(28 days)
The HiRise is intended to be used for 3-D imaging of the upper and the lower 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.
Here's a breakdown of the acceptance criteria and study details for the HiRise device, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Image Quality / Clinical Acceptability | Images of new imaging protocols are clinically acceptable and adequate diagnostic quality. | Letter from fellowship-trained MSK radiologist validating images to be clinically acceptable and of clinical adequate diagnostic quality. This indicates the device met this criterion. |
| Labeling | Updated labeling | Labeling updated for: - New tube voltage range - New tube current range - New scan times - New max exposure times - New imaging volumes - Changes in protocol resolution - Updated body parts imaged (removal of humerus, forearm protocol configurations) - New scanner weight - New power requirements - New scatter numbers. This indicates the device met this criterion. |
| Internal Verification (X-Ray Circuitry) | Passes all internal verification with no anomalies causing increased risk. | All applicable test plans passed with no anomalies increasing risk. This indicates the device met this criterion. |
| Third-Party Testing (Safety & Compliance) | Passing all third-party testing to all applicable requirements. | Completed 3rd party testing with no outstanding failures for IEC 60601-1 and all applicable collateral and particular standards (specifically 60601-1-2, 60601-1-3, and 60601-2-44). This indicates the device met this criterion. |
| Increased Weight | (No specific numerical criterion, implied that negligible increase is acceptable) | Weight changed to 900 lbs (from 850 lbs for scanner). Acknowledged as negligible increase (approx. 50 pounds). Labeling updated. This indicates the change was handled and deemed acceptable. |
| Minor Material Changes (Biocompatibility) | Biocompatibility assessed in alignment with 10993 and do not impact the safety of the device. | Biocompatibility assessed in alignment with 10993 and do not impact the safety of the device. This indicates the device met this criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective based on the nature of "clinical review of images," implying existing images were evaluated rather than prospectively acquired data specifically for this study. The context suggests it was an internal validation of changes to an existing device (HiRise V2 compared to HiRise V1).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
"fellowship-trained MSK radiologist."
The document states one fellowship-trained MSK radiologist was used. The specific number of years of experience is not provided, but "fellowship-trained" indicates advanced specialization in Musculoskeletal Radiology.
4. Adjudication Method
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). Since only one radiologist
is mentioned for the clinical review, it implies no formal multi-reader adjudication was performed for establishing the ground truth of the test set. The single expert's opinion served as the validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The validation involved a single radiologist reviewing images from the device's new protocols, focused on demonstrating diagnostic quality rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was implied through the "Internal Verification in alignment with all internal testing of previous HiRise" and "Completed 3rd party testing," which would assess the device's technical and imaging output characteristics independently of human interpretation.
However, the clinical acceptability for diagnostic quality was evaluated by the radiologist, which is human-in-the-loop, but the core technical performance before that step is standalone. The document does not describe an AI/algorithm where a standalone AI performance would be distinct from the device's imaging capabilities. This device is a CT X-ray system, not primarily an AI diagnostic algorithm.
7. Type of Ground Truth Used
The ground truth for assessing image quality and diagnostic acceptability was expert consensus from a single fellowship-trained MSK radiologist. The radiologist determined if the images were "clinically acceptable and adequate diagnostic quality."
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. Since this submission is for changes to an existing CT X-ray system (HiRise V2) and its imaging protocols, and not for a new AI/Machine Learning algorithm, the concept of a "training set" in the context of AI development is not directly applicable here. The device's performance relies on its hardware and reconstruction algorithms, which are validated through technical performance standards and clinical review, not typically "trained" on data in the same way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a training set is not directly applicable in the context of this device's submission as described. Therefore, there is no information on how ground truth for a training set was established.
