopy, neurology, urology, critical care and emergency room procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiation experts in a clinical setting (diagnostic, surgical procedures, critical care and emergency room).
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
Non Clinical tests were conducted on the subject device Digiscan FDX software version 1.0.0.0 during product development.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)s 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.
Non Clinical performance testing has been performed on the Digiscan FDX machine 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:
- IEC 60601-1:2012, ed. 3.1
- IEC 60601-1-2 Edition 4.0 2014-02
- IEC 60601-1-3 Edition 2.1 2013-04
- IEC 60601-2-28 Edition 2.0 2010-03
- IEC 60601-2-43 Edition 2.1, 2017
- IEC 60601-2-54, (Edition 1.1 2015).
- IEC 62304 (Edition 1.1, 2015)
- IEC 60601-1-6, (Edition 3.1 2013).
- IEC 62366-1 Edition 1.0 2015-02
- ISO 14971 Second Edition 2007-03
- IEC 60825-1 Edition 2.0 2007-03
Independent views of Urologist, orthopedic, Gastroenterologists, Neurologist were obtained on the imaging performances and the acquired images were of adequate quality for the indicated use. The acquired images included examination of the Cardiac, neurology, fluoroscopic loop, Fluoroscopic LIH and Digital spot images. The results of the validation activities confirmed that the device is safe and effective for its intended application.
The Digiscan FDX was found to provide adequate image quality for the specific view and procedures identified in the IFU.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall, Unit II, Bhankarpur, Mubarakpur Road, Derabassi, Distt Mohali, Punjab 140507 INDIA
Re: K200218
Trade/Device Name: Digiscan FDX Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO
Dear Sanjeev Marjara:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 3, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT7: Office of In Vitro Diagnostics and Radiological Health, (301) 796-5933, laurel.burk(@fda.hhs.gov.
Sincerely,
| Laurel M. | Digitally signed by
Laurel M. Burk -S | |
|-----------|------------------------------------------|-----|
| Burk -S | Date: 2020.08.07
09:44:10 -04'00' | For |
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
August 7, 2020
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue letters. The logos are placed side by side.
Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall, Unit II, Bhankarpur, Mubarakpur Road, Derabassi, Distt Mohali, Punjab 140507 INDIA
Re: K200218
Trade/Device Name: Digiscan FDX Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: June 9, 2020 Received: June 15, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
July 15, 2020
2
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 (QS) 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K200218
Device Name
Digiscan FDX
Indications for Use (Describe)
The Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures.
Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), Gl procedures like endoscopy , neurology, urology, critical care and emergency room procedures.
Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique.
Exclusion: Digiscan FDX Family is not recommended for Mammography.
Contraindications: Exposure of X-Ray should be avoided during pregnancy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
✔ | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
(K200218)
This summary of 510(k) is being submitted in accordance with requirements of SMDA1990 and 21 CFR Part 807.92.
1. Contact Person and Address
| Company Name: | Allengers Medical Systems Limited |
|---|---|
| Company Address: | FDA Hall, Unit II, Bhankharpur, Mubarakpur |
| Road, Derabassi, Distt Mohali-140507, India | |
| Telephone No: | +91 1762-282600 |
| +919872980168 | |
| rnd@allengers.net | |
| Contact Person: | Sanjeev K. Marjara |
| Date Prepared: | 11 July 2020 |
2. Proposed Device:
| Device (trade) name: | Digiscan FDX |
|---|---|
| Model Number: | Digiscan FDX-V, Digiscan FDX-R, Digiscan FDX-S |
| Common Name: | Flat Panel Based High Frequency C-Arm Machine |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA, OXO |
3. Predicate Device:
| Device (trade) name: | Ziehim Vision RFD |
|---|---|
| 510(K) Number : | K132904 |
| Clearance Date : | December 05, 2013 |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1650 |
| Device Class : | Class II |
| Product Code: | OWB, JAA, OXO |
4. Reference devices:
Reference Device
| Device (trade) name: | OEC Elite |
|---|---|
| 510(K) Number: | K172550 |
| Clearance Date: | November 16, 2017 |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA, OXO |
5
Reference Device
| Device (trade) name: | Cios Fusion |
|---|---|
| 510(K) Number: | K153244 |
| Clearance Date: | March 7, 2016 |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, 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 | K100102 |
| Varex Imaging corporation - Paxscan 3030 | K113548 |
| MX Imaging – CFP 2222 | K171755 |
| MX Imaging – CFP 3131 | K171755 |
| Thales Group – Pixium Surgical 2121S-A | K183040 |
| Thales Group – Pixium 2121S-AU | -- |
| Thales Group – Pixium Surgical 3030S-A | K172822 |
| Thales Group – Pixium 3030S-AU | -- |
| IRAY Technology – Mercu 0909F | -- |
Table 1 List of Solid State X-Ray Image Detectors
5. Device description:
The Digiscan FDX Family (Digiscan FDX-V, Digiscan FDX-R and Digiscan FDX-S) are mobile X-Ray C-Arm fluoroscopic device used by radiation experts. Digiscan FDX family is a digital fluoroscopic imaging system with Solid State X-Ray Image Detetors (FPD) used in diagnostic. The device is designed in such a way that it can moved around and can be positioned for the required be anatomical/clinical/procedural position.
