(107 days)
These are Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The systems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions.
DR Vision Neo is flat panel state-of-art digital imaging suite, driving significant improvements in productivity and quality. The streamlined efficiency of the DR Vision Neo enhance the entire radiographic operation, improving workflow by delivering diagnostic images instantly, and allowing users to move x-ray images clectronically to remote workstations, image archives, and printers. The DR Vision Neo is a Trixell Pixium 4600 flat panel detector based direct digital radiography system with ceiling suspended design. These are essentially standard diagnostic x-ray systems which have added to them a digital x-ray acquisition panel. The DR Vision Neo has a single panel while the DR Vision Duo has two panels, one in a wall stand and one in the patient table. Features are:
- Flat panel detector: Amorphous silicon panel with cesium iodide scintillator offers exceptional DQE 17" x 17" size eliminates the need to rotate the panel for transverse views l 43 x 143 micron pixels in matrix of 3121 x 3121 x 14 bits. * High-precision 9 million pixel resolution. * 14-bit digital data conversion with 16.000 grayscales. * Motorized detector panel movements with auto-tracking with ceiling suspended tube stand. Battery operated mobile elevating table for radiological applications with 4-way floating table top allows easy and quick patient positioning. * IHE/HL-7/DICOM Standard
The provided text is a 510(k) summary for the DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems, which focuses on establishing substantial equivalence to a predicate device. It does not contain detailed information about a clinical study with acceptance criteria and specific device performance metrics in the way a traditional performance study would.
Instead, the submission for these diagnostic X-ray systems relies on demonstrating substantial equivalence to a legally marketed predicate device (K061054 Siemens Axiom Aristos FX Plus Digital Radiography System). This is a common pathway for medical devices that are similar in technology and intended use to existing devices.
The "acceptance criteria" in this context are not performance thresholds for a disease detection task, but rather the criteria for demonstrating substantial equivalence to the predicate device. The "study" proving this is a comparison of technical characteristics and safety/effectiveness claims.
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance/Comparison (DR Vision Neo/Duo vs. Predicate) |
|---|---|
| Intended Use: Device performs radiographic X-ray examinations of the whole body (excluding mammography) in various patient positions. | Meets: Identical stated Indications for Use. |
| Performance Standard: Compliance with 21 CFR 1020.30. | Meets: States "SAME" as predicate device for 21 CFR 1020.30. |
| Power Range: Comparable X-ray generator power. | Meets: DR Vision Pro/Duo: 32-80 Kw vs. Predicate: 50 Kw or 80 Kw (within comparable range). |
| Digital Panel: Utilizes a similar or identical digital detector. | Meets: States "Identical" Trixell 4600 digital panel as the predicate device. |
| Electrical Safety: Compliance with IEC-60601 and UL listing. | Meets: States "SAME" as predicate device for electrical safety per IEC-60601 and UL listed. |
| Safety and Effectiveness: Bench, test laboratory, and clinical testing indicate the new device is as safe and effective as predicate. | Meets: "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices." (General statement, no specific performance metrics provided in this summary). |
| Technological Differences: Few technological differences, no new indications for use. | Meets: "few technological differences, and has no new indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
- The document mentions "bench, test laboratory and clinical testing," but does not specify a sample size for any test set or clinical study.
- Data Provenance: Not specified. There is no information on the country of origin of the data or if it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish ground truth or their qualifications. The evaluation for substantial equivalence relies on comparing technical specifications and general safety/effectiveness, rather than expert-derived ground truth for diagnostic accuracy in a specific condition.
4. Adjudication Method
- Not applicable/Not specified. Since a specific clinical study with detailed diagnostic outcomes is not described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe a MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. This device is a diagnostic X-ray system, not an AI-powered diagnostic aid.
6. Standalone (Algorithm Only) Performance Study
- No. The document does not describe a standalone performance study. This is an X-ray imaging system, not an algorithm being evaluated for standalone performance.
7. Type of Ground Truth Used
- Not applicable in the context of diagnostic accuracy. The "ground truth" here is effectively the accepted technical specifications and safety profile of the predicate device, which the new device is compared against for substantial equivalence. There's no mention of pathology, outcomes data, or expert consensus being used as ground truth for diagnostic performance of the device in a clinical setting in this summary.
8. Sample Size for the Training Set
- Not applicable/Not specified. This document does not describe an AI or machine learning model that would require a "training set." It is related to the hardware and basic functionality of a digital X-ray system.
