(167 days)
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.
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.
The provided text does not describe acceptance criteria for an AI/ML powered device, nor does it present a study proving the device meets particular acceptance criteria. The document is a 510(k) summary for the Allengers Medical Systems Limited's Digiscan FDX, a Mobile C-Arm X-Ray System. It focuses on demonstrating substantial equivalence to predicate and reference devices, rather than establishing direct performance against specific acceptance criteria for an AI component.
However, based on the provided text, I can infer some aspects of performance testing and equivalence argument:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table format for performance. Instead, it compares detailed technical specifications of the "Digiscan FDX (Subject Device)" against a "Ziehm Vision RFD (Predicate Device)" and "OEC Elite" and "Cios Fusion" (Reference Devices). The "Discussion of Difference" column informally indicates whether the subject device's performance characteristics are considered "Same," "Similar," or have "No impact on safety or efficacy."
Here's a summary of the comparisons, which serve as the de-facto "performance evaluation" in this substantial equivalence submission:
| Feature | Acceptance Criteria (Predicate/Reference) | Reported Device Performance (Digiscan FDX) | Discussion of Difference/Conclusion |
|---|---|---|---|
| Product Code | OXO, OWB, JAA | OXO, OWB, JAA | Same |
| Product Classification | 21 CFR 892.1650 | 21 CFR 892.1650 | Same |
| Indication for Use | General fluoroscopic imaging (orthopedic, GI, etc.) | General fluoroscopic imaging (orthopedic, Fertility, GI, etc.) | Essentially the same. No differences concerning indication and intended use. |
| X-Ray Generator Type | Monoblock and High Frequency Generator | Monoblock and High Frequency Generator | Same |
| Generator Kilowatt Rating | Predicate: 20 KW (Standard), 7.5KW (Optional); Reference: 15KW, 2.3 KW | Digiscan FDX-V: 15 KWDigiscan FDX-R: 6 KWDigiscan FDX-S: 3.5 KW | Similar (SE #1). Less X-Ray source and capacity. Deemed not to raise additional risk concerns as typical fluoroscopy requires 1 kW or less. |
| Generator KV Min/Max | 40 KV / 120 KV (Predicate/OEC Elite) | 40 KV / 120 KV | Same as Predicate/Reference (OEC Elite). |
| Dose Control System | Yes | Yes | Same |
| Dose Area Product | Yes | Yes | Same |
| X-Ray Tube Type | Rotating Anode (for A-145, RAD 99B), Stationary anode (for KL25, OX/110) | Rotating Anode (A-145, RAD 99B/Hangzhou Wandong), Stationary Anode (Hangzhou Kailong / C.E.I) | Same / Similar (SE #2). Differences do not change or add new potential safety risks. |
| Tube Cooling HU/min | Predicate: 85000 HU/min; OEC Elite: 85000 HU/min; Cios Fusion: 70000 HU/min | Dependent on specific tube model (e.g., 70000 HU/min for A-145, 25000 HU/min for XD56, 3800 HU/min for KL25, 46200 HU/min for OX/110-05) | Similar (SE #2). Differences between subject and predicate/reference devices do not change or add new potential safety risks. |
| Anode Heat Capacity | Predicate: 365 KHU; OEC Elite: 300 KHU; Cios Fusion: 300 KHU | Dependent on specific tube model (e.g., 300 KHU for A-145, 300 KHU for XD56, 42 KHU for KL25, 42 KHU for OX/110-05) | Same as Reference Device OEC Elite / Similar (SE #3). Differences between subject and predicate/reference devices do not change or add new potential safety risks. |
| Focal Spot Size, mm | Dual Focus 0.3/0.6 (Predicate/OEC Elite); Dual Focus 0.6/1.5 (Cios Fusion) | Dual Focus 0.3/0.6 (most models); Dual Focus 0.6/1 (KL25); Dual Focus 0.5/1.4 (OX/110-05) | Same / Similar (SE #5). Differences due to different X-Ray tube manufacturers, deemed to have no impact on safety or efficacy. |
