(51 days)
No
The summary describes standard image processing algorithms and software functions typical of digital radiography systems, with no mention of AI, ML, or related concepts.
No.
The device is an image acquisition and processing software application for radiographic examinations; it creates images but does not directly treat or diagnose conditions.
No
The device is an image acquisition and processing software application for digital image capture in general radiographic examinations, and does not provide a diagnosis.
No
The device is described as an "image acquisition and processing software application" that is "specifically designed for integration with production equipment of the SEDECal group" and "communicates with the SEDECal equipment through software modules (DLL)". While the core component is software, its function is intrinsically tied to and dependent on specific hardware (Flat Panel detectors, mobile units, fixed installations, X-ray generators, collimators, stands) for image acquisition and control. It is not a standalone software application that operates independently of dedicated medical device hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "digital image capture use in general radiographic examinations." This is clearly related to medical imaging for diagnosis based on visual interpretation of anatomical structures, not on the analysis of biological samples (in vitro).
- Device Description: The description focuses on software for acquiring, processing, and managing radiographic images. It interacts with X-ray equipment and handles patient data and image processing algorithms. This aligns with a medical imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
In summary, the device is a component of a medical imaging system used for generating and processing radiographic images for diagnostic purposes, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
MQB
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. ●
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 -
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiography
Anatomical Site
skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Indicated Patient Age Range
Not Found
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
Clinical testing. Not required for a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K171270, K170332, K162687, K162687, K201043, K201004, K123644, K210316, K210314
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| 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."
3
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. +39.035.584311 -FAX +39.035.580220 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.
-
- 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.
-
- 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. ●
4
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
Properties | Sedecal SA K130883
Sedecal Digital Radiographic
Upgrade Model SDRU-T | PRIMO S | Comparison
Results |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 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. | 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. | SAME |
| X-ray Generator | Sedecal | Sedecal | SAME |
| Digital X-Ray
Detectors | Toshiba FDX 3543RP, FDX 4343R;
(Now called Canon) | Same plus additional panels, see list
below. | SAME |
5
| Comparable
Properties | Sedecal SA K130883
Sedecal Digital Radiographic
Upgrade Model SDRU-T | PRIMO S | Comparison
Results |
|--------------------------|------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------|
| Panel Sizes | 14 x 17, 17 x 17 Inches | 14 x 17, 17 x 17, 10 x 12 Inches | Almost
IDENTICAL.
10 x 12
Inches
added for
imaging
extremities |
| Operating
System | Windows 7 | Windows 10 | Updated OS
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
Recognition
Number | Standard
Developing
Organization | Standard Designation
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
Usability Engineering To Medical Devices |
| 5-40 | ISO | ISO14971 | Medical devices - Applications of risk
management to medical devices |
| 12-238 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in
Medicine (DICOM) Set |
6
| FDA
Recognition
Number | Standard
Developing
Organization | Standard Designation
Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 5-117 | ISO | ISO 15223-1:2016. | Medical devices — Symbols to be used with
medical device labels, labelling and information to
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.
- 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.