Digiscan FDX family composed of C-Arm, X-Ray generating equipment (X-Ray controller, high voltage generator, X-Ray tube), FPD, and workstation (Console computer and Monitor(s)). C-Arm unit with generator is capable of movements which are essential for patient positioning, like horizontal travel, orbital movement, vertical movement, wig-wag movement and C rotation. The X-Ray generator, X-Ray control system and collimator controls are housed in the C-Arm unit.
Synergy FDX-CR imaging software is a Digital Imaging System (DIS) designed for C-arm Fluoroscopic Mobile X-Ray System. Synergy FDX-CR imaging software provides useful functions to manage X-Ray images obtained from Digiscan FDX family FPD Fluoroscopic Mobile X-Ray System.
6
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 Digiscan FDX-V | XGEN-15 |
| X-Ray Generator | Allengers Digiscan FDX-R | XGEN-6 |
| X-Ray Generator | Allengers Digiscan FDX-S | XGEN-3.5 |
| X-Ray Tube | Varex Imaging Digiscan FDX-V | A-145 |
| Varex Imaging Digiscan FDX-R | RAD 99 | |
| Varex Imaging Digiscan FDX-R | RAD 99B | |
| X-Ray Tube | Hangzhou Wandong Digiscan FDX-V | XD-56 5/17 |
| Hangzhou Wandong Digiscan FDX-R | ||
| X-Ray Tube | Hangzhou Kailong Digiscan FDX-S | KL25-0.6/1.5-125 |
| X-Ray Tube | C.E.I Digiscan FDX-S | OX/110-0514 |
| Solid State X-Ray | ||
| Image Detectors | Varex Imaging Digiscan FDX-V | Paxscan 2020 |
| Varex Imaging Digiscan FDX-R | Paxscan 3030 | |
| Varex Imaging Digiscan FDX-S | ||
| Solid State X-Ray | ||
| Image Detectors | IRAY Technology Digiscan FDX-V | |
| IRAY Technology Digiscan FDX-R | Mercu 0909F | |
| IRAY Technology Digiscan FDX-S | ||
| Solid State X-Ray | ||
| Image Detectors | Thales Group Digiscan FDX-V | Pixium 2121S-AU |
| Thales Group Digiscan FDX-R | Pixium Surgical | |
| 2121S-A | ||
| Thales Group Digiscan FDX-S | Pixium Surgical | |
| 3030S-A | ||
| Solid State X-Ray | ||
| Image Detectors | MX Imaging Digiscan FDX-V | |
| MX Imaging Digiscan FDX-R | CFP 2222 | |
| MX Imaging Digiscan FDX-S | CFP 3131 |
Table 2 Combination Details
7
6. Indications for Use:
The Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures.
Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), GI procedures like endoscopy, neurology, critical care and emergency room procedures.
Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique.
Exclusion: Digiscan FDX Family is not recommended for Mammography.
Contraindications: Exposure of X-Ray should be avoided during pregnancy.
7. Technological Characteristics Comparison to Predicate & Reference Devices:
The Digiscan FDX family having set of components similar to the Ziehm Vision RFD. OEC Elite and Cios fusion System 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 devices.
8. Software Feature
The software feature set and functions is essentially the same as the predicate & reference devices, with the system complying with DICOM 3.0 specifications .Refer to section 11 Image processing and storage of the following table for a list of top level functions
9. Substantial Equivalence:
The Digiscan FDX Mobile C-Arm X-Ray Machine is substantially equivalent to the commercially available Ziehm Vision RFD (K132904), OEC Elite (K172550) and Cios Fusion (K153244). Functional and specification differences are identifying in the following table.
