(234 days)
The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general RIF, angiography and pediativ examinations.
The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastroninal examinations, cramil, skeletal, procecc and hing exposures as well as examination of the units may also be used in lymphography, endocony, myelography, venggraphy, pediatrics, arthrography, interventional radiology, digital angiocraphy and digital subtaction angiography (DSA).
HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA).
HDR Vision is a universal fluoroscopic x-ray diagnostic system (RIF system), with an overtable X-ray tube assembly. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
HDR Vision can be configured as a single tube system, with only an overtable tube or it can be combined with an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically and a bucky wall stand.
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate radiographic and fluoroscopic images of the anatomy. HDR Vision is not a stand-alone device, but functions as the platform for specific X-ray components, X-ray tube and housing, flat detector, digital imaging system, Bucky wall stand, collimator, generator etc. Many of the components used in HDR Vision are either commercially available with current Pausch systems or include minor modifications to existing components.
This 510(k) premarket notification for the HDR Vision device does not include a detailed study with acceptance criteria and reported device performance in the way typically expected for AI/ML-based medical devices.
Instead, this submission claims substantial equivalence to a predicate device (Siemens Medical Systems AXIOM Luminos dRF, K062623), meaning it asserts that the new device is as safe and effective as a legally marketed device. The focus is on demonstrating similar technological characteristics and intended use, rather than presenting a de-novo study with quantitative acceptance criteria for diagnostic performance.
Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered with the provided text because these elements are typically associated with studies proving the performance of an AI algorithm, which is not the primary subject of this 2008 submission for a general fluoroscopic X-ray system.
However, I can extract the relevant information regarding the device itself and the basis of its clearance.
Description of Device and Substantial Equivalence Claim
The HDR Vision is a universal diagnostic imaging system for radiographic and fluoroscopic studies. It is intended to visualize anatomical structures by converting X-rays into a visible image. It can perform a range of applications including general R/F, angiography, and pediatric examinations.
The device claims substantial equivalence to the Siemens Medical Systems AXIOM Luminos dRF (K062623). The Flat Panel Detector Pixium RF 4343 in the HDR Vision is also claimed to be substantially equivalent to the Pixium 5100 in the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable (N/A) in the context of this 510(k) submission.
This 510(k) submission primarily focuses on demonstrating substantial equivalence in terms of intended use and technological characteristics to a predicate device, rather than presenting specific quantitative acceptance criteria for diagnostic performance of an AI algorithm or a de novo clinical study with reported performance metrics. The submission states: "The HDR Vision complies with the same or equivalent standards and has the same intended use as the predicate device and does not raise new questions of safety or effectiveness and is substantially equivalent to the Siemens AXIOM Luminos dRF; K062623 (August 22, 2007)."
Therefore, there are no specific quantitative acceptance criteria or reported device performance metrics for diagnostic accuracy presented in this document. The "acceptance criteria" here are implicitly satisfied by demonstrating equivalence to the predicate device's established safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable (N/A).
As this is a substantial equivalence claim for a conventional imaging system, there is no "test set" in the context of an algorithmic performance evaluation described in the provided text. No patient data or images were used to test the diagnostic accuracy of the device as an AI/ML product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not Applicable (N/A).
No test set for diagnostic accuracy is described, therefore no experts were used to establish ground truth for such a set within this submission.
4. Adjudication Method for the Test Set
Not Applicable (N/A).
No test set for diagnostic accuracy or algorithmic performance is described, so no adjudication method is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
This type of study is typically conducted for AI/ML-enabled devices to compare human reader performance with and without AI assistance. The HDR Vision is a conventional fluoroscopic X-ray system, and its premarket notification does not include such a study.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done.
The HDR Vision is an imaging system designed for human operators; it is not an algorithm-only device. Its premarket notification does not describe a standalone performance study in the context of AI/ML.
7. The Type of Ground Truth Used
Not Applicable (N/A).
No ground truth for an AI/ML algorithm or diagnostic performance study is mentioned in this submission. For a conventional imaging device like the HDR Vision, the "ground truth" is inherently the clinical diagnosis made by medical professionals using the images produced by the device, in conjunction with other clinical information.
8. The Sample Size for the Training Set
Not Applicable (N/A).
This document describes a conventional X-ray system, not an AI/ML-based device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable (N/A).
As no training set is relevant for this conventional imaging device, no ground truth establishment method is described.
