HiRise

K203187 · Curvebeam, LLC · JAK · Nov 18, 2020 · Radiology

Device Facts

• Record ID: K203187
• Device Name: HiRise
• Applicant: Curvebeam, LLC
• Product Code: JAK · Radiology
• Decision Date: Nov 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The HiRise is intended to be used for 3-D imaging of the upper extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. The device is to be operated in a professional healthcare environment by qualified health care professionals only.

Device Story

HiRise is a Cone Beam Computed Tomography (CBCT) system for 3D imaging of upper extremities and pelvis. Device uses a gantry assembly with X-ray source, flat panel detector, and motorized vertical actuators to capture 360-degree rotational projection sequences. Reconstructed 3D volumetric images are sent to DICOM-compliant viewing software. Operated by qualified healthcare professionals in hospitals and orthopedic clinics. Patient positioning involves a non-weight bearing chair or standing platform. Output images assist clinicians in visualizing osseous structures for diagnostic purposes. Benefits include high-resolution 3D visualization of anatomy for orthopedic assessment.

Clinical Evidence

Bench testing only. No clinical trials. Performance verified by scanning image quality phantoms evaluated by a medical physicist. Diagnostic quality of images for all claimed anatomical regions (humerus, elbow, forearm, hand, wrist, pelvis/hips, femur, knee, shin, foot/ankle) confirmed by board-certified radiologist review.

Technological Characteristics

Cone Beam CT; 360-degree rotation. Materials: Polyester platform lining, vinyl cushion, carbon fiber positioners, powder-coated aluminum. X-ray source: 130kV max, 0.5mm focal spot. Detector: Amorphous silicon flat panel. Connectivity: DICOM-compliant. Standards: AAMI ES60601-1, IEC 60601-1 series, IEC 62304, IEC 62366. Reconstruction: Filtered back projection with non-linear filtering.

Indications for Use

Indicated for 3-D imaging of upper extremities and pelvis in adult and pediatric patients weighing 40-450 lbs. Operated by qualified healthcare professionals in professional environments.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• CurveBeam LineUP (K180727)

Submission Summary (Full Text)

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November 18, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CurveBeam, LLC % Mr. Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd WARREN NJ 07059

Re: K203187

Trade/Device Name: HiRise Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 25, 2020 Received: October 27, 2020

Dear Mr. Yungvirt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

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combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name HiRise

Indications for Use (Describe)

The HiRise is intended to be used for 3-D imaging of the upper extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.

The device is to be operated in a professional healthcare environment by qualified health care professionals only.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Section 5 510(k) Summary

# Contents

| Table 5-1 Device Information | 1 |
|---------------------------------------------------------------------|---|
| Predicate Device: | 2 |
| Indications for Use: | 2 |
| Device Description: | 2 |
| Device Characteristics and Performance. | 2 |
| Key Device Components | 2 |
| Environment of Use | 3 |
| Patient Contacting Materials. | 3 |
| Table 5-3 LineUP Substantial Equivalence Technical Characteristics. | 3 |
| Substantial Equivalence Discussion: | 6 |
| Safety and Effectiveness Information: | 7 |
| Conformity | 7 |
| FDA Guidance | 7 |
| Conclusion: | 8 |

# Table 5-1 Device Information

| 510 (k) Submitter/Owner | CurveBeam, LLC |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| | 2800 Bronze Drive, Suite 112 |
| | Hatfield, PA 19440 |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person | Ryan Conlon<br>Director of Quality and Regulatory Affairs<br>267-483-8081<br>Email: [e-mail] |
| Date Prepared | August 14, 2020 |
| Trade Name | HiRise |
| Common Name | Computed tomography x-ray system |
| Classification Name | Computed tomography x-ray system |

CurveBeam, LLC – HiRise 510(k) Application

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| Product Code | JAK |
|-----------------------|-------------|
| 510(k) Type | Traditional |
| Regulation Number | 892.1750 |
| Device Classification | Class II |

This is the first 510(k) submission for this device. There were no prior submissions.

