(22 days)
No
The summary describes a standard Cone Beam CT device and its reconstruction algorithm (Filtered back projection). There is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The reconstruction method described is a traditional image processing technique, not an AI/ML algorithm.
No
The device is an imaging device used for diagnostic purposes (3-D imaging), not for treating or mitigating a disease.
Yes
The device is a Cone Beam Computed Tomography Imaging Device that produces 3D volumetric images. These images are stated to be of "diagnostic quality" and are reviewed by a radiologist, indicating their use in diagnosing conditions.
No
The device description explicitly details hardware components such as an X-ray source, image detector, motorized gantry, and vertical actuators, indicating it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, the HiRise device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HiRise Function: The HiRise is an imaging device that uses X-rays to create 3D images of anatomical structures (upper extremities and pelvis). It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "3-D imaging of the upper extremities and pelvis." This is an imaging function, not a diagnostic test performed on a sample.
Therefore, the HiRise falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JAK
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone Beam Computed Tomography X-Ray
Anatomical Site
upper extremities and pelvis
Humerus, elbow, forearm (radius/ulna), hand, wrist, pelvis/hips, femur, knee, shin (lower leg or tib/fib) and ankle/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.
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
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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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3
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 Conlon |
| Director of Quality and Regulatory Affairs | |
| 267-483-8081 | |
| Email: 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
4
| Product Code | JAK |
|---|---|
| 510(k) Type | Traditional |
| Regulation Number | 892.1750 |
| Device Classification | Class II |
This is the first 510(k) submission for this device. There were no prior submissions.
Predicate Device:
Table 5-2 Predicate Device
| Company | Device name | Product Code | 510(k) | Regulation Number | Device
Classification |
|-------------------|-------------|--------------|---------|-------------------|--------------------------|
| 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
5
Patient Platform and Positioners Patient non-weight bearing chair Operator Control Box External Server
Environment of Use
The HiRise is to be used in medical facilities including hospitals, and orthopedic clinics. The HiRise should be installed and operated according to state and federal regulations regarding radiationemitting products and the device room layout should be approved by a certified medical prior to installation.
Patient Contacting Materials
The materials that could contact the patient are listed below.
- (1) Polyester patient platform lining
- (2) Vinyl Transporter cushion
- (3) Carbon fiber positioners
- (4) Powder coated Aluminum handlebars
| | CurveBeam HiRise Computed
tomography x-ray system | CurveBeam LineUP Computed
tomography x-ray system | Variance Explanation |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K180727 | |
| Product code | JAK | JAK | |
| Regulation
number | 21 CFR 892.1750 | 21 CFR 892.1750 | |
| 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. | The LineUP is intended to be used
for 3-D imaging of the foot, knee,
hand, and elbow regions to
visualize and assess the osseous
and certain soft tissue structures,
including joint spaces, bone angles
and fractures.
It is also intended to capture 2-D
images (standard plain x-ray
projections) of the foot, knee,
hand, and elbow regions.
This modality is anticipated to be
applicable to pediatric* cases as
well as adults, when appropriate
diagnosis of a given condition is
considered necessary. Patient
parameters: 50 lbs to 400 lbs
*2D Imaging not intended for
pediatric use | 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 increased weight range has be
tested and verified by third party
60601-1 testing. |
| Principle of
Operation | Cone Beam Computed
Tomography X-Ray | Cone Beam Computed
Tomography 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. |
| 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. | 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: 130kV
Focal Spot: 0.5mm nominal
Target Angle: 15 degree | Stationary anode, glass envelope x-ray tube.
Max KV: 130kV
Focal Spot: 0.5mm nominal
Target Angle: 20 degree | Change of target angle does not impact the image sequence output quality. HiRise utilizes a more robust tube with a smaller target angle. |
| Tube Housing | Same except for shape of aperture | Same except for shape of aperture | New aperture allows for appropriate output |
| High Voltage
Power Supply | High frequency generator | High frequency generator | No change, same supply |
| Tube voltage | 100-130 kVP for CT scans | 100-120 kVP for CT scans
60 kVp for 2D X-Rays | 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).
