(29 days)
The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique. Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies
The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
The provided S510(k) summary for the Koro890 SmartSPOT PrimaX describes the device as a high-resolution digital imaging system for Digital Spot Imaging, indicating it's an update to a previously marketed device (SMARTSPOT K961307). However, the submission does not include specific acceptance criteria or details of a study proving the device meets acceptance criteria in the format explicitly requested.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device by stating: "Tests data demonstrate that the SMARTSPOT PrimaX meets the required specifications. No adverse affects have been detected." and highlighting changes made to improve cost-effectiveness and update aging technologies/components, while asserting that "The device major functions and principle of operation were not changed."
Therefore, it's not possible to populate the requested table and answer the study-related questions based on the provided text. The document is a regulatory submission for a 510(k) clearance, which primarily focuses on demonstrating substantial equivalence rather than presenting detailed performance study results with specific acceptance criteria.
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth.
- Qualifications of experts.
- Adjudication method.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement effect size.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
The document states that "The device has been designed verified and validated complying with 21 CFR 820.30 regulations," which refers to the Quality System Regulation, outlining general requirements for design controls, but does not provide the specific performance data or acceptance criteria.
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Koro890
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name: SmartSPOT PrimaX
Establishment Name and Registration Number of Submitter
APR 2 9 2008
Name: CMT Medical Technologies Ltd. (CMT hereafter) Registration: 8030112 Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
| Product Code: | LLZ |
|---|---|
| Regulation Number: | 892.2050 |
| Common Name: | PACS - Picture archiving &communications system |
| Classification Name: | Picture archiving and communications system |
| Regulatory class: | Class II |
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed Equivalent Devices
K961307 SMARTSPOT
Device Description
The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
Indications for use
The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA that were not possible with conventional technique.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
Safety & Effectiveness
The device has been designed verified and validated complying with 21 CFR 820.30 regulations. Tests data demonstrate that the SMARTSPOT PrimaX meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is CMT opinion that the SmartSPOT PrimaX is substantially equivalent in terms of safety and effectiveness to the predicate device.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2008
CMT Medical Technologies Ltd. c/o Mr. Dan Laor Quasar Quality Ltd. 6 Sireni HAIFA 32972, ISRAEL
Re: K080890
Trade/Device Name: SmartSPOT PrimaX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: March 27, 2008 Received: March 31, 2008
Dear Mr. Laor:
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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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 yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
k osorqa
SmartSPOT PrimaX Device Name:
Indications For Use: The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies
Prescription Use: YE (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
Page 1 of
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).