(74 days)
This digital radiographic system is 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, extremitics, and other body parts. Applications can be performed with the patient 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 ceiling suspension OR a U-Arm, along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 K V or 40 - 150 k V with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. Models: Model DR3000 (U-arm single detector) and Model DR4000 (dual detector-ceiling suspension and table and upright bucky) and DR1000 single detector (standing bucky and cciling suspension. The digital subsystem is the SmartRad (CMT Medical Technologies) K003438.
This 510(k) summary (K082604) for the Viztek DR Series Digital Diagnostic Digital X-Ray Systems (Multiple Models) is a submission for substantial equivalence to predicate devices, not a study presenting novel performance data. Therefore, many of the requested elements regarding acceptance criteria and study details are not directly applicable.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it is a submission for substantial equivalence, not a direct performance study against a predefined clinical benchmark. The acceptance criteria essentially revolve around demonstrating equivalence to legally marketed predicate devices in terms of technical characteristics and intended use.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as URS LP Digital, Millennium, Radpro (Sedecal) K042876 | "SAME" - Intended for diagnostic radiographic exposures of skull, spine, chest, abdomen, extremities, and other body parts in adults and pediatrics, with patient sitting, standing, or lying prone/supine. |
| Configuration | U-Arm mount or Ceiling Suspension (same as predicate) | "SAME" - U-Arm mount or Ceiling Suspension. |
| Performance Standard | Compliance with 21 CFR 1020.30 (same as predicate) | "SAME" - Compliance with 21 CFR 1020.30. |
| Generator | High frequency made by Sedecal (same as predicate) | "Uses same generator made by Sedecal". |
| Electrical Safety | Electrical Safety per IEC-60601, UL listed (same as predicate) | "SAME" - Electrical Safety per IEC-60601, UL listed. |
| Safety and Effectiveness | Bench and laboratory test results indicate safety and effectiveness comparable to predicate devices. | "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices." |
Note on "Digital Panel" and "Number of panels": While these are present in the comparison chart, they highlight differences rather than direct "acceptance criteria" for performance. The Viztek device uses a Pixium 4600 panel and can have one or two panels, while the predicate uses a CANON CXDI 50G and has one. The implication is that these differences do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission for substantial equivalence, not a clinical study involving a test set of patient data for performance evaluation. The "tests" mentioned are bench and laboratory tests, not clinical evaluations with a patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical ground truth establishment or expert review of a test set of images is described for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a digital X-ray system, not an AI-powered diagnostic tool, and no MRMC study is described. The submission focuses on the hardware and its equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a digital X-ray system, and there is no "algorithm only" performance reported in this context. The device's primary function is to acquire X-ray images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense. The "ground truth" for this submission is adherence to recognized performance standards (e.g., 21 CFR 1020.30, IEC-60601 for electrical safety), and the technical specifications and intended use of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
{0}------------------------------------------------
510(k) Summary 510(k) Number 6082600 Viztek, Inc. 6491 Powers Avenue Jacksonville, FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: July 30, 2008 Bruce Ashby, Sales and Marketing Manager Contact:
-
- Identification of the Device: Proprietary-Trade Name: Viztek DR Series Digital Diagnostic Digital X-Ray Systems (Multiple Models) Classification Name: Stationary x-ray system, Product Codc 90 KPR and Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital Stationary Diagnostic X-Ray System
-
- Indications for Use (intended use) This digital radiographic system is 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, extremitics, 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 4. tubehead/collimator assembly mounted on a ceiling suspension OR a U-Arm, along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 K V or 40 - 150 k V with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. Models: Model DR3000 (U-arm single detector) and Model DR4000 (dual detector-ceiling suspension and table and upright bucky) and DR1000 single detector (standing bucky and cciling suspension. The digital subsystem is the SmartRad (CMT Medical Technologies) K003438.
-
- 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.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows three different models of equipment. The first model is labeled "Model 3000" and appears to be a type of medical or industrial device with a movable arm and a base. The other two models are labeled "Models 4000 and 1000" and seem to be variations of a similar type of equipment, possibly X-ray machines or similar diagnostic tools. One of the models has a table attached.
6 Substantial Equivalence Chart
| Substantial Equivalence Chart | ||
|---|---|---|
| Characteristic | URS LP Digital, Millennium, Radpro(Sedecal) K042876 | Viztek DR Series |
| Intended Use: | Intended for use by a qualified/traineddoctor or technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull,spinal column, chest, abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position. | SAME |
| Configuration | U-Arm mount or Ceiling Suspension | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | Uses same generator madeby Sedecal |
| Digital Panel | CANON CXDI 50G | Pixium 4600 |
| Number of panels | One | One or two |
| Electrical safety | Electrical Safety per IEC-60601. ULlisted | SAME |
7. Conclusion
After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Viztek Inc that the Viztek DR Digital 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard. Rockville MD 20850
NOV 21 2008
VIZTEK
% Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K082604
Trade/Device Name: Viztek DR Series Diagnostic Digital X-Ray Systems (Multiple Models) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 1, 2008 Received: September 11, 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 your device in the Federal Register.
{3}------------------------------------------------
Page 2
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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 vours.
loque M. Whang
Joyce M. Whang, Ph.D. Acting 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): K0826 D4
Device Name: Viztek DR Series Diagnostic Digital X-Ray Systems (Multiple Models)
Indications For Use:
This Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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.
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)
Signature
Pivision Sign-Off) n i vision of Reproductive, Abdominal, Cand Radiological Devices 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.