| Max Tube Power Rating, KW | Predicate: 25 KW; OEC Elite: 15 KW; Cios Fusion: 2.3 KW | Dependent on specific tube model (e.g., 25 KW for A-145, 17 KW for XD56, 4 KW for KL25, 4.5 KW for OX/110-05) | Same as Predicate / Similar (SE #4). Differences between subject and predicate/reference devices do not change or add new potential safety risks. |
| Radiographic Mode KV Range | 40-120 KV (Predicate/Reference) | 40-120 KV | Same as Predicate/Reference (OEC Elite). |
| Radiographic Mode mA Range | Ranges from 7.5 KW - 1.5 - 75 mA to 20 KW - 1.5 - 200 mA (Predicate/Reference) | Digiscan FDX-V: 150 mADigiscan FDX-R: 120 mADigiscan FDX-S: 80 mA | Similar (SE #6). Differences in X-Ray current do not raise new safety/effectiveness questions; device passed electrical safety testing. |
| Fluoroscopic Mode KV Range | 40-120 KV (Predicate/Reference) | 40-120 KV | Same as Predicate/Reference (OEC Elite). |
| Pulse Fluoroscopic | Yes | Yes | Same |
| ABS Control | Yes | Yes | Same |
| Snapshot Mode | Yes | Yes | Same |
| Fluoroscopic Max mA Range | 0.2-10 mA to 0.2-30 mA (Predicate/Reference) | 0.2 mA-15 mA (Normal Mode) / 0.2 mA -30 mA (HLF) | Similar (SE #6). Differences in X-Ray current do not raise new safety/effectiveness questions; device passed electrical safety testing. |
| Pulses per second (max) | 1 to 25 / up to 30 (Predicate/Reference) | Up to 15 (15361536), up to 30 (10241024) | Similar (SE #7). Differences do not raise new safety/effectiveness questions; device passed electrical safety testing. |
| Cine (fps) (max) | 1-25 frames/s / up to 30 frames/s (Predicate/Reference) | Up to 15 (15361536), up to 30 (10241024) | Similar (SE #8). Differences do not raise new safety/effectiveness questions; device passed electrical safety testing. |
| Solid State X-Ray Image Detectors Type | Amorphous Silicon, CMOS (Predicate/Reference) | Amorphous Silicon, CMOS | Same as Predicate/Reference (Cios Fusion). Detector technology is comparable; FPDs used are already cleared by FDA. No new safety concerns. |
| Active Area, Limiting Resolution, Pixel Matrix, DQE, MTF, A/D Conversion, Pixel Pitch | Variable across predicate/reference devices; Specific values provided. | Variable across Digiscan FDX FPD options; Specific values provided. | Similar (SE #9). Detector technology is comparable to predicate and reference devices per SSXI Guidance document; FPDs are already FDA cleared. No new safety concerns. |
| Viewing Monitor(s) Size | 19", 27" (Predicate/Reference) | 27" & 32" (Single Monitor); 19" & 21" (Dual Monitors) | Similar (SE #10). Same resolution, larger screen size. No impact on safety or efficacy. |
| Touch Screen | Yes (Predicate/Cios Fusion), No (OEC Elite) | Yes | Same as Predicate Device & Reference Device Cios Fusion. |
| Imaging Mode | Pulsed Fluoroscopy, Digital Spot | Pulsed Fluoroscopy, Digital Spot | Same |
| Video storage type | Internal HDD, USB, CD/DVD | Internal HDD, USB, CD/DVD | Same as Predicate Device & Reference Device Cios Fusion. |
| Image Interference | Detector Dependant | Detector Dependant | Same |
| Capacity Number of Images | Up to 100,000 to 150,000 (Predicate/Reference) | Up to 100,000 | Same as Predicate Device. |
| Image matrix size | 15361536 Pixels, 10241024 Pixels, 1.5K x 1.5K CFD | 15361536 Pixels, 10241024 Pixels | Same as Predicate Device. |
| LIH | Yes | Yes | Same |
| DICOM conformance | Yes | Yes | Same |
| PACS Interfaces | Ethernet or WLAN | Ethernet or WLAN | Same |
| Hard copy devices | Printer, DICOM print, film/thermal printers, USB, CD/DVD | Printer and DICOM print | Same as Predicate Device. |
| Power Requirement | 110/230 Vac, 50/60 Hz | 110/230 Vac, 50/60 Hz | Same |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a dataset for algorithmic evaluation.
