(90 days)
These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic ratiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the pationi sitting, standing, or lying in the prone or supine position.
This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a U-Arm suspension along with a generator, generator control, and a mobile patient table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. 64 kw is the standard size. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10s. The system is provided with a digital imaging detector, either the QXR16 or the QXR9 CCD Image Detector and Acquisition Workstation. This device represents the interconnection of two already cleared devices: The X-ray system and the digital detector system.
The provided text describes a 510(k) submission (K082261) for the DX800 & DX808 Digital Diagnostic Radiographic Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with strict acceptance criteria.
Therefore, the submission does not contain the detailed clinical study information typically associated with establishing specific performance criteria and device performance as might be seen for novel devices. Instead, it relies on demonstrating that the new device is as safe and effective as existing predicate devices.
Here's a breakdown of the information given in the document, formatted to address your request as much as possible, along with explanations for missing sections where the document does not provide the requested detail:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating substantial equivalence to existing predicate devices based on technical specifications and safety standards, rather than clinical performance metrics (like sensitivity, specificity, or reader agreement).
| Characteristic | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (DX800 & DX808) |
|---|---|---|
| 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 skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying. | SAME (as predicate device) |
| Configuration | Column mount (of x-ray system) | SAME (as predicate device) |
| Performance Standard | 21 CFR 1020.30 (Federal performance standard for diagnostic x-ray systems) | SAME (as predicate device) |
| Detectors | 3056 x 3056 (9 megapixels) or 4096 x 4096 (16 megapixels) | SAME (as predicate device, specifically the QXR16 or QXR9 CCD Image Detector, which align with these specs) |
| Generator | High frequency generator made by Sedecal | Uses same generator made by Sedecal |
| Electrical Safety | Electrical Safety per IEC-60601. UL listed (referencing the predicate device's compliance) | SAME (as predicate device, implying compliance with IEC-60601 and UL listing) |
| Safety and Effectiveness | Demonstrated by results of bench and test laboratory comparing to predicate devices. | Results of bench and test laboratory indicate the new device is as safe and effective as the predicate devices. |
The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is the 510(k) submission itself and the associated testing summarized within it. The document states: "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of dxRAD that the DX800 & DX808 Digital Diagnostic Radiographic 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."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable or not specified in this type of submission. This 510(k) is based on technical comparisons and bench/laboratory testing, not a clinical study with a "test set" of patient data in the typical sense for evaluating diagnostic accuracy.
- Data Provenance: Not applicable or not specified. This document does not refer to clinical patient data from a specific country or whether it was retrospective/prospective. The testing mentioned is "bench and test laboratory" and "external laboratory testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. As this relies on technical equivalence, there is no mention of human experts establishing ground truth for a clinical test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in this submission. This 510(k) does not present evidence from such a clinical study.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not explicitly detailed in the context of an "algorithm only" performance. The device is a complete X-ray system. The performance is assessed against standards and predicate devices for the system's output and safety, not a standalone algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" used is primarily compliance with established performance standards (e.g., 21 CFR 1020.30, IEC-60601), technical specifications of predicate devices, and bench/laboratory test results demonstrating that the device functions as intended and is comparable to its predicates in terms of safety and effectiveness. There is no mention of clinical ground truth like pathology or outcomes data in this document.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document does not describe the development or training of an AI algorithm or model. The device is a hardware system.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As no AI algorithm training is described, there's no mention of a training set or its ground truth establishment.
{0}------------------------------------------------
NOV - 6 2008
510(k) Summary 510(k) Number K08 dXRAD Solutions Ltd. 1000, 888 3rd Street SW Calgary, AB, Canada T2P 5C5 Phone + 1 403 471 4409 Fax +1403 287 0704 Date Prepared: August 1, 2008 Contact: Darryl Stein, President
P
-
- Identification of the Device: Proprietary-Trade Name: DX800 & DX808 Digital Diagnostic Radiographic Systems Classification Name: Stationary x-ray system, Product Codes KPR and MQB Common/Usual Name: Stationary Digital Diagnostic X-Ray
-
- Indications for Use (intended use) These 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 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.
-
- Description of the Device: This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a U-Arm suspension along with a generator, generator control, and a mobile patient table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. 64 kw is the standard size. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10s. The system is provided with a digital imaging detector, either the QXR16 or the QXR9 CCD Image Detector and Acquisition Workstation. This device represents the interconnection of two already cleared devices: The X-ray system and the digital detector system.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices.
Image /page/0/Picture/8 description: The image shows two separate scenes. On the left, a person is depicted carrying a book and a device, possibly a handheld computer or scanner. On the right, there is a computer setup including a monitor, keyboard, mouse, and a computer tower. The image appears to be a black and white print or scan.
{1}------------------------------------------------
| Characteristic | Vidar Vision 3000 and Vidar Vision4000 (K071193). | DX800 & DX808 DigitalDiagnostic RadiographicSystems |
|---|---|---|
| Intended Use: | Intended for use by aqualified/trained doctor or technicianon both adult and pediatric subjectsfor taking diagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen, extremities,and other body parts. Applicationscan be performed with the patientsitting, standing, or lying in the proneor supine position. | SAME |
| Configuration | Column mount | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Detectors | 3056 x 3056 (9 megapixels) or 4096x 4096 (16 megapixels) | SAME |
| Generator | High frequency made by Sedecal | Uses same generator made bySedecal |
| Electrical safety | Electrical Safety per IEC-60601. ULlisted | SAME |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of dxRAD that the DX800 & DX808 Digital Diagnostic Radiographic 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.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
dXRAD Solutions Ltd. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
AUG - 9 2013
Re: K082261
Trade/Device Name: DX800 & DX808 Digital Diagnostic Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 4, 2008 Received: September 23, 2008
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 6, 2008.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see 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 Parts 801 and 809); medical device reporting (reporting of
{3}------------------------------------------------
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/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.fda.gov/cdrb/industry/support/index.html.
Sincerely Yours,
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
{4}------------------------------------------------
ndications for Use 510(k) Number (if known): KQ8 2.2 b
Device Name: DX800 & DX808 Digital Diagnostic Radiographic Systems
Indications For Use:
These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic ratiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the pationi sitting, standing, or lying in the prone or supine position.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Usc (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)
Losm. M. Wher
(Division Sign-Off)
Division of Repro and Radiological De 510(k) Number
Page 1 of 1
N/A