SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY by SEDECAL S.A.

These Digital 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 skill, 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.

Device Description

Sedecal Digital Mobiles (various models) are mobile x-ray units that covers, with a range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These cordless units combine stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging. Two different brands of digital image acquisition panels are offered: Trixell and Varian. Integrated software for Dicom compatibility is also included.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Sedecal Mobile Digital Diagnostic X-Ray Systems (various models)". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance metrics like sensitivity or specificity.

Therefore, many of the requested elements for a study that proves a device meets acceptance criteria cannot be extracted from this document, as it is not the type of study described.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.

Characteristic	Acceptance Criteria (Predicate Performance)	Reported Device Performance (Sedecal Mobile Digital Diagnostic X-Ray Systems)
Intended Use	Same as K090322	SAME (Identical to predicate)
Configuration	Same as K090322	SAME (Identical to predicate)
Performance Standard	21 CFR 1020.30 (for predicate device)	SAME (Compliance with 21 CFR 1020.30)
Generator	High frequency made by Sedecal	SAME (Identical to predicate)
Generator power levels	20 to 50 kw (4 models)	20 to 50 kw (8 models) - Technological difference noted, but considered equivalent
Collimator	Ralco R221 DHHS	SAME (Identical to predicate)
Image acquisition	Digital CANON 50G	Trixell or Varian - Technological difference noted, but considered equivalent
Electrical safety	Electrical Safety per IEC-60601. UL listed	SAME (Compliance with IEC-60601. UL listed)

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated. The document mentions "bench, test laboratory results, and clinical image comparisons," but does not provide details on the number of images or subjects included in these comparisons.
Data provenance: Not explicitly stated. It's implied that the clinical image comparisons would involve human subjects, but specifics regarding country of origin or whether the data was retrospective or prospective are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document mentions "clinical image comparisons" but does not detail how ground truth was established or if experts were involved in a formal review process for comparing the new device's images to the predicate's images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This document describes an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is a medical imaging device, not a standalone algorithm. The performance evaluation focuses on the safety and effectiveness of the hardware and integrated software for image acquisition, not on an algorithm's diagnostic performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated. Given the context of "clinical image comparisons" for an X-ray system, the "ground truth" would likely be derived from the diagnostic interpretations of the images by qualified medical professionals using the predicate device, against which the images from the new device would be compared for qualitative assessment.

8. The sample size for the training set:

Not applicable. This is not a machine learning device that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. This is not a machine learning device that requires a "training set."

Summary of Study:

The "study" described in the 510(k) summary is a substantial equivalence comparison against a predicate device (Sedecal Easy Moving Digital K090322 and K091364, DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL I.4, GEHM UND REHBEIN GMBH). The primary method used to demonstrate equivalence was:

Bench testing: Laboratory tests to verify technical specifications and performance.
Test laboratory results: Further laboratory-based evaluations.
Clinical image comparisons: Qualitative assessment presumably comparing images acquired by the new device to those acquired by the predicate device to ensure comparable diagnostic quality.

The conclusion is that "bench, test laboratory results, and clinical image comparisons indicate that the new devices are as safe and effective as the predicate devices," with "few technological differences" and "no new indications for use." The focus is on demonstrating that the new device performs equivalently to the predicate in terms of safety and imaging capabilities, rather than achieving specific quantitative performance metrics against a defined ground truth.

Summary

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510(k) Summary 510(k) Number K10 1517 Sedecal, Inc. SEDECAL SA C/ Pelaya, 9 - 13 Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel.- +34 91 6280544 Fax .- +34 91 6280574 Date Prepared: May 27, 2010 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

l . Identification of the Device: Proprietary-Trade Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Classification Name: Mobile x-ray system, Product Code IZL and Solid State X-Ray Inager (Flat Panel/Digital Imager) MQB, with Image Processing Software Code LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
1. Equivalent legally marketed devices: K090322 Easy Moving Plus Mobile X-Ray, and K091364, DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL I.4, GEHM UND REHBEIN GMBH
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 skill, spinal column, chest, abdomen, extremities, and other body parts. Applications on the performed with the patient sitting, standing, or lying in the prone or supine position.
1. Description of the Device: Sedecal Digital Mobiles (various models) are mobile x-ray units that covers, with a range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These cordless units combine stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging. Two different brands of digital image acquisition panels are offered: Trixell and Varian. Integrated software for Dicom compatibility is also included. Model list: For Varian: SM-20HF-B-D-V, SM-32HF-B-D-V, SM-40HF-B-D-V, SM-50HF-B-D-V For Trixell: SM-20HF-B-D-T, SM-32HF-B-D-T, SM-40HF-B-D-T, SM-50HF-B-D-T, SM-50HF-B-D-T, The numeric value indicates the generator power in kW. All units are supplied with Dicom software. (K091364)
1. Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, and clinical image comparisons indicate that the new devices are as safe and effective as the predicate devices.

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6. Substantial Equivalence Chart

Characteristic	Sedecal Easy MovingDigital K090322	Sedecal Mobile DigitalDiagnostic X-Ray Systems(various models)
Intended Use:	Intended for use by aqualified/trained doctor ortechnician on both adultand pediatric subjects fortaking diagnosticradiographic exposures ofthe skull, spinal column,chest, abdomen,extremities, and otherbody parts. Applicationscan be performed with thepatient sitting, standing, orlying in the prone orsupine position.	SAME
Configuration	Battery or line operatedmobile	SAME
PerformanceStandard	21 CFR 1020.30	SAME
Generator	High frequency made bySedecal	SAME
Generator powerlevels	20 to 50 kw (4 models)	20 to 50 kw (8 models)
Collimator	Ralco R221 DHHS	SAME
Image acquisition	Digital CANON 50G	Trixell or Varian
Electrical safety	Electrical Safety per IEC-60601. UL listed	SAME

7. Conclusion

After analyzing bench, laboratory, and clinical testing to applicable standards, it is the conclusion of Sedecal Inc the modified Sedecal Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing right, and its feet are visible below. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

SEP 1 2 2013

SEDECAL SA % Mr. Danial Kamm, P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K101517

Trade/Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: June 15, 2011 Received: June 17, 2011

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of August 9, 2011.

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 (sec 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 (21 CFR Part 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 devices to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Viro 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 cvents under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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.lda.gov/cdrh/industry/suport/index.html.

Sincerely yours.

Sm
for

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): K10 ประ 17

Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models)

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)

Mary Sootel

Division of Redinton

510K KL01517

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.