## Predicate Device:

Table 5-2 Predicate Device

| Company | Device name | Product Code | 510(k) | Regulation Number | Device<br>Classification |
|-------------------|-------------|--------------|---------|-------------------|--------------------------|
| CurveBeam,<br>LLC | HiRise | JAK | K180727 | 892.1750 | Class II |

## Indications for Use:

The HiRise is intended to be used for 3-D imaging of the upper extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.

The device is to be operated in a professional healthcare environment by qualified health care professionals only.

## Device Description:

#### Device Characteristics and Performance

The HiRise is a Cone Beam Computed Tomography Imaging Device that acquires 360-degree rotational projection sequences which are reconstructed into 3D volumetric images of the examined anatomical region. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry. The gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For non-weight bearing scans of the lower extremity, a patient positioner accessory allows the patient to sit into a position where he/she can comfortably place his/her anatomy into the imaging bore.

The gantry assembly is mounted on vertical actuators and can travel vertically to capture weight-bearing anatomy at various heights ranging from the feet to the pelvis regions. The HiRise provides total vertical travel of 37 inches to accommodate patients of various sizes. Images produced by the HiRise can be sent electronically to a DICOM complaint image viewing software.

#### Key Device Components

Embedded Controller Flat Panel Detector Gantry Assembly X-Ray Source X-Ray Power Supply

CurveBeam, LLC - HiRise 510(k) Application

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Patient Platform and Positioners Patient non-weight bearing chair Operator Control Box External Server

## Environment of Use

The HiRise is to be used in medical facilities including hospitals, and orthopedic clinics. The HiRise should be installed and operated according to state and federal regulations regarding radiationemitting products and the device room layout should be approved by a certified medical prior to installation.

## Patient Contacting Materials

The materials that could contact the patient are listed below.

- (1) Polyester patient platform lining
- (2) Vinyl Transporter cushion
- (3) Carbon fiber positioners
- (4) Powder coated Aluminum handlebars