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July 12, 2024
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 % Ryan Conlon Director of Quality and Regulatory Affairs 2800 Bronze Drive Suite #110 Suite 110 HATFIELD, PA 19440
Re: K241713
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: June 11, 2024 Received: June 14, 2024
Dear Ryan Conlon:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
| Submission Number (if known) | K241713 |
|---|---|
| Device Name | HiRise |
Indications for Use (Describe)
The HiRise is intended to be used for 3-D imaging of the upper and the lower 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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510(k) Number: K241713 510(k) Summary
Contents
| Table 5-1 Device Information | 2 |
|---|---|
| Predicate Device: | 2 |
| High-level change description: | 2 |
| Device Description: | 3 |
| Device Characteristics and Performance | 3 |
| Key Device Components | 3 |
| Environment of Use | 3 |
| Patient Contacting Materials | 4 |
| Changes that resulted in a new 510(k) | 4 |
| Substantial equivalence comparison table: | 5 |
| Design Control Activities Summary: | 11 |
| Substantial Equivalence Discussion: | 12 |
| Safety and Effectiveness Information: | 12 |
| Conformity | 12 |
| FDA Guidance | 13 |
| Conclusion: | 13 |
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Table 5-1 Device Information
| Manufacturer Name: | Curvebeam LLC |
|---|---|
| Manufacturer Address: | 2800 Bronze Drive, Suite 110, Hatfield, PA |
| Registration Number/FEI number: | 3009543051 |
| Contact Person: | Ryan Conlon |
| Submission Date | July 11, 2024 |
| Device Name: | HiRise |
| Classification: | Class II |
| Product code: | JAK |
| Regulation Number: | 21 CFR 892.1750 |
| Regulation Name: | Computed Tomography X-Ray System |
| Device Description: | The HiRise is a Computed Tomography X-ray |
| Intended Use: | The HiRise is intended to be used for 3-D |
Predicate Device:
| Company | Device name | ProductCode | 510(k) | Regulation Number | DeviceClassification |
|---|---|---|---|---|---|
| CurveBeam,LLC | HiRise | JAK | K203187 | 892.1750 | Class II |
High-level change description:
| Device Name: | HiRise |
|---|---|
| Indications for Use: | The HiRise is intended to be used for 3-D imaging of the upper and the lowerextremities 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 qualifiedhealth care professionals only. |
| Device class: | Class II (21 CFR 892.1750) |
| Product code: | JAK |
| 510k Number/Type: | K203187 / Traditional 510k |
| Basic UDI-DI | 8631520003CBCTDevicesCL |
| Date of change: | TBA |
| Description of Change: | Changing the maximum mA output from 6.5mA to 20mA |
| Reason for Change: | The HiRise is indicated for imaging of upper and lower extremities. Current imagingprotocols for the HiRise have been deemed clinically acceptable, but the image |
CurveBeam, LLC – HiRise 510(k) Application
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| characteristics on certain patients, based on anatomy, could be improved forenhanced contrast and lower noise. |
|---|
| When it comes to imaging the Hip, there is naturally a significantly higher volume ofadipose tissue for the X-Rays to penetrate. Therefore, a higher energy imagingprotocol is proposed to enhance the image characteristics of hip scans (especially forlarger patients, based on anatomy). |
| The HiRise is a versatile device, as prior to each scan the imaging protocol is selectedbased on anatomy being scanned, purpose of the scan and size of patient. Due tosuch complexities and variabilities the HiRise is also indicated to be operated bytrained 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 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 physicist prior to CurveBeam, LLC – HiRise 510(k) Application Page 3
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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
- (5) Powder coated Aluminum handlebars
Changes that resulted in a new 510(k).
The proposed higher energy protocols (performance specifications) and the underlying component changes required to support the proposed protocols were evaluated. In summary, the conclusion is that this results in a performance change and there is an increased risk when it comes to patient radiation dose.
The most significant changes to the device include a redesign of the x-ray generator electronics. This includes the x-ray source (tube housing) and the x-ray power supply (high voltage power supply) along with the supporting cabling and safety electronics (isolation toroid and circuit breaker). All the above components exist in the current design but have been modified to support and enable higher energy imaging protocols to enhance the image characteristics of hip scans (especially for larger patients, based on anatomy).
The HiRise is a versatile device, as prior to each scan the imaging protocol is selected based on anatomy being scanned, purpose of the scan and size of patient. Due to such complexities and variabilities both the current and higher energy protocol versions of the HiRise are indicated to be operated by trained professionals only.
