(267 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-driven devices.
No.
The device is described as an X-ray imaging system indicated for acquiring images for diagnostic purposes, not for treating any medical condition or disease.
Yes
The "Device Description" section states, "The See Factor CT3™ consists of a Diagnostic CBCT (Cone Beam Computed Tomography) device..." This explicitly identifies it as a diagnostic device. Additionally, its intended use is to acquire images for clinical and intra-operative use, which supports diagnosis.
No
The device description explicitly states it consists of a "Diagnostic CBCT (Cone Beam Computed Tomography) device" which includes hardware components like a gantry, flat panel detector, and a mobile platform. While it includes software, it is not solely software.
Based on the provided information, the See Factor CT3™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- See Factor CT3™ Function: The See Factor CT3™ is an X-ray imaging system that acquires images of anatomical structures within the body using computed tomography, digital radiography, and fluoroscopy. It does not analyze biological specimens.
- Intended Use: The intended use is for acquiring images of specific anatomical areas for diagnostic and clinical use, not for analyzing samples taken from the body.
- Device Description: The description focuses on the imaging technology and its physical components, not on the analysis of biological materials.
Therefore, the See Factor CT3™ falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The See Factor CT3™ is a flat panel cone beam computed tomography X-ray imaging system that is indicated for acquiring images of the head, neck, and limbs in all adult patients. It can also acquire portions of the thorax, spine, and pelvic bones with high x-ray attenuation such as bony structures in supine body parts no wider than 60cm. The device has a 62.5cm gantry bore with a 30cm field of view that can provide 2D and 3D images for all of the stated anatomical areas for both intra-operative and clinical use. The device is also capable of acquiring digital radiography and fluoroscopy images of the anatomical areas identified above.
Product codes
OWB, JAK
Device Description
The See Factor CT3™ consists of a Diagnostic CBCT (Cone Beam Computed Tomography) device that integrates High-Definition Computed Tomography (HDCT) for obtaining High Resolution 3D Volume with 2D High Resolution Scouting, through Dynamic Scouting and Single Pulse Modality. Flat panel detector technology allows for multimodality utilization for computed tomography, aigital radiography, and fluoroscopy. The qantry of the device is mounted to a battery powered mobile platform that allows use in various clinical settings such as an imaging center, a hospital, or an operating room where adequate radiation shielding is installed. Stray radiation mapping demonstrates no significant difference from the predicate See Factor CT3. The energy source and methodology for obtaining diagnostic CT images utilized by the See Factor CT3™ remains the same as its predicate device. No part of the See Factor CT3™ is intended to come into contact with patients during typical scans that take less than 20 minutes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, Fluoroscopy, Digital radiography
Anatomical Site
Head, neck, limbs, portions of the thorax, spine, and pelvic bones
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
The device is to be operated by licensed and credentialed medical professionals such as physicians, and radiology technicians.
Imaging center, a hospital, or an operating room where adequate radiation shielding is installed.
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: Electrical safety and electromagnetic compatibility (EMC) testing; Software Verification and Validation Testing; Bench Testing (performance testing for 3D imaging, 3D clinical sample images obtained)
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: The system complies with standards IEC 60601-1, IEC 60601-1-6, IEC 60601-1-6, IEC 60601-2-43, IEC 60601-2-44, IEC 60601-2-54, for safety, and IEC 60601-1-2 for EMC. Software verification and validation testing documents were provided as recommended by FDA’s Guidance. In all instances, the See Factor CT3™ functioned as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
June 21, 2024
Image /page/0/Picture/1 description: The image shows 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 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.
Epica International, Inc. % Craig Glaiberman Chief Medical Officer 1875 East Main St., Spark Warehouse 92, Dock 12 & 13 DUNCAN, SC 29334
Re: K233230
Trade/Device Name: See Factor CT3TM Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAK Dated: May 21, 2024 Received: May 21, 2024
Dear Craig Glaiberman:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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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).
Sincerely,
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
Indications for Use
510(k) Number (if known) K233230
Device Name See Factor CT3TM
Indications for Use (Describe)
The See Factor CT3™ is a flat panel cone beam computed tomography X-ray imaging system that is indicated for acquiring images of the head, neck, and limbs in all adult patients. It can also acquire portions of the thorax, spine, and pelvic bones with high x-ray attenuation such as bony structures in supine body parts no wider than 60cm. The device has a 62.5cm gantry bore with a 30cm field of view that can provide 2D and 3D images for all of the stated anatomical areas for both intra-operative and clinical use. The device is also capable of acquiring digital radiography and fluoroscopy images of the anatomical areas identified above.
