(22 days)
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.
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.
The provided text describes the HiRise, a Cone Beam Computed Tomography (CBCT) X-ray system, and states that it has been determined substantially equivalent to its predicate device, the CurveBeam LineUP.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the HiRise device are primarily established through its demonstrated substantial equivalence to the predicate device, the CurveBeam LineUP. The reported device performance is presented in the context of this comparison and in studies confirming diagnostic quality and safety.
| Feature / Criteria (Derived from comparison to Predicate) | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (HiRise) |
|---|---|---|
| Indications for Use | 3-D imaging of foot, knee, hand, elbow. | Expands to 3-D imaging of the upper extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. Performance: Datasets of the humerus, elbow, forearm, hand, wrist, pelvis/hip, femur, knee, shin (lower leg or tib/fib) and foot/ankle were reviewed by a board-certified radiologist and found to be of diagnostic quality. |
| Patient Weight Range | 50 lbs to 400 lbs | Expands to 40 lbs to 450 lbs. Performance: The increased weight range has been tested and verified by third-party 60601-1 testing. |
| Scan Axis | Horizontal and vertical | Horizontal and vertical Performance: 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. |
| Tube Voltage (CT scans) | 100-120 kVp | 100-130 kVp. Performance: Bench testing determined optimal X-Ray tube voltage for each anatomy and patient size. Higher kVp was determined to be required to clinically image the new anatomy (hips and pelvis). |
| Tube Current | 5 mA | 5.5 or 6.5 mA. Performance: Increased tube current was required to provide diagnostic quality image sequences in the new anatomy (hips and pelvis). |
| Scan Time (CT) | 21 sec | 26 sec. Performance: HiRise is slightly slower to allow for greater exposure time required for the denser anatomy. Image quality performance was verified with Bench Testing. |
| Image Detector | CMOS flat panel | Amorphous Silicon flat panel. Performance: Detector performance testing verified image quality met requirements. Performance testing demonstrated that the image quality of the amorphous silicon flat panel is statistically equivalent to that of the predicate. |
| 3D Imaging Volume | 20cm (high) x 35 cm (diameter) | Large FOV: 8" (20cm) height x 16" (40cm) diameter; Medium FOV: 8" (20cm) height x 10" (25cm) diameter. Performance: Image sequences captured utilizing both volumes were included in the datasets sent to the board-certified radiologist and found to be of diagnostic quality. |
| Typical Resolution | 0.3 mm voxel | LFOV: 0.3mm, MFOV: 0.25mm. Performance: Image sequences captured utilizing both volumes, and subsequent resolutions, were included in the datasets sent to the board-certified radiologist and found to be of diagnostic quality. |
| Image Quality (Overall) | Diagnostic quality (Implied by predicate) | Performance: Image quality phantoms were scanned in the HiRise and evaluated by a medical physicist. The scans were reviewed by a radiologist and found to be of diagnostic quality. Clinical review of images by a radiologist indicated that HiRise is safe and effective when used as labeled. |
| Safety and Effectiveness | Compliance with regulations and standards | Performance: Complies with applicable FDA and international standards pertaining to electrical, mechanical, software, EMC, and radiation safety of medical devices (e.g., AAMI ES60601-1, IEC 60601-1-3, IEC 62366, IEC 62304, IEC 60601-2-44, IEC 60601-1-2, IEC 61223-3-5, NEMA PS 3.1-3.20, IEC 60825-1). |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in terms of patient cases for a statistical performance study comparing the HiRise to a ground truth or predicate quantitatively. Instead, it relies on two primary methods:
- Phantom Scans: "image quality phantoms were scanned in the HiRise and evaluated by a medical physicist." The sample size of phantoms is not specified.
- Clinical Image Review: "datasets of the humerus, elbow, forearm, hand, wrist, pelvis/hip, femur, knee, shin (lower leg or tib/fib) and foot/ankle were reviewed by a board-certified radiologist and found to be of diagnostic quality." The number of patient cases (datasets) reviewed is not specified.
The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). However, the "clinical review of images" suggests actual patient data, likely retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: At least one board-certified radiologist.
- Qualifications: "board-certified radiologist." Specific years of experience are not mentioned.
