(89 days)
Not Found
No. The text describes a medical imaging device (C-arm X-ray) and mentions image processing but does not contain any keywords related to AI, such as "AI," "ML," "machine learning," "deep learning," or "neural network."
No
The device is used for radiological guidance and visualization to assist in diagnostic, interventional, and surgical procedures, not to provide therapy itself. It generates images, which is a diagnostic function.
Yes
The device is used for "radiological guidance and visualization during diagnostic, interventional and surgical procedures," and its technical description details how it acquires and displays radiological images, which are used for diagnostic purposes.
No
The device is explicitly described as a "C-arm mobile unit with flat panel detector" and includes components like an "X-ray generator," "Monitor unit," and "Stand with c-arm." It acquires images using "X-rays emitted by an X-ray source" and a "flat panel detector." While it mentions a "video processor" for image display, the core functionality heavily relies on physical hardware that produces and captures X-ray images, making it a hardware medical device, not software-only.
No.
This device is an X-ray imaging system used for radiological guidance and visualization. It does not perform tests on specimens derived from the human body.
N/A
Intended Use / Indications for Use
PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device.
Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.
Product codes
OWB, OXO
Device Description
PERSONA C HR is a C-arm mobile unit with flat panel detector.
It allows imaging under the following modes:
- Low Dose Fluoroscopy,
- High Quality Fluoroscopy,
- High Quality + Fluoroscopy
- Digital radiography (Snapshot),
- Fluoroscopy in Road Mapping mode (optional),
- Fluoroscopy in DSA mode (optional).
It is provided with a 30x30 cm Flat Panel detector and a 25 kW X-ray generator.
The unit is composed of: Monitor unit, Stand with c-arm, X-ray commands, Printer (optional).
The device acquires images employing X-rays emitted by an X-ray source which can produce up to 25kW.
The unit, which is powered by a single-phase electrical supply, generates ionizing radiations (X-rays) which, as they pass through the patient, reach a flat panel detector that produces radiological images.
An x-ray collimator, placed on the monobloc, is responsible for limiting the emission beam of ionizing radiation.
The images collected by the detector are sent to a video processor, which, after processing the information received, allows radiological images to be displayed on the display monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
all patients, except pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on the proposed PERSONA C HR and it demonstrates compliance with the following International and FDA-recognized consensus standards:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures.
- IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
Compliance with the "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" guidance and "Content of Premarket Submissions for Device Software Functions" guidance.
Compliance of the modified device PERSONA C HR to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
Substantial equivalence was supported by engineering-based performance testing, including evaluation of image quality using test phantoms and cadaver images by an "American Board of Radiology" radiologist.
The verification/validation activities successfully confirmed device requirements have been fulfilled, system functionality is consistent with the user needs, intended use, and performs as designed, and raises no new questions regarding either safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter - Persona C HR
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 30, 2025
A.T.S. Applicazione Tecnologie Speciali s.r.l.
℅ Francesca Pedretti
Quality Management System and Regulatory Affairs Manager
Via Alessandro Volta, 10
TORRE DE' ROVERI, BG 24060
ITALY
Re: K250282
Trade/Device Name: Persona C HR
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, OXO
Dated: January 30, 2025
Received: January 31, 2025
Dear Francesca Pedretti:
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 (the 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 available 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.
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K250282 - Francesca Pedretti Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250282 - Francesca Pedretti Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250282
Device Name: Persona C HR
Indications for Use (Describe)
PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device.
Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-0609
10903 New Hampshire Avenue Silver Spring,
MD 20993-0002
April 30th, 2025
In accordance with 21CFR §807.92 the following 510(k) summary information is provided:
Applicant and Manufacturer: A.T.S. Applicazione Tecnologie Speciali S.r.l.
