Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Device Description

This device is simply the combination of two cleared devices, the Wireless Portable Detector FD-W17 (K090625) marketed by Philips Medical Systems and the Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) made by Sedecal. The x-ray source is a motor driven mobile x-ray and the x-ray receptor panel is a digital wireless unit. The Wireless Portable Detector FD-W17 consists of three main parts: Portable radiography detector (x-ray sensitive part), docking station which is directly connected to the radiographic workstation, backup cable which can connect the detector to the docking station if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um、Image resolution up to 3.5 LP/mm

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MobileDiagnost wDR device:

This 510(k) summary focuses on demonstrating substantial equivalence for the MobileDiagnost wDR as a combination of two already cleared predicate devices. It does not contain a traditional clinical study with detailed performance metrics against specific acceptance criteria for a novel algorithm. Instead, the "study" is a comparison to predicate devices, focusing on the absence of significant differences.

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly define acceptance criteria as quantitative performance metrics for the MobileDiagnost wDR itself (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to its predicate devices, implying that if it performs comparably to already cleared devices, it meets the required safety and effectiveness.

Characteristic	Acceptance Criteria (implied by predicate)	Reported Device Performance (MobileDiagnost wDR)
Intended Use	Same as Sedecal Easy Moving Digital (K090322)	SAME
Configuration	Battery or line operated mobile	SAME
Performance Standard	21 CFR 1020.30	SAME
Generator	High frequency made by Sedecal	SAME
Generator power levels	20 to 50 kw (4 models)	20 to 50 kw (4 models)
Collimator	Ralco R221 DHHS	Ralco 108F DHHS (equivalent)
Image acquisition	Digital CANON CDXI-50G (K031447)	Philips Wireless Portable Detector FD-W17 (K090625)
Electrical safety	Electrical Safety per IEC-60601, UL listed	SAME
Clinical Images	No significant differences compared to predicate	No significant differences
Software Validation	All tests passed	Tests performed, results indicate safety and effectiveness
Risk Analysis	Acceptable risk profile	Analysis performed
Hardware Compliance	US Performance Standards, CSA Certified	Conforms to US Performance Standards, CSA Certified

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

Sample Size: The document states "Clinical images were acquired and compared to our predicate images." It does not specify the number of clinical images acquired.
Data Provenance: Not explicitly stated (e.g., retrospective/prospective, country of origin). It's implied that the images were taken for the purpose of this comparison.

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

Not applicable. This was a direct comparison of images from the new device to those from predicate devices, likely for visual assessment of image quality, not for diagnostic accuracy against a ground truth diagnosis established by experts. The comparison involved assessing clinical images for "significant differences," which would typically be done by qualified personnel familiar with diagnostic image quality, but no specific number or qualification of experts is mentioned for this task.

4. Adjudication method for the test set

Not applicable. There's no mention of an adjudication process, as the goal was a direct comparison of image quality between two systems, not a diagnostic accuracy assessment requiring consensus on diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. A MRMC study was not performed. The study described is a comparison of "Clinical images... acquired and compared to our predicate images." This indicates a technical comparison rather than a human reader performance study.

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

Yes, in a way. The "algorithm" here refers to the overall device's image acquisition and processing. The comparison of clinical images and software validation are assessments of the device's standalone performance in producing images and functioning correctly, without explicit human assistance in the "performance" measurement.

7. The type of ground truth used

Not explicitly stated. For the "clinical images were acquired and compared to our predicate images" statement, the "ground truth" would be the expected image quality and diagnostic information provided by the predicate device. The comparison aimed to show that the new device produced images of essentially the same quality and diagnostic utility as the predicate. It did not involve comparing readings against a histopathological diagnosis or clinical outcomes.

8. The sample size for the training set

Not applicable. The device is a combination of existing cleared devices (a mobile X-ray unit and a digital detector). This is not an AI/ML algorithm that requires a separate "training set." The software validation refers to functional testing, not model training.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned in this submission.