- Additionally, a "medical physicist" evaluated image quality phantoms.
4. Adjudication method
The adjudication method for the clinical image review is not explicitly described. It states that "a board-certified radiologist... found [images] to be of diagnostic quality." This implies a single expert's assessment without mentioning a consensus process or multiple readers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or described. The HiRise device is a Computed Tomography X-Ray System, which directly acquires images, and the provided documentation focuses on its imaging performance versus a predicate device, not on AI-assisted interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, an assessment of the device's standalone performance was done. The "performance testing by a medical physicist" and "clinical review of images by a radiologist" evaluating the HiRise images themselves indicate a standalone assessment of the device's output quality. There's no mention of a human-in-the-loop component being evaluated for the device's image acquisition functionality.
7. The type of ground truth used
The ground truth for evaluating the HiRise's performance was established through:
- Expert Consensus/Opinion: For clinical images, it was the "diagnostic quality" determined by a "board-certified radiologist."
- Bench Testing/Phantom Standards: For image quality phantoms, evaluation by a "medical physicist" against established image quality requirements, and verification of "optimal X-Ray tube voltage" and "increased tube current" through bench testing. Additionally, "Detector performance testing" verified image quality met requirements.
8. The sample size for the training set
The document describes the HiRise as an imaging device (hardware and associated software for image acquisition and reconstruction), not a machine learning or AI algorithm in the context of image interpretation. Therefore, there is no "training set" for an AI model mentioned in this submission. The "training set" concept is not applicable here as the device's functionality doesn't appear to be based on a trained AI for image analysis.
9. How the ground truth for the training set was established
As there is no "training set" for an AI model mentioned, this question is not applicable based on the provided 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 267-483-8081 | |
| Fax: 267-483-8086 | |
| Contact Person | Ryan ConlonDirector of Quality and Regulatory Affairs267-483-8081Email: Ryan.Conlon@curvebeam.com |
| 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 | DeviceClassification |
|---|---|---|---|---|---|
| CurveBeam,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 Computedtomography x-ray system | CurveBeam LineUP Computedtomography x-ray system | Variance Explanation | |
|---|---|---|---|
| 510(k) number | K180727 | ||
| Product code | JAK | JAK | |
| Regulationnumber | 21 CFR 892.1750 | 21 CFR 892.1750 | |
| Indications forUse | The HiRise is intended to beused for 3-D imaging of theupper and the lowerextremities and pelvis ofadult and pediatric patientsweighing from 40 to 450 lbs.The device is to be operatedin a professional healthcareenvironment by qualifiedhealth care professionalsonly. | The LineUP is intended to be usedfor 3-D imaging of the foot, knee,hand, and elbow regions tovisualize and assess the osseousand certain soft tissue structures,including joint spaces, bone anglesand fractures.It is also intended to capture 2-Dimages (standard plain x-rayprojections) of the foot, knee,hand, and elbow regions.This modality is anticipated to beapplicable to pediatric* cases aswell as adults, when appropriatediagnosis of a given condition isconsidered necessary. Patientparameters: 50 lbs to 400 lbs*2D Imaging not intended forpediatric use | Datasets of the humerus, elbow,forearm, hand, wrist, pelvis/hip,femur, knee, shin (lower leg ortib/fib) and foot/ankle werereviewed by a board-certifiedradiologist and found to be ofdiagnostic quality.The increased weight range has betested and verified by third party60601-1 testing. |
| Principle ofOperation | Cone Beam ComputedTomography X-Ray | Cone Beam ComputedTomography X-Ray& 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. |
| MechanicalLayout | 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.Max KV: 130kVFocal Spot: 0.5mm nominalTarget Angle: 15 degree | Stationary anode, glass envelope x-ray tube.Max KV: 130kVFocal Spot: 0.5mm nominalTarget 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 VoltagePower Supply | High frequency generator | High frequency generator | No change, same supply |
