(41 days)
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No
The document describes a system integrating existing components and does not mention AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is described as an imaging system for diagnostic and interventional procedures, not a device that directly treats a condition. Its function is to provide cardiovascular x-ray imaging.
Yes
The "Intended Use / Indications for Use" section explicitly states "The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures".
No
The device description explicitly mentions integrating new and/or refurbished/rebuilt positioners, components, and digital imaging systems, including replacing hardware like Image Intensifiers with flat panel detectors and integrating a system interface rack. This indicates the device is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "cardiovascular x-ray imaging applications, including diagnostic and interventional procedures". This describes a device used for imaging the inside of the body using X-rays, which is an in vivo (within the living body) procedure, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details components related to X-ray imaging, such as positioners, digital imaging systems, image intensifiers, and flat panel detectors. These are all characteristic of medical imaging equipment used on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining features of an IVD.
Therefore, this device falls under the category of medical imaging equipment used for diagnostic and interventional procedures performed directly on patients.
N/A
Intended Use / Indications for Use
The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures (such as PTCA, stent placement, atherectomies), pacemaker implantations, and electrophysiology. It may also be used for other imaging applications at the physician's discretion.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
Device Description
The MIS NewBrid System is the result of integrating new and or refurbished/rebuilt positioners. components and digital imaging systems that are previously cleared by the FDA. Some of the new components will change the original manufacturers specifications and functionality. For example, MIS could remove the original manufacturers Image Intensifier-based imaging chain and replace it with new components or with a solid-state flat panel detector. MIS will integrate its own system interface rack for system control. The image acquisition package with a system purchased from an OEM that has 510[k] approval. The pivoting base will allow for an extend area of patient imaging coverage.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray imaging
Anatomical Site
cardiovascular
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Philips Integris Series [K984545], GE Medical System Advantx LCV+ [K960575], GE Medical System Innova [K023178]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS (21CFR 807.92)
1. SUBMITTER:
Nancy Butcher Medical Imaging Solutions, Inc. 400 Central Avenue Jefferson, LA 70121
2. DEVICE NAME:
Trade/Proprietary Name: NewBrid
3. DEVICE CLASSIFICATION:
21 CFR 892.1600 - Angiographic x-ray system 21 CFR 892.1650 - Image-intensified fluoroscopic x-ray system Class II (90 IZI and MQB)
4. DEVICE DESCRIPTION AND INTENDED USE:
The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures.
The MIS NewBrid System is the result of integrating new and or refurbished/rebuilt positioners. components and digital imaging systems that are previously cleared by the FDA. Some of the new components will change the original manufacturers specifications and functionality. For example, MIS could remove the original manufacturers Image Intensifier-based imaging chain and replace it with new components or with a solid-state flat panel detector. MIS will integrate its own system interface rack for system control. The image acquisition package with a system purchased from an OEM that has 510[k] approval. The pivoting base will allow for an extend area of patient imaging coverage.
5. INDICATION FOR USE:
The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures (such as PTCA, stent placement, atherectomies), pacemaker implantations, and electrophysiology. It may also be used for other imaging applications at the physician's discretion.
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7. PREDICATE DEVICE(s):
The MIS Newbrid System is substantially equivalent, in terms of its intended use in: Philips Integris Series [K984545] GE Medical System Advantx LCV+ [K960575] GE Medical System Innova [K023178]
8. SAFETY INFORMATION:
The finished device and its peripherals will comply with applicable requirements of the Underwriter Laboratories Standard for Safety UL 2601, Title 21 CFR part 1020, and comply with the ACR/NEMA DICOM digital imaging communications standard.
Only trained professionals will utilize the MIS NewBrid system. Trained professionals allow sufficient review to afford identification and intervention in the event of a malfunction.
Medical Imaging Solutions will consider using only components from angiographic and fluoroscopic xray systems that were previously cleared by the FDA for their refurbishing and rebuilding process. By retaining criteria for the substitution of components, any concerns about safety or efficacy and substantial equivalence can be satisfactorily met by a determination that the component substitution will not significantly change in the system. This is consistent with the existing Agency guidance.
9. CONCLUSION:
Medical Imaging Solutions concludes that the subject device is safe and effective including the component and accessory devices. The system does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Medical Imaging Solutions believes sufficient information is included to reach a determination of substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is rendered in blue. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Nancy Butcher Regulatory Affairs Medical Imaging Solutions, Inc. 800 Central Ave. JEFFERSON LA 70121
JUL 30 2012
Re: K041780
Trade/Device Name: NewBird Angiographic and Fluoroscopic X-ray Systems Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: July 1, 2004 Received: July 1, 2004
Dear Ms. Butcher:
This letter corrects our substantially equivalent letter of August 11, 2004.
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
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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510(k) Number (if known): N/A
Device Name: NewBrid Angiographic and Fluoroscopic X-ray Systems
Indications for Use:
The system is intended for use in cardiovascular x-ray imaging applications, including I the System intentional procedures (such as PTCA, stent placement, atherectomics), ulaghosic and intervebiler processor siology. . It may also be used for other imaging applications at the physician's discretion.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Nancy Brandon
(Division Sigh-Off) Division of Reproductive, and Radiological Device 510(k) Number