Who is the manufacturer of See Factor CT3?

Epica International, Inc. filed the 510(k) submission for See Factor CT3 (K233230).

What is the FDA product code for See Factor CT3?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for See Factor CT3?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like See Factor CT3?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

See Factor CT3

K233230 · Epica International, Inc. · OWB · Jun 21, 2024 · Radiology

Device Facts

Record ID	K233230
Device Name	See Factor CT3
Applicant	Epica International, Inc.
Product Code	OWB · Radiology
Decision Date	Jun 21, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2

Intended 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 technologists, and other legally qualified professionals.

Device Story

Mobile flat panel cone beam computed tomography (CBCT) system; integrates High-Definition Computed Tomography (HDCT) for 3D volume and 2D scouting. Inputs: X-ray radiation; transforms via flat panel detector and reconstruction software into 2D/3D DICOM images. Outputs: Digital radiography, fluoroscopy, and CT images. Used in imaging centers, hospitals, or operating rooms; operated by physicians and radiology technicians. Features battery-powered mobile platform and drive system; gantry indexes over patient for extended scan length. Provides high-resolution isotropic voxels without interpolation. Healthcare providers use output for diagnosis, surgical planning, and interventional guidance. Benefits include intra-operative imaging capability and high-resolution diagnostic visualization.

Clinical Evidence

Bench testing only. Performance testing per FDA guidance for solid-state X-ray imaging devices; 3D clinical sample images obtained to support CBCT modality performance. Electrical safety and EMC compliance verified against IEC 60601 series standards.

Technological Characteristics

Mobile CBCT system; flat panel detector; 62.5cm gantry bore; 30cm field of view. Energy source: X-ray. Connectivity: DICOM compatible. Software: Reconstruction of 2D/3D images. Standards: IEC 60601-1, 60601-1-6, 60601-2-43, 60601-2-44, 60601-2-54, IEC 60601-1-2.

Indications for Use

Indicated for adult patients (18+ years) for imaging of head, neck, limbs, and portions of thorax, spine, and pelvic bones (supine, max 60cm width). Used for 2D/3D diagnostic imaging, intra-operative, and clinical applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Siemens Artis zeego (K181407)

Related Devices

K190856 — SeeFactorCT3 · Epica International, Inc. · Sep 20, 2019
K180393 — AIRO Computed Tomography (CT) X-ray System · Mobius Imaging, LLC · Mar 15, 2018
K151000 — O-Arm O2 Imaging System · Medtronic, Inc. · Aug 6, 2015
K160126 — AIRO Computed Tomography (CT) X-ray System · Mobius Imaging · Apr 19, 2016
K221230 — TRON · Xoran Technologies, LLC · Jul 28, 2022

Submission Summary (Full Text)

{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). {1}------------------------------------------------ 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) #### 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) 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. {6}------------------------------------------------ {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. | | | | | | | | | | | | | | | |…