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Substantial equivalence comparison table:
| SUBSTANTIAL EQUIVALENCE TABLE | |||
|---|---|---|---|
| Feature/Component | HiRise V1 | HiRise V2 | Variance/Rationale |
| 510(k) number | K203187 | ||
| Product code | JAK | No changes | |
| Regulationnumber | 21 CFR 892.1750 | No changes | |
| Indications foruse | The HiRise is intended to be usedfor 3-D imaging of the upper andthe lower extremities and pelvisof adult and pediatric patientsweighing from 40 to 450 lbs.The device is to be operated in aprofessional healthcareenvironment by qualified healthcare professionals only. | No changes | |
| Principal ofoperation | Computed Tomography X-raySystem | No changes | |
| Scan axis | Horizontal and vertical | No changes | |
| MechanicalLayout | A horizontal doughnut, with thex-ray source and flat paneldetector mounted at each end ofa rotating gantry. The gantryassembly lifts for scanning of thelower extremities. Rotation of thegantry to vertical imaging modeallows for the positioning andimaging of upper extremities. Anon-weight bearing chair allowsfor non-weight bearing imaging ofthe foot, ankle, and knee. | No changes | |
| Controller | Firmware Exposure Controller | No changes | |
| Tube | Stationary anode, glass envelopex-ray tube.Max KV: 130kVFocal Spot: 0.5mm nominalTarget Angle: 15° degrees | Rotating Anode, glassenvelope x-ray tube.Max KV: 130kVFocal Spot: 0.3mm &0.6mm nominalTarget Angle: 16°degrees | The overall changes utilize a more robusttube. Change of target angle and doesnot impact the image sequence outputquality. Both the focal spot size andtarget angle have been assessed in thedata sets sent to board-certifiedradiologist and found to be of diagnosticquality. |
| Tube Housing | Same except for shape ofaperture | Enlarged to accountfor the rotatinganode tube | The updated Tube housing was designedwith the same principles as the previousversion but is designed for the updatedImaging requirements.While the tube housing has been madelarger, the collimation ensures that theoutput is kept as low as possible and onlyexposes the active imaging area of thepanel.All electrical changes have been verifiedby third party to meet IEC 60601-1testing, including all particular andcollateral standards (specifically 60601-1-2, 60601-1-3, and 60601-2-44). |
| High VoltagePower Supply | High frequency generator | High frequencygenerator updated toallow for theincreased outputrequirements | The updated High Voltage Power supplyutilizes the same design principles as theprevious version but is designed for theupdated Imaging requirements.All electrical changes have been verifiedby third party IEC 60601-1 testing,including all particular and collateralstandards (specifically 60601-1-2, 60601-1-3, and 60601-2-44). |
| Tube voltage | 100-130 kVP for CT scans | 100-120 kVP for CTscans | Previous imaging protocols were limitedby the system requirements.Bench testing determined optimal X-Raytube voltage (imaging characteristics) foreach anatomy and patient size.Imaging characteristics have beenoptimized for clinical diagnostic quality.(especially for larger patients, based onanatomy).Labeling has been updated in alignmentwith the new tube voltage range. |
| Tube current | 5.5 or 6.5 mA | 12 or 20 mA | Previous imaging protocols were limitedby the system requirements.Bench testing determined optimal tubecurrent (imaging characteristics) for eachanatomy and patient size.Imaging characteristics have beenoptimized for clinical diagnostic quality. |
| Scan time | 26 sec for CT | 26 to 60 sec | (especially for larger patients, based on anatomy).Labeling has been updated in alignment with the new tube current range.Bench testing determined optimal imaging characteristics for each anatomy and patient size.Based on device design, maintaining an appropriate duty cycle is critical.Increases in mAs require longer scan times to maintain device duty cycle.Labeling has been updated in alignment with the new scan times. |
| Max exposure time | 15 sec | 26 sec | Bench testing determined optimal imaging characteristics for each anatomy and patient size. Higher energy (exposure time) imaging protocol is proposed to enhance the image characteristics of hip scans (especially for larger patients, based on anatomy).Labeling has been updated in alignment with the new max exposure times. |
| Image detector | Amorphous Silicon flat panel | No changes | |
| Reconstruction Algorithm | Filtered back projection with non-linear filtering for 3D Cone-Beam CT reconstruction | No changes | |
| Gray scale | 16 bit | No changes | |
