(171 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard imaging technology.
No
The 'Intended Use' section states the device is for "diagnostic support" and displays images for "diagnostic quality." It is a 'Diagnostic CBCT' device.
Yes
The "Intended Use / Indications for Use" section states: "SeeFactorCT3 is a cone beam computed tomography x-ray imaging system... for use in diagnostic support." Additionally, the "Device Description" explicitly states: "See Factor CT3 is a Diagnostic CBCT (Cone Beam Computed Tomography) device".
No
The device description explicitly states it is a "cone beam computed tomography x-ray imaging system" and a "Diagnostic CBCT (Cone Beam Computed Tomography) device," which are hardware-based imaging modalities.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body. The intended use and device description clearly state that this device is an x-ray imaging system that acquires images of anatomical regions of the human body. It does not mention analyzing blood, urine, tissue samples, or any other biological specimens.
- The device's function is diagnostic imaging. It acquires and displays images for diagnostic support, which is a different category of medical device than IVD.
The information provided describes a medical imaging device used for visualizing internal structures of the body, not for testing biological samples.
N/A
Intended Use / Indications for Use
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMI), other areas of human skull and neck with sections of upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
See Factor CT3 is 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography x-ray imaging
Anatomical Site
head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
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)
Non Clinical: Living and deceased animals were imaged during the development of this device. A substantial number of diagnostic-quality animal images are shown in the appendices.
Clinical Testing: No clinical testing was performed in the development of this product. A substantial number of diagnostic-quality animal images are shown the appendices.
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
September 20, 2019
Epica International Inc. % Frank Pokrop Consultant (510K) Frank Pokrop 3577 Sand Court CARLSBAD, CA 92010
Re: K190856
Trade/Device Name: SeeFactorCT3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 10, 2019 Received: April 15, 2019
Dear Frank Pokrop:
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
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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-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 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,
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
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Indications for Use
510(k) Number (if known)
K190856 Device Name SeeFactorCT3
Indications for Use (Describe)
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMI), other areas of human skull and neck with sections of upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
7 Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
5.1 Applicant/Submitter
| Company Name | : | Epica International Inc. |
|---|---|---|
| Establishment Registration Number | : | |
| Phone Number | : | 1-425-941-7365 |
| Company Street Address | : | 2753 Camino Capistrano. Suite A-10 |
| Fax Number | : | (949) 238-6322 |
| City | : | San Clemente |
| State | : | CA |
| Country | : | USA |
| Zip Code | : | 92672 |
5.2 Contact Person
| Full Name | : Frank Pokrop |
|---|---|
| Job Title | : Consultant (510(k)) |
| Phone | : 1-442-273-4827 |
| : pokropf53@outlook.com |
5.3 Date of Preparation
Date of Preparation : 03/29/2019
5.4 Device Information
Table - Device Information
| Trade Name | SeeFactorCT3 |
|---|---|
| Common or Usual Name | Computed tomography x-ray system. |
| Classfication Name | 21 CFR 892.1750 |
| Regulatory Class | 2 |
| Product Code | OAS |
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5.5 Predicate Device(s)
Table - Predicate Device(s)
| Predicate Type | 510(k) Number | Device Name | Manufacturer |
|---|---|---|---|
| Primary Device | K142222 | NewTom 5G | THEMA S.r.l. (Italy) |
| Reference Device | K130442 | NewvTom VG i and] | |
| NewTomn 5G | THEMA S.r.l. (Italy) |
5.6 Device Description
See Factor CT3 is 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.
5.7 Intended Use/Indications for Use
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
5.8 Comparison of Technological Characteristics with Predicate
See Appendix #1 for a detailed comparsion of the proposed device and the predicate device.
Method of Preformance and Operation :
Both the proposed device and the predicate device utilize the same type of energy and the same type of methodology for obtaining diagnostics imaging: cone-beam computed tomography x-ray imaging.
5.9 Performace Data
Non Clinical :
Living and deceased animals were imaged during the development of this device. A substantial number of diagnostic-quality animal images are shown in the appendices. See Appendices 2, 3 and 4.
5.10 Biocompatibility Testing
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Biocompatibility testing for patient contact materials wsa not performed due to the limited period of patient exposure which typically occurs at lengthy intervals. The factory statement is attached here.
5.11 Clinical Testing
No clinical testing was performed in the development of this product. A substantial number of diagnostic-quality animal images are shown the appendices.
5.12 Conclusion
The proposed device operates the same as the predicate device using the same source of power, the same method of image acquisition, the same intended use, the same indications for use and both are targeted towards the same group of professional healthcare workers.
The proposed device while identical in many ways and similar in a some others, does have superior imaging resolution, it weighs less, it can be moved and it can be covered during surgical procedures should there be a need.