PRIMO S

K211542 · A.T.S. Applicazione Tecnologie Speciali S.R.L. · MQB · Jul 9, 2021 · Radiology

Device Facts

• Record ID: K211542
• Device Name: PRIMO S
• Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L.
• Product Code: MQB · Radiology
• Decision Date: Jul 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

Device Story

PRIMO S is an image acquisition and processing software application for flat panel detectors used with Sedecal X-ray equipment (mobile or fixed). It manages patient data (manual entry or DICOM Worklist), controls X-ray exposure parameters via DLL modules, and performs image processing, stitching, and optimization. The system is operated by clinicians in clinical settings. It provides a GUI for system status monitoring and examination selection. Output includes diagnostic images stored locally or exported via DICOM services (Store, Print, CDROM, MPPS, RDSR, Storage Commitment) or USB. The device benefits patients by enabling digital radiographic imaging with integrated workflow management and automated image processing.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, risk analysis, and adherence to recognized standards (IEC 62304, EN/IEC 62366-1, ISO 14971, NEMA PS 3.1-3.20).

Technological Characteristics

Software application for digital radiography. Operates on Windows 10. Integrates with Sedecal X-ray generators (SFHR/SHF series) and various flat panel detectors (Canon/Toshiba, iRay). Connectivity via DICOM (Store, Print, CDROM, MPPS, RDSR, Storage Commitment). Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and NEMA DICOM standards.

Indications for Use

Indicated for digital image capture in general radiographic examinations (skull, chest, shoulders, spine, abdomen, pelvis, extremities) where conventional screen-film systems are used. Excludes fluoroscopy, angiography, and mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

• Sedecal Digital Radiographic Upgrade Model SDRU-T (K130883)

Reference Devices

• Canon/Toshiba AR-A4343W (K171270)
• Canon/Toshiba AR-A3543W (K170332)
• Canon/Toshiba FDXA4343R-HD (K162687)
• Canon/Toshiba FDX2530RPW (K162687)
• iRay Mars1717V-VSI (K201043)
• iRay Mars1417V-TSI (K201004)
• iRay Venu1717 (K123644)
• iRay Mars 1417X (K210316)
• iRay Mars 1717X (K210314)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services (HHS) seal on the left and the FDA acronym and full name on the right. The HHS seal features an emblem with a staff and serpent, while the FDA part includes the acronym in a blue square and the words "U.S. Food & Drug Administration" in blue text.

A.T.S. Applicazione Tecnologie Speciali S.R.L. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

#### Re: K211542

Trade/Device Name: PRIMO S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: May 13, 2021 Received: May 19, 2021

Dear Mr. Kamm:

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 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

July 9, 2021

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K211542

Device Name PRIMO S

Indications for Use (Describe)

Intended for digital image capture use in general radiographic examinational screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Summary K211542

Image /page/3/Picture/1 description: The image shows the logo for ATS in blue against a light blue background. The logo is made up of three block letters, A, T, and S. The A is a triangle shape, the T is a rectangle shape, and the S is a curved shape.

## A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.. VIA A. VOLTA, 10 -24060 TORRE DE' ROVERI (BG) ITALY -TEL. [phone] -FAX [phone] Date Prepared: July 2, 2021

#### 1. Administrative Information

Submitter: Submission contact person: Eng. Livia PILLITTERI, QMS & Regulatory Affairs Manager

ldentification: Trade/Device Name: PRIMO S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB, IZL

Substantially equivalent device: Sedecal SA K130883 Trade/Device Name: Sedecal Digital Radiographic Upgrade Model SDRU-T Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB

Reference devices: See table of compatible digital panels below.

- 2. Indications for Use: Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
- 3. Device description: PRIMO S is an image acquisition and processing software application, in radiography mode for Flat Panel detectors. The software is specifically designed for integration with production equipment of the SEDECAL group. The PRIMO S application will be used on different types of Sedecal equipment / systems:
- mobile units ●
- fixed installations. ●

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The PRIMO S VP application provides the following functions:

- User login: the device is usable only by authenticated users -
- Management of the operator interface GUIs and setup of the application itself -
- -The operator interface GUI must reserve a space on the monitor for the Sedecal equipment/system GUI (choice of examination (APR), X-ray generator commands, collimator, stand, etc.)
- Management of patient data through manual entry and reception from the DICOM WORKLIST service
- -Management of image processing algorithms for each type of examination
- Management of the automatic advancement procedures of the operations during the study. -
- Image acquisition and processing -
- Saving in Hard Disk of the acquired images -
- -Automatic and manual image stitching procedure
- Off-line image editing and optimization using process and graphic functions -
- Documentation of images and study data using DICOM services of STORE, PRINT, CDROM, -MPPS, RDSR, STORAGE COMMITMENT
- -Application configuration setup
- Export and automatic saving of images on external support (USB key) -