| | CurveBeam HiRise Computed<br>tomography x-ray system | CurveBeam LineUP Computed<br>tomography x-ray system | Variance Explanation |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K180727 | |
| Product code | JAK | JAK | |
| Regulation<br>number | 21 CFR 892.1750 | 21 CFR 892.1750 | |
| Indications for<br>Use | The HiRise is intended to be<br>used for 3-D imaging of the<br>upper and the lower<br>extremities and pelvis of<br>adult and pediatric patients<br>weighing from 40 to 450 lbs.<br><br>The device is to be operated<br>in a professional healthcare<br>environment by qualified<br>health care professionals<br>only. | The LineUP is intended to be used<br>for 3-D imaging of the foot, knee,<br>hand, and elbow regions to<br>visualize and assess the osseous<br>and certain soft tissue structures,<br>including joint spaces, bone angles<br>and fractures.<br><br>It is also intended to capture 2-D<br>images (standard plain x-ray<br>projections) of the foot, knee,<br>hand, and elbow regions.<br><br>This modality is anticipated to be<br>applicable to pediatric* cases as<br>well as adults, when appropriate<br>diagnosis of a given condition is<br>considered necessary. Patient<br>parameters: 50 lbs to 400 lbs<br><br>*2D Imaging not intended for<br>pediatric use | Datasets of the humerus, elbow,<br>forearm, hand, wrist, pelvis/hip,<br>femur, knee, shin (lower leg or<br>tib/fib) and foot/ankle were<br>reviewed by a board-certified<br>radiologist and found to be of<br>diagnostic quality.<br><br>The increased weight range has be<br>tested and verified by third party<br>60601-1 testing. |
| Principle of<br>Operation | Cone Beam Computed<br>Tomography X-Ray | Cone Beam Computed<br>Tomography X-Ray<br>& 2D Imaging | |
| Scan axis | Horizontal and vertical | Horizontal and vertical | Image sequences captured utilizing the gantry in vertical scanning mode were included in the datasets sent to the board-certified radiologist and found to be of diagnostic quality. |
| Mechanical<br>Layout | A horizontal doughnut, with the x-ray source and flat panel detector mounted at each end of a rotating gantry. The gantry assembly lifts for scanning of the lower extremities. Rotation of the gantry to vertical imaging mode allows for the positioning and imaging of upper extremities. A non-weight bearing chair allows for non-weight bearing imaging of the foot, ankle, and knee. | A horizontal doughnut, with the x-ray source and flat panel detector mounted at each end of a rotating gantry. Gantry assembly lifts for scanning of the knee. Reclining Transporter allows for positioning of upper extremity in bore. | The addition of anatomy above the knee use the same CBCT concept as foot, ankle, and knee. |
| Controller | Firmware Exposure Controller | Firmware Exposure Controller | |
| Tube | Stationary anode, glass envelope x-ray tube.<br>Max KV: 130kV<br>Focal Spot: 0.5mm nominal<br>Target Angle: 15 degree | Stationary anode, glass envelope x-ray tube.<br>Max KV: 130kV<br>Focal Spot: 0.5mm nominal<br>Target Angle: 20 degree | Change of target angle does not impact the image sequence output quality. HiRise utilizes a more robust tube with a smaller target angle. |
| Tube Housing | Same except for shape of aperture | Same except for shape of aperture | New aperture allows for appropriate output |
| High Voltage<br>Power Supply | High frequency generator | High frequency generator | No change, same supply |
| Tube voltage | 100-130 kVP for CT scans | 100-120 kVP for CT scans<br>60 kVp for 2D X-Rays | Bench testing determined optimal X-Ray tube voltage for each anatomy and patient size<br><br>Higher kVP was determined to be required to clinically image the new anatomy (hips and pelvis).<br><br>2D X-Rays are not required for use of the HiRise |
| Tube current | 5.5 or 6.5 mA | 5 mA | Increased tube current was required to provide diagnostic quality image sequences in the new anatomy (hips and pelvis). |
| Scan time | 26 sec for CT | 21 sec for CT | CT: HiRise is slightly slower to allow for greater exposure time required for the denser anatomy. Image quality performance was verified with Bench Testing. |
| Max exposure time | 8.7 sec | 9 sec | Similar exposure times |
| Image detector | Amorphous Silicon flat panel | CMOS flat panel | Detector performance testing verified<br>image quality met requirements |
| Reconstruction<br>Algorithm | Filtered back projection with<br>non-linear filtering for 3D<br>Cone-Beam CT reconstruction | Filtered back projection with non-<br>linear filtering for 3D Cone-Beam<br>CT reconstruction | Both the HiRise and the LineUP use<br>the same reconstruction engine. |
| Gray scale | 16 bit | 14 bit | The panel uses a 16 bit panel to utilize<br>a larger dynamic range of the imaging<br>sequences. |