| Tube voltage | 100-130 kVP for CT scans | 100-120 kVP for CT scans60 kVp for 2D X-Rays | Bench testing determined optimal X-Ray tube voltage for each anatomy and patient sizeHigher kVP was determined to be required to clinically image the new anatomy (hips and pelvis).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 verifiedimage quality met requirements |
| ReconstructionAlgorithm | Filtered back projection withnon-linear filtering for 3DCone-Beam CT reconstruction | Filtered back projection with non-linear filtering for 3D Cone-BeamCT reconstruction | Both the HiRise and the LineUP usethe same reconstruction engine. |
| Gray scale | 16 bit | 14 bit | The panel uses a 16 bit panel to utilizea larger dynamic range of the imagingsequences. |
| 3D ImagingVolume | Large FOV: 8" (20cm) height x16" (40cm) diameterMedium FOV: 8" (20cm) heightx 10" (25cm) diameter | 20cm (high) x 35 cm (diameter) | Image sequences captured utilizingboth volumes were included in thedatasets sent to the board-certifiedradiologist and found to be ofdiagnostic quality. |
| Typicalresolution | LFOV: 0.3mm, MFOV: 0.25mm | 0.3 mm voxel | Image sequences captured utilizingboth volumes, and subsequentresolutions, were included in thedatasets sent to the board-certifiedradiologist and found to be ofdiagnostic quality. |
| Body partscanned | Humerus, elbow, forearm(radius/ulna), hand, wrist,pelvis/hips, femur, knee, shin(lower leg or tib/fib) andankle/foot. | Foot, knee, hand, elbow | Datasets of the humerus, elbow,forearm (radius/ulna), hand, wrist,pelvis/hips, femur, knee, shin(lower leg or tib/fib) andfoot/ankle are included in Section 37 |
| Size, inchesh x d x w | 57"x58"x73" (145cm x 147cm x185cm) | 62.63"x49.01"x51.71" | Both devices designed to be easilyinstalled and to fit in a professionalhealthcare environment with minimalmodifications. |
| Weight, Ibs | Scanner 850 lbs (385.554 kg),Transporter 250 lb (113.398 kg) | Scanner 750 lbs (340.194 kg),Transporter 250 lb (113.398 kg) | HiRise is larger and has morecomponents to accommodateadditional anatomy. |
| PowerRequirements | 920VA | 1150VA | HiRise is rated a slightly lower powerconsumption. |
| Tissue DensityRange | 0 to 2000 HU's (HounsfieldUnits) | 0 to 2000 HU's (Hounsfield Units) | |
| Patient SupportStructure | Flat plastic platform andhandlebars for weight-bearingimaging sequences, positionerplate for knee, transporteraccessory for non-weight-bearing imaging sequences | Flat plastic platform andhandlebars for weight-bearingfoot/ankle, positioner plate forknee, transporter accessory forupper extremities and non-weight-bearing foot | New support structures permitscanning of additional anatomicalregions. Support structures tested toStandards specified in Section 9 -Declarations of Conformity andSummary Report |
| DetectorPosition | Source to Imager DistanceFixed distance from detector tox-ray beam center, parallel to | Source to Imager Distance Fixeddistance from detector to x-raybeam center, parallel to axis of | |
| axis of rotation and orthogonalto x-ray beam. | rotation and orthogonal to x-raybeam. | ||
| X-Ray BeamPosition | Beam size matches the 40cm x31cm flat panel (with a narrowunexposed margin), there aretwo vertical beam offsets frompanel center: beam offsetbelow the panel center for footscans, and beam offset abovethe panel center for otherextremity scans | Beam size matches the 30cm x30cm flat panel detector (with anarrow unexposed margin), thebeam center is vertically positionedbelow the panel center (towardsthe bottom of the FOV) where thedensest bones in the foot arelocated. | HiRise and LineUP utilize similar twooffsets to image different parts of theanatomy described in the intendeduse. |
| SoftwareCapture Tool | Virtualized Windowsenvironment based application | Virtualized Windows environmentbased application | |
| Display | Computer with mouse andkeyboard | Computer with mouse andkeyboard | |
| ProjectionGeometry | Beam collimated to a squareshape, Source to ImagerDistance: 767 mm, Source toAxis of rotation Distance: 503mm | Beam collimated to a squareshape, Source to Imager Distance:767 mm, Source to Axis of rotationDistance: 528 mm | Slightly different geometryaccommodates patients up to the Hip.Performance testing demonstratedthat new geometry does not harmimage quality. |
| Patientpositioningguide | Foot: Circular Markings onPlatform | Foot: Circular Markings on Platform | HiRise includes a tool to measure theheight of the knee and hips. The |
