HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F

K081073 · Pausch, LLC · OWB · Dec 5, 2008 · Radiology

Device Facts

• Record ID: K081073
• Device Name: HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
• Applicant: Pausch, LLC
• Product Code: OWB · Radiology
• Decision Date: Dec 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

HDR Vision is a universal diagnostic X-ray system for radiographic and fluoroscopic imaging. Input: X-ray patterns converted to visible images via digital flat panel detector (Trixell Pixium RF 4343). Operation: System integrates X-ray tube, generator, collimator, and detector; configurable as single-tube or with overhead tube crane and bucky wall stand. Used in clinical settings (outpatient, emergency, mobile transport) by healthcare professionals. Output: Digital images displayed and transmitted to external devices. Clinical utility: Visualization of anatomical structures for diagnostic procedures (e.g., GI, skeletal, angiography). Benefits: Enables broad range of diagnostic exams including pediatric and interventional radiology. Safety: System includes visual/audible warnings and automated error monitoring/blocking.

Clinical Evidence

Bench testing only. No clinical data provided. The device relies on substantial equivalence to the predicate system and adherence to established performance standards for diagnostic X-ray equipment.

Technological Characteristics

Universal R/F system; utilizes ionizing radiation. Components: X-ray tube/housing, generator, collimator, Bucky wall stand, and Trixell Pixium RF 4343 digital flat panel detector. Configurable as single-tube or with 3D overhead tube crane. Connectivity: Image transmission to external devices. Safety: Visual/audible warnings, automated error monitoring/system blocking. Complies with 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard).

Indications for Use

Indicated for radiographic and fluoroscopic diagnostic imaging of head, chest, abdomen, spine, neck, and limbs. Applicable for gastrointestinal, skeletal, thoracic, lung, urogenital, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, and digital angiography/DSA. Suitable for pediatric, outpatient, emergency, and mobile transport patients. Excludes mammography and computed tomography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Siemens Medical Systems AXIOM Luminos dRF (K062623)

Submission Summary (Full Text)

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K081073

## 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 [phone] [phone]

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,<br>Federal Diagnostic X-ray Equipment Standard |
|----------------------------------------------------------|-----------------------------------------------------------------------------|
| Predicate Device Claiming<br>Substantial Equivalence to: | Siemens Medical Systems AXIOM Luminos dRF<br>510(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

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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 [phone]. 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 [phone] or [phone] 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

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Indications for use without Letterhead

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