2D X-Rays are not required for use of the HiRise |
| Tube current | 5.5 or 6.5 mA | 5 mA | Increased tube current was required to provide diagnostic quality image sequences in the new anatomy (hips and pelvis). |
| Scan time | 26 sec for CT | 21 sec for CT | CT: HiRise is slightly slower to allow for greater exposure time required for the denser anatomy. Image quality performance was verified with Bench Testing. |
| Max exposure time | 8.7 sec | 9 sec | Similar exposure times |
| Image detector | Amorphous Silicon flat panel | CMOS flat panel | Detector performance testing verified
image quality met requirements |
| Reconstruction
Algorithm | Filtered back projection with
non-linear filtering for 3D
Cone-Beam CT reconstruction | Filtered back projection with non-
linear filtering for 3D Cone-Beam
CT reconstruction | Both the HiRise and the LineUP use
the same reconstruction engine. |
| Gray scale | 16 bit | 14 bit | The panel uses a 16 bit panel to utilize
a larger dynamic range of the imaging
sequences. |
| 3D Imaging
Volume | Large FOV: 8" (20cm) height x
16" (40cm) diameter
Medium FOV: 8" (20cm) height
x 10" (25cm) diameter | 20cm (high) x 35 cm (diameter) | 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 | LFOV: 0.3mm, MFOV: 0.25mm | 0.3 mm voxel | 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. |
| Body part
scanned | Humerus, elbow, forearm
(radius/ulna), hand, wrist,
pelvis/hips, femur, knee, shin
(lower leg or tib/fib) and
ankle/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) and
foot/ankle are included in Section 37 |
| Size, inches
h x d x w | 57"x58"x73" (145cm x 147cm x
185cm) | 62.63"x49.01"x51.71" | Both devices designed to be easily
installed and to fit in a professional
healthcare environment with minimal
modifications. |
| 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 more
components to accommodate
additional anatomy.
|
| Power
Requirements | 920VA | 1150VA | HiRise is rated a slightly lower power
consumption. |
| Tissue Density
Range | 0 to 2000 HU's (Hounsfield
Units) | 0 to 2000 HU's (Hounsfield Units) | |
| 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 | Flat plastic platform and
handlebars for weight-bearing
foot/ankle, positioner plate for
knee, transporter accessory for
upper extremities and non-weight-
bearing foot | New support structures permit
scanning of additional anatomical
regions. Support structures tested to
Standards specified in Section 9 -
Declarations of Conformity and
Summary Report |
| Detector
Position | Source to Imager Distance
Fixed distance from detector to
x-ray beam center, parallel to | Source to Imager Distance Fixed
distance from detector to x-ray
beam center, parallel to axis of | |
| | axis of rotation and orthogonal
to x-ray beam. | rotation and orthogonal to x-ray
beam. | |
| | | | |
| X-Ray Beam
Position | Beam size matches the 40cm x
31cm 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 30cm x
30cm flat panel detector (with a
narrow unexposed margin), the
beam center is vertically positioned
below the panel center (towards
the bottom of the FOV) where the
densest bones in the foot are
located. | HiRise and LineUP utilize similar two
offsets to image different parts of the
anatomy described in the intended
use. |
| | | | |
| | | | |
| | | | |
| | | | |
| Software
Capture Tool | Virtualized Windows
environment based application | Virtualized Windows environment
based application | |
| | | | |
| Display | Computer with mouse and
keyboard | Computer with mouse and
keyboard | |
| | | | |
| Projection
Geometry | Beam collimated to a square
shape, Source to Imager
Distance: 767 mm, Source to
Axis of rotation Distance: 503
mm | Beam collimated to a square
shape, Source to Imager Distance:
767 mm, Source to Axis of rotation
Distance: 528 mm | Slightly different geometry
accommodates patients up to the Hip.
Performance testing demonstrated
that new geometry does not harm
image quality. |
| | | | |
| | | | |
| | | | |
| | | | |
| Patient
positioning
guide | Foot: Circular Markings on
Platform | Foot: Circular Markings on Platform | HiRise includes a tool to measure the
height of the knee and hips. The |
| | Knees/Hips: Accumeasure
controls height of Gantry | Knees: Markings on Knee
Positioner | |
| | Upper Extremity: Marks on
upper extremity platform
insert | Upper Extremity: Marks on upper
extremity platform insert | |
| | | | |
| | | | |
| | | | |
| Patient
Contacting
Materials | (1) Polyester patient platform
lining (2) Vinyl Transporter
cushion (3) carbon fiber
positioners (4) Powder coated
Aluminum handlebars | (1) Polyester patient platform lining
(2) Vinyl Transporter cushion (3)
carbon fiber positioners (4) Lexan
panel shield (5) Powder coated
Aluminum handlebars | The instructions for use regarding
contact with the machine on the
LineUP and HiRise are similar. The
User Manual on both devices
recommends avoiding direct contact
with the scanner using readily
available 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
9
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
10
- 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.