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not specified. As there is no training set mentioned, there is no information on how its ground truth would be established.
Conclusion from the document:
The regulatory submission for the DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems establishes substantial equivalence by demonstrating that they have the same intended use, comply with the same performance and safety standards, have comparable power ranges, and utilize the identical digital panel as the legally marketed Siemens Axiom Aristos FX Plus Digital Radiography System. The conclusion is that the new devices are as safe and effective as the predicate, with few technological differences and no new indications for use.
{0}------------------------------------------------
K080614
pg. 1 of 2
510(k) Summary
510(k) Number K08 Almana Medical Imaging P.O. Box 3568 Alkhobar 31952 Kingdom of Saudi Arabia T: +966 3 8679400 F: +966 3 8962421 Date Prepared: February 11, 2007 Mohammed Irfanullah Farooqui, Contact: Sales and Marketing Manager
JUN 2 0 2008
-
- Identification of the Device: Proprietary-Trade Name: DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems Classification Name: Stationary x-ray system, Product Codes 90 KPR and MQB Common/Usual Name: Stationary Diagnostic X-Ray
-
- Equivalent legally marketed device: K061054 Siemens Axiom Aristos FX Plus Digital Radiography System (uses identical digital panel).
-
- Indications for Use (intended use) Thesc arc Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The systems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions ..
-
- Description of the Device: DR Vision Neo is flat panel state-of-art digital imaging suite, driving significant improvements in productivity and quality. The streamlined efficiency of the DR Vision Neo enhance the entire radiographic operation, improving workflow by delivering diagnostic images instantly, and allowing users to move x-ray images clectronically to remote workstations, image archives, and printers. The DR Vision Neo is a Trixell Pixium 4600 flat panel detector based direct digital radiography system with ceiling suspended design. These are essentially standard diagnostic x-ray systems which have added to them a digital x-ray acquisition panel. The DR Vision Neo has a single panel while the DR Vision Duo has two panels, one in a wall stand and one in the patient table. Features are:
- Flat panel detector: Amorphous silicon panel with cesium iodide scintillator offers exceptional DQE 17" x 17" size eliminates the need to rotate the panel for transverse views l 43 x 143 micron pixels in matrix of 3121 x 3121 x 14 bits. * High-precision 9 million pixel resolution. * 14-bit digital data conversion with 16.000 grayscales. * Motorized detector panel movements with auto-tracking with ceiling suspended tube stand. Battery operated mobile elevating table for radiological applications with 4-way floating table top allows easy and quick patient positioning. * IHE/HL-7/DICOM Standard
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a combination of alphanumeric characters and symbols. The first line reads "K0806/4", and the second line reads "Pg. 2 of 2". The text is written in a cursive style, and the overall impression is that of a page number or document identifier.
| Characteristic | K061054 Siemens Axiom Aristos FXPlus | DR Vision Neo and DR Vision Duo |
|---|---|---|
| Intended Use: | A dedicated x-ray system with a flatpanel detector, which allows theacquisition of x-ray exposures withoutthe use of conventional film/screensystems. The AXIOM Aristos FX Plusallows radiographic exposures of thewhole body including skull, spinalcolumn, chest, abdomen, extremities,excluding mammography.Radiographic exposures may be takenwith the patient in the sitting,standing, or lying positions. | These are Radiographic X-RaySystems with a flat paneldetector(s), which allow theacquisition of x-ray exposureswithout the use of conventionalfilm/screen systems. The systemsallow radiographic exposures of thewhole body including skull, spinalcolumn, chest, abdomen,extremities, excludingmammography. Radiographicexposures may be taken with thepatient in the sitting, standing, orlying positions. |
| PerformanceStandard | 21 CFR 1020.30 | SAME |
| Power range | 50 Kw or 80 Kw | 32-80 Kw |
| Digital Panel | Trixell 4600 | Identical |
| Electrical safety | Electrical Safety per IEC-60601. ULlisted | SAME |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Almana Medical Imaging that the DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
Almana Medical Imaging % Mr. Daniel Kamm, P.E. Regulatory Engineer, Submission Correspondnet Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K080614
Trade/Device Name: DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 27, 2008 Received: May 30, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 vour device in the Federal Register.
{3}------------------------------------------------
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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K080614
Device Name: DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems
Indications For Use:
These are Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The svstems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions.
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 Device Evaluation (ODE)
Aoyui Mphy
(Division Sign/C Division of Reproductive, Abdominal and Radiological Devices K080614 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 1 of 1 ·
§ 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.