| 3D Imaging Volume | Large FOV: 7.7" (19.5cm) height x 15.79" (40.1cm) diameterMedium FOV: 7.7" (19.5cm) height x 9.9" (25.2cm) diameter | Large FOV: 7.67" (19.5cm) height x 16.53" (42.0 cm) diameter*Medium FOV: 7.67" (19.5cm) height x 9.84" (25.0 cm) diameter**Reconstructed Imaged Volume | Slight changes to the imaging volume are based on the new Tube housing design (see Tube housing comparison).The imaging volumes were reviewed by a board-certified radiologist and found to be of diagnostic quality.Labeling has been updated in alignment with the new Imaging volumes. |
| Typical resolution | LFOV: 0.3mm, MFOV: 0.25mm | Typical resolution defined by anatomy imaged | |
| 0.25 mm, 0.3 mm, 0.5 mm | board-certified radiologist and found to be of diagnostic quality. | ||
| Labeling has been updated in alignment with the changes in protocol resolution. Minor specific protocol changes from the predicate device and are covered under the intended use (lower extremity) of both the predicate and updated HiRise. Removal of humerus, forearm (radius/ulna) particular protocols were deemed not critical as imaging of these partial anatomy protocols has not been utilized in real-world use. The specific humerus and forearm protocols configurations have been removed in the updated HiRise. Labeling has been updated in alignment with body parts imaged. | |||
| Body part scanned | Upper and lower extremities, including the Humerus, Elbow, Forearm (radius/ulna), Hand, Wrist, Hip, Femur, Knee, Shin (lower leg or tib/fib) and Ankle, and Foot. | Upper and lower extremities, including the Elbow, Hand, Wrist, Pelvis, Hip, Femur, Knee, shin (lower leg or tib/fib), Ankle, and Foot. | |
| Size, inches h x d x w | 57"x58"x73" (145cm x 147cm x 185cm) | No changes | |
| Weight, lbs | Scanner 850 lbs (385.554 kg), Transporter 250 lb (113.398 kg) | Weight changed to 900lbs | Increased weight of tube housing plus Added counterweight. Both Devices were designed to be as small as possible and to be installed in a professional medical environment with minimal modifications. Labeling has been updated in alignment with the new scanner weight. |
| Power Requirements | 920VA | 4800 VA | The power consumption has increased from the predicate in alignment with the updated imaging characteristics. All electrical changes have been verified by third party 60601-1 testing, including all particular and collateral standards (specifically 60601-1-2, 60601-1-3, and 60601-2-44). Labing has been updated in alignment with the new power requirements. |
| Tissue Density Range | 0 to 2000 HU's (Hounsfield Units) | No changes | |
| Scatter Radiation Range | 0.0003 to 4.83mR | 0.2 to 12.9mR | When comparing the new scatter measurement numbers to the predicate, |
| expected as higher energy imagingprotocols are proposed to enhance theimage characteristics of hip scans(especially for larger patients, based onanatomy).The scatter radiation is in alignment withthe increased imaging protocols and hasnot increased outside of the expectedamount.Labeling has been updated in alignmentwith the new scatter numbers. | |||
| Patient SupportStructure | Flat plastic platform andhandlebars for weight-bearingimaging sequences, positionerplate for knee, transporteraccessory for non-weight-bearingimaging sequences | No changes | |
| DetectorPosition | Source to Imager Distance Fixeddistance from detector to x-raybeam center, parallel to axis ofrotation and orthogonal to x-raybeam. | No changes | |
| X-Ray BeamPosition | Beam size matches the 40cm x30cm flat panel (with a narrowunexposed margin), there are twovertical beam offsets from panelcenter: beam offset below thepanel center for foot scans, andbeam offset above the panelcenter for other extremity scans | Beam size matchesthe 40cm x 30cm flatpanel (with a narrowunexposed margin),there are twovertical beam offsetsfrom panel center:Beam offset belowthe panel center isutilized for foot scansor any protocols thatare continuous andcombine with thefoot. Beam offsetsabove the panelcenter for otherextremity scans | The slight change in the definition ofbeam position was included in thedatasets sent to the board-certifiedradiologist and found to be of diagnosticquality. |
| SoftwareCapture Tool | Virtualized Windows environmentbased application | No changes | There is new version of the software toinclude the updated imaging protocols.The application is still a virtualizedwindows environment-based application. |
| Display | Computer with mouse andkeyboard | No changes | |
| ProjectionGeometry | Beam collimated to a squareshape, Source to Imager Distance: | Beam collimated to asquare shape, Sourceto Imager Distance: | Slight changes to the projectiongeometry are based on the new Tube |