Via Alessandro Volta n°10
24060 Torre de' Roveri (BG)
Italy
Ph. +39 035 584 311
Email: sales@atsmed.it
Primary Contact: Francesca Pedretti
Quality & Regulatory Manager
Ph. +39 035 584 310
Email: quality@atsmed.it
Secondary email: Francesca.pedretti@atsmed.it
Secondary Contacts: Andrea Ghisi
Quality & Regulatory specialist
Ph. +39 035 584 366
Email: andrea.ghisi@atsmed.it
Pag. 1 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
Proposed Device
Device Common Name: Interventional Fluoroscopic C-arm
Trade Name: PERSONA C HR
Submission number: K250282
Classification Name: Image-intensified fluoroscopic x-ray system (21 CFR, Part 892.1650)
Product Code: OWB, OXO
Regulatory Class: II
Predicate Device
Device Common Name: Interventional Fluoroscopic C-arm
Trade Name: ARCO FP
Submission number: K182086
Classification Name: Image-intensified fluoroscopic x-ray system (21 CFR, Part 892.1650)
Product Code: OWB, OXO
Regulatory Class: II
Device Description: PERSONA C HR is a C-arm mobile unit with flat panel detector.
It allows imaging under the following modes:
- Low Dose Fluoroscopy,
- High Quality Fluoroscopy,
- High Quality + Fluoroscopy
- Digital radiography (Snapshot),
- Fluoroscopy in Road Mapping mode (optional),
- Fluoroscopy in DSA mode (optional).
It is provided with a 30x30 cm Flat Panel detector and a 25 kW X-ray generator.
The unit is composed of: Monitor unit, Stand with c-arm, X-ray commands, Printer (optional).
The device acquires images employing X-rays emitted by an X-ray source which can produce up to 25kW.
Pag. 2 of 14
Page 7
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
The unit, which is powered by a single-phase electrical supply, generates ionizing radiations (X-rays) which, as they pass through the patient, reach a flat panel detector that produces radiological images.
An x-ray collimator, placed on the monobloc, is responsible for limiting the emission beam of ionizing radiation.
The images collected by the detector are sent to a video processor, which, after processing the information received, allows radiological images to be displayed on the display monitor.
The proposed device PERSONA C HR is substantial equivalent to the currently marketed predicate device ARCO FP (K182086), in terms of indications for use, fundamental scientific technology, safety and effectiveness. Software and firmware architecture design are identical to those of the predicate ARCO FP (K182086).
Indications for Use: PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device.
Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.
The intended use is substantially equivalent to that of the predicate device ARCO FP (K182086).
Summary of technological characteristics: PERSONA C HR device employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the monobloc produces X-rays, which as they pass through the patient, reach a flat panel detector for visualizing radiological images. An x-ray collimator, placed on the monobloc, is responsible for limiting the emission beam of ionizing radiation (X-rays). The images collected by the detector are sent to a video processor which, after processing the information received, allows radiological images to be displayed on the display monitor.
The images from the device assist the physician in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures.
The PERSONA C HR C-arm mobile unit is a flat panel detector and fluoroscopic X-ray imaging system consisting of a Stand (C-arm) and a Monitor unit. The main components of the Stand are
Pag. 3 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
a monobloc with high voltage generator (with rotating anode tube and cooling system), an X-ray collimator, and a flat panel detector (FDP). The C-arm supports the monobloc and the flat panel detector (FPD) on opposite sides. The Monitor unit is a mobile platform connected to the Stand by a cable.
The proposed modified device PERSONA C HR employs the same fundamental control, and substantially equivalent scientific technology as that of the predicate device ARCO FP (K182086).
Software architecture design is substantially equivalent to that of the predicate device ARCO FP (K182086).
The primary modifications to the predicate device ARCO FP (K182086) are:
-
an aSi-IGZO (Indium gallium zinc oxide) flat panel detector (FPD) which has substantially equivalent technology characteristics as the predicate device ARCO FP (K182086).
The system design and housing are identical to the Predicate ARCO FP K182086 and both detectors use safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI/FDP).
The new generation aSi-IGZO detector of the proposed device allows faster speed and better performances (up to 30 fps always at full resolution) respect to the one of the predicate device ARCO FP (K182086). -
A max power output 25kW generator instead of 20kW. The generator has the same technological characteristics as the predicate device ARCO FP (K182086).
