SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T by SEDECAL SA

Sedecal Digital Radiographic Upgrade Model SDRU-T is intended for digital image capture use in general radiographic examinations, wherever conventional screenfilm 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

This Digital Radiographic Upgrade is intended for those radiographic examination rooms where the X-rav image receptors used are Cassette with Film or CR. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the Digital Radiography Operator Console (DROC) software: Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images. Edit existing patient information. Emergency registration and edit Emergency settings. Pick from a selection of procedures, which defines the series of images to be taken. Adjust technique settings before capturing the X-ray image. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations. Save an incomplete procedure, for which the rest of the exposures will be made at a later time. Close a procedure when all images have been captured. Review History images. resend and reprint images. Re-exam a completed patient. Protect patient records from being deleted by the system. Delete an examined Study with all images being captured. Edit user accounts. Check statistical information. Image QC. Image stitching.

AI/ML Overview

Here's an analysis of the provided text regarding the Sedecal Digital Radiographic Upgrade (SDRU-T) and its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Electrical Safety (IEC 60601-1)	Device passed testing.
	Electromagnetic Compatibility (IEC 60601-1-2)	Device passed testing.
Effectiveness/Performance	Software Validation	Device passed testing.
	Diagnostic Image Quality (General Radiography)	Images were acquired, evaluated, and found to be of good diagnostic quality.
Substantial Equivalence	Same technological characteristics (design, material, chemical composition, energy source) as predicate devices.	Stated to have the same technological characteristics, specifications are identical.
	Safe, effective, and performs as well as or better than legally marketed devices.	Concluded to be safe and effective, performing as well as predicate devices.
	Materials and construction methods nearly identical to predicate.	Stated to be nearly identical.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size for the "test images" acquired. It only states that "Test images were acquired and evaluated."
Data Provenance: The document does not explicitly state the country of origin of the data. It also does not specify if the images were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts, their qualifications, or how they established ground truth for the test images. It only mentions that images were "evaluated."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on demonstrating substantial equivalence to predicate devices rather than directly comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a form of standalone performance evaluation was conducted. The device (specifically the digital panel component) performance was evaluated based on "Test images... acquired and evaluated based on the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." The images "were evaluated and found to be of good diagnostic quality." This implies an evaluation of the device's output quality without direct human-in-the-loop intervention for the evaluation phase of those test images. However, the overall device is an "upgrade" that works with a human operator.

7. Type of Ground Truth Used

The type of ground truth used was primarily expert evaluation of "diagnostic quality." It is not stated to be pathology, outcomes data, or a formal expert consensus process as typically understood for algorithm validation. It appears to be an assessment of the visual quality and interpretability of the generated images by qualified individuals, likely radiologists or imaging specialists, who implicitly form a consensus on "good diagnostic quality."

8. Sample Size for the Training Set

The document does not mention or provide any information regarding a training set sample size. This is likely because the device is an "upgrade kit" combining well-established components (digital X-ray panels and imaging software) that would have been trained/validated independently by their respective manufacturers, or are based on traditional signal processing rather than deep learning models requiring a specific training set. The submission focuses on the integration and functionality of these already cleared components.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for this specific device in the context of this 510(k) submission, there is no information on how its ground truth would have been established.

Summary

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Sedecal 510(k) Summary 510(k) Number K130883

l. Submitter: SEDECAL SA C/ Pelaya. 9-13. Pol. Ind. Río de Janeiro 28110 Algete. Madrid, España (Spain) Tel.- +3491 6280544. Fax.- +34 91 6280574 Date Prepared: April 5. 2013 Contact: Mª Luisa Gómez de Agüero. Quality and Regulatory Manager

1. Identification of the Device: Proprietary-Trade Name: Sedecal Digital Radiographic Upgrade Model SDRI-T Classification Name: Stationary x-ray system Common/Usual Name: Stationary x-ray system Regulation Number: 21 CFR 892.1680 Product Code: MQB)
- 1. Equivalent legally marketed device: This device uses the same digital x-ray panels as: Meridian Medical Universal Digital Interface UDI 1717. K112527 OR Meridian Medical Universal Digital Interface Wireless - UDI 1417W, KII11305 and uses the same software as the Medicatech Krystalrad 660, K 1 1 2 1 32.
- 1. Description of the Device: This Digital Radiographic Upgrade is intended for those radiographic examination rooms where the X-rav image receptors used are Cassette with Film or CR. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the Digital Radiography Operator Console (DROC) software:
  - Add new patients to the system, enter information about the patient and physician that will be . associated with the digital radiographic images.
  - . Edit existing patient information.
  - Emergency registration and edit Emergency settings. .
  - Pick from a selection of procedures, which defines the series of images to be taken. .
  - Adjust technique settings before capturing the X-ray image. .
  - Preview the image, accept or reject the image entering comments or rejection reasons to the . image. Accepted images will be sent to the selected output destinations.
  - . Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
  - Close a procedure when all images have been captured. .
  - . Review History images. resend and reprint images.
  - Re-exam a completed patient. t
  - . Protect patient records from being deleted by the system.
  - . Delete an examined Study with all images being captured.
  - Edit user accounts. .
  - Check statistical information. .
  - Image QC. �
  - Image stitching. .

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1. Indications for Use (intended use) Sedecal Digital Radiographic Upgrade Model SDRU 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.
1. Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. Specifications are for all intents and purposes identical. This submission represents the combination of two cleared devices: Software, and Digital X-Ray panel.
1. Discussion of the nonclinical and clinical tests in the premarket notification submission for a determination of substantial equivalence: We performed electrical safety (IEC 60601-1). electromagnetic compatibility testing, (IEC 60601-1-2), software validation testing, Test images were acquired and evaluated based on the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. Clinical testing is not required because the digital panel was already cleared but images were acquired for verification/validation purposes. They were evaluated and found to be of good diagnostic quality.
1. Conclusion. Based on the results of the nonclinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices) we conclude that this new digital x-ray upgrade kit is safe and effective as the predicates identified in paragraph (3). Furthermore, the materials and construction methods are nearly identical to the predicate.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 18, 2013

SEDECAL SA % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25TH STREET NW BUFFALO MN 55313

Re: 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: MOB Dated: March 28, 2013 Received: March 29, 2013

Dear Mr. Job:

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. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Jaminghi. Messa

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130883

Device Name: SEDECAL DIGITAL RADIOGRAPHIC UPGRADE. Model: SDRU-T

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Remington. Press

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

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Regulation Number and Section

§ 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.