8
Table 3: Functional and specification differe
| Feature | Digiscan FDX
(Subject Device) | Ziehm Vision RFD
(Predicate Device) | OEC Elite
(Reference Device) | Cios Fusion
(Reference Device) | Discussion of
Difference |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k) | K200218 | K132904 | K172550 | K153244 | |
| 2. Product Code | OXO, OWB, and JAA | OXO, OWB and JAA | OXO, OWB and JAA | OXO, OWB and JAA | Same |
| 3. Product Classification | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | Same |
| 4. Indication for Use | The Digiscan FDX a Mobile
C-Arm X-Ray System, is
intended to provide
Fluoroscopic images of the
patient during diagnostic,
surgical procedures. | The ZIEHM VISION RFD is
intended for use in providing
medical imaging, using pulsed
and continuous fluoroscopic
digital imaging, as well as digital
subtraction and cine image
capture during diagnostic
interventional and surgical
procedures where
intraoperative 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 | The OEC Elite mobile
fluoroscopy system is
designed to provide
fluoroscopic and
digital spot images of
adult and
pediatric patient
populations during
diagnostic,
interventional, and
surgical procedures.
Examples of a clinical
application
may include:
orthopedic,
gastrointestinal,
endoscopic, urologic,
neurologic, vascular,
cardiac, critical care,
and emergency
procedures. | The Cios Fusion is a
mobile X-Ray system
designed to provide X-
Ray imaging of the
anatomical structures of
patient
During clinical
applications. Clinical
applications may
include but are not
limited to: interventional
fluoroscopic,
gastrointestinal,
endoscopic, urologic,
pain management,
orthopedic, neurologic,
vascular, cardiac,
critical care and
emergency
room procedures. The
patient population may
include pediatric | Essentially the
same
Note: There are no
differences
between
the subject device
and the predicate &
reference devices
with respect to
indication and
intended use. |
| Indications for
Use | Clinical applications may
include (but are not limited
to ) orthopaedic, Fertility
studies (HSG), GI
procedures like endoscopy
, neurology, urology,
critical care and emergency
room procedures.
Digiscan FDX C-Arm is
indicated for visualization in
real time and/or recording
of surgical region of interest
and anatomy, using X-Ray
imaging technique. | interventional cardiology, heart
surgery, hybrid procedures,
interventional radiology,
interventional angiography,
electrophysiology, pediatrics,
endloscopic, | | | |
9
| Exclusion: Digiscan FDX
is not recommended for
Mammography. | Contraindications:
Exposure of X-Ray should
be avoided during
pregnancy. | patients. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------|
| urological, gastroenterology,
orthopedic, maxillofacial
surgery, neurology,
neurosurgery, critical care,
emergency roomprocedures,
and those procedures
visualizing structures of the
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 in and
around high magnetic fields.
The visualization of such
anatomical structures assists
the clinician in the clinical
outcome. At the discretion of a
physician, the device may be
used or other imaging
applications.
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. | | |
Section 5-0
5-0-6
10
| 5. X-Ray Generator | |||||||
|---|---|---|---|---|---|---|---|
| Type | Monoblock and High | ||||||
| Frequency Generator | Kilowatt Rating | Monoblock and High Frequency | |||||
| Generator | High Frequency split | ||||||
| block | Monoblock and High | ||||||
| Frequency Generator | Same | ||||||
| Digiscan FDX-V | |||||||
| Digiscan FDX-R | |||||||
| Digiscan FDX-S | 15KW | ||||||
| 6KW | |||||||
| 3.5KW | 20 KW Standard | ||||||
| 7.5KW Optional | 15KW | 2.3 KW | Similar | ||||
| (SE #1) | |||||||
| KV Minimum | 40 KV | 40 KV | 40 KV | 40 KV | Same | ||
| KV Maximum | 120KV | 120 KV | 120KV | 110 KV | Same as Predicate | ||
| Device & | |||||||
| Reference Device | |||||||
| OEC Elite | |||||||
| Dose Control | |||||||
| System | Yes | Yes | Yes | Yes | Same | ||
| Dose Area | |||||||
| Product | Yes | Yes | Yes | Yes | Same | ||