-
The monitor unit is composed by a single 32" Monitor instead of the two 21,5" Monitors of ARCO FP (K182086) predicate device. The technological characteristics of the monitor of the proposed device PERSONA C HR and the predicate device ARCO FP (K182086) are equivalent.
-
A new Control panel, the successor to the one mounted on the predicate, with a 13" screen instead of 12".
The comparison of the predicate device and the proposed device shows that the scientific and technical characteristics of PERSONA C HR are substantially equivalent to those of ARCO FP (K182086) predicate device.
Pag. 4 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
Substantial equivalence discussion
The changes of the proposed device PERSONA C HR, described in the table, do not change the fundamental control mechanism, operating principle, energy type, and intended use found on predicate device (ARCO FP K182086) and are substantially equivalent to the predicate device.
Differences between the predicate device (ARCO FP) and the proposed device (PERSONA C HR) do not raise new safety or effectiveness concerns.
| Comparison Chart | PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | Substantial equivalence discussion |
|---|---|---|---|
| 510(k) Number | K250282 | K182086 | - |
| CLASS | 2 | 2 | Identical |
| Product code | OWB | OWB | Identical |
| Secondary Product code | OXO | OXO | Identical |
Intended Use
PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device.
Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.
ARCO FP is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
In particular, the device is to be applied during orthopaedic, neuro, abdominal, vascular, thoracic, and cardiac procedures.
ARCO FP device can be used on all patients, except paediatric patients, within the limits of the device.
Substantially equivalent
PERFORMANCE SPECIFICATION
| PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | |
|---|---|---|
| Mechanical size and weight | ||
| Stand | 195 (L) x 89 (W) x 161 (H) | 195 (L) x 89 (W) x 161 (H) |
| 280 kg | 280 kg |
Identical
Pag. 5 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
| Comparison Chart | PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | Substantial equivalence discussion |
|---|---|---|---|
| 510(k) Number | K250282 | K182086 | - |
| Monitor Trolley | 76,4(L) x 76,4(W) x 152(H) | 76,4(L) x 76,4(W) x 158(H) | Substantially equivalent |
| 140 kg | 140 kg |
Electrical requirements
| Supply type | Single phase (live/neutral, separate earth) | Single phase (live/neutral, separate earth) | Identical |
| Input Voltage | 120 V, 230 V @50-60Hz | 100, 110, 120, 130 V | Substantially equivalent. |
| | | 210, 220, 230, 240 V @50-60Hz | The available supply voltage has been limited because the removed ones are not required by the distributor. The insulation transformer and other power circuitry are identical. |
X-ray generator (see Device Description, Paragraph 3.7)
| Max parameters | 25kW: | 5kW: | Substantially equivalent. |
| | - 120 kV | - 120 kV | |
| | - 200 mA | - 40 mA | The proposed device has a higher max power output (25kW: 100kV-250mA), using the same housing, x-ray tube, and monobloc thus keeping the same dimensions. |
| | (fluoroscopy) | (fluoroscopy) | |
| | - 250mA | - 32,5 mA | |
| | (digital RAD) | (digital RAD) | |
| | | | |
| | | 20kW: | |
| | | - 120 kV | |
| | | - 100 mA | |
| | | (fluoroscopy) | |
| | | - 200 mA | |
| | | (digital RAD) | |
Pag. 6 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
| Comparison Chart | PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | Substantial equivalence discussion |
|---|---|---|---|
| 510(k) Number | K250282 | K182086 | - |
| Fluoroscopy: Pulse and duration | Pulse Rate: | Pulse Rate: | Substantially equivalent. |
| 1,2,4,8,15,30 | 1,2,4,8,15 or 1,3,6,12,25 | ||
| General system exposure control technology and operational functionality are identical to the Predicate ARCO FP K182086. | |||
| Pulse width (msec): | Pulse width (msec): | ||
| 7 - 8 - 10 - 16 - 20 - 40** | 7- 13 - 16 - 20 - 40 | ||
| *Pulse width shortened to allow 30 fps, also result in maintaining very similar patient dose level. | |||
