(52 days)
K1608557
No
The summary describes a standard Cone Beam CT and 2D X-ray imaging device with a 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 intended for visualizing and assessing anatomical structures for diagnostic purposes, not for treating conditions.
Yes
Explanation: The device is intended to be used for 3-D imaging and 2-D imaging of specific body regions to "visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures" and for "appropriate diagnosis of a given condition". It produces images that are said to be of "diagnostic quality", directly supporting its role in the diagnostic process.
No
The device description explicitly details hardware components such as a gantry assembly, X-ray source, image detector, motorized gantry, vertical actuators, and a patient transporter accessory. This indicates it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc. The tests are performed in vitro (in glass, or outside the body).
- The LineUP is an imaging device. It uses X-rays to create images of anatomical structures within the patient's body (in vivo).
The description clearly states that the LineUP is a "Cone Beam Computed Tomography Imaging Device" and a "2D plain X-Ray projections" device used to visualize and assess structures within the foot, knee, hand, and elbow regions of patients. This is the definition of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The LineUP 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. It can also capture 2D plain X-Ray projections. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For hand and elbow scans, a patient transporter accessory allows the patient to sit and then recline into a position where he/she can comfortably place his/her anatomy into the imaging bore. The transporter can also be configured to permit a seated non-weight bearing scan of the feet.
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 knee regions. The LineUP provides total vertical travel of 17 inches to accommodate patients of various sizes. Images produced by the LineUP can be sent electronically to a DICOM complaint image viewing software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone Beam Computed Tomography X-Ray, 2D Standard Plain X-Ray
Anatomical Site
foot, knee, hand, elbow
Indicated Patient Age Range
pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. *2D Imaging not intended for pediatric use
Intended User / Care Setting
medical facilities including hospitals, private practices, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To establish equivalency in performance, an image quality phantom was scanned in the LineUP and evaluated by a medical physicist. Anatomic hand, foot, elbow, and knee phantom scans were also reviewed by a radiologist and found to be of diagnostic quality.
Performance testing demonstrated that the image quality of the CMOS detector is statistically equivalent or superior to that of the predicate.
2D X-Ray performance bench testing was done and the LineUP was found to perform to industry standards. A board certified radiologist reviewed X-Ray images of the foot, knee, hand, and elbow regions and found them to be of diagnostic quality. The LineUP was also tested to IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy and was found to meet all safety and performance requirements.
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.
K1608557
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 11, 2018
CurveBeam, LLC % Mr. Dave Yungvirt, CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place MILLBURN NJ 07041
Re: K180727
Trade/Device Name: LineUP Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 30, 2018 Received: May 1, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name LineUP
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
Section 5 510(k) Summary - K180727
Contents
| Table 5-1 Device Information |
|---|
| Predicate Device: |
| Indications for Use: |
| Device Description: |
| Device Characteristics and Performance |
| Key Device Components |
| Environment of Use |
| Patient Contacting Materials |
| Table 5-3 pedCAT Substantial Equivalence Technical Characteristics |
| Substantial Equivalence Discussion: |
| 2D X-Ray Imaging |
| Safety and Effectiveness Information: |
| Conformity |
| FDA Guidance |
| Conclusion: |
Table 5-1 Device Information
| 510 (k) Submitter/Owner | CurveBeam, LLC
175 Titus Ave, Suite 300
Warrington, PA 18976
Phone: 267-483-8081
Fax: 267-483-8086 |
|-------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person | Stuti Singh
Senior Project Engineer
267-483-8081
Email: Stuti.singh@curvebeam.com |
| Date Prepared | April 26, 2018 |
| Trade Name | LineUP |
| Common Name | Computed tomography x-ray system |
4
| Classification Name | Computed tomography x-ray system |
|---|---|
| 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 | PedCat | JAK | K113548 | 892.1750 | Class II |
Indications for Use:
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
Device Description:
Device Characteristics and Performance
The LineUP 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. It can also capture 2D plain X-Ray projections. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For hand and elbow scans, a patient transporter accessory allows the patient to sit and then recline into a position where he/she can comfortably place his/her anatomy into the imaging bore. The transporter can also be configured to permit a seated non-weight bearing scan of the feet.
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 knee regions. The LineUP provides total vertical travel of 17 inches to accommodate patients of various sizes. Images produced by the LineUP can be sent electronically to a DICOM complaint image viewing software.
