(28 days)
Not Found
No
The summary describes a standard Cone Beam Computed Tomography (CBCT) device using a traditional filtered back projection reconstruction algorithm. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is described as an imaging device for diagnosis, not for treating any condition.
Yes
Explanation: The device is intended for 3-D imaging of anatomical regions, and the images it produces are described as being of "adequate diagnostic quality" and "clinically acceptable," indicating their use in diagnosis by qualified healthcare professionals.
No
The device description explicitly states it is a "Cone Beam Computed Tomography Imaging Device" that includes hardware components such as an X-ray source, image detector, motorized gantry, and vertical actuators.
Based on the provided information, the HiRise device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The HiRise device is an imaging system that directly images the human body (upper and lower extremities and pelvis) using X-rays. It does not analyze biological samples like blood, urine, or tissue.
- The intended use clearly describes imaging of anatomical regions. The purpose is to create 3D images of the patient's body for diagnostic purposes, not to perform tests on samples taken from the body.
- The device description details an imaging system. It describes an X-ray source, detector, and gantry for acquiring images, which is characteristic of an in-vivo imaging device, not an in-vitro diagnostic device.
Therefore, the HiRise device falls under the category of medical imaging devices rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The HiRise is a Computed Tomography X-ray System. 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
Mentions image processing
Acquires 360-degree rotational projection sequences which are reconstructed into 3D volumetric images.
Images produced by the HiRise can be sent electronically to a DICOM complaint image viewing software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
Upper and lower extremities, including the Elbow, Hand, Wrist, Pelvis, Hip, Femur, Knee, shin (lower leg or tib/fib), Ankle, and Foot.
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Professional healthcare environment by qualified health care professionals only.
The HiRise is to be used in medical facilities including hospitals, and orthopedic clinics. Revolution CT is to be operated by a trained technologist.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Verification/Validation
Sample Size: Not specified for image review, but testing included internal verification, external third-party testing, and validation by a fellowship-trained MSK radiologist.
Key Results:
- All applicable test plans passed with no anomalies increasing risk.
- Completed 3rd party testing with no outstanding failures.
- Images of new imaging protocols were validated by a fellowship-trained MSK radiologist to be clinically acceptable and of clinical adequate diagnostic quality.
- Comparison of characteristics and performance data with the predicate device demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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
2
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) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
4
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 | Product
Code | 510(k) | Regulation Number | Device
Classification |
|-------------------|-------------|-----------------|---------|-------------------|--------------------------|
| 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 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. | |
| 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 imaging |
| protocols for the HiRise have been deemed clinically acceptable, but the image |
CurveBeam, LLC – HiRise 510(k) Application
5
| characteristics on certain patients, based on anatomy, could be improved for
| enhanced contrast and lower noise. |
|---|
| When it comes to imaging the Hip, there is naturally a significantly higher volume of |
| adipose tissue for the X-Rays to penetrate. Therefore, a higher energy imaging |
| protocol is proposed 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 the HiRise is also indicated to be operated by |
| trained 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
6
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.