| 767 mm, Source to Axis ofrotation Distance: 503 mm | 730.55 mm, Sourceto Axis of rotationDistance: 466.95 mm | housing design (see Tube housingcomparison).Performance testing demonstrated thatnew geometry does not harm imagequality.The imaging volumes were reviewed by aboard-certified radiologist and found tobe of diagnostic quality. | |
| PatientPositioningGuide | Foot: Circular markings onplatformKnee/Hips: Accumeasure controlsheight of the GantryUpper Extremity: Marks on upperextremity platform insert | No changes | |
| PatientContactingMaterial | Powder coated Aluminum(Handlebar and Device cover),Polyester Vinyl, Carbon fibers | Powder coatedAluminum(Handlebar andDevice cover),Polyester Vinyl,Carbon fibers,Nylon (fastener forhand platform &Shielding curtain)and Polycarbonate | Minor material changes, biocompatibilityassessed in alignment with 10993 and donot impact the safety of the device.The instructions for use regarding contactwith the machine on the predicate andnew version have not changed. The UserManual on both devices recommendsavoiding direct contact with the scannerusing readily available materials. |
| ReconstructionMethod | Filtered back projection withnon-linear filtering for 3DCone-Beam CT reconstructionFiltered back projection with nonlinearfiltering for 3D Cone-Beam | No changes |
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CurveBeam, LLC – HiRise 510(k) Application
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CurveBeam, LLC – HiRise 510(k) Application
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| Design Control Activities Summary: | ||||
|---|---|---|---|---|
| Device Change | Risks | Verification/Validation methods | Acceptance Criteria | Summary of Results |
| Change of X-Ray generatingcircuitry and supportingelectronics• Tube• Tube housing.◦ Projectiongeometry◦ 3D imagingvolume• HVPS• Tube current• Increased powerrequirements• Additional coolingfeatures• Additional bow tiefilter mechanism | Increased Doseto the patient | Internal Verification inalignment with all internaltesting of previous HiRise.External third-party testingby ASCA testing facility to60601-1 and all applicablecollateral and particularstandards.*Note: Bowtie filter notused in this update.Future use will be enabledunder the same designcontrols employed by thecurrent QMS. | Passes all internalverification with noanomalies causingincreased risk.Passing all thirdparty testing to allapplicablerequirements. | All applicable testplans passed withno anomaliesincreasing risk.Completed 3rd partytesting with nooutstandingfailures. |
| Increased energy outputprotocols• Scan time• Max Exposure time• Increased mAcapabilities | Validation by fellowship-trained MSK radiologist. | Updated labelingA letter statingImages of newimaging protocolsare clinicallyacceptable andadequatediagnostic quality. | Labeling updated.Letter fromfellowship-trainedMSK radiologistvalidating images tobe clinicallyacceptable and ofclinical adequatediagnostic quality. | |
| Increased weight of thesystem | Negligibleincrease(approx. 50pounds) | No verification required | Updated labeling | Labeling updated. |
Design Control Activities Summary:
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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 as described.
Both the predicate HiRise and updated HiRise devices image extremities of similar bone density ranges and utilize a similar gantry to capture the desired anatomy. Images of the difference between the two devices have been reviewed by a radiologist and have been found to be of adequate diagnostic quality.
The combination of performance testing internally, safety and functional testing by a certified thirdparty 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:
IEC 60601-1:2005, Edition 3.2, 08/2020 IEC 60601-1-3:2008, Edition 2.2, 01/2021 IEC 60601-1-6, Edition 3.2, 07/2022 IEC 60601-2-44, Edition 3.2, 03/2016 (12-302) IEC 62366-1, Edition 1.1, 06/2020 IEC 60825-1, Edition 3, 05/2014 IEC 62304:2006 Ed.1 +A1, 06/2015 IEC 60601-1-2, Edition 4, 02/2014 IEC 61223-3-5, Edition 2.0, 09/2019 (12-328) NEMA PS 3.1-3.20, 2023e (12-352) NEMA PS 3.1-3.20, 2023d (12-349) 61223-2-6 Second Edition 2006-11 (12-266)
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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
- Guidance for the Content of Premarket Submissions for Device Software Functions
- Applying Human Factors and Usability Engineering to Medical Devices
- Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered ● Medical Devices
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
- Pediatric Information for X-ray Device Premarket Notifications Imaging
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.
N/A