5
Key Device Components
- Embedded Controller CMOS Flat Panel Detector Gantry Assembly X-Ray Source X-Ray Power Supply Patient Platform and Positioners Patient Transporter Operator Control Box External Server
Environment of Use
The LineUP is to be used in medical facilities including hospitals, private practices, and orthopedic clinics. The LineUP should be installed and operated according to state and federal regarding radiation-emitting products and the device room layout should be approved by a certified medical physicist 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) Lexan panel shield
- (5) Powder coated Aluminum handlebars
| Feature or
Component | CurveBeam LineUP Computed
tomography x-ray system | CurveBeam pedCAT Computed
tomography x-ray system | Variance Explanation |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | JAK | K113548 | |
| Product code | JAK | JAK | |
| Regulation
number | 21 CFR 892.1750 | 21 CFR 892.1750 | |
| Indications for
Use | 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. | The PedCAT is intended to be used
for 3-D imaging of the foot & ankle
region, to visualize and
assess the osseous and certain soft
tissue structures, including joint
spaces, bone angles and
fractures. This modality is
anticipated to be applicable to
pediatric* cases as well as adults*,
when appropriate diagnosis of a
given foot condition is considered
necessary. | Datasets of foot, knee, hand, and
elbow regions were reviewed by a
board-certified radiologist and found
to be of diagnostic quality. |
| | 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 | * Patient parameters: Weight
range for pediatric patients: 50 lbs
to 99 lbs, adult patients: 100 lbs to
400 lbs; plus
Groin region at least 22" above the
floor | |
| Principle of
Operation | Cone Beam Computed
Tomography X-Ray
and
2D Standard Plain X-Ray
projections | Cone Beam Computed Tomography
X-Ray | For 2-D X-Rays, The LineUP was tested
to IEC 60601-2-54: Medical electrical
equipment - Part 2-54: Particular
requirements for the basic safety and
essential performance of X-ray
equipment for radiography and
radioscopy and was found to meet all
performance requirements.
A medical physicist did performance
and image quality tests on X-Ray
Images and found them to meet
industry standards.
A radiologist reviewed 2D images of
the foot, knee, hand and elbow and
found them to be of diagnostic
quality. |
| Scan axis | Horizontal | Horizontal | |
| Mechanical
Layout | 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 hand
or elbow in bore. | A horizontal doughnut, with the x-
ray source and flat panel detector
mounted at each end of a rotating
gantry. | Knee hand and elbow are new
indications but use same CBCT
concept as foot scan |
| Controller | Firmware Exposure Controller | Firmware Exposure Controller | |
| Tube | Same in both devices | Same in both devices | |
| Tube Housing | Same except for shape of
aperture | Same except for shape of aperture | New aperture allows for wider X-Ray
beam angle |
| High Voltage
Power Supply | High frequency generator | High frequency generator | |
| Tube voltage | 100 and 120 kVP for CT scans
60 kVp for 2D X-Rays | 100 and 120 kVP for CT scans | The LineUP was tested to IEC 60601-2-
54: Medical electrical equipment - Part
2-54: Particular requirements for the
basic safety and essential
performance of X-ray equipment for
radiography and radioscopy and was
found to meet all performance
requirements. |
| | | | Bench testing determined optimal 2D |
| | | | X-Ray tube voltage for each anatomy |
| | | | and patient size |
| Tube current | 5 mA | 5 mA | |
| Scan time | 21 sec for CT
0.15-1.3 sec for X-Ray | 17 and 56 sec for CT | CT: LineUP utilizes a single-orbit half
fan mode to capture a larger volume
instead of utilizing two full orbits with
the panel offset on either side like the
pedCAT. Image quality performance
was verified with Bench Testing. |
| | | | X-Ray: Bench testing determined
optimal exposure time for each
anatomy and patient size |
| Max exposure
time | 6 sec for CT
1.3 sec for 2D X-Ray | 9 sec | LineUP utilizes a single-orbit half fan
mode to capture a larger volume
instead of utilizing two full orbits with
the panel offset on either side like the
pedCAT. Image quality performance
was verified with Bench Testing. |
| Image detector | CMOS flat panel | Amorphous Silicon 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 | Feldkamp-Davis-Kress (FDK)
algorithm for 3D Cone-Beam CT
reconstruction | New reconstruction method's
performance has been evaluated in
bench testing and found to be
equivalent to predicate method |
| Gray scale | 14 bit | 14 bit | |
| 3D Imaging
Volume | 20cm (high) x 35 cm (diameter) | 20cm (high) x 35 cm (diameter) | |
| Typical
resolution | 0.3 mm voxel | 0.3 mm voxel | |
| Body part
scanned | Foot, knee, hand, elbow | Foot and ankle | Datasets of foot, knee, hand, and
elbow were reviewed by a radiologist
in Section 37 |
| Size, inches
h x d x w | 50"x63"x49" | 47"x59"x48" | |
| Weight, lbs | Scanner 750 lbs (340 kg),
Transporter 250 lb (113 kg) | Scanner 400 lbs | LineUP is larger and has more
components to accommodate
additional anatomy and has an
additional transporter device |
| Power
Requirements | 1150VA | 1150VA | |
| Tissue Density
Range | 0 to 2000 HU's (Hounsfield
Units) | 0 to 2000 HU's (Hounsfield Units) | |
| Scatter
Radiation
Range | .001 to .18 mR | .005 to .503 mR | |
| Patient Support
Structure | Flat plastic platform and
handlebars for weight-bearing
foot/ankle, positioner plate for
knee, transporter accessory for
hand, elbow and non-weight-
bearing foot | Flat plastic platform and
handlebars for weight-bearing
foot/ankle, seat for non-weight
bearing foot/ankle | New support structures permit