| 6. X-Ray Tube | |||||||
| Model | A-145 | -- | -- | -- | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | NA | Same | ||
| Cooling | |||||||
| HU/min | 70000 HU/ min | 85000 HU/min | 85000 HU/min | NA | Similar (SE #2) | ||
| Anode Heat | |||||||
| Capacity | 300 KHU | 365 KHU | 300 KHU | NA | Same as | ||
| Reference Device | |||||||
| OEC Elite. | |||||||
| Focal Spot | |||||||
| Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | Same | ||
| Maximum | |||||||
| Tube Power | |||||||
| Rating, KW | 25 KW | 25 KW | 15KW | NA | Same as Predicate | ||
| Device |
11
| Optional | Optional | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Model | RAD 99B | -- | -- | RAD 99 | -- | -- | |||||||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | |||||||
| Cooling HU/min | 85280 HU/min | 85000 HU/min | NA | 70000 HU/min | 85000 HU/min | NA | |||||||
| Anode Heat Capacity | 300 KHU | 365 KHU | NA | 300 KHU | 300 KHU | NA | |||||||
| Focal Spot Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | |||||||
| Maximum Tube Power Rating, KW | 22.5 KW | 25 KW | NA | 22.5 KW | 25 KW | NA | |||||||
| Same | Similar (SE #2) | Same | Similar (SE #2) | ||||||||||
| Same as Reference Device OEC Elite. | Same as Reference Device OEC Elite. | ||||||||||||
| Same | Same | ||||||||||||
| Similar (SE #4) | Similar (SE #4) |
Allengers Medical Systems Limited Diigiscan FDX 510(k)
Section 5-0
12
| Allengers Medical Systems Limited | |||||
|---|---|---|---|---|---|
| Model | XD56-5/17/130 | -- | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | NA | S |
| Cooling HU/min | 25000 HU/ min | 85000 HU/min | 85000 HU/min | NA | S |
| Anode Heat Capacity | 300 KHU | 365 KHU | 300 KHU | NA | R |
| C | |||||
| Focal Spot Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | S |
| Maximum Tube Power rating, KW | 17 KW | 25 KW | 15KW | NA | S |
| Optional |
| nited
im
Li
| l |
|---|
| Systems |
| Medical |
| llengers |
| or in the | |||||
|---|---|---|---|---|---|
| ube Type | otating Anoc | Anode | |||
| Rotating | otating Anod | র্বাম | Same | ||
| Cooling HU/min | 5000 HU/ mir | HU/mir | |||
| 35000 | 5000 HU/mi | NA | (SE #2 | ||
| Similar | |||||
| node Hea Capacity | 300 KHL | 365 KHU | 300 KHL | রাম | Same as Reference Devic OEC Elite. |
| Focal Spor Size, mm | ual Focus 0.3/0 | Dual Focus 0.3/0 | ual Focus 0.3/0 | NA | Same |
| ្រព្រែកច្រើន ព្រះពុទ្ធសាសនា ស្រី នារា ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក | 17 KW | 25 KW | 5KW | রাম | (SE #4 |
| Similar | |||||
| Model | .25-0.6/1.5-12 | - | - | - | |
| ube Type | ationary Anod | র্বাম | র | ationary Anod | Same |
| Cooling HU/min | 3800 HU/ mi | NA | NA | 7300 HU/ mir | (SE #2 |
| Similar | |||||
| ട് വലിവാഹം പ്രാറ്റലും പുറത്തുക വാഴ്ച്ചുകളുടെ വാറ്റ് വാഴ്ച്ചു ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള പ്ര | 42 KHU | NA | র্বাম | 61.1 KHL | SE #3 |
| Similar | |||||
| ual Focus 0.6/ | NA | NA | 0.6 | (SE #5 | |
| Similar | |||||
| מורים חיצוניים | 4 KW | রাম | রাম | 2.3 KW | (SE #4 |
| Similar | |||||
| Model | X/110-05 | - | -- | -- | |
| ube Type | ationary And | NA | NA | ationary Ano | lame as Reference devic Cios Fusion. _________________________________________________________________________________________________________________________________________ |
Section 5-0
5-0-9
13
| Allengers Medical Systems Limited | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cooling | |||||||||||||
| HU/min | 46200 HU/ min | NA | NA | 37300 HU/ min | Similar (SE #2) | Max mA Range | |||||||
| Anode Heat | |||||||||||||
| Capacity | 42 KHU | NA | NA | 61.1 KHU | Similar (SE #3) | Digiscan FDX-V | 0.2 mA-15 mA (Normal Mode) | ||||||
| 0.2 mA -30 mA (HLF) | |||||||||||||
| Focal Spot | |||||||||||||
| Size, mm | Dual Focus 0.5/1.4 | NA | NA | 0.6 | Similar (SE #5) | Digiscan FDX-R | 0.2 mA-15 mA (Normal Mode) | ||||||
| 0.2 mA -30 mA (HLF) | 0.2- 10 mA (Normal mode) | ||||||||||||
| 0.2 – 20 mA (HLF) | 3 mA to 25 mA | Similar (SE #6) | |||||||||||
| Maximum | |||||||||||||
| Tube Power | |||||||||||||