| 3D Imaging<br>Volume | Large FOV: 8" (20cm) height x<br>16" (40cm) diameter<br>Medium FOV: 8" (20cm) height<br>x 10" (25cm) diameter | 20cm (high) x 35 cm (diameter) | Image sequences captured utilizing<br>both volumes were included in the<br>datasets sent to the board-certified<br>radiologist and found to be of<br>diagnostic quality. |
| Typical<br>resolution | LFOV: 0.3mm, MFOV: 0.25mm | 0.3 mm voxel | Image sequences captured utilizing<br>both volumes, and subsequent<br>resolutions, were included in the<br>datasets sent to the board-certified<br>radiologist and found to be of<br>diagnostic quality. |
| Body part<br>scanned | Humerus, elbow, forearm<br>(radius/ulna), hand, wrist,<br>pelvis/hips, femur, knee, shin<br>(lower leg or tib/fib) and<br>ankle/foot. | Foot, knee, hand, elbow | Datasets of the humerus, elbow,<br>forearm (radius/ulna), hand, wrist,<br>pelvis/hips, femur, knee, shin<br>(lower leg or tib/fib) and<br>foot/ankle are included in Section 37 |
| Size, inches<br>h x d x w | 57"x58"x73" (145cm x 147cm x<br>185cm) | 62.63"x49.01"x51.71" | Both devices designed to be easily<br>installed and to fit in a professional<br>healthcare environment with minimal<br>modifications. |
| Weight, Ibs | Scanner 850 lbs (385.554 kg),<br>Transporter 250 lb (113.398 kg) | Scanner 750 lbs (340.194 kg),<br>Transporter 250 lb (113.398 kg) | HiRise is larger and has more<br>components to accommodate<br>additional anatomy.<br> |
| Power<br>Requirements | 920VA | 1150VA | HiRise is rated a slightly lower power<br>consumption. |
| Tissue Density<br>Range | 0 to 2000 HU's (Hounsfield<br>Units) | 0 to 2000 HU's (Hounsfield Units) | |
| Patient Support<br>Structure | Flat plastic platform and<br>handlebars for weight-bearing<br>imaging sequences, positioner<br>plate for knee, transporter<br>accessory for non-weight-<br>bearing imaging sequences | Flat plastic platform and<br>handlebars for weight-bearing<br>foot/ankle, positioner plate for<br>knee, transporter accessory for<br>upper extremities and non-weight-<br>bearing foot | New support structures permit<br>scanning of additional anatomical<br>regions. Support structures tested to<br>Standards specified in Section 9 -<br>Declarations of Conformity and<br>Summary Report |
| Detector<br>Position | Source to Imager Distance<br>Fixed distance from detector to<br>x-ray beam center, parallel to | Source to Imager Distance Fixed<br>distance from detector to x-ray<br>beam center, parallel to axis of | |
| | axis of rotation and orthogonal<br>to x-ray beam. | rotation and orthogonal to x-ray<br>beam. | |
| | | | |
| X-Ray Beam<br>Position | Beam size matches the 40cm x<br>31cm flat panel (with a narrow<br>unexposed margin), there are<br>two vertical beam offsets from<br>panel center: beam offset<br>below the panel center for foot<br>scans, and beam offset above<br>the panel center for other<br>extremity scans | Beam size matches the 30cm x<br>30cm flat panel detector (with a<br>narrow unexposed margin), the<br>beam center is vertically positioned<br>below the panel center (towards<br>the bottom of the FOV) where the<br>densest bones in the foot are<br>located. | HiRise and LineUP utilize similar two<br>offsets to image different parts of the<br>anatomy described in the intended<br>use. |
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| Software<br>Capture Tool | Virtualized Windows<br>environment based application | Virtualized Windows environment<br>based application | |
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| Display | Computer with mouse and<br>keyboard | Computer with mouse and<br>keyboard | |
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| Projection<br>Geometry | Beam collimated to a square<br>shape, Source to Imager<br>Distance: 767 mm, Source to<br>Axis of rotation Distance: 503<br>mm | Beam collimated to a square<br>shape, Source to Imager Distance:<br>767 mm, Source to Axis of rotation<br>Distance: 528 mm | Slightly different geometry<br>accommodates patients up to the Hip.<br>Performance testing demonstrated<br>that new geometry does not harm<br>image quality. |
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| Patient<br>positioning<br>guide | Foot: Circular Markings on<br>Platform | Foot: Circular Markings on Platform | HiRise includes a tool to measure the<br>height of the knee and hips. The |
| | Knees/Hips: Accumeasure<br>controls height of Gantry | Knees: Markings on Knee<br>Positioner | |
| | Upper Extremity: Marks on<br>upper extremity platform<br>insert | Upper Extremity: Marks on upper<br>extremity platform insert | |
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