The device is to be operated by licensed and credentialed medical professionals such as physicians, and radiology technicians.
| 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)
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510(k) SUMMARY Epica International, Inc.'s See Factor CT3™ K233230
Submitter
Epica International, Inc. 19810 Asheville Hwy Landrum. SC 29356 Phone: +1 (916) 850-5866 Contact Person: Craig Glaiberman, MD, Chief Medical Officer
Date Prepared: June 21, 2024
Name of Device: See Factor CT3™
Common or Usual Name: Image-intensified fluoroscopic x-ray system
Classification Name: 21 CFR 892.1650
Regulatory Class: 2
Product Code: OWB, JAK
Predicate Device: Siemens Artis zeego (K181407)
Device Description
The See Factor CT3™ consists of a Diagnostic CBCT (Cone Beam Computed Tomography) device that integrates High-Definition Computed Tomography (HDCT) for obtaining High Resolution 3D Volume with 2D High Resolution Scouting, through Dynamic Scouting and Single Pulse Modality. Flat panel detector technology allows for multimodality utilization for computed tomography, aigital radiography, and fluoroscopy. The qantry of the device is mounted to a battery powered mobile platform that allows use in various clinical settings such as an imaging center, a hospital, or an operating room where adequate radiation shielding is installed. Stray radiation mapping demonstrates no significant difference from the predicate See Factor CT3. The energy source and methodology for obtaining diagnostic CT images utilized by the See Factor CT3™ remains the same as its predicate device. No part of the See Factor CT3™ is intended to come into contact with patients during typical scans that take less than 20 minutes.
Intended Use / Indications for Use
The See Factor CT3™ is a flat panel cone beam computed tomography X-ray imaging system that is indicated for acquiring images of the head, neck, and limbs in adult patients. It can also acquire images of portions of the thorax, spine, and pelvic bones with high x-ray attenuation such as in supine body parts no wider than 60cm. The device has a 62.5cm gantry bore with a 30cm field of view that can provide 2D and 3D images for all of the stated anatomical areas for both intra-operative and clinical use. The device is also capable of acquiring digital radiography and fluoroscopy images of the anatomical areas identified above.
4
The device is operated and used by physicians, x-ray technologists, and other legally qualified professionals.
Summary of Technological Characteristics
Computed tomography is the technological principle for both the subject and predicate device. Subject and predicate device are cone beam x-ray imaging systems that acquire diagnostic twoand three-dimensional images in DICOM format. At a high level, the subject and predicate devices are based on the following same technological elements:
-
Subject and predicate devices have the same energy source for x-ray production, similar . flat panel detectors, are DICOM compatible, and are both mobile or stationary.
The following technological differences exist between the subject and predicate devices: -
· The See Factor CT3™ has the additional ability to obtain digital radiography and fluoroscopic images in DICOM format.
-
· The gantry of the See Factor CT3™ also has the capability to index over the patient providing a longer scan length. It also has higher resolution and isotropic voxels without interpolation.
-
· The subject See Factor CT3™ includes a drive system to aid in moving of the system.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the See Factor CT3™ system. The system complies with standards IEC 60601-1. IEC 60601-1-6, IEC 60601-1-6, IEC 60601-2-43. IEC 60601-2-44, IEC 60601-2-54, for safety, and IEC 60601-1-2 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions."
Bench Testing
Performance testing as outlined in Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Section VI have been performed to demonstrate adequate device performance. Additionally, bench testing for 3D imaging was conducted and 3D clinical sample images were obtained to support the performance of the CBCT modality.
In all instances, the See Factor CT3™ functioned as intended.
Conclusions
The See Factor CT3™ is as safe and effective compared to its predicate. The See Factor CT3™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended
5
diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the See Factor CT3™ and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the See Factor CT3™ is as safe and effective as the predicate device. Thus, the See Factor CT3™ is substantially equivalent.
| | See Factor CT3
Proposed Device | Siemens Artis zeego
(K181407) primary predicate
device | Comment |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Device | Image-intensified
fluoroscopic x-ray system | Image-intensified
fluoroscopic x-ray system | |
| FDA Product Code | OWB, JAK | OWB, IZI, JAA, JAK | |
| FDA Regulation | 21 CFR 892.1650 | 21 CFR 892.1650 | |
| Device Class | Class II | Class II | |
| Indications for
Use | The See Factor CT3TM is a
flat panel cone beam
computed tomography X-ray
imaging system that is
indicated for acquiring
images of the head, neck,
and limbs in adult patients. It
can also acquire images of
portions of the thorax, spine,
and pelvic bones with high x-
ray attenuation such as bony
structures in supine body
parts no wider than 60cm.
The device has a 62.5cm
gantry bore with a 30cm field
of view that can provide 2D
and 3D images for all of the
stated anatomical areas for
both intra-operative and
clinical use. The device is
also capable of acquiring
digital radiography and
fluoroscopy images of the
anatomical areas identified
above.
The device is operated and
used by physicians, x-ray
technologists, and other
legally qualified
professionals. | Artis is a family of dedicated
angiography systems
developed for single and
biplane diagnostic imaging
and interventional
procedures including, but not
limited to, pediatric and
obese patients.
Procedures that can be
performed with the Artis
family include cardiac
angiography, neuro-
angiography, general
angiography, rotational
angiography; multipurpose
angiography and whole body
radiographic/fluoroscopic
procedures as well as
procedures next to the table
for i.e. patient extremities.