- Data Provenance: Not applicable as this is a traditional X-ray system, not an AI/ML device that processes data. The "clinical tests" involved "independent views" on "acquired images" from procedures, but these are not described as a formal 'test set' for an AI algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: "Independent views of Urologist, orthopedic, Gastroenterologists, Neurologist were obtained." The specific number of experts is not quantified (e.g., 2, 3, or more).
- Qualifications: "Urologist, orthopedic, Gastroenterologists, Neurologist." No details on their years of experience or board certification are provided. They are referred to as "radiation experts" within the device description.
- Ground Truth Establishment: Their views confirmed that "the acquired images were of adequate quality for the indicated use." This indicates a qualitative assessment of image quality, not a ground truth for a diagnostic outcome that an AI would predict.
4. Adjudication Method for the Test Set:
- Not applicable in the context of an AI/ML device with an adjudication process. The experts provided "independent views," suggesting no formal adjudication method (like 2+1 or 3+1 consensus) was explicitly described for discrepancy resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of Human Improvement with AI vs. without AI Assistance:
- No, an MRMC comparative effectiveness study involving AI assistance was not conducted or described. This submission is for a conventional X-ray system, not an AI-powered diagnostic tool. The document establishes substantial equivalence based on technical specifications and safety standards, and qualitative clinical assessment of image quality.
6. If a Standalone (Algorithm Only) Performance Study was done:
- No, a standalone (algorithm only) performance study was not done. The device is a fluoroscopic X-ray system, not an AI algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for the device's performance was the qualitative assessment of image adequacy by medical experts. The "acquired images were of adequate quality for the specific view and procedures identified in the IFU," as determined by Urologists, Orthopedists, Gastroenterologists, and Neurologists. This is not a pathology report, an outcome measure, or an expert consensus for a diagnostic AI task.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for an AI/ML component, no ground truth was established for it.
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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 byLaurel M. Burk -S | |
|---|---|---|
| Burk -S | Date: 2020.08.0709:44:10 -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
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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
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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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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, MubarakpurRoad, Derabassi, Distt Mohali-140507, India |
| Telephone No: | +91 1762-282600+919872980168rnd@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 |
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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.
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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-RayImage Detectors | Varex Imaging Digiscan FDX-V | Paxscan 2020 |
| Varex Imaging Digiscan FDX-R | Paxscan 3030 | |
| Varex Imaging Digiscan FDX-S | ||
| Solid State X-RayImage Detectors | IRAY Technology Digiscan FDX-V | |
| IRAY Technology Digiscan FDX-R | Mercu 0909F | |
| IRAY Technology Digiscan FDX-S | ||
| Solid State X-RayImage Detectors | Thales Group Digiscan FDX-V | Pixium 2121S-AU |
| Thales Group Digiscan FDX-R | Pixium Surgical2121S-A | |
| Thales Group Digiscan FDX-S | Pixium Surgical3030S-A | |
| Solid State X-RayImage Detectors | MX Imaging Digiscan FDX-V | |
| MX Imaging Digiscan FDX-R | CFP 2222 | |
| MX Imaging Digiscan FDX-S | CFP 3131 |
Table 2 Combination Details
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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.
