(71 days)
No
The document describes a conventional radiographic system with changes to components like the digital x-ray receptor panel, tubestand, table, generator, and collimator. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is described as an X-ray system intended for diagnostic radiographic exposures, not for treating diseases or conditions.
Yes.
The device is intended for "taking diagnostic radiographic exposures" and produces images that are of "good diagnostic quality" and are "evaluated by professional radiologists."
No
The device description explicitly details changes to hardware components such as the digital x-ray receptor panel, tubestand, table, generator, and collimator. This indicates it is a hardware-based medical device with associated software, not a software-only device.
Based on the provided information, the ddR Versa™ Motion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use of the ddR Versa™ Motion System is to take diagnostic radiographic exposures of the patient's body parts directly.
- The device description and intended use clearly indicate it's an imaging system for capturing X-ray images of the human body. This falls under the category of medical imaging devices, not IVD devices.
Therefore, the ddR Versa™ Motion System is a medical imaging device used for diagnostic radiography, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
MQB and KPR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Conclusions: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary: K123005
-
- 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).
-
- 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)
-
- 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 (Now
owned by
Sedecal)
(K083109) | Swissray
ddRElement™
(K110828) | Swissray ddRVersa™
Motion
(K123005) (New
modified device) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Overall Configuration | Image: Suinsa (Now owned by Sedecal) (K083109) | Image: Swissray ddRElement™ (K110828) | Image: Swissray ddRVersa™ Motion (K123005) (New modified device) |
| Characteristic | Suinsa (Now
owned by
Sedecal)
(K083109) | Swissray
ddRElement™
(K110828) | Swissray ddRVersa™
Motion
(K123005) (New
modified device) |
| Intended Use | General purpose
radiography except
not for
mammography | SAME | SAME |
| Control System:
Positioning | Software Driven with
Touch Panel LCD
(Sedecal product) | Manual | Software Driven via
Windows workstation with
touch-screen monitor,
keyboard, and mouse |
| Control System: Exposure | Software Driven with
Touch Panel LCD
(Sedecal product) | Software Driven via
Windows workstation with
touch-screen monitor,
keyboard, and mouse
(Samsung LTX240AA01-A,
K090742) | Software Driven via
Windows workstation with
touch-screen monitor,
keyboard, and mouse
(Pixium 4343 RC or Portable
3543 EZ) |
| Configuration: Tube | Ceiling-mounted
single tube; automatic
positioning (utilizing
Sedecal Nova FA X-
Ray tube overhead
support system) | Single tube column-
mounted on U-Arm with
detector; manual
positioning | SAME AS SEDECAL
Ceiling-mounted single
tube; automatic positioning
(utilizing Sedecal Nova FA X-
Ray tube overhead support
system) |
| Configuration:
Detector/Image Receptor | Not applicable | One detector system:
Column-mounted U-Arm
with tube with Samsung
LTX240AA01-A panel
(K090742) | Two detector system: Wall-
mounted (column) and
Table-mounted |
| Receptor Details | Not applicable | Technology Single A-Si TFT
- photodiode plate
Cesium iodide scintillator
(Csl)
A/D conversion 14 bit
Active detector area 43 cm
x 43 cm
Spatial resolution 3.0
lp/mm
Active pixel matrix 3072 x
3072 pixels
Pixel size 143 μm
Energy range 40-150 kVp
Sensitivity > 120 LSB/μGy | Technology Single A-Si TFT +
photodiode plate Cesium
iodide scintillator (Csl)
A/D conversion 16 bit
Active detector area 43 cm
x 43 cm
Spatial resolution 3.5
lp/mm
Active pixel matrix Active
pixel matrix 2880 x 2880
pixels
Pixel size 148 μm
Energy range 40- 150 kVp
Sensitivity up to 850
LSB/μGy |
| Generator: Type | High frequency made
by Sedecal | CPI Canada CMP200 high
frequency generator | High Frequency SHF
635/645 or SHF 835/845
made by Sedecal |
| Generator: Capacity | 30 kW to 64 kW | 65 - 80 kW | 64kW or 80kW |
| Characteristic | Suinsa (Now
owned by
Sedecal)
(K083109) | Swissray
ddRElement™
(K110828) | Swissray ddRVersa™
Motion
(K123005) (New
modified device) |
| Detector/Image Receptor:
Resolution | Not applicable | Samsung LTX240AA01-A
(K090742) | Trixell 4343 RC a-si TFT flat
panel or Pixium Portable
3543 EZ : 148 microns pixel
size, 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 43x43cm
Motorized filters
1mm AL +0.1mm Cu
1mm AL +0.2mm Cu
2mm AL |
| Energy Source: | 120V, 230/240 V
50/60 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
-
- 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.
-
- 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.
-
- 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:
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)
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