| Monobloc Thermal Management | Active cooling | Passive cooling | Substantially equivalent. |
| The x-ray part (tube, housing, control circuitry, etc) are basically the same as the Predicate device ARCOFP. | |||
| It allows to increase the heat dissipation, thus increasing the operating time. |
Booster capacitors group (see Device Description, Paragraph 3.14)
| Booster | 64.800 μF capacitors | 30.000 μF capacitors | Substantially equivalent. |
| | | | The system design and housing are identical to the Predicate ARCO FP K182086. |
X-ray tube (see Device Description, Paragraph 3.3 Technical Data)
Pag. 7 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
| Comparison Chart | PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | Substantial equivalence discussion |
|---|---|---|---|
| 510(k) Number | K250282 | K182086 | - |
| Rotating anode | Same model | Same model | Identical |
Collimator (see Device Description, Paragraph 3.11 X-Ray Collimator)
| Collimator | Possibility of asymmetrically move the parallel shutters. | Symmetrical movement of the parallel shutters. | Substantially equivalent. |
Anti-scatter grid (see Device Description, Paragraph 3.3 Technical Data)
| Removable grid | Same model | Same model | Identical |
Laser centering device (see Device Description, Paragraph 3.3 Technical Data)
| Pointer | CLASS 1M (Red light) 635 nm | CLASS 1M (Red light) 635 nm | Substantially equivalent. |
| | CLASS 1 (Green light) 515 nm | | The system design and housing are identical to the Predicate ARCO FP K182086. |
Image detector (see Device Description, Paragraph 3.6 Flat Panel Detector)
| Technology | - Amorphous Silicon Flat Panel Detector aSi-IGZO. | - Amorphous Silicon Flat Panel Detector (aSi). | Substantially equivalent. |
| | | | This new generation aSi- IGZO detector allows faster speed and better performance (up to 30 fps always at full resolution). |
| | - Scintillator: | - Scintillator: | |
| | Cesium-Iodide (CsI) | Cesium-Iodide (CsI) | The system design and housing are identical to the Predicate ARCO FP K182086. |
| Dimension | 30 x 30 cm | 30 x 30 cm or | Substantially equivalent. |
| | | 21 x 21 cm | |
Pag. 8 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
| Comparison Chart | PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | Substantial equivalence discussion |
|---|---|---|---|
| 510(k) Number | K250282 | K182086 | - |
| Features | - Detector matrix: 2048 x 2048 pixels | - Detector matrix: 1956 x 1956 pixels | Substantially equivalent. |
| - Zoom field 1: 1440 x 1440 pixels | - Zoom field 1: 1344 x 1344 pixels | ||
| - Zoom field 2: 1104 x 1104 pixels | - Zoom field 2: 1024 x 1024 pixels | ||
| - Scintillator CsI | - Scintillator CsI | ||
| - DQE (@9μGy, RQA5): 72% @ 0 lp/mm | - DQE (@2μGy, RQA5): 77% @ 0 lp/mm | ||
| 56% @ 1 lp/mm | 57% @ 1 lp/mm | ||
| 44% @ 2 lp/mm | 48% @ 2 lp/mm | ||
| Considering that the two values were measured at different doses, they are comparable and found to be substantially equivalent. | |||
| - MTF: 56% @ 1 lp/mm | - MTF: 59% @ 1 lp/mm | ||
| 27% @ 2 lp/mm | 29% @ 2 lp/mm | ||
| - Pixel size 146 μm | - Pixel size 154 μm |
Monitors (see Device Description, Paragraphs 3.12 Monitor and 3.8 Control Panel, respectively)
| Display | - 1x 32" LCD UHD | - 2x 21,5" LCD full HD | Substantially equivalent |
| | - 3840 x 2160 pixels (4K) | - 1920 x 1080 pixels | |
| | - 850 cd/m² (typ.) | - 600 cd/m² (typ.) | Higher brightness and resolution. |
| Control Panel | - 13,3" | - 12,5" | Substantially equivalent |
| | - 1920 x 1080 pixels | - 1920 x 1080 pixels | |
| | - 400 cd/m² (typ.) | - 400 cd/m² (typ.) | |
X-ray switches (see Device Description, Paragraph 3.15 X-Ray Commands)
Pag. 9 of 14
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
| Comparison Chart | PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | Substantial equivalence discussion |
|---|---|---|---|
| 510(k) Number | K250282 | K182086 | - |
| X-ray footswitch | Same model | Same model | Identical |
| X-ray handswitch | Same model | Same model | Identical |
| X-ray handswitch (pushbutton) | Two-pushbuttons handswitch | Not provided | Substantially equivalent. |