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DEC 0 5 2008
Pausch. LLC 510(k) Pre-market Notification; HDR Vision
Date: Submitter's Name: Submitter's Address:
Submitter's Contact: Submitter's Telephone Number: Submitter's Fax Number:
510(k) Summary
March 28th, 2008 Pausch, LLC 808 Shrewsbury Avenue Tinton Falls, NJ 07724-3002 Justin Tice. President (732) 747-6110 (732) 747-6882
Establishment Registration Number:
2243057
· Device Name and Classification
| Trade Name: | HDR Vision | CFR Section: | 21 CFR § 892.1650 |
|---|---|---|---|
| Classification Panel: | Radiology | Device Class: | Class II |
| Classification Name: | Image intensified fluoroscopic X-ray System | Device Code: | MQB, OWB, JAA |
| Common Name: | Fluoroscopic digital flat panel detector system |
| Performance Standard: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard |
|---|---|
| Predicate Device ClaimingSubstantial Equivalence to: | Siemens Medical Systems AXIOM Luminos dRF510(k) Control Number: K062623 |
Reason For Submission
New device
Description of this Device:
The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA).
Summary of Intended Uses:
This system is intended for use as a general radiography device for the head, chest, abdomen, spine, neck and limbs. This system is used for image acquisition, image display, and the transmission/output of images to external devices. Excluded indications include mammography, computed tomography. HDR Vision is a universal fluoroscopic x-ray diagnostic system (RIF system), with an overtable X-ray
510k Summarv
Section H Page 1 of 2
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tube assembly. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
The HDR Vision with Flat Detector is substantially equivalent to the commercially available AXIOM Luminos dRF with Flat Detector Siemens system.
The AXIOM Luminos dRF with Flat Detector, and generally marketed as the AXIOM Luminos dRF, was described in premarket notification K062623 which received FDA Clearance on August 22, 2007.
The Flat Panel Detector Pixium RF 4343 manufactured by Trixell and equipped with the HDR Vision is substantially equivalent to the Pixium 5100 manufactured by Trixell and equipped with the AXIOM Luminos dRF that was described in premarket notification K062623 which received FDA Clearance on August 22, 2007.
HDR Vision can be configured as a single tube system, with only an overtable tube or it can be combined with an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically and a bucky wall stand.
Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate radiographic and fluoroscopic images of the anatomy. HDR Vision is not a stand-alone device, but functions as the platform for specific X-ray components, X-ray tube and housing, flat detector, digital imaging system, Bucky wall stand, collimator, generator etc. Many of the components used in HDR Vision are either commercially available with current Pausch systems or include minor modifications to existing components.
Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling, and the information provided will emable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the HDR Vision is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with, and responsible for, the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Pausch adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
Conclusion:
The HDR Vision complies with the same or equivalent standards and has the same intended use as the predicate device and does not raise new questions of safety or effectiveness and is substantially equivalent to the Siemens AXIOM Luminos dRF; K062623 (August 22, 2007).
Bnd of 510(k) Summary.
510k Summary
Section H Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol features a stylized human figure with outstretched arms, and the text is in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Justin Tice President PAUSCH LLC 808 Shrewsbury Avenue TINTON FALLS NJ 07724
JUL 30 2012
Re: K081073 Trade/Device Name: HDR Vision Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA. and MOB Dated: October 16, 2008 Received: October 17, 2008
Dear Mr. Tice:
This letter corrects our substantially equivalent letter of December 5, 2008.
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 (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 (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in vour 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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Indications for Use
5.10(k) Number (if known):
Device Name: HDR Vision
Indications For Use:
The HDR Vision is intended to be used as a miversal diagnostic imaging system for radiographic and finoroscopic studies. Using a digital flat detector, it can perform a range of applications including general RIF, angiography and pediativ examinations.
The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastroninal examinations, cramil, skeletal, procecc and hing exposures as well as examination of the units may also be used in lymphography, endocony, myelography, venggraphy, pediatrics, arthrography, interventional radiology, digital angiocraphy and digital subtaction angiography (DSA).
HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
(Please do not write below this line - continue on another page if needed) Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (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 of Reproductive, Abdomin
f Reproductive, Abdominal,
and Radiological Devices
510(k) Number K081073
Page 1 of 1
Indications for use without Letterhead
Section G Page 1 of 1
§ 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.