(71 days)
DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
The NICAL NDR+ is a digital image acquisition system to be used in conjunction with an image Intensifier during radiography or fluoroscopy x-ray examination to capture images by a camera, digitalize the image, review images and format images according to DICOM 3.0 protocol to be sent through network connection.
The provided text is a 510(k) summary for the NICAL SPA NDR+/DIVA-D digital image acquisition system. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, specific device performance, or a clinical study proving its performance. The document is primarily a comparison of features and intended use between the NDR+/DIVA-D and the INFIMED Platinum ONE (ORION) system.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets specific acceptance criteria based solely on the provided text. The document does not describe any specific performance study, sample sizes, ground truth establishment, or multi-reader multi-case studies.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and the Reported Device Performance:
This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence through feature comparison with a predicate device, rather than presenting specific performance metrics against pre-defined acceptance criteria from a study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided document. No test set or clinical study details are mentioned.
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):
This information is not available in the provided document. No ground truth establishment related to a clinical study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document. No adjudication method for a test set is mentioned.
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:
This information is not available in the provided document. The device is a digital image acquisition system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not available in the provided document. The device is an image acquisition and processing system, not an algorithm with standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided document, as no specific clinical study or ground truth establishment is described.
8. The sample size for the training set:
This information is not available in the provided document, as no machine learning or AI training is described.
9. How the ground truth for the training set was established:
This information is not available in the provided document, as no machine learning or AI training is described.
Summary of what is available from the document:
- Device Trade Name: NDR+/DIVA-D
- Common Name: Digital image acquisition system
- Intended Use: "DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUNCTION WITH AN IMAGE INTENSIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION." (This indicates it's a system for acquiring, digitalizing, reviewing, and formatting X-ray images, not a diagnostic AI device requiring a clinical performance study with "acceptance criteria" in the typical sense for a new diagnostic claim.)
- Predicate Device: INFIMED Platinum ONE (certified under the name ORION) (K012490)
- Comparison with Predicate Device features: The document primarily lists technical specifications and features of the NDR+/DIVA-D and compares them to the predicate device to establish substantial equivalence. These features include:
- Image Acquisition (CCD camera 1024x1024 12 bit for both)
- Speed Acquisition (NDR+/DIVA-D: 1024x1024 at 25 fps for FLUORO and all radiographic exams; INFIMED: Up to 30 fps for FLUORO acquisition and up to 15 fps for spot acquisition)
- Edge Enhancer (NDR+/DIVA-D: Completely hardware in real time; INFIMED: Software package)
- Noise Reduction (NDR+/DIVA-D: Dynamic recursive filter; INFIMED: Standard recursive filter)
- Image Storage, Post Processing, DSA Application, Multi Image, DICOM Functions, Laser Interface, Interface Commands.
The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through technical comparison and compliance with relevant standards, rather than extensive clinical performance studies to meet specific "acceptance criteria" for a diagnostic accuracy claim.
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JAN 6 2006
Attachment 1 - 510 (k) SUMMARY
510(k) summary for NDR+- DIVA-D
Identification
| Applicant | NICAL SPA43 Via SoffrediniMilan (MI), ITALY 20126Registration Number: 3003314115 |
|---|---|
| Contact Person | Mr. Roberto Niccolucci - President |
| Telephone (applicant) | +39 022571110 |
| Designated Agentin the US | Mr. Gerald Silverman71 Rose StreetHasting On Hudson, NY 10706Phone: +1 914 674 1085 |
| Manufacturing site | NICAL SPA43 Via SoffrediniMilan (MI), ITALY 20126Registration Number: 3003314115 |
Trade name: NDR+/DIVA-D
Common name: Digital image acquisition system Classification:
The equipment is classified as a class II
CFR21- 892.2050: Picture archiving and communication system
CFR21 - 892.1650: Image Intensified Fluoroscopic X-ray system.
Substantial equivalent device: the NDR+/DIVA-D is defined as Substantially Equivalent (SE) to the INFIMED Platinum ONE digital image acquisition system (certified under the name ORION) (K012490).
