(18 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on visualization, segmentation, and measurement tools, which are common features in traditional medical imaging software and do not inherently require AI/ML.
No.
The device is a planning software that aids in the creation of 3D models and planning dental surgical treatments, but it does not directly treat or diagnose a disease or condition.
Yes
The software aids in planning dental surgical treatments and placement of dental implants by providing visualization and measurement tools, and the ability to segment anatomical structures and measure bone density. Although it doesn't directly diagnose a disease, it processes medical images and provides information that assists in medical decision-making for treatment, which falls under the broad category of diagnostic or assistive diagnostic tools. The predicate devices also support this categorization.
Yes
The device description explicitly states "IPS is a Dental 3D Planning Software" and describes its function as processing DICOM data from medical scanners. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this software is used for the visualization and image segmentation of DICOM data from medical scanners (like CT) and aids in planning dental surgical treatments and placement of dental implants. It works with medical images, not biological samples.
- Intended Use: The intended use is focused on surgical planning and visualization based on imaging data, not on analyzing biological samples for diagnostic purposes.
- Device Description: The description reinforces that it's a "Dental 3D Planning Software" that uses data from "radiological devices."
- Regulation Mentioned: The mention of "21CFR892.2050 System, Image Processing, Radiological" further confirms its classification as a radiological image processing device, not an IVD.
In summary, the device operates on medical images to assist in surgical planning, which is distinct from the analysis of biological samples that defines an IVD.
N/A
Intended Use / Indications for Use
IPS is prescription use software used by dentists and dental lab technicians for the visualization and image segmentation of DICOM data from medical scanners such as CT. The software aids the user in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
IPS is a Dental 3D Planning Software that aids dentists and dental lab technicians in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants. The data used for planning the treatment course is obtained from radiological devices (e.g., CT) complying with DICOM format. IPS provides dentists with various visualization and measurement tools which facilitate in generating dental panoramic view, segmenting of the dental anatomical structures and measuring bone density and distance between the dental implants.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone beam CT machines, CT scanners
Anatomical Site
oral maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists, dental technician
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)
Validation and verification was performed to demonstrate DICOM conformance. Following test cases were used to validate DICOM conformance:
- Importing DICOM Data.
- Sorting DICOM data.
- Grouping multiple DICOM case
These test cases have been adopted to perform a validation process according to the IPS DICOM Conformance statement. These test cases are performed on the patient's DICOM images to ensure that the IPS application's modules are fully compliant with the DICOM conformance.
The results of all testing demonstrate that IPS does not raise any new issues of safety, effectiveness or performance when compared to the existing predicate devices.
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.
Not Found
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510k Summary
DEC - 6 2011
Device Owner Address:
Telephone: Fax:
Official Correspondent
Telephone: Email:
Symbvo Dental, LLC, 15310 Amberly Drive suite#250 Tampa FL 33647 (877) 479-6296 (866) 697-8559
Amberry Drive suite#250
FL 33647
479-6296
697-8559
Parul Chansoria 87 Hulme Ct Apt. 216 Stanford CA 94305 877-479-6296 parul@symbyo.com
Device Name and Classification
| Trade Name/Product Name: | IPS | Areas of
Comparison | Simplant system
K033849 | Sicat implant
K090119 | IPS |
|-------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Dental 3D Planning Software | Description | Pure software device | Pure software device | Pure software device |
| Classification Name: | System, Image Processing, Radiological; 21CFR892.2050 | Input source | CT scanners, MRI
machines | CT scanners, DVT
scanners | Cone beam CT
machines, CT
scanners |
| Product Code: | LLZ | Data conformance | DICOM | DICOM | DICOM |
| Regulation Number: | Picture Archiving and Communication System, 21CFR892.2050 | Regulation
description | Picture archiving and
communication system | Picture archiving and
communication system | Picture archiving and
communication system |
| Panel: | Radiology | Intended use | Visualization and
planning simulation that
aids the user in the
placement of dental
implants and planning
for surgical treatments | Visualization and planning
simulation that aids the
user in the placement of
dental implants and
planning for surgical
treatments | Visualization and
planning simulation
that aids the user in the
placement of dental
implants and planning
for surgical treatments |
| Class | 2 | Intended user | Well trained dentist
dental technicians | Well trained dentist | Dentists, dental
technician |
| Substantial Equivalence claimed to: | MATERIALISE N.V. Simplant system (K033849) | Main tools | Visualization, implant
placement,
measurement of
distance, angle
measurement, density
determination,
segmentation tool | Visualization, implant
placement, measurement
of distance, angle
measurement, density
determination | Visualization, implant
and nerve placement,
measurement of
distance, angle
measurement, density
determination,
segmentation tool |
| | siCAT GmbH & Co. KG Sicat implant (K090119) | Host platform | PC | PC | PC |
| Operating system | Not specified | Not specified | Windows XP, vista, 7 | | |
| Output
compatibility | CAD, rapid prototyping
machines | CAD, rapid prototyping
machines | CAD, rapid
prototyping machines | | |
| Operating system
compatibility | - Windows XP or vista
- Intel based MAC
(computer should be
booted from windows
not MAC OS) | - Windows XP - Windows Vista
- WINDOWS 7 | - Windows XP
- Windows Vista
- WINDOWS 7 | | |
Device Description
IPS is a Dental 3D Planning Software that aids dentists and dental lab technicians in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants. The data used for planning the treatment course is obtained from radiological devices (e.g., CT) complying with DICOM format. IPS provides dentists with various visualization and measurement tools which facilitate in generating dental panoramic view, segmenting of the dental anatomical structures and measuring bone density and distance between the dental implants.
Indications for Use
IPS is prescription use software used by dentists and dental lab technicians for the visualization and image segmentation of DICOM data from medical scanners such as CT. The software aids the user in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