7
Substantial equivalence comparison table:
| SUBSTANTIAL EQUIVALENCE TABLE | |||
|---|---|---|---|
| Feature/ | |||
| Component | HiRise V1 | HiRise V2 | Variance/Rationale |
| 510(k) number | K203187 | ||
| Product code | JAK | No changes | |
| Regulation | |||
| number | 21 CFR 892.1750 | No changes | |
| Indications for | |||
| use | 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. | No changes | ||
| Principal of | |||
| operation | Computed Tomography X-ray | ||
| System | No changes | ||
| Scan axis | Horizontal and vertical | No changes | |
| Mechanical | |||
| 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. | No changes | ||
| Controller | Firmware Exposure Controller | No changes | |
| Tube | Stationary anode, glass envelope | ||
| x-ray tube. | |||
| Max KV: 130kV | |||
| Focal Spot: 0.5mm nominal | |||
| Target Angle: 15° degrees | Rotating Anode, glass | ||
| envelope x-ray tube. | |||
| Max KV: 130kV | |||
| Focal Spot: 0.3mm & | |||
| 0.6mm nominal | |||
| Target Angle: 16° | |||
| degrees | The overall changes utilize a more robust | ||
| tube. Change of target angle and does | |||
| not impact the image sequence output | |||
| quality. Both the focal spot size and | |||
| target angle have been assessed in the | |||
| data sets sent to board-certified | |||
| radiologist and found to be of diagnostic | |||
| quality. | |||
| Tube Housing | Same except for shape of | ||
| aperture | Enlarged to account | ||
| for the rotating | |||
| anode tube | The updated Tube housing was designed | ||
| with the same principles as the previous | |||
| version but is designed for the updated | |||
| Imaging requirements. | |||
| While the tube housing has been made | |||
| larger, the collimation ensures that the | |||
| output is kept as low as possible and only | |||
| exposes the active imaging area of the | |||
| panel. | |||
| All electrical changes have been verified | |||
| by third party to meet IEC 60601-1 | |||
| testing, including all particular and | |||
| collateral standards (specifically 60601-1- | |||
| 2, 60601-1-3, and 60601-2-44). | |||
| High Voltage | |||
| Power Supply | High frequency generator | High frequency | |
| generator updated to | |||
| allow for the | |||
| increased output | |||
| requirements | The updated High Voltage Power supply | ||
| utilizes the same design principles as the | |||
| previous version but is designed for the | |||
| updated Imaging requirements. | |||
| All electrical changes have been verified | |||
| by third party IEC 60601-1 testing, | |||
| including all particular and collateral | |||
| standards (specifically 60601-1-2, 60601- | |||
| 1-3, and 60601-2-44). | |||
| Tube voltage | 100-130 kVP for CT scans | 100-120 kVP for CT | |
| scans | Previous imaging protocols were limited | ||
| by the system requirements. | |||
| Bench testing determined optimal X-Ray | |||
| tube voltage (imaging characteristics) for | |||
| each anatomy and patient size. | |||
| Imaging characteristics have been | |||
| optimized for clinical diagnostic quality. | |||
| (especially for larger patients, based on | |||
| anatomy). | |||
| Labeling has been updated in alignment | |||
| with the new tube voltage range. | |||
| Tube current | 5.5 or 6.5 mA | 12 or 20 mA | Previous imaging protocols were limited |
| by the system requirements. | |||
| Bench testing determined optimal tube | |||
| current (imaging characteristics) for each | |||
| anatomy and patient size. | |||
| Imaging characteristics have been | |||
| optimized 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) diameter | ||
| Medium 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 imaging | |||
| protocols are proposed to enhance the | |||
| image characteristics of hip scans | |||
| (especially for larger patients, based on | |||
| anatomy). | |||
| The scatter radiation is in alignment with | |||
| the increased imaging protocols and has | |||
| not increased outside of the expected | |||
| amount. | |||
| Labeling has been updated in alignment | |||
| with the new scatter numbers. | |||
| Patient Support | |||
| Structure | Flat plastic platform and | ||
| handlebars for weight-bearing | |||
| imaging sequences, positioner | |||
| plate for knee, transporter | |||
| accessory for non-weight-bearing | |||
| imaging sequences | No changes | ||
| Detector | |||
| Position | Source to Imager Distance Fixed | ||
| distance from detector to x-ray | |||
| beam center, parallel to axis of | |||
| rotation and orthogonal to x-ray | |||
| beam. | No changes | ||
| X-Ray Beam | |||
| Position | Beam size matches the 40cm x | ||
| 30cm flat panel (with a narrow | |||
| unexposed margin), there are two | |||
| vertical beam offsets from panel | |||
| center: beam offset below the | |||
| panel center for foot scans, and | |||
| beam offset above the panel | |||
| center for other extremity scans | Beam size matches | ||
| the 40cm x 30cm flat | |||
| panel (with a narrow | |||