The following table compares the NDR+/DIVA-D and the predicate device
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| FEATURES | NICAL (NDR+/DIVA D) | INFIMED (Platinum ONE) |
|---|---|---|
| Intended use | The NICAL NDR+ is a digital imageacquisition system to be used inconjunction with an image Intensifierduring radiography or fluoroscopy x-ray examination to capture images bya camera, digitalize the image, reviewimages and format images accordingto DICOM 3.0 protocol to be sentthrough network connection | The INFIMED Orion Fluoroscopicimaging system is a high resolution,digital imaging system designed fordigital videography. It is intended toreplace conventional film techniquesin multipurpose or dedicatedapplications where generalfluoroscopy, interventionalfluoroscopy or angiography orcardiac imaging procedures areperformed.The Orion system allows theoperator to view and enhance 1000line fluoroscopy. High resolutiondigital spot images ( 1024x1024)may be acquired at single or rapidacquisition rates. Images may beviewed and enhanced enabling theoperator to bring out diagnosticdetails difficult or impossible to seeusing conventional imagingtechniques.The Orion system enables theoperator to hardcopy image with alaser printer or send images over anetwork. The major systemcomponents include: a fluoroscopicTV camera, monitors, and an imageprocessor. · |
| Image Acquisition | CCD camera 1024x1024 12 bit | CCD camera 1024x1024 12 bit |
| Speed Acquisition | 1024x1024 at 25 fps for FLUORO andall radiographic exams | Up to 30 fps for FLUOROacquisition and up to 15 fps for spotacquisition |
| Edge Enhancer | Completely hardware in real time | Software package |
| Start Up System | Automatic hardware and software testfor each ignition | Automatic system calibration andremote system diagnostics |
| Noise Reduction | Dynamic recursive filter whichoffering an automatic noise/blurringoptimization effect it gives zeropersistence | Standard recursive filter |
| Image Storage | Up to 36000 frames with matrix1024x1024.All the images are stored directly fromthe CCD camera head without anykind of edge enhancement and digitalcompression. | NA |
| Post ProcessingWorking | All the images stored in the system canbe elaborated in order to modify thewindowing, the gray scale, the zoom,the annotation package, the edgeenhancement and the noise reduction | Brightness/contrast polarityenhancement. Measurement andannotation package |
| DSA Application | Real time mask subtraction, roadmapping, land marking, pixel shiftfunction, auto loop replay, injectorsynchronization, automatic or manualpossibility to change the mask, maxopfunction and stepping angio | Real time mask subtraction, roadmapping, land marking, percentStenosis vascular package, auto loopreplay, injector synchronization. |
| Multi Image | Thumbnail image viewing with thepossibility to choose the first image forevery run or the 50% of the run. | Thumbnail image viewing |
| DICOM Functions | Full DICOM 3.0 integrated | Full DICOM 3.0 integrated |
| Laser Interface | When DICOM network is notavailable in the site installation, it ispossible to send the images to a laserprinter using the protocol P831 orP859 | NA |
| Interface Commands | Flat keyboard with waterproof surface | Standard pc keyboard + standard pcmouse |
510(K) Summary for NDR+/DIVA-D
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Indication for use.
The indication for use of the NDR+/DIVA-D is: DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NICAL SPA % Mr. Gerald Silverman Designated Agent 71 Rose Street Hasting on Hudson, NY 10706
AUG 2 3 2013
Re: K053029
Trade/Device Name: NDR+/DIVA-D Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 27, 2005 Received: November 25, 2005
Dear Mr. Silverman:
This letter corrects our substantially equivalent letter of January 6, 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
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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
Janine M. Morri 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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6.1. Indication for use Statement
510(k) Number: Kos 30 2 7
Device Name: NDR+ or DIVA-D
The indication for use of the NDR+/DIVA-D is: DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE RADIOGRAPHY INTESIFIER DURING OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
Daniel A. Lysom
Division Sign-Off ivision of Reproductive. Abdominal nd Radiological Devic
Prescription Use
§ 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.