| Rating, KW | 4.5 KW | NA | NA | 2.3 KW | Similar (SE #4) | Digiscan FDX-S | 0.2 mA-10 mA (Normal Mode) | ||||||
| 0.2 mA -20 mA (HLF) | |||||||||||||
| 7. Radiographic Mode | Pulses per second (pps) (max) | Upto 15 (1536*1536) , | |||||||||||
| upto 30 (1024*1024) | 1 to 25 | upto 30 | upto 30 | Similar (SE #7) | |||||||||
| KV Range | 40-120 KV | 40-120 KV | 40-120 KV | 40-110 KV | Same as Predicate | ||||||||
| Device & | |||||||||||||
| Reference Device | |||||||||||||
| OEC Elite. | Cine (fps) (max) | Upto 15 (1536*1536) , | |||||||||||
| upto 30 (1024*1024) | 1-25 frames/s | upto 30 frames/s | upto 30 frame/s | Similar (SE #8) | |||||||||
| mA Range | Digiscan FDX-V | ||||||||||||
| 150 mA | Digiscan FDX-R | ||||||||||||
| 120 mA | 7.5 KW - 1.5 - 75 mA | ||||||||||||
| 20 KW - 1.5 - 200 mA | Upto 75 mA | Similar (SE #6) | 9. Solid State X-Ray Image Detectors | ||||||||||
| Digiscan FDX-S | |||||||||||||
| 80 mA | Upto 25 mA | Make | Varex's, Paxscan 3030 | -- | -- | ||||||||
| 8. Fluoroscopic Mode | Type | Amorphous Silicon | CMOS | Amorphous Silicon | Same as Predicate Device & | ||||||||
| Reference Device | |||||||||||||
| Cios Fusion | |||||||||||||
| KV Range | 40-120 kV | 40-120 KV | 40-120 KV | 40-110 KV | Same as Predicate | ||||||||
| Device & | |||||||||||||
| Reference Device | |||||||||||||
| OEC Elite. | Active Area | 298mm (h) x 298mm (v) (11.7 x 11.7 in) | -- | 305mm (h) x 305mm (v) (12 x12 in) | Same as Predicate Device | ||||||||
| Pulse | |||||||||||||
| fluoroscopic | Yes | Yes | Yes | Yes | Same | Limiting resolution (Max) | 2.58 lp/mm | -- | 3.5 lp/mm | Same as Predicate Device | |||
| ABS Control | Yes | Yes | Yes | Yes | Same | Pixel Matrix | 1,536 (h) x 1,536 (v) | 1548 (h) x 1524 (v) | 1536 (h) x 1,536 (v) | Same as Predicate Device & | |||
| Snapshot | |||||||||||||
| Mode | Yes | Yes | Yes | Yes | Same |
Allengers Medical Systems Limited Diigiscan FDX 510(k)
Section 5-0
14
Allengers Medical Systems Limited Diigiscan FDX 510(k)
Section 5-0
15
| DQE | 80% at 0lp/mm | 80% at 0lp/mm | 72% | 55% at 1lp/mm | Reference Device
Cios Fusion |
|---------------------------------------------|------------------------------------|---------------------------------------|------------------------------|--------------------------|------------------------------------------------------------------|
| Modulation
Transfer
Function
(MTF) | 55% at 1lp/mm | 55% at 1lp/mm | -- | 55% at 1lp/mm | Same as Predicate
Device &
Reference Device
Cios Fusion |
| A/D
Conversion | 16 bit | 16 bit | 16 bit | 16 bit | Same |
| Pixel Pitch | 194µm | 194µm | 198.0 µm | 194µm | Same as Predicate
Device &
Reference Device
Cios Fusion |
| Optional | | | | | |
| Make | Varex's, Paxscan 2020 | Varex's, Paxscan 2020 | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | CMOS | Amorphous Silicon | Same as Predicate
Device &
Reference Device
Cios Fusion |
| Active Area | 199mm (h) x 199mm (v) | 199mm (h) x 199mm (v) | -- | 203mm (h) x 203mm
(v) | Same as Predicate
Device |
| Limiting
resolution
(Max) | 2.58 lp/mm | 2.58 lp/mm | 3.5 lp/mm | 3.1lp/mm | Same as Predicate
Device |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | 1536 (h) x 1496 (v) | 1,024 (h) x 1,024 (v) | Same as Predicate
Device &
Reference Device
Cios Fusion |
| DQE | 80% at 0lp/mm | 80% at 1lp/mm | 72% | 55% at 1lp/mm | Same as Predicate
Device |
| Modulation
Transfer
Function
(MTF) | 55% at 1lp/mm | 55% at 1lp/mm | -- | 55% at 1lp/mm | Same as Predicate
Device &
Reference Device
Cios Fusion |
| VD
Conversion | 16 bit | 16 bit | 16 bit | 16 bit | Same |
| Pixel Pitch | 194μm | 194µm | 135.3 µm | 194µm | Same as Predicate
Device &
Reference Device
Cios Fusion |
| Optional | | | | | |
| Make | IRAY 's, Mercu 0909F | Varex, Paxscan 3030 | -- | Varex, Paxscan 3030 | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | Amorphous Silicon | NA |
| Active Area | 228.6mm (h)x228.6mm (v) | 199mm (h) x 199mm (v) | NA | 199mm (h) x 199mm (v) | NA |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | NA | 1,024 (h) x 1,024 (v) | NA |
| DQE | 77% at 0lp/mm | 80% at 1lp/mm | NA | 80% at 1lp/mm | NA |
| Modulation
Transfer