| unexposed margin), | |||
| there are two | |||
| vertical beam offsets | |||
| from panel center: | |||
| Beam offset below | |||
| the panel center is | |||
| utilized for foot scans | |||
| or any protocols that | |||
| are continuous and | |||
| combine with the | |||
| foot. Beam offsets | |||
| above the panel | |||
| center for other | |||
| extremity scans | The slight change in the definition of | ||
| beam position was included in the | |||
| datasets sent to the board-certified | |||
| radiologist and found to be of diagnostic | |||
| quality. | |||
| Software | |||
| Capture Tool | Virtualized Windows environment | ||
| based application | No changes | There is new version of the software to | |
| include the updated imaging protocols. | |||
| The application is still a virtualized | |||
| windows environment-based application. | |||
| Display | Computer with mouse and | ||
| keyboard | No changes | ||
| Projection | |||
| Geometry | Beam collimated to a square | ||
| shape, Source to Imager Distance: | Beam collimated to a | ||
| square shape, Source | |||
| to Imager Distance: | Slight changes to the projection | ||
| geometry are based on the new Tube | |||
| 767 mm, Source to Axis of | |||
| rotation Distance: 503 mm | 730.55 mm, Source | ||
| to Axis of rotation | |||
| Distance: 466.95 mm | housing design (see Tube housing | ||
| comparison). | |||
| Performance testing demonstrated that | |||
| new geometry does not harm image | |||
| quality. | |||
| The imaging volumes were reviewed by a | |||
| board-certified radiologist and found to | |||
| be of diagnostic quality. | |||
| Patient | |||
| Positioning | |||
| Guide | Foot: Circular markings on | ||
| platform | |||
| Knee/Hips: Accumeasure controls | |||
| height of the Gantry | |||
| Upper Extremity: Marks on upper | |||
| extremity platform insert | No changes | ||
| Patient | |||
| Contacting | |||
| Material | Powder coated Aluminum | ||
| (Handlebar and Device cover), | |||
| Polyester Vinyl, Carbon fibers | Powder coated | ||
| Aluminum | |||
| (Handlebar and | |||
| Device cover), | |||
| Polyester Vinyl, | |||
| Carbon fibers, | |||
| Nylon (fastener for | |||
| hand platform & | |||
| Shielding curtain) | |||
| and Polycarbonate | Minor material changes, biocompatibility | ||
| assessed in alignment with 10993 and do | |||
| not impact the safety of the device. | |||
| The instructions for use regarding contact | |||
| with the machine on the predicate and | |||
| new version have not changed. The User | |||
| Manual on both devices recommends | |||
| avoiding direct contact with the scanner | |||
| using readily available materials. | |||
| Reconstruction | |||
| Method | Filtered back projection with | ||
| non-linear filtering for 3D | |||
| Cone-Beam CT reconstruction | |||
| Filtered back projection with nonlinear | |||
| filtering for 3D Cone-Beam | No changes |
8
9
10
CurveBeam, LLC – HiRise 510(k) Application
11
CurveBeam, LLC – HiRise 510(k) Application
12
13
| Design Control Activities Summary: | ||||
|---|---|---|---|---|
| Device Change | Risks | Verification/Validation methods | Acceptance Criteria | Summary of Results |
| Change of X-Ray generating | ||||
| circuitry and supporting | ||||
| electronics | ||||
| • Tube | ||||
| • Tube housing. | ||||
| ◦ Projection | ||||
| geometry | ||||
| ◦ 3D imaging | ||||
| volume | ||||
| • HVPS | ||||
| • Tube current | ||||
| • Increased power | ||||
| requirements | ||||
| • Additional cooling | ||||
| features | ||||
| • Additional bow tie | ||||
| filter mechanism | Increased Dose | |||
| to the patient | Internal Verification in | |||
| alignment with all internal | ||||
| testing of previous HiRise. |
External third-party testing
by ASCA testing facility to
60601-1 and all applicable
collateral and particular
standards.
*Note: Bowtie filter not
used in this update.
Future use will be enabled
under the same design
controls employed by the
current QMS. | Passes all internal
verification with no
anomalies causing
increased risk.
Passing all third
party testing to all
applicable
requirements. | All applicable test
plans passed with
no anomalies
increasing risk.
Completed 3rd party
testing with no
outstanding
failures. |
| Increased energy output
protocols
• Scan time
• Max Exposure time
• Increased mA
capabilities | | Validation by fellowship-
trained MSK radiologist. | Updated labeling
A letter stating
Images of new
imaging protocols
are clinically
acceptable and
adequate
diagnostic quality. | Labeling updated.
Letter from
fellowship-trained
MSK radiologist
validating images to
be clinically
acceptable and of
clinical adequate
diagnostic quality. |
| Increased weight of the
system | Negligible
increase
(approx. 50
pounds) | No verification required | Updated labeling | Labeling updated. |
Design Control Activities Summary:
14
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)
15
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.