The ddR Versa™ Motion System is intended for use by a qualified/trained doctor or technician on 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

ddRVersa™ Motion uses the same core technology as our ddRElement but is modified in that: The supplier for the digital x-ray receptor panel has changed. The system can now accommodate two digital x-ray receptor panels instead of just one. A Wi-Fi digital x-ray receptor panel may be chosen as the second panel. The tubestand is changed from a C-arm configuration to an overhead plus wall stand configuration. The table is changed from non-motorized to motorized. The generator supplier has been changed. The collimator has been changed.

AI/ML Overview

The provided text describes a 510(k) summary for the ddRVersa™ Motion Digital Diagnostic X-Ray System (K123005), which is a modification of a predicate device. The information focuses on demonstrating substantial equivalence to the predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software component.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned in the provided text for device performance. The submission aims to show "substantial equivalence" to a predicate device, meaning it performs "as well as or better than" the legally marketed predicate.

Instead, the "acceptance criteria" are implied by the comparative nature of the 510(k) process, which focuses on demonstrating equivalence to the predicate device in terms of safety and effectiveness.

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety (conformance to IEC 60601-1)	The modified unit has undergone electrical safety testing and conforms to IEC 60601-1.
Electromagnetic Compatibility (conformance to IEC 60601-1-2)	The modified unit has undergone electromagnetic compatibility testing and conforms to IEC 60601-1-2.
Software Validation	Software validation was performed.
Risk Analysis	Risk analysis was performed.
Technical Characteristics of New Panel (Bench Testing)	Technical characteristics of the new panel (Trixell 4343 RC or Pixium Portable 3543 EZ, with 148 microns pixel size, 2880 x 2880 pixels, 16 bit A/D conversion, spatial resolution 3.5 lp/mm, sensitivity up to 850 LSB/μGy) were measured and included in bench testing information. This implies performance equal to or better than the predicate's panel (Samsung LTX240AA01-A, spatial resolution 3.0 lp/mm, sensitivity > 120 LSB/μGy).
Diagnostic Quality (Clinical Study of Images)	Clinical images were obtained and evaluated by professional radiologists, who found them to be of good diagnostic quality. This indicates that the image quality is clinically acceptable and comparable to the predicate.
Substantial Equivalence to Predicate (Overall Safety & Effectiveness)	Nonclinical and clinical tests demonstrated that the device is "as safe, as effective, and performs as well as or better than" the predicate device (ddRElement™ K110828 and Suinsa K083109).

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

Sample Size for Test Set: The document states that "Clinical images were obtained." However, it does not specify the sample size (i.e., number of images or patients) used for the clinical evaluation.
Data Provenance: 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 the Ground Truth for the Test Set and Their Qualifications

Number of Experts: The document states images were "evaluated by professional radiologists." It does not specify the exact number of radiologists involved.
Qualifications of Experts: The experts are described as "professional radiologists." No further specific qualifications like years of experience or subspecialty are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies among expert readers or for establishing a definitive ground truth from the radiologists' evaluations. It simply states they "evaluated" the images.

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

Was a MRMC study done? No. The document does not mention a MRMC comparative effectiveness study to assess how much human readers improve with AI vs without AI assistance. This device is an X-ray system, not an AI-powered diagnostic aide.

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

Was a standalone study done? No. The device is a digital X-ray system that produces images for human interpretation, not an algorithm designed for standalone diagnostic performance.

7. Type of Ground Truth Used

The ground truth for the clinical evaluation was established by "professional radiologists" who found the images to be of "good diagnostic quality." This implies an expert consensus/opinion on image diagnosticity, rather than pathology, outcomes data, or a pre-defined reference standard.

8. Sample Size for the Training Set

The document does not refer to a "training set" as this device is a hardware system undergoing modifications and demonstrating substantial equivalence, not a machine learning model requiring a training phase.

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

Not applicable, as there is no mention of a training set for an algorithm in this submission.

Summary

{0}------------------------------------------------

510(k) Summary: K123005

1. Submitter: Swissray Medical AG Turbistrasse 25 - 27 CH-6280 Hochdorf Switzerland Phone +41 41 914 12 12 Fax +41 41 914 12 13 Date Prepared: November 13, 2012 Contact: Markus Bütler, Quality Manager
Identification of the Device: ddRVersa™ Motion (Digital Diagnostic X-Ray System); 2. Recommended classification regulation: 21 CFR 892.1650, 892.1680 Device class: II, Panel: Radiology, Product code: MQB and KPR
Predicate Device: This is a MODIFICATION to ddRElement™ under document number K110828 and 3. Suinsa (Now owned by Sedecal) (K083109).
1. A description of the device: ddRVersa™ Motion uses the same core technology as our ddRElement but is modified in that: The supplier for the digital x-ray receptor panel has changed. The system can now accommodate two digital x-ray receptor panels instead of just one. A Wi-Fi digital x-ray receptor panel may be chosen as the second panel. The tubestand is changed from a C-arm configuration to an overhead plus wall stand configuration. The table is changed from non-motorized to motorized. The generator supplier has been changed. The collimator has been changed. (See comparison table below)
1. Intended for use by a qualified/trained doctor or technician on Intended use of the device: 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) (SAME as predicate)
The ddRVersa™ Motion has essentially the same technological characteristics (i.e., design, material, 6. chemical composition, energy source) as the predicate device ddRElement™. See the comparison table below. There are really only two main differences: The tubehead is now an overhead version and the system can now accommodate two digital panels. The panel resolution and technology remains the same.

