These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)

Device Description

The Sedecal Dragon LW portable x-ray generator consists of: X-ray Unit with: Control Panel with controls and displays for radiographic operations; Power Module containing control and power components; HV Tank that comprises the High Voltage Transformer, the Filament Transformer and the X-ray Tube; and a Collimator with controls to limit the X-ray beam; a Handswitch and a portable column with an Articulated Arm, a Cassette Basket, and any of the following (previously cleared) Canon Digital X-Ray Receptor Panels: CXDI-501, CXDI-70C, or CXDI-80C. Each of these panels has their own 510(k) clearance. The two generator units are capable of either 4 or 8 kW depending on the model. They are AC line operated. The user interface is the same touchscreen control that was introduced in the K042361 SP-HF-4.0 D Portable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Electrical Safety	Conforms to IEC 60601-1
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2
Software Validation	Validated
X-ray System Performance	Conforms to IEC 60601-1-3 and IEC 60601-2-7
Clinical Image Evaluation	Clinical images acquired and evaluated based on FDA Guidance for Solid State X-ray Imaging Devices. Device concluded to be as safe, effective, and perform as well as or better than legally marketed predicate devices.

Note: The document states that the device is "as safe, as effective, and performs as well as or better than the legally marketed devices" (predicates K103522 and K042361). Specific quantifiable metrics for clinical performance (e.g., sensitivity, specificity, image quality scores) are not provided in this summary. The acceptance criteria for clinical performance are implied by the comparison to predicate devices and adherence to FDA guidance.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired and evaluated," but does not provide the number of images or patients.
Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The document only mentions that "Clinical images were acquired and evaluated."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study focused on demonstrating substantial equivalence to existing predicate devices through non-clinical and clinical image evaluations, not on comparing performance with and without AI assistance or quantifying improvements in human readers. This device is an X-ray unit, not an AI-powered diagnostic tool in the typical sense.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable/not explicitly stated. This device is an X-ray unit, which generates images. It is not an algorithm designed for standalone diagnostic interpretation. Its performance is as an imaging device.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For "clinical images," the ground truth implicitly refers to the diagnostic findings determined by the evaluating professionals (likely radiologists or other trained clinicians), but the specific methodology for establishing this ground truth (e.g., expert consensus, pathology, follow-up outcomes) is not provided.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document describes an X-ray imaging device, not an AI/machine learning model that typically requires a separate training set. The "testing" mentioned refers to engineering and clinical performance validation of the hardware and associated software.

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

Ground Truth for Training Set: Not applicable (see point 8).

Summary

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Sedecal 510(k) Summary 510(k) Number K121410 Page 1 of 2

l. Submitter: SEDECAL SA C/ Pelaya, 9 -- 13, Pol. Ind. Río de Janciro 28110 Algete, Madrid, España (Spain) Tel .- +34 91 6280544, Fax .- +34 91 6280574 Date Prepared: June 12, 2012 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

1. Identification of the Device: Proprietary-Trade Name: Sedecal Digital Portable X-ray Units: SPSLW4 and SPSLW8 ("Dragon LW")
  Classification Name: Mobile x-ray system, Product Code IZL and Digital X-Ray Receptor Panel Product Code MQB

Common/Usual Name: Portable Diagnostic X-Ray System with Digital X-Ray Receptor

1. Equivalent legally marketed device: K103522 SPL-HF-4.0 Portable (Sedecal) AND K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D (Sedecal)
1. Description of the Device: The Sedecal Dragon LW portable x-ray generator consists of: X-ray Unit with: Control Panel with controls and displays for radiographic operations; Power Module containing control and power components; HV Tank that comprises the High Voltage Transformer, the Filament Transformer and the X-ray Tube; and a Collimator with controls to limit the X-ray beam; a Handswitch and a portable column with an Articulated Arm, a Cassette Basket, and any of the following (previously cleared) Canon Digital X-Ray Receptor Panels: CXDI-501, CXDI-70C, or CXDI-80C. Each of these panels has their own 510(k) clearance. The two generator units are capable of either 4 or 8 kW depending on the model. They are AC line operated. The user interface is the same touchscreen control that was introduced in the K042361 SP-HF-4.0 D Portable.
1. Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
1. Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. Specifications are nearly identical. This submission represents the combination of the same generator cleared in K103533 with Canon cleared panels. The Touch Screen Control present in the K042361 Portable has been carried forward into the updated design.

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Sedecal 510(k) Summary K121410 Page 2 of 2

1. Discussion of the nonclinical and clinical tests in the premarket notification submission for a determination of substantial equivalence: We performed clectrical safety (IEC 60601-1), electromagnetic compatibility testing, (IEC 60601-1-2), software validation testing, and testing to IEC 60601-1-3 and IEC 60601-2-7. Clinical images were acquired and evaluated based on the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."
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 modified x-ray system is safe and effective as the predicate identified in paragraph (3). Furthermore, the materials and construction methods are nearly identical to the predicate.

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Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

2 2012 AUG

SEDECAL SA % Daniel Kamm, P.E. Submission Correspondent Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K121410

Trade/Device Name: Sedecal Digital Portable X-ray Units: SPSLW4 and SPSLW8

("Dragon LW") Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MOB Dated: July 13, 2012 Received: July 30, 2012

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. The r earlie, ontrols 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 (24 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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

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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): K12

Device Name: Sedecal Digital Portable X-ray Units: SPSLW4 and SPSLW8 ("Dragon LW")

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In-vitro Diagnostics (OIVD)

(Division Sign-Off)

(Division of Radiological Devices)
Division of Radiological Devices
510k K12498

Page 1 of 1

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.