Additional procedures that
can be performed include
angiography in the operating
room, image-guided surgery
by X-ray, by image fusion,
and by navigation systems.
The examination table as an
integrated part of the system
can be used for X-ray
imaging, surgery, and
interventions.
Artis can also support the
acquisition of position
triggered imaging for spatial
data synthesis. | Substantially equivalent.
Both the subject and
proposed predicate device
provide fluoroscopic imaging
and CT capabilities (both
offer software reconstruction
methods of x-ray images into
2D and 3D image formats). |
| | | | |
| | | The Artis systems include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures, and treatment follow-up. | |
| Intended Use
Environment | Imaging center, a hospital, or an operating room where adequate radiation shielding is installed. | Imaging center, a hospital, or an operating room where adequate radiation shielding is installed. | Same |
| Patient population | Adults (>18 years old) | Adults, pediatrics, obese patients | Predicate has expanded population indications compared to subject device.
However this difference does not raise different questions of safety or effectiveness. |
| Imaging Modality | CT
Fluoroscopy
Digital radiography | Angiography
Whole body radiographic/fluoroscopic procedures
DynaCT
Angio-CT configuration (SOMATOM Family Sliding Gantry) | Substantially similar. The subject device offers a subset of imaging modalities similar to those of the predicate device.
However this difference does not raise different questions of safety or effectiveness. |
| Patient Diagnostic | Yes | Yes | Same |
| Intraoperative Use | Yes | Yes | Same |
| Set-Up | Fixed placement | Fixed placement
Single or biplane | Similar |
| Mobile | Yes | No | Different. However, this difference does not raise different questions in terms of intended use, safety or effectiveness of the device as demonstrated by performance testing. |
| Gantry Bore Size | Circular bore maximum width of 62,5 cm | C-arm maximum depth 80cm | Substantially similar in configuration of source and detector position that does |
| | | | not raise different questions
of safety or effectiveness. |
| Power supply | 230 VAC 60/50 Hz, 5000VA
(max) | N/A - information not
available | Same |
| DAP | Yes | Yes | Same |
| MAR | Yes | Yes | Same |
| MIP | Yes | Yes | Same |
A table comparing the key features of the subject and predicate devices is provided below.
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7
8
| | See Factor CT3
Proposed Device | Siemens Artis zeego
(K181407) primary
predicate device | Comment |
|------------------|------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|
| Type of Device | Image-intensified
fluoroscopic x-ray system | Image-intensified
fluoroscopic x-ray system | Same |
| FDA Product Code | OWB, JAK | OWB, IZI, JAA, JAK | Similar for fluoroscopic
functionality of proposed
device |
| FDA Regulation | 21 CFR 892.1650 | 21 CFR 892.1650 | Same |
| Device Class | Class II | Class II | Same |
9
| Indications for Use | ||
|---|---|---|
| The See Factor CT3™ is a flat | ||
| panel cone beam computed | ||
| tomography X-ray imaging | ||
| system that is indicated for | ||
| acquiring images of the head, | ||
| neck, and limbs in adult | ||
| patients. It can also acquire | ||
| images of portions of the thorax, | ||
| spine, and pelvic bones with | ||
| high x-ray attenuation such as | ||
| bony structures in supine body | ||
| parts no wider than 60cm. The | ||
| device has a 62.5cm gantry | ||
| bore with a 30cm field of view | ||
| that can provide 2D and 3D | ||
| images for all of the stated | ||
| anatomical areas for both intra- | ||
| operative and clinical use. The | ||
| device is also capable of | ||
| acquiring digital radiography | ||
| and fluoroscopy images of the | ||
| anatomical areas identified | ||
| above. |
The device is operated and
used by physicians, x-ray
technologistsand other legally
qualified professionals. | Artis is a family of dedicated
angiography systems
developed for single and
biplane diagnostic imaging and
interventional procedures
including, but not limited to,
pediatric and obese patients.
Procedures that can be
performed with the Artis family
include cardiac angiography,
neuro-angiography, general
angiography, rotational
angiography; multipurpose
angiography and whole body
radiographic/fluoroscopic
procedures as well as
procedures next to the table for
i.e. patient extremities.
Additional procedures that can
be performed include
angiography in the operating
room, image-guided surgery by
X-ray, by image fusion, and by
navigation systems. The
examination table as an
integrated part of the system
can be used for X-ray imaging,
surgery, and interventions.
Artis can also support the
acquisition of position triggered
imaging for spatial data
synthesis.
The Artis systems include also
the software option DynaCT
with following IFU:
DynaCT is an x-ray imaging
software option, which allows
the reconstruction of two-
dimensional images acquired
with a standard angiographic C-
arm device into a three-
dimensional image format.
DynaCT is intended for imaging
both hard and soft tissues as
well as other internal body
structures for diagnosis, | Substantially equivalent.
Both the subject and
proposed predicate device
provide fluoroscopic imaging
and CT capabilities (both
offer software reconstruction
methods of x-ray images into
2D and 3D image formats). |
| | procedures, and treatment
follow-up. | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
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