The application communicates with the Sedecal equipment through software modules (DLL) for:

- -The choice of the examination, made by the operator through a GUI defined by Sedecal (APR)
- -Send the exposure parameters foreseen by the selected exam (kV, mA, mAs, ms, collimator aperture, stand position, ...)
- Receive the system status parameters and the exposure result -

## 4. Technological characteristics: Comparison Table

| Comparable<br>Properties | Sedecal SA K130883<br>Sedecal Digital Radiographic<br>Upgrade Model SDRU-T | PRIMO S | Comparison<br>Results |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Indications for<br>use | Intended for digital image capture use<br>in general radiographic examinations,<br>wherever conventional screen-film<br>systems may be used, excluding<br>fluoroscopy, angiography and<br>mammography. The kit allows imaging<br>of the skull, chest, shoulders, spine,<br>abdomen, pelvis, and extremities. | Intended for digital image capture use<br>in general radiographic examinations,<br>wherever conventional screen-film<br>systems may be used, excluding<br>fluoroscopy, angiography and<br>mammography. The kit allows imaging<br>of the skull, chest, shoulders, spine,<br>abdomen, pelvis, and extremities. | SAME |
| X-ray Generator | Sedecal | Sedecal | SAME |
| Digital X-Ray<br>Detectors | Toshiba FDX 3543RP, FDX 4343R;<br>(Now called Canon) | Same plus additional panels, see list<br>below. | SAME |

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| Comparable<br>Properties | Sedecal SA K130883<br>Sedecal Digital Radiographic<br>Upgrade Model SDRU-T | PRIMO S | Comparison<br>Results |
|--------------------------|------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------|
| Panel Sizes | 14 x 17, 17 x 17 Inches | 14 x 17, 17 x 17, 10 x 12 Inches | Almost<br>IDENTICAL.<br>10 x 12<br>Inches<br>added for<br>imaging<br>extremities |
| Operating<br>System | Windows 7 | Windows 10 | Updated OS<br>is required. |
| Power Source | AC Line | AC Line | SAME. |
| Standards | Same as below | See below | SAME |

## Compatible Flat Panel Display (FPD) List

| FPD Trade mark | FPD model | 510(K) File |
|-----------------|-----------------------------------------|-------------|
| Canon / Toshiba | AR-A4343W (same as CXDI-401 C Wireless) | K171270 |
| | AR-A3543W (same as CDXI-701C Wireless) | K170332 |
| | FDXA4343R-HD | K162687 |
| | FDX2530RPW | K162687 |
| iRay | Mars1717V-VSI | K201043 |
| | Mars1417V-TSI | K201004 |
| | Venu1717 | K123644 |
| | Mars 1417X | K210316 |
| | Mars 1717X | K210314 |

## 5. Non clinical testing: The following standards were employed in the development of this software:

| FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------|
| 13-79 | IEC | IEC 62304 | Medical device Software life-cycle processes |
| 5-114 | EN/IEC | EN/IEC 62366-1:2015 | Medical Devices - Part 1: Application Of<br>Usability Engineering To Medical Devices |
| 5-40 | ISO | ISO14971 | Medical devices - Applications of risk<br>management to medical devices |
| 12-238 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in<br>Medicine (DICOM) Set |

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| FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 5-117 | ISO | ISO 15223-1:2016. | Medical devices — Symbols to be used with<br>medical device labels, labelling and information to<br>be supplied — Part 1: General requirements |

The software has been validated with Sedecal diagnostic x-ray generators. Compatible Sedecal generators: SFHR and SHF Series.

In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software user manual. Software validation was conducted according to the FDA document: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The User Manual contains pediatric and cybersecurity considerations. Each system is tested for proper integration prior to shipment to the end customer. Since multiple configurations are available (generator and panel models), service engineers fully test each new system upon installation at the customer site.

6. Clinical testing. Not required for a determination of substantial equivalence.

# 7. Substantial Equivalence Discussion.

The PRIMO S performs the same functions as the predicate using the same technological methods to produce and store diagnostic x-ray images. In all material aspects, the Sedecal and the A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. devices are substantially equivalent to each other.

# 8. Substantial Equivalence Conclusion:

After analyzing bench test results, risk analysis, and standards compliance, it is the conclusion of A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.. that the PRIMO S series of upgrade kits are as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.