Function
(MTF) | 64% at 1lp/mm | 55% at 1lp/mm | NA | 55% at 1lp/mm | Similar (SE #9) |
| VD
Conversion | 16 bit | 16 bit | NA | 16 bit | Same |
| Pixel Pitch | 205µm | 194μm | NA | 194µm | Similar (SE #9) |
| Optional | | | | | |
| Make | Thales, Pixium 2121S-AU | Varex's, Paxscan 2020 | -- | Varex's, Paxscan 2020 | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | Amorphous Silicon | Same |
| Active Area | 205mm (h) x 205mm (v) | 199mm (h) x 199mm (v) | NA | 199mm (h) x 199mm (v) | Similar (SE #9) |
| | Allengers Medical Systems Limited | | | | |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | NA | NA | Same |
| DQE | 78% at 0lp/mm | 80% at 0lp/mm | NA | NA | Similar (SE #9) |
| Modulation
Transfer
Function
(MTF) | 53% at 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| VD
Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 200 μm | 194 μm | NA | NA | Similar (SE #9) |
| Optional | | | | | |
| Make | Thales, Pixium Surgical
2121S-A | Varex's, Paxscan 2020 | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | NA | Same |
| Active Area | 207mm (h) x 207mm (v) | 199mm (h) x 199mm (v) | NA | NA | Similar (SE #9) |
| Pixel Matrix | 1,344 (h) x 1,344 (v) | 1,344 (h) x 1,024 (v) | NA | NA | Similar (SE #9) |
| DQE | 76% at 0lp/mm | 65% at 1lp/mm | NA | NA | Similar (SE #9) |
| Modulation
Transfer
Function
(MTF) | 59% at 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| VD
Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 154 μm | 194μm | NA | NA | Similar (SE #9) |
| Optional | | | | | |
| Make | MX CFP 2222 | Varex, Paxscan 3030 | -- | -- | -- |
| Type | CMOS | Amorphous Silicon | CMOS | NA | Same as
Reference Device
OEC Elite |
| | Allengers Medical Systems Limited | | | | |
| Active Area | 217mm (h) x 217mm (v) | 199mm (h) x 199mm (v) | NA | | Similar (SE #9) |
| Pixel Matrix | 2170 (h) x 2170 (v) | 1,024 (h) x 1,024 (v) | 1536 (h) x 1496 (v) | NA | Similar (SE #9) |
| DQE | 75% at 0lp/mm | 80% at 1lp/mm | 72% | NA | Similar (SE #9) |
| Modulation
Transfer
Function
(MTF) | 70% at 1lp/mm | 55% at 1lp/mm | Information not
available | NA | Similar (SE #9) |
| A/D
Conversion | 16 bit | 16 bit | 16 bit | NA | Same |
| Pixel Pitch | 100 μm | 194 μm | 135.3 μm | NA | Similar (SE #9) |
| Optional | | | | | |
| Make | MX CFP 3131 | Varex, Paxscan 3030 | -- | -- | -- |
| Type | CMOS | Amorphous Silicon | CMOS | NA | Same as
Reference Device
OEC Elite. |
| Active Area | 309.4mm (h) x 307.2mm (v) | 199mm (h) x 199mm (v) | | NA | Similar (SE #9) |
| Pixel Matrix | 3094 (h) x 3072 (v) | 1,024 (h) x 1,024 (v) | 1536 (h) x 1496 (v) | NA | Similar (SE #9) |
| DQE | 75% at 0lp/mm | 80% at 1lp/mm | 72% | NA | Similar (SE #9) |
| Modulation
Transfer
Function
(MTF) | 70% at 1lp/mm | 55% at 1lp/mm | Information not
available | NA | Similar (SE #9) |
| A/D
Conversion | 14 bit | 16 bit | 16 bit | NA | Similar (SE #9) |
| Pixel Pitch | 100 μm | 194μm | 135.3 µm | NA | Similar (SE #9) |
| Optional | | | | | |
| Make | Thales, Pixium Surgical
3030S-A | Varex Paxscan 3030 | -- | == | -- |
| | Allengers Medical Systems Limited | | | | |
| Type | Amorphous Silicon | Amorphous Silicon | NA | NA | Same |
| Active Area | 301mm (h) x301mm (v) | 298mm (h) x 298mm (v) | NA | NA | Similar (SE #9) |
| Pixel Matrix | 1,956 (h) x 1,956 (v) | 1,536 (h) x 1,536 (v) | NA | NA | Similar (SE #9) |
| DQE | 75% at 0lp/mm | 80% at 0lp/mm | NA | NA | Similar (SE #9) |
| Modulation Transfer Function (MTF) | 59% @ 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| A/D Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 154 μm | 194 μm | NA | NA | Similar (SE #9) |
| Optional | | | | | |
| Make | Thales, Pixium 3030S-AU | Varex Paxscan 3030 | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | NA | Same |
| Active Area | 300mm (h) x300mm (v) | 298mm (h) x 298mm (v) (11.7 x11.7 in) | NA | NA | Similar (SE #9) |
| Pixel Matrix | 1,536 (h) x 1,536 (v) | 1,536 (h) x 1,536 (v) | NA | NA | Same |
| DQE | 78% at 0lp/mm | 80% at 0lp/mm | NA | NA | Similar (SE #9) |
