(163 days)
CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.
The CPI RAD VISION product will provide a user interface to control the digital imaging functions of a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images from a Solid State X-ray Imager (SSXI)).
The CPI RAD VISION product will also provide either an option on the user interface to control the x-ray generator functions required by a radiographic acquisition modality or an optional hardware interface to allow the x-ray generator functions to be controlled by an independent third-party operator console while maintaining synchronization with the digital imaging functions of the product.
CPI RAD VISION is a component of a complete radiographic x-ray system.
The provided text is a 510(k) summary for the CPI RAD VISION device, a digital imaging system for radiography. The text states that the device's performance testing demonstrated its safety and effectiveness, and its equivalence to predicate devices, through "Electrical safety (IEC60601-1:2005) and Electromagnetic compatibility (IEC60601-1-2, Edition 3:2007-03), Software verification (IEC60601-1-4:2000), other performance testing and the acquisition of sample clinical images." However, the document does not include specific acceptance criteria, detailed device performance metrics, or the study specifics (like sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone studies, or details on ground truth for training/test sets) requested in the prompt.
Therefore, most of the requested information cannot be extracted from this document.
1. A table of acceptance criteria and the reported device performance
The document does not specify acceptance criteria or quantitative device performance metrics. It generally states that the device "demonstrated that CPI RAD VISION is safe and effective, and is equivalent to the aforementioned predicates devices" based on compliance with electrical safety, EMC, and software verification standards, and the acquisition of "sample clinical images."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The document only mentions "acquisition of sample clinical images" without any details on sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
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 provided in the document. The device is described as a "digital imaging system," not explicitly an AI-assisted device for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not explicitly stated or detailed in the document. The device is a system for image capture and display, implying human interaction for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document. The document mentions "acquisition of sample clinical images" but does not detail how ground truth was established for these images for evaluation purposes.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document.
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Image /page/0/Picture/1 description: The image shows the logo for Communications & Power Industries. The logo is black and white and features the letters "CPI" in a stylized font. The words "Communications & Power Industries" are written in a smaller font below the letters. The logo is simple and modern.
FEB 1 5 2013
e
510(k) Summary
Prepared in accordance with 21 CFR 807.92(c)
Date Prepared:
December 19, 2012
Name of Contact Person: Norm Morikawa
| Address: | Communications & Power Industries Canada Inc.45 River Drive, Georgetown, Ontario, L7G 2J4, Canada |
|---|---|
| Telephone: | 905-877-0161 |
| Fax: | 905-877-5327 |
| Device Trade Name: | CPI RAD VISION |
| Common Name: | Digital Radiography |
| Classification Name: | Stationary x-ray system (21 CFR 892.1680, Product CodeMQB). |
Device Description:
The CPI RAD VISION product will provide a user interface to control the digital imaging functions of a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images from a Solid State X-ray Imager (SSXI)).
The CPI RAD VISION product will also provide either an option on the user interface to control the x-ray generator functions required by a radiographic acquisition modality or an optional hardware interface to allow the x-ray generator functions to be controlled by an independent third-party operator console while maintaining synchronization with the digital imaging functions of the product.
CPI RAD VISION is a component of a complete radiographic x-ray system.
Intended Use:
CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.
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Image /page/1/Picture/0 description: The image shows the logo for Communications & Power Industries. The logo consists of the letters CPI in a stylized font, with the words "Communications & Power Industries" written below it. Below that is the text "Communications & Power Industries Canada Inc."
Comparison to substantially equivalent devices:
The CPI RAD VISION product is substantially equivalent to the Carestream DRX-1 System (K090318) and the InfiMed is Digital X-ray Imaging System (K093066) since it shares the same intended use, major components, technology, and standard features as these two predicate devices. The following table depicts the comparison characteristics:
| CPI RADVISION | CarestreamDRX-1System | i 5 Digital X-ray ImagingSystem | |
|---|---|---|---|
| Indicated for use in general radiographicexaminations and applications. Not intendedfor mammographic, fluoroscopic orangiographic applications. | ✓ | ✓ | ✓ |
| Components / Technology | |||
| High-performance desktop ComputerWorkstation, large-area LCD DisplayMonitor, Software | ✓ | ✓ | ✓ |
| High-resolution Solid State X-ray Imager | ✓ | ✓ | ✓ |
| Interface for non-integrated configuration,based on a modern circuit board withstandard electrical I/O. | ✓(optional) | ✓ | ✓(optional) |
| Medical Grade Isolation Transformer | ✓ | x | x |
| Features | |||
| Radiographic image acquisition from SolidState X-ray Imagers. | ✓ | ✓ | ✓ |
| Enhancement, display, manipulation, reviewand distribution of radiographic images. | ✓ | ✓ | ✓ |
| Work list for patient scheduling. | ✓ | ✓ | ✓ |
| Option for user to manage x-ray settings | ✓ | x | ✓ |
Performance Testing:
A comprehensive Electrical safety (IEC60601-1:2005) and Electromagnetic compatibility (IEC60601-1-2, Edition 3:2007-03), Software verification (IEC60601-1-4:2000), other performance testing and the acquisition of sample clinical images were performed on CPI RAD VISION product which demonstrated that CPI RAD VISION is safe and effective, and is equivalent to the aforementioned predicates devices.
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Image /page/2/Picture/0 description: The image shows the logo for Communications & Power Industries Canada Inc. The logo consists of the letters "CPI" in a stylized font, with the words "Communications & Power Industries" written below it. The words "Communications & Power Industries Canada Inc." are written below that. The logo is black and white.
Conclusion:
The Performance Data demonstrate that CPI RAD VISION product is safe and effective as the predicate devices. Based on the information in this submission, similarity to the predicates devices, and the acquisition of sample clinical images, it is the opinion of CPI (Communications & Power Industries) Canada Inc. that CPI RAD VISION described in this submission is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2013
Mr. Norm Morikawa QA Manager Communications and Power Industries Canada, Inc. 45 River Drive GEORGETOWN, ONTARIO, L7G2J4, CANADA
Re: K122726
Trade/Device Name: CPI Rad Vision Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: January 18, 2013 Received: February 1, 2013
Dear Mr. Morikawa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical 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.
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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,
Smh
5270
Janine M. Morris Director, Diagnostic X-Ray Systems Branch Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
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Indications for Use
K122726 510(k) Number (if known):
CPI RAD VISION
Indications For Use:
Device Name:
CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.
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 In Vitro Diagnostics and Radiological Health (OIR)
Image /page/5/Picture/10 description: The image shows a logo with the letters FDA. The letters are stylized and appear to be hand-drawn. The logo is black and white and has a rough, textured appearance. The letters are connected and overlapping, making the logo appear complex and intricate.
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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
§ 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.