(149 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, extremittes, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Excludes fluoroscopy, angiography, and mammography.
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 KV or 40 - 150 kV 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 ceiling suspension. The digital panel is the Pixium 3543pR (K090625) and the digital subsystem is the SmartRad, CMT Medical Technologies, K003438.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek WL Series Digital Diagnostic Digital X-Ray Systems (K091752):
It is important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data for new acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics tested against pre-defined acceptance criteria is not explicitly present in this type of document.
The "acceptance criteria" in this context are primarily tied to demonstrating the Viztek WL Series is as "safe and effective" and "substantially equivalent" to its predicate devices (K082604, K090625, and K003438). This usually involves showing that performance characteristics (like pixel size, software, safety standards) are comparable, and there are no new risks or concerns.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary for substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate device. The "reported device performance" is essentially that it meets or is comparable to these characteristics.
| Characteristic (Implied Acceptance Criteria from Predicate) | Reported Viztek WL Series Performance |
|---|---|
| Intended Use: Diagnostic radiographic exposures of skull, spine, chest, abdomen, extremities, and other body parts for adult and pediatric subjects; patient positioning (sitting, standing, prone, supine). | SAME, with added clarity: "Excludes fluoroscopy, angiography, and mammography." (This addition is for clarity, not a change in fundamental intended use). |
| Configuration: U-Arm mount or Ceiling Suspension | SAME |
| Performance Standard: 21 CFR 1020.30 | SAME |
| Generator: High frequency made by Sedecal | SAME |
| Digital Panel: Pixium 4600, Pixel size 143 µm, 3000 x 3000 pixels | Pixium 3543pR (K090625), Pixel size 144 µm, 2372 x 3000 pixels (Slight variation, but deemed substantially equivalent) |
| Software: Employs K003438.SmartRad, CMT Medical Technologies. | SAME |
| Electrical Safety: IEC-60601, UL listed | SAME |
Summary of "Acceptance": The device's performance is deemed "as safe and effective" and "substantially equivalent" to the predicate devices due to having "few technological differences" and "no new indications for use." The primary "acceptance" relies on meeting the same regulatory standards and having comparable technical specifications.
2. Sample Size Used for the Test Set and Data Provenance
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..."
- Sample Size for Test Set: Not specified. The document does not detail specific sample sizes for any testing (e.g., number of images, number of patients).
- Data Provenance: The testing is referred to as "bench and external laboratory testing." The country of origin for this data is not specified, nor is whether it was retrospective or prospective. It's typical for bench testing to not involve patient data in the same way clinical trials do.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not specified. This type of 510(k) summary for an X-ray system, especially one establishing substantial equivalence based on technical specifications and safety standards, does not typically involve expert review for "ground truth" derived from patient images in the way AI/CAD devices do. The "ground truth" here is compliance with technical specifications and safety standards.
4. Adjudication Method for the Test Set
Not applicable/Not specified. As no expert review for "ground truth" is mentioned, no adjudication method would be detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. This document is for a digital X-ray system, not an AI or CAD system designed to aid human readers. Therefore, there's no discussion of human reader improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Not applicable/Not specified. This is a digital X-ray system, not an AI algorithm. Its performance is measured by its ability to acquire diagnostic images according to established standards and technical specifications, not as a standalone diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Bench and external laboratory testing to applicable standards: This implies objective measurements of physical characteristics, adherence to electrical safety standards (IEC-60601), and performance standards (21 CFR 1020.30).
- Comparison of technical specifications: Matching or demonstrating acceptable differences in parameters like pixel size and other hardware components against the predicate device.
It does not rely on expert consensus, pathology, or outcomes data, as it's not evaluating diagnostic accuracy of a finding but rather the system's ability to produce images safely and effectively.
8. Sample Size for the Training Set
Not applicable/Not specified. This document does not describe the development of an AI algorithm with a training set. The software component mentioned (SmartRad) is an existing, previously cleared device (K003438), which would have had its own validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. As there is no AI algorithm being developed by Viztek for this submission that would require a dedicated training set, this information is not available in the document.
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510(k) Summarv P. 1 of 2 510(k) Number K09/752 Viztek, Inc. 6491 Powers Avenue Jacksonville, FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 NOV 12 2009 Date Prepared: May 27, 2009 Contact: Bruce Ashby, Sales and Marketing Manager
l . Identification of the Device: Proprietary-Trade Name: Viztek WL Series Digital Diagnostic Digital X-Ray Systems (Multiple Models) Classification Name: Stationary x-ray system, Product Code 90 KPR and Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital Stationary Diagnostic X-Ray System
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- Equivalent legally marketed device: K082604, VIZTEK DR, MODELS: DR1000, DR3000, DR4000 and K090625, WIRELESS PORTABLE DETECTOR FD-W17, PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO (This is the 510(k) for the wireless panel); K003438.SmartRad, CMT Medical Technologies. (This is the 510(k) for the software)
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- 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, extremittes, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Excludes fluoroscopy, angiography, and mammography.
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- Description of the Device: 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 KV or 40 - 150 kV 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 ceiling suspension. The digital panel is the Pixium 3543pR (K090625) and the digital subsystem is the SmartRad, CMT Medical Technologies, K003438.
- Safety and Effectiveness, comparison to predicate device. The results of bench and test 5. laboratory indicates that the new device is as safe and effective as the predicate devices.
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K091752
p. 2 of 2
| 6. Substantial Equivalence Chart | ||
|---|---|---|
| Characteristic | K082604, VIZTEK DR, MODELS:DR1000, DR3000, DR4000 and | Viztek WL Series |
| Intended Use: | Intended for use by aqualified/trained doctor or technicianon both adult and pediatric subjectsfor taking diagnostic radiographicexposures of the skull, spinal column,chest, abdomen, extremities, andother body parts. Applications can beperformed with the patient sitting,standing, or lying in the prone orsupine position. | SAME, but updated: "Excludesfluoroscopy, angiography, andmammography." (Statement addedfor the sake of clarity) |
| Configuration | U-Arm mount or Ceiling Suspension | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | SAME |
| Digital Panel | Pixium 4600Pixel size 143 µm3000 x 3000 pixels | Pixium 3543pR (K090625)Pixel size 144 µm2372 x 3000 pixels |
| Software | Employs K003438.SmartRad, CMTMedical Technologies. | SAME |
| 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 WL 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.
පිහිටා පිහිටා ක්රියා විශ්වයි.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV 12 2009
Viztek, Inc. % Mr. Daniel Kamm, P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates 333 Milford Rd. DEERFIELD IL 60015
Re: K091752
Trade/Device Name: Viztek WL Diagnostic Digital X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: September 9, 2009 Received: September 11, 2009
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 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 of medical
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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.
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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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' Indications for Use
510(k) Number (if known): K.09/ 7 2 2
Device Name: Viztek WL Diagnostic Digital X-Ray System
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. Excludes fluoroscopy, angiography, and 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 Device Evaluation (ODE)
Vom K2hz
(Division Sign-O (Division Sign-Off)
Division of Reproductive, Abdominal, Division of Rical Devices 510(k) Number
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§ 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.