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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 ofDifference |
|---|---|---|---|---|---|
| 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 MobileC-Arm X-Ray System, isintended to provideFluoroscopic images of thepatient during diagnostic,surgical procedures. | The ZIEHM VISION RFD isintended for use in providingmedical imaging, using pulsedand continuous fluoroscopicdigital imaging, as well as digitalsubtraction and cine imagecapture during diagnosticinterventional and surgicalprocedures whereintraoperative imaging andvisualization of complexanatomical structures of bothlower and higher contrastdensity are required. Suchprocedures may include but arenot limited to those of | The OEC Elite mobilefluoroscopy system isdesigned to providefluoroscopic anddigital spot images ofadult andpediatric patientpopulations duringdiagnostic,interventional, andsurgical procedures.Examples of a clinicalapplicationmay include:orthopedic,gastrointestinal,endoscopic, urologic,neurologic, vascular,cardiac, critical care,and emergencyprocedures. | The Cios Fusion is amobile X-Ray systemdesigned to provide X-Ray imaging of theanatomical structures ofpatientDuring clinicalapplications. Clinicalapplications mayinclude but are notlimited to: interventionalfluoroscopic,gastrointestinal,endoscopic, urologic,pain management,orthopedic, neurologic,vascular, cardiac,critical care andemergencyroom procedures. Thepatient population mayinclude pediatric | Essentially thesameNote: There are nodifferencesbetweenthe subject deviceand the predicate &reference deviceswith respect toindication andintended use. |
| Indications forUse | Clinical applications mayinclude (but are not limitedto ) orthopaedic, Fertilitystudies (HSG), GIprocedures like endoscopy, neurology, urology,critical care and emergencyroom procedures.Digiscan FDX C-Arm isindicated for visualization inreal time and/or recordingof surgical region of interestand anatomy, using X-Rayimaging technique. | interventional cardiology, heartsurgery, hybrid procedures,interventional radiology,interventional angiography,electrophysiology, pediatrics,endloscopic, |
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| Exclusion: Digiscan FDXis not recommended forMammography. | Contraindications:Exposure of X-Ray shouldbe avoided duringpregnancy. | patients. |
|---|---|---|
| urological, gastroenterology,orthopedic, maxillofacialsurgery, neurology,neurosurgery, critical care,emergency roomprocedures,and those proceduresvisualizing structures of thecervical, thoracic, and lumberregions of the spine and jointfractures of the upper and lowerextremities, and where digitalimage data is required forcomputer aided surgeryprocedures, and whenever theclinician benefits from the highdegree of geometric imagingaccuracy, and where suchfluoroscopic, cine and DSAimaging is required in andaround high magnetic fields.The visualization of suchanatomical structures assiststhe clinician in the clinicaloutcome. At the discretion of aphysician, the device may beused or other imagingapplications.This device does not supportdirect radiographic filmexposures and is not intendedfor use in performingmammography. The system isnot intended for use near MRIsystems. |
Section 5-0
5-0-6
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| 5. X-Ray Generator | |||||||
|---|---|---|---|---|---|---|---|
| Type | Monoblock and HighFrequency Generator | Kilowatt Rating | Monoblock and High FrequencyGenerator | High Frequency splitblock | Monoblock and HighFrequency Generator | Same | |
| Digiscan FDX-VDigiscan FDX-RDigiscan FDX-S | 15KW6KW3.5KW | 20 KW Standard7.5KW 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 PredicateDevice &Reference DeviceOEC Elite | ||
| Dose ControlSystem | Yes | Yes | Yes | Yes | Same | ||
| Dose AreaProduct | Yes | Yes | Yes | Yes | Same | ||
| 6. X-Ray Tube | |||||||
| Model | A-145 | -- | -- | -- | -- | ||
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | NA | Same | ||
| CoolingHU/min | 70000 HU/ min | 85000 HU/min | 85000 HU/min | NA | Similar (SE #2) | ||
| Anode HeatCapacity | 300 KHU | 365 KHU | 300 KHU | NA | Same asReference DeviceOEC Elite. | ||
| Focal SpotSize, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | Same | ||
| MaximumTube PowerRating, KW | 25 KW | 25 KW | 15KW | NA | Same as PredicateDevice |
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| 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
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| 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 | RC |
| 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 |
| nitedimLil |
|---|
| Systems |
| Medical |
| llengers |
| or in the | |||||
|---|---|---|---|---|---|
| ube Type | otating Anoc | AnodeRotating | otating Anod | র্বাম | Same |
| Cooling HU/min | 5000 HU/ mir | HU/mir35000 | 5000 HU/mi | NA | (SE #2Similar |
| 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 #4Similar |
