(43 days)
The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The CPIVision Digital Imaging system allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The CPIVision Digital Imaging system enables the operator to hardcopy image with a laser printer or send images over a network. The major system includes: a fluoroscopic CCD camera/lens, monitors, and an image processor.
The CPIVision Digital Imaging system allows the use of digital imaging to be applied to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camera/lens on the output port of the image intensifier and digitizing the video output on the image intensifier. The digital image can be displayed on the monitor; it can be stored to the hard drive, or sent to an external device such as a laser imager or Network Storage Provider. The image can also be computer processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
The CPIVision Digital Imaging enables the operator to hardcopy image with a laser printer or send images over a network. The major system components are: a fluoroscopic CCD camera/lens, monitors, and an image processor.
This document describes the CPIVision Digital Imaging System, a digital radiography device. However, this document does not contain explicit acceptance criteria or a study dedicated to proving the device meets specific performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (INFIMED INC. ORION FLUOROSCOPIC IMAGING SYSTEM 510(k) – K012490) based on its device description and intended use. This is a common regulatory pathway for medical devices that are similar in technology and purpose to devices already on the market.
Therefore, many of your specific questions cannot be answered from the provided text, as the focus is not on a direct performance study against a predefined set of acceptance criteria.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The document implies that the "acceptance criteria" for regulatory approval were met by demonstrating substantial equivalence to the predicate device. This means its performance is considered acceptable if it performs comparably to the predicate for its intended use.
- Reported Device Performance: Not directly reported in quantitative terms. The document describes the system's capabilities (e.g., high resolution, digital videography, image enhancement, rapid acquisition rates, hardcopying, networking) but does not provide specific performance metrics (e.g., spatial resolution in lp/mm, signal-to-noise ratio, frame rates under specific conditions, diagnostic accuracy for particular findings).
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. The document does not describe a performance study with a test set of images or patient data. The basis for comparison is the functional and intended use equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not provided. No specific test set or ground truth establishment process is described.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. No test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study. It focuses on the device's capabilities and its equivalence to an existing device, not on comparing human reader performance with and without the device.
6. Standalone Performance Study:
- No. The document does not describe a standalone (algorithm-only) performance study. The system described is hardware and software designed to process and display fluoroscopic images for human interpretation, not an AI algorithm making diagnoses independently.
7. Type of Ground Truth Used:
- Not applicable / Not provided. No specific ground truth is referenced as no performance study is described. The "ground truth" for regulatory approval in this context is that the device functions as intended and is as safe and effective as the predicate device.
8. Sample Size for the Training Set:
- Not applicable / Not provided. The CPIVision Digital Imaging system as described is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a digital imaging system replacing analog film techniques.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. As it's not an AI/ML algorithm requiring a training set, this question is not relevant to the provided text.
Summary based on the provided text:
The CPIVision Digital Imaging system sought 510(k) clearance by demonstrating substantial equivalence to the INFIMED INC. ORION FLUOROSCOPIC IMAGING SYSTEM (K012490). The acceptance criteria were implicitly met by showing the new device shares the same intended use and fundamentally similar technological characteristics to the predicate, ensuring it is as safe and effective. No specific performance study with a defined test set, ground truth, or statistical analysis against pre-specified acceptance metrics is described in this document.
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Section S
510 (k) Summary of Safety and Effectiveness
| Date Prepared: | April 16, 2006 |
|---|---|
| Name of Contact Person: | Norm Morikawa |
| Address: | Communications & Power Industries Canada Inc.Communications & Medical Products Division45 River Drive, Georgetown, Ontario, L7G 2J4, Canada |
| Telephone: | 905-877-0161 |
| Fax: | 905-877-5327 |
| Device Trade Name: | CPIVISION DIGITAL IMAGING SYSTEM |
| Common Name: | Digital Radiography |
| Classification Name: | Image Intensified Fluoroscopic X-ray System |
Device Description:
The CPIVision Digital Imaging system allows the use of digital imaging to be applicd to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camerallens on the output port of the image intensifier and digitizing the video output on the image intensifier. The digital image can be displayed on the monitor: it can be stored to the hard drive, or sent to an external device such as a laser imager or Network Storage Provider. The image can also be computer processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
Intended Use:
The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The CPIVision Digital Imaging allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic difficult or impossible to see using conventional imaging techniques.
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The CPIVision Digital Imaging enables the operator to hardcopy image with a laser printer or send images over a network. The major system components are: a fluoroscopic CCD camera/lens, monitors, and an image processor.
Conclusion drawn from comparison:
The CPIVision Digital Imaging can be considered to be substantially equivalent to:
INFIMED INC.
ORION FLUOROSCOPIC IMAGING SYSTEM 510 (k) – K012490
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Norm Marikawa QA Manager/Regulatory Affairs CPI (Communications & Power Industries) Canada, Inc. Communications & Medical Products 45 River Drive, Georgetown, Ontario, L7G 2J4 CANADA
Re: K061173
Trade/Device Name: CPIVision Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: April 17, 2006 Received: April 27, 2006
Dear Mr. Morikawa:
This letter corrects our substantially equivalent letter of June 9, 2006.
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 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 of
MAY - 7 20-2
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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/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/cdrh/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
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Section 4
Indications for Use
Not to will at this time KO6 1 73 510(k) Number:
Device Name: CPIVision Digital Imaging System
Indications for Use: The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The CPIVision Digital Imaging system allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The CPIVision Digital Imaging system enables the operator to hardcopy image with a laser printer or send images over a network. The major system includes: a fluoroscopic CCD camera/lens, monitors, and an image processor.
Prescription Device √
Concurrence of CDRH, Office of Device Evaluation (ODE.
Daniel R. Tyson
Division Sign Off
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.