| Modulation Transfer Function (MTF) | 59% @ 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| A/D Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 200 μm | 194μm | NA | NA | Similar (SE #9) |
| 10. Viewing Monitor(s) Size, in | 27" & 32 " (In Single Monitor) | 19" | 27" | 19" | Similar (SE #10) |
Allengers Medical Systems Limited Diigiscan FDX 510(k)
Section 5-0
16
Section 5-0
5-0-13
17
Section 5-0
5-0-14
Allengers Medical Systems Limited Diigiscan FDX 510(k)
Allengers Medical Svstems Limited
18
" -. C -INTE Allo Section 5-0
5-0-15
19
Section 5-0
5-0-16
20
| 19" & 21" (In dual Monitors) | |||||
|---|---|---|---|---|---|
| Touch Screen | Yes | Yes | No | Yes | Same as Predicate Device & |
| Reference Device | |||||
| Cios Fusion. | |||||
| 11. Image Processing and storage | |||||
| Imaging Mode | • Pulsed Fluoroscopy | ||||
| • Digital Spot | • 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 | Digital Memory, USB, | ||||
| HDD | Internal HDD drive, USB, | ||||
| CD/DV D-RW drive | Same as Predicate Device & | ||||
| Reference Device | |||||
| Cios Fusion. | |||||
| Image Interference | Detector Dependant | Detector Dependant | Detector Dependant | Detector Dependant | Same |
| Capacity Number of Images | Upto 100,000 | Upto 100,000 | Upto 50,000 | Upto 150,000 | Same as Predicate Device |
| Image matrix size | 1536*1536 Pixels | ||||
| 1024*1024 Pixels | 1536*1536 Pixels | ||||
| 1024*1024 Pixels | 1.5K x 1.5K CFD | Upto 1.5K x 1.5K | Same as Predicate Device | ||
| LIH | Yes | Yes | Yes | Yes | Same |
| Dicom conformance | Yes | Yes | Yes | Yes | Same |
| PACS Interfaces | Ethernet or WLAN | Ethernet or WLAN | Ethernet | Ethernet or WLAN | Same |
| Hard copy devices | Printer and DICOM print | Printer Pyngaper and/or Film, | |||
| DICOM print | Integrated film/ | ||||
| thermal printers/paper film | USB, CD/DVD, Paper film | Same as Predicate Device | |||
| 12. Power Requirement | |||||
| Power Requirement | 110/230 Vac,(±10%) | ||||
| 50/60 Hz | 110/240 VAC,(±10%) 50/60 Hz | 230/110 Vac,(±10%) | |||
| 50/60 Hz | 110/240 VAC,(±10%) | ||||
| 50/60 Hz | Same |
Section 5-0
5-0-17
510(K)
21
| Difference Discussion | Allengers Medical Systems Limited |
|---|---|
| SE- # | Substantial Equivalence discussion |
| SE #1 | #1 |
| Digiscan FDX Family Fluoroscopic Mobile X-Ray System requires less X-Ray source and therefore less capacity for the X-Ray generator and tube heat storage compared to predicate & reference devices. | |
| Such differences in performance do not raise additional risk concerns. A typical fluoroscopy mode for Predicate & Reference devices and Digiscan FDX family requires the power of 1 kW or less. Therefore, the generator outputs for Digiscan FDX family and predicate & reference devices in fluoroscopy mode is not significantly different. | |
| SE#2, #3, | |
| #4 & #5 | #2, #3, #4 |
| 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 devices 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. | |
| #5 | The focal spot on the X-Ray tube (Stationary anode) is different between the subject device and the Reference device Cios Fusion (K153244). The "focal spot" is the area of the anode surface which receives the beam of electrons from the cathode. The size and shape of the focal spot is determined by the size and shape of the electron beam when it strikes the anode. Size and shape of the electron beam is determined by: dimensions of the filament tungsten coil, construction of the focusing cup, and position of the filament in the focusing cup. Since the subject device and Reference device (i. Cios Fusion K153244) are using different X-Ray tube manufactures, the focal spot is different. The differences between the subject device and reference device (Cios Fusion (K153244) 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#6, #7 & | |
| #8 | #6, #7 & #8 |
| The differences in the X-Ray current produced by the generators made by Allengers do not raise any new questions of safety and effectiveness between the subject and Predicate & reference devices, as the subject device has successfully passed electrical safety testing per IEC 60601-1, and IEC 60601-2-54. | |
| SE#09 | #09 |