Comparison Table

Characteristic	Suinsa (Nowowned bySedecal)(K083109)	SwissrayddRElement™(K110828)	Swissray ddRVersa™Motion(K123005) (Newmodified device)
Overall Configuration	Image: Suinsa (Now owned by Sedecal) (K083109)	Image: Swissray ddRElement™ (K110828)	Image: Swissray ddRVersa™ Motion (K123005) (New modified device)
Characteristic	Suinsa (Nowowned bySedecal)(K083109)	SwissrayddRElement™(K110828)	Swissray ddRVersa™Motion(K123005) (Newmodified device)
Intended Use	General purposeradiography exceptnot formammography	SAME	SAME
Control System:Positioning	Software Driven withTouch Panel LCD(Sedecal product)	Manual	Software Driven viaWindows workstation withtouch-screen monitor,keyboard, and mouse
Control System: Exposure	Software Driven withTouch Panel LCD(Sedecal product)	Software Driven viaWindows workstation withtouch-screen monitor,keyboard, and mouse(Samsung LTX240AA01-A,K090742)	Software Driven viaWindows workstation withtouch-screen monitor,keyboard, and mouse(Pixium 4343 RC or Portable3543 EZ)
Configuration: Tube	Ceiling-mountedsingle tube; automaticpositioning (utilizingSedecal Nova FA X-Ray tube overheadsupport system)	Single tube column-mounted on U-Arm withdetector; manualpositioning	SAME AS SEDECALCeiling-mounted singletube; automatic positioning(utilizing Sedecal Nova FA X-Ray tube overhead supportsystem)
Configuration:Detector/Image Receptor	Not applicable	One detector system:Column-mounted U-Armwith tube with SamsungLTX240AA01-A panel(K090742)	Two detector system: Wall-mounted (column) andTable-mounted
Receptor Details	Not applicable	Technology Single A-Si TFT+ photodiode plateCesium iodide scintillator(Csl)A/D conversion 14 bitActive detector area 43 cmx 43 cmSpatial resolution 3.0lp/mmActive pixel matrix 3072 x3072 pixelsPixel size 143 μmEnergy range 40-150 kVpSensitivity > 120 LSB/μGy	Technology Single A-Si TFT +photodiode plate Cesiumiodide scintillator (Csl)A/D conversion 16 bitActive detector area 43 cmx 43 cmSpatial resolution 3.5lp/mmActive pixel matrix Activepixel matrix 2880 x 2880pixelsPixel size 148 μmEnergy range 40- 150 kVpSensitivity up to 850LSB/μGy
Generator: Type	High frequency madeby Sedecal	CPI Canada CMP200 highfrequency generator	High Frequency SHF635/645 or SHF 835/845made by Sedecal
Generator: Capacity	30 kW to 64 kW	65 - 80 kW	64kW or 80kW
Characteristic	Suinsa (Nowowned bySedecal)(K083109)	SwissrayddRElement™(K110828)	Swissray ddRVersa™Motion(K123005) (Newmodified device)
Detector/Image Receptor:Resolution	Not applicable	Samsung LTX240AA01-A(K090742)	Trixell 4343 RC a-si TFT flatpanel or Pixium Portable3543 EZ : 148 microns pixelsize, with 2880 x 2880 pixels(8.2 mil pixels) 16 bit
Tube: Type	Toshiba 7869x 0.6/1.2	Dunlee DR1436CRSR	Toshiba 7869x 0.6/1.2
Tube: Capacity	150KV	150KV	150KV
Collimator + cu filter	Huestis	Siemens ML02	Ralco 225 43x43cmMotorized filters1mm AL +0.1mm Cu1mm AL +0.2mm Cu2mm AL
Energy Source:	120V, 230/240 V50/60 Hz	SAME	SAME
Performance Standard	21 CFR 1020.30	SAME	SAME
Electrical Safety	IEC 60601-1	IEC 60601-1	IEC 60601-1
EMC	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2

DEC 7 2012

{1}------------------------------------------------

{2}------------------------------------------------

1. Description of non-clinical tests. The modified unit has undergone electrical safety and electromagnetic compatibility testing, as well as software validation and risk analysis. The technical characteristics of the new panel have been measured and included in the bench testing information.
1. Description of clinical tests. Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were compared to our predicate images and evaluated by professional radiologists and found to be of good diagnostic quality.
1. Conclusions drawn: The nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem is a graphic representation of an eagle or bird-like figure, with three curved lines forming its body and wings. The overall design is simple and recognizable, representing the department's role in health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 7, 2012

Swissray Medical AG % Mr. Daniel Kamm, P.E. Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34113

Re: K123005

Trade/Device Name: ddRVersa™ Motion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: November 16, 2012 Received: November 20, 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 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 (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.

{4}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Michael D. O'Hara

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K123005

Device Name: ddRVersa™ Motion

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 and Radiological Health (OIR)

Michael D. O'Hara

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

510(k) K123005

Page 1 of

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.