scanning of additional anatomical
regions. Support structures tested to
applicable safety standards. |
JCAT Cubatantial Cauivolonao Toghniaal Ch
6
7
8
| Detector
Position | | X-Ray Beam
Position | Software
Capture Tool | Display | Projection
Geometry | Patient
positioning
guide | Patient
Contacting
Materials |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | X-Ray Beam
Position | Beam size matches the 31cm 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 knee, hand
and elbow scans | Software
Capture Tool | Virtualized Windows
environment based application | Display | Computer with mouse and
keyboard |
| | | | 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. | | | | |
| | | | LineUP has a second offset to x-ray
beam center for knee, hand and
elbow scans | | | | |
| | | Software
Capture Tool | Virtualized Windows environment
based application | | | | |
| | | Display | 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: 528
mm | | Beam collimated to a square
shape, Source to Imager Distance:
734 mm,
Source to Axis of rotation Distance:
536mm | | Slightly different geometry
accommodates patients with wider
hips to receive a knee scan in the
LineUP. Performance testing
demonstrated that new geometry
does not harm image quality. |
| | | Patient
positioning
guide | Foot: Circular Markings on
Platform
Knees: Markings on Knee
Positioner
Hand and Elbow: Marks on
Hand and Elbow platform
insert | | Foot/ Ankle: Circular Markings on
Platform
Knees: N/A
Hand and Elbow: N/A | | LineUP includes additional positioning
guides for new anatomies |
| | | Patient
Contacting
Materials | (1) Polyester patient platform
lining (2) Vinyl Transporter
cushion (3) carbon fiber
positioners (4) Lexan panel
shield (5) Powder coated
Aluminum handlebars | | (1) the non-conducting Autoflex
EBG (Polyester) patient support (2)
the powder coated aluminum hand
rails | | The instructions for use regarding
contact with the machine on the
pedCAT and LineUP are similar. The
User Manual on both devices
recommends avoiding direct contact
with the scanner using readily
available materials. |
Substantial Equivalence Discussion:
The overall technology, key components and intended use of the LineUP Computed Tomography x-ray system and the predicate device are substantially similar, with certain inconsequential differences described henceforth.
Both the LineUP and pedCAT 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 in a bilateral position. The LineUP has an added capability to elevate the gantry and scan the knees, as well as a transporter accessory to assist in scanning the hand and elbow. The additional support structures on the LineUP have been tested to applicable safety standards. Images of the additional anatomy have been reviewed by a radiologist and
CurveBeam, LLC - LineUP 510(k) Application
9
have been found to be of adequate diagnostic quality.
To establish equivalency in performance, an image quality phantom was scanned in the LineUP and evaluated by a medical physicist. Anatomic hand, foot, elbow, and knee phantom scans were also reviewed by a radiologist and found to be of diagnostic quality.
The LineUP uses the same X-Ray tubehead and a similar power supply as the PedCat. The LineUP utilizes a CMOS flat panel image detector while the PedCat uses an amorphous silicon flat panel detector to capture projection images. Performance testing demonstrated that the image quality of the CMOS detector is statistically equivalent or superior 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 LineUP is safe and effective when used as labeled.
2D X-Ray Imaging
Since the predicate device does not capture 2D Plain X-Ray projections, a reference device was used to evaluate the technical performance characteristics of this feature. Information about the reference device is presented in Table 5-4.
| Company | Device name | Product Code | 510(k) | Regulation Number | Device Classification |
|---|---|---|---|---|---|
| X-Cel X-Ray Corporation | HF 718BD X-Ray System | KPR | K160857 | 892.1680 | Class II |
Table 5-4 Reference Device
2D X-Ray performance bench testing was done and the LineUP was found to perform to industry standards. A board certified radiologist reviewed X-Ray images of the foot, knee, hand, and elbow regions and found them to be of diagnostic quality. The LineUP was also tested to IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy and was found to meet all safety and performance requirements.
The described tests and features establish that the LineUP produces diagnostic quality 2D X-Rays in a safe and effective manner, similar to the currently marketed X-Cel X-Ray Corporation HF 718BD X-Ray System.
Safety and Effectiveness Information:
The LineUP Computed Tomography X-ray system is a Class II medical device.
The LineUP Computed Tomography X-ray system complies with applicable FDA and international standards pertaining to electrical, mechanical, software, EMC, and radiation safety of medical devices.
10
Conformity
The LineUP device has been tested to the following standards to ensure safety, effectiveness, and compliance with industry norms:
AAMI ES60601-1:2005+C1; A2 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 IEC 60601-2-44, Edition 3.1, 09/2012 IEC 60601-2-54:2009Ed.1+C1; C2; A1 IEC 60601-1-2, Edition 4, 02/2014 IEC 61223-3-5, first edition, 08/2004 NEMA PS 3.1-3.20, 2016
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 Submission Of Premarket Notifications for Medical Image Management Devices
- 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
- . Pediatric Information for X-ray Imaging Device Premarket Notifications
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 LineUP Computed Tomography X-ray System is substantially equivalent to the predicate device.