| 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 #2Similar |
| ട് വലിവാഹം പ്രാറ്റലും പുറത്തുക വാഴ്ച്ചുകളുടെ വാറ്റ് വാഴ്ച്ചു ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള പ്ര | 42 KHU | NA | র্বাম | 61.1 KHL | SE #3Similar |
| ual Focus 0.6/ | NA | NA | 0.6 | (SE #5Similar | |
| מורים חיצוניים | 4 KW | রাম | রাম | 2.3 KW | (SE #4Similar |
| Model | X/110-05 | - | -- | -- | |
| ube Type | ationary And | NA | NA | ationary Ano | lame as Reference devic Cios Fusion. _________________________________________________________________________________________________________________________________________ |
Section 5-0
5-0-9
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| Allengers Medical Systems Limited | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CoolingHU/min | 46200 HU/ min | NA | NA | 37300 HU/ min | Similar (SE #2) | Max mA Range | |||||||
| Anode HeatCapacity | 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 SpotSize, 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) | |||
| MaximumTube PowerRating, 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 (15361536) ,upto 30 (10241024) | 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 PredicateDevice &Reference DeviceOEC Elite. | Cine (fps) (max) | Upto 15 (15361536) ,upto 30 (10241024) | 1-25 frames/s | upto 30 frames/s | upto 30 frame/s | Similar (SE #8) | ||
| mA Range | Digiscan FDX-V150 mA | Digiscan FDX-R120 mA | 7.5 KW - 1.5 - 75 mA20 KW - 1.5 - 200 mA | Upto 75 mA | Similar (SE #6) | 9. Solid State X-Ray Image Detectors | |||||||
| Digiscan FDX-S80 mA | Upto 25 mA | Make | Varex's, Paxscan 3030 | -- | -- | ||||||||
| 8. Fluoroscopic Mode | Type | Amorphous Silicon | CMOS | Amorphous Silicon | Same as Predicate Device &Reference DeviceCios Fusion | ||||||||
| KV Range | 40-120 kV | 40-120 KV | 40-120 KV | 40-110 KV | Same as PredicateDevice &Reference DeviceOEC 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 | |||
| Pulsefluoroscopic | 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 & | |||
| SnapshotMode | Yes | Yes | Yes | Yes | Same |
Allengers Medical Systems Limited Diigiscan FDX 510(k)
Section 5-0
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Allengers Medical Systems Limited Diigiscan FDX 510(k)
Section 5-0
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| DQE | 80% at 0lp/mm | 80% at 0lp/mm | 72% | 55% at 1lp/mm | Reference DeviceCios Fusion |
|---|---|---|---|---|---|
| ModulationTransferFunction(MTF) | 55% at 1lp/mm | 55% at 1lp/mm | -- | 55% at 1lp/mm | Same as PredicateDevice &Reference DeviceCios Fusion |
| A/DConversion | 16 bit | 16 bit | 16 bit | 16 bit | Same |
| Pixel Pitch | 194µm | 194µm | 198.0 µm | 194µm | Same as PredicateDevice &Reference DeviceCios Fusion |
| Optional | |||||
| Make | Varex's, Paxscan 2020 | Varex's, Paxscan 2020 | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | CMOS | Amorphous Silicon | Same as PredicateDevice &Reference DeviceCios Fusion |
| Active Area | 199mm (h) x 199mm (v) | 199mm (h) x 199mm (v) | -- | 203mm (h) x 203mm(v) | Same as PredicateDevice |
| Limitingresolution(Max) | 2.58 lp/mm | 2.58 lp/mm | 3.5 lp/mm | 3.1lp/mm | Same as PredicateDevice |
| 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 PredicateDevice &Reference DeviceCios Fusion |
| DQE | 80% at 0lp/mm | 80% at 1lp/mm | 72% | 55% at 1lp/mm | Same as PredicateDevice |
| ModulationTransferFunction(MTF) | 55% at 1lp/mm | 55% at 1lp/mm | -- | 55% at 1lp/mm | Same as PredicateDevice &Reference DeviceCios Fusion |
| VDConversion | 16 bit | 16 bit | 16 bit | 16 bit | Same |
| Pixel Pitch | 194μm | 194µm | 135.3 µm | 194µm | Same as PredicateDevice &Reference DeviceCios 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 |
| ModulationTransferFunction(MTF) | 64% at 1lp/mm | 55% at 1lp/mm | NA | 55% at 1lp/mm | Similar (SE #9) |
| VDConversion | 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) |
| ModulationTransferFunction(MTF) | 53% at 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| VDConversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 200 μm | 194 μm | NA | NA | Similar (SE #9) |
| Optional | |||||
| Make | Thales, Pixium Surgical2121S-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) |
| ModulationTransferFunction(MTF) | 59% at 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| VDConversion | 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 asReference DeviceOEC 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) |
| ModulationTransferFunction(MTF) | 70% at 1lp/mm | 55% at 1lp/mm | Information notavailable | NA | Similar (SE #9) |
| A/DConversion | 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 asReference DeviceOEC 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) |
| ModulationTransferFunction(MTF) | 70% at 1lp/mm | 55% at 1lp/mm | Information notavailable | NA | Similar (SE #9) |