Summary

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510(K) Summary, Special 510(k) K11

Page 1 of 2Submitters:		K111729
PHILIPS Medical Systems DMC GmbH	SEDECAL SA
Roentgenstrasse 24	Pelaya 9- Poligono Industrial Rio De Janeiro
22335 Hamburg	28110 - Algete
Germany	Madrid Spain
Tel. +49-040 2899 - 0	Tel +34- 91-628 0544/91-628 1592
Fax: +49-040 2899 - 2002	Fax +34- 91-628 0574

Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager, Sedecal SA Date Prepared: June 10, 2011

Identification of the Device: 1.

Proprietary-Trade Name: MobileDiagnost wDR Classification Name: System, x-ray, mobile, IZL and solid state x-ray imager (flat panel/digital imager), MQB Common/Usual Name: Mobile Diagnostic X-ray System with Digital Panel

Equivalent legally marketed devices: 2.

Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) marketed by Sedecal .
The Detector is identical to the Wireless Portable Detector FD-W17 (K090625) marketed by . Philips Medical Systems
1. Description of the Device: This device is simply the combination of two cleared devices, the Wireless Portable Detector FD-W17 (K090625) marketed by Philips Medical Systems and the Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) made by Sedecal. The x-ray source is a motor driven mobile x-ray and the x-ray receptor panel is a digital wireless unit. The Wireless Portable Detector FD-W17 consists of three main parts:
- · Portable radiography detector (x-ray sensitive part)
- · docking station which is directly connected to the radiographic workstation
- · backup cable which can connect the detector to the docking station if the wireless connection cannot be used.

Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um、Image resolution up to 3.5 LP/mm

1. Indications for Use (intended use): Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
1. Safety and Effectiveness, comparison to predicate device. This modified device has the same indications for use and technological characteristics as the predicate devices, in fact employing the predicate devices in the end product.
Description of Testing: Clinical images were acquired and compared to our predicate images. 6. There were no significant differences between them. We also performed software validation testing. The results of clinical, bench, safety test, and software validation testing indicates that the new device is as safe and effective as our predicate device. The modified device conforms to US Performance Standards and the hardware is CSA Certified compliant to US Standards for safety for medical devices.

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510(k) Summary K11 Page 2 of 2

Characteristic	Sedecal Easy Moving DigitalK090322	MobileDiagnost wDR
Intended Use:	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographic exposuresof the skull, spinal column, chest,abdomen, extremities, and otherbody parts. Applications can beperformed with the patient sitting;standing, or lying in the prone orsupine position. (Not formammography)	SAME
Configuration	Battery or line operated mobile	SAME
Performance Standard	21 CFR 1020.30	SAME
Generator	High frequency made by Sedecal	SAME
Generator power levels	20 to 50 kw (4 models)	20 to 50 kw (4 models)
Collimator	Ralco R221 DHHS	Ralco 108F DHHS-equivalent
Image acquisition	Digital CANON CDXI-50GK031447	Philips Wireless Portable DetectorFD-W17 K090625
Electrical safety	Electrical Safety per IEC-60601.UL listed	SAME

7. Substantial Equivalence Chart

Conclusion: After analyzing risk analysis, software validation, safety testing data, and clinical 8. images, it is the conclusion of Sedecal that the MobileDiagnost wDR is as safe and effective as the predicate devices, have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices.
:

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus, indicating the department's name and affiliation with the United States of America.

Public Health Service

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

Sedecal SA % Ms. Jennifer Cartledge VP Product Development and Program Management REU Associates, Inc. 409 Woodridge Dr SENECA SC 29672

Re: K111725

Trade/Device Name: MobileDiagnost wDR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: June 16, 2011 Received: June 20, 2011

JUL 1 9 2011

Dear Ms. Cartledge:

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 aboye) 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 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.

Mary S Patel

Mary S. Pastel. Sc.D. 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): K11

Device Name: MobileDiagnost wDR

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 Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostis

Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Library Leagues Li

510K K111725

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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.