| The Subject device utilized different Solid State X-Ray Image Detectors (FPD) as compare to reference devices OEC Elite (K172550) & | |
| Cios Fusion (K153244), however Detector technology is comparable to predicate and reference devices 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 K100102, K113548, K183040, and K172822 & K171755. | |
| SE#10 | #10 |
| The Digiscan FDX family monitor(s) has the same resolution as the predicate & reference devices which were Ziehm Vision RFD (K 132904), OEC Elite (K172550) & Cios Fusion (K153244), however the screen size is similar or 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. |
Section 5-0
22
10. Technological characteristics comparison to predicate & reference devices:
The indications for use, operating principle, technical specifications such as X-Ray tube head and generator as well as safety characteristics of Digiscan FDX family are identical to those of the predicate & reference devices. Digiscan FDX family is designed as a set of components (X-Ray tube and housing, detector, digital imaging system, collimator, generator etc.) similar to the predicate & reference device Ziehm Vision RFD (K132904), OEC Elite (K172550) & Cios Fusion (K153244). Based on the recognized standard conformity evidences related to electro-mechanical, software-, and risk management, Allengers Medical Systems certifies that technological characteristics of Digiscan FDX family are substantially equivalent to Ziehm Vision RFD, OEC Elite and Cios Fusion, the predicate & reference devices.
The Digiscan FDX mobile X-Ray C-Arm is a set of components similar to the predicate & reference devices as compared in table 3 of this 510(K) summary. This table above show that the system are either similar or the same, as the predicate & reference devices..
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)s 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 Digiscan FDX Family appears to be as safe and effective as predicate & reference devices..
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. Non Clinical tests were conducted on the subject device Digiscan FDX software version 1.0.0.0 during product development.
13. Description of Non Clinical tests
Non Clinical performance testing has been performed on the Digiscan FDX machine 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 ●
23
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 |
| 12-204 | Radiology | Medical electrical equipment - Part 2-28: Particular
requirements for the basic
safety and essential
performance of X-ray tube
assemblies for medical
diagnosis | 60601-2-28
Edition 2.0 2010-
03 | IEC |
| 12-308 | Radiology | Particular requirements for
the safety of X-Ray
equipment for interventional
procedures | 60601-2-43
Edition 2.1, 2017 | IEC |
| 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 |
24
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 |
Non-clinical verification test results demonstrate that the Digiscan FDX complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents.
25
14. Description of clinical tests
Independent views of Urologist, orthopedic, Gastroenterologists, Neurologist were obtained on the imaging performances and the acquired images were of adequate quality for the indicated use. The acquired images included examination of the Cardiac, neurology, fluoroscopic loop, Fluoroscopic LIH and Digital spot images. The results of the validation activities confirmed that the device is safe and effective for its intended application.
The Digiscan FDX was found to provide adequate image quality for the specific view and procedures identified in the IFU.
15. Substantial Equivalence Conclusion:
Digiscan FDX Family do not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The Digiscan FDX Family, the subject device is substantially equivalent to the predicate & reference devices, Ziehm Vision RFD (K132904), OEC Elite (K172550) and Cios Fusion (K153244). The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate & reference devices. 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 devices.