| Additional pushbutton duplicating the footswitch function |
Image acquisition modalities (see Device Description, Paragraph 3.5 X-Ray emission modes)
| Fluoroscopy | - Fluoro LD | - Fluoro LD | Substantially equivalent. |
| | - Fluoro HQ | - Fluoro HQ | |
| | - Fluoro HQ + | - RoadMap | New generator and booster group allow to reach higher mA curve (6), associated with the new acquisition modality. |
| | - RoadMap | - DSA | |
| | - DSA | | |
Video Processor (see Device Description, Paragraph 3.3 Technical Data)
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
| Comparison Chart | PROPOSED DEVICE PERSONA C HR | PREDICATE DEVICE ARCO FP | Substantial equivalence discussion |
|---|---|---|---|
| 510(k) Number | K250282 | K182086 | - |
| PC host | - CPU: Intel i7, 11700, 2,5GHz, Rocket Lake. | - CPU: Intel i5, 6400, 2,7GHz, Sky Lake. | Substantially equivalent. |
| - Operating system: WINDOWS 7 embedded ENG 64bit. | Technological evolution. | ||
| - Operating system: WINDOWS 10 IoT Enterprise 2019 LTSC (ESD) ENG 64bit. | - RAM: 16 Gb. | ||
| - Hard disk: HD SATA 3, 500 Gb. | |||
| - RAM: 16 Gb or more | |||
| - Hard disk: HD SATA 3, 1Tb or more |
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
Summary of non-clinical and clinical test data:
PERSONA C HR is based on direct modifications to cleared predicate device ARCO FP (K182086).
The design of the modified PERSONA C HR was completed in accordance with A.T.S. Applicazione Tecnologie Speciali Quality Management System Design Controls, 21 CFR 820 and applicable standards. Verification and Validation testing were successfully conducted on the device in compliance with FDA requirements as stated in the provided documentation.
Non-clinical performance testing has been performed on the proposed PERSONA C HR and it demonstrates compliance with the following International and FDA-recognized consensus standards:
• ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
• IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
• IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
• IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
• IEC 60601-2-43 Edition 3.0 2022-12
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures.
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
• IEC 60601-2-54 Edition 2.0 2022-09
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
Both the equipment documentation and the tests carried out are in compliance with:
• "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" guidance,
• "Content of Premarket Submissions for Device Software Functions" guidance.
Further, the device meets all applicable sections of 21 CFR Subchapter J.
The flat panel detector documentation provided in this submission demonstrates compliance of the modified device PERSONA C HR to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
The modified device PERSONA C HR development occurred under our design control processes, software development processes, and overall quality management system.
The device has been demonstrated to be substantially equivalent to the identified predicate device. It has the same intended use and incorporates technological characteristics that are either identical or substantially equivalent. Substantial equivalence was supported by engineering-based performance testing, including evaluation of image quality using test phantoms and cadaver images by an "American Board of Radiology" radiologist.
System safety and effectiveness have been appropriately validated in accordance with FDA-recognized standards and guidances.
Conclusions drawn from nonclinical and clinical tests:
The verification/validation activities successfully confirmed device requirements have been fulfilled, system functionality is consistent with the user needs, intended use, and performs as designed, and raises no new questions regarding either safety or effectiveness.
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device ARCO FP (K182086).
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A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
Sincerely,
Stefano Daniotti
CEO
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