| A/DConversion | 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 Surgical3030S-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
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Section 5-0
5-0-13
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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
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Section 5-0
5-0-16
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| 19" & 21" (In dual Monitors) | |||||
|---|---|---|---|---|---|
| Touch Screen | Yes | Yes | No | Yes | Same as Predicate Device &Reference DeviceCios 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 DeviceCios 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 | 15361536 Pixels10241024 Pixels | 15361536 Pixels10241024 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 | #1Digiscan 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, #4There 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  | #6, #7 & #8The 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 | #09The 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 | #10The 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
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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 ●
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and with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| RecognitionNumber | ProductArea | Title of standard | ReferenceNumber anddate | StandardDevelopmentorganization |
|---|---|---|---|---|
| 19-4 | General | Medical Electrical Equipment- Part 1: Generalrequirements for basic safetyand essential performance | 60601-1:2012,ed. 3.1 | IEC |
| 19-8 | General | Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:ElectromagneticCompatibility - Requirementsand tests | 60601-1-2 Edition4.0 2014-02 | IEC |
| 12-269 | Radiology | Medical Electrical EquipmentPart 1-3: GeneralRequirements for BasicSafety and EssentialPerformance. - CollateralStandard: RadiationProtection in Diagnostic X-Ray Equipment. | 60601-1-3 Edition2.1 2013-04 | IEC |
| 12-204 | Radiology | Medical electrical equipment- Part 2-28: Particularrequirements for the basicsafety and essentialperformance of X-ray tubeassemblies for medicaldiagnosis | 60601-2-28Edition 2.0 2010-03 | IEC |
| 12-308 | Radiology | Particular requirements forthe safety of X-Rayequipment for interventionalprocedures | 60601-2-43Edition 2.1, 2017 | IEC |
| 12-296 | Radiology | Medical ElectricalEquipment- Part 2-54:Particular Requirements forthe Basic Safety andEssential Performance of X-Ray Equipment forRadiography andRadioscopy | 60601-2-54,(Edition 1.12015). | IEC |
| 13-79 | General | Medical device software -Software life cycle processes | 62304 (Edition1.1, 2015) | IEC |
| 5-89 | General | Medical Electrical EquipmentPart 1-6: GeneralRequirements• for BasicSafety and EssentialPerformance- CollateralStandard: Usability | 60601-1-6,(Edition 3.12013). | IEC |
| 5-114 | General | Application of UsabilityEngineering to MedicalDevices | 62366-1 Edition1.0 2015-02 | IEC |
| 5-40 | General I(QS/RM) | Medical devices – applicationof risk management tomedical devices | 14971 SecondEdition 2007-03 | ISO |
| 12-273 | Radiology | Safety of laser products –Part 1: Equipmentclassification, andrequirements | 60825-1 Edition2.02007-03 | IEC |
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Table 4: FDA Guidance Documents
| FDA Guidance Documents and Effective Date | |
|---|---|
| 1 | Guidance for Industry and FDA Staff – User Fees and Refunds for PremarketNotification Submissions 510(k)Document issued on October 2, 2017 |
| 2 | Guidance for Industry and Food and Drug Administration Staff: Refuse to AcceptPolicy for 510(k)sDocument issued on September 13, 2019. |
| 3 | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s- Guidance for Industry and FDA StaffDocument issued on September 13, 2019. |
| 4 | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications [510(k)]Document Issued on July 28, 2014 |
| 5 | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s forSolid State X-ray Imaging DevicesDocument issued on September 1, 2016 |
| 6 | Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical DevicesDocument issued on May 11, 2005 |
| 7 | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use inMedical DevicesDocument issued on September 27, 2019. |
| 8 | Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016 |
| 9 | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging DevicePremarket Notifications.Document issued on November 28, 2017 |
| 10 | Guidance for Industry and FDA Staff: Content of Premarket Submissions formanagement of Cybersecurity in Medical devices.Document issued on October 2, 2014. |
| 11 | Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered Medical DevicesDocument 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.
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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.
§ 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.