| Knees/Hips: Accumeasurecontrols height of Gantry | Knees: Markings on KneePositioner | ||
| Upper Extremity: Marks onupper extremity platforminsert | Upper Extremity: Marks on upperextremity platform insert | ||
| PatientContactingMaterials | (1) Polyester patient platformlining (2) Vinyl Transportercushion (3) carbon fiberpositioners (4) Powder coatedAluminum handlebars | (1) Polyester patient platform lining(2) Vinyl Transporter cushion (3)carbon fiber positioners (4) Lexanpanel shield (5) Powder coatedAluminum handlebars | The instructions for use regardingcontact with the machine on theLineUP and HiRise are similar. TheUser Manual on both devicesrecommends avoiding direct contactwith the scanner using readilyavailable materials. |
CurveBeam, LLC - HiRise 510(k) Application
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Substantial Equivalence Discussion:
The overall technology, key components and intended use of the HiRise Computed Tomography x-ray system and the predicate device are substantially similar, with certain inconsequential differences described henceforth.
Both the HiRise and LineUP devices image extremities of similar bone density ranges and utilize a similar gantry to capture the desired anatomy. They are both able to scan feet and knees in a bilateral position as well as scan the hand and elbow regions. The HiRise has an added capability to scan the entire lower up to the pelvis and to scan the entire upper extremities. The additional support structures on the HiRise have been tested to applicable safety standards. Images of the additional anatomy have been reviewed by a radiologist and have been found to be of adequate diagnostic quality.
To establish equivalency in performance, image quality phantoms were scanned in the HiRise and evaluated by a medical physicist. Also, the scans were reviewed by a radiologist and found to be of CurveBeam, LLC - HiRise 510(k) Application Section 5 - Page 6
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diagnostic quality.
The HiRise uses a similar X-Ray tubehead and the same power supply as the LineUP utilizes a CMOS flat panel image detector while the HiRise uses an amorphous silicon flat panel detector to capture projection images. Performance testing demonstrated that the image quality of the amorphous silicon flat panel is statistically equivalent to that of the predicate.
The combination of performance testing by a medical physicist, safety and functional testing by a certified third-party testing body, and clinical review of images by a radiologist indicate that HiRise is safe and effective when used as labeled.
Safety and Effectiveness Information:
The HiRise Computed Tomography X-ray system is a Class II medical device.
The HiRise Computed Tomography X-ray system complicable FDA and international standards pertaining to electrical, mechanical, software, EMC, and radiation safety of medical devices.
Conformity
The HiRise device has been tested to the following standards to ensure safety, effectiveness, and compliance with industry norms:
AAMI ES60601-1:2005+C1; A1 IEC 60601-1:2005, 3rd Edition+C1; C2; A1 IEC 60601-1-3, Edition 2.1, 04/2013 IEC 60601-1-6, Edition 3.1, 10/2013 IEC 62366, Edition 1.1, 01/2014 IEC 62304:2006 Ed.1 +A1, 06/2015 IEC 60601-2-44, Edition 3.2, 03/2016 IEC 60601-1-2, Edition 4, 02/2014 IEC 61223-3-5, first edition, 08/2004 NEMA PS 3.1-3.20, 2016 IEC 60825-1, Edition 3, 05/2014
FDA Guidance
The following FDA Guidance Documents were referenced to the extent they were applicable in the preparation of this 510(k) Submission
- Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
- 0 Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices
CurveBeam, LLC - HiRise 510(k) Application
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- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- . Applying Human Factors and Usability Engineering to Medical Devices
- Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical ● Devices
- . Information for X-ray Imaging Device Premarket Pediatric Notifications
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices Part 1: ● Evaluation and testing within a risk management process"
- . Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
Conclusion:
CurveBeam, LLC has demonstrated through its comparison of characteristics with the predicate device and comparison of performance data with the predicate device that the HiRise Computed Tomography X-ray System is substantially equivalent to the predicate device.
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.