(261 days)
The Brivo XR385 Digital X-Ray System is intended for use on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The Brivo XR385 Digital Diagnostic Radiographic system provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Brivo XR385 system configuration includes an integrated tube stand and patient support table with a floating table top, under-the-table high-voltage generator and power distribution unit, an X-ray tube assembly with dual focal spot X-ray tube, a manual beam limiting device, and a wall stand and a digital detector that captures radiographic images in digital form. The system also includes an acquisition and review workstation for image post-processing, short-term storage, and quick in-room viewing of images. Images may be transferred manually or automatically via a DICOM network for printing, long-term storage archive, and detailed review.
This submission for the Brivo XR385 Digital Diagnostic Radiographic system explicitly states that clinical studies were not required to support substantial equivalence (ref. page 3). Therefore, much of the requested information about acceptance criteria, device performance from a test set, and detailed study parameters for proving performance against acceptance criteria is not present in the provided text.
The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, adherence to voluntary standards, and bench testing, rather than a clinical performance study.
However, based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics from a clinical study within the provided text. The "acceptance criteria" are implied to be conformance with voluntary standards and related FDA guidance, and the successful completion of various engineering and quality assurance tests.
- Reported Device Performance: Not reported in terms of specific clinical accuracy, sensitivity, or specificity from a study. The general statement is that the device provides "state of the art image quality, image manipulation, operator control, dose reporting and system maintenance" (ref. page 1), and "high quality radiographic images in a digital environment".
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Compliance with voluntary standards and related FDA guidance | "High quality radiographic images in a digital environment" |
| Successful completion of Quality Assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit testing, Integration testing, Performance testing, Safety testing, Simulated use testing | Device functions as intended and provides "state of the art image quality, image manipulation, operator control, dose reporting and system maintenance" |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable, as no clinical test set was used for a performance study.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set with expert-established ground truth was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set with adjudicated ground truth was used.
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:
- No MRMC comparative effectiveness study was done. The submission explicitly states "The subject of this premarket submission, Brivo XR385, did not require clinical studies to support substantial equivalence" (ref. page 3). The device described is an X-ray system, not specifically an AI-powered diagnostic tool, so an MRMC study with AI assistance would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was done. This device is an X-ray system, not a standalone algorithm.
7. The type of ground truth used:
- Not applicable for a clinical performance study. The "ground truth" for the non-clinical testing would be the engineering specifications and test results, ensuring the device met its design and safety requirements.
8. The sample size for the training set:
- Not applicable, as this is an X-ray system and not an AI/algorithm-based device that would typically have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
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AUG 1 2 2011
GE Healthcare 510(k) Premarket Notification Submission
Section 5: 510(k) Summary
Brivo XR385
510(k) Summary
5-2
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510(k) Premarket Notification Submission
:
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | November 19, 2010 |
| Submitter: | GE Healthcare, (GE MEDICAL SYSTEMS, LLC)3000 N. Grandview blvd. W-709 |
| Primary Contact Person: | John L. SchmidtRegulatory Affairs Leader-X-RayGE Healthcare, (GE MEDICAL SYSTEMS, LLC)TEL: (262) 548-4964FAX: (262) 548-2721e-mail: John.L.Schmidt@ge.com |
| Secondary Contact Person: | David BlonskiRegulatory Affairs DirectorGE Healthcare, (GE MEDICAL SYSTEMS, LLC)3000 N. Grandview blvd. (W-709)262 513-4072548-2721e-mail: David.Blonski@ge.com |
| Device: Trade Name: | Brivo XR385 |
| Common/Usual Name: | Digital Diagnostic Radiographic System |
| Classification Names: | Stationary X-Ray System (21CFR § 892.1680) and solid state x-ray imager (21CFR § 892.1650) |
| Product Code: | KPR and MQB |
| Predicate Device(s): | Stationary x-ray system MODEL: Silhouette VR (K982955)GE Tethered Portable Digital Radiographic Detector (K041922)Canon digital radiography CXDI-50G (K031447) |
| Device Description: | The Brivo XR385 Digital Diagnostic Radiographic systemprovides state of the art image quality, image manipulation,operator control, dose reporting and system maintenance. Thesefeatures make this system easy to use and reliable whileproviding high quality radiographic images in a digitalenvironment. The Brivo XR385 system configuration includes anintegrated tube stand and patient support table with a floatingtable top, under-the-table high-voltage generator and power |
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ray tube, a manual beam limiting device, a wall stand and a digital detector that captures radiographic images in digital form. The system also includes an acquisition and review workstation for image post-processing, short-term storage, and quick in-room viewing of images. Images may be transferred manually or automatically via a DICOM network for printing, long-term storage archive, and detailed review.
The Brivo XR385 Digital X-Ray System is intended for use on Intended Use: both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
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The Brivo XR385 Digital Diagnostic Radiographic system Technology: employs the same construction of Silhouette VR Radiographic system: an integrated tube stand and patient support table with a floating table top, under-the-table high-voltage generator and power distribution unit, an X-ray tube assembly with dual focal spot X-ray tube, a manual beam limiting device, and a wall stand. The Brivo XR385 also employs GE's patented digital detector that captures radiographic images in digital form. The digital detector design is the same as the GE Tethered Portable Digital Radiographic detector (also referred to as Trad) with the exception of the scintillator material changing from Csl to GdOS as is in the Canon digital detector CXDI-50G. The system also includes an acquisition and review workstation for image post-processing, short-term storage, and quick in-room viewing of images. Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The Brivo XR385 and its applications comply with voluntary standards and related FDA guidance as detailed in Section 9, 17 and 12 of this premarket submission. The following quality assurance measures were applied to the development of the system: Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, Brivo XR385, did not require clinical studies to support substantial equivalence.
After analyzing standards testing and bench data, it is the Conclusion:
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conclusion of GE Healthcare that the Brivo XR385 is substantially equivalent to other marketed devices with similar indications for use and meeting the same standards.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. John L. Schmidt Regulatory Affairs Leader-X-Ray GE Healthcare 3000 N. Grandview Blvd. WAUKESHA WI 53188
AUG 1 2 2011
Re: K103448
Trade/Device Name: Brivo XR385 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 30, 2011 Received: July 1, 2011
Dear Mr. Schmidt:
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.
ff 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 Viro 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.
Mary Patil.
Mary S. Pastel, Sc.D. 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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Indications for Use
510(k) Number (if known): N/A
Device Name: Brivo XR385
Indications for Use:
The Brivo XR385 Digital X-Ray System is intended for use on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Marp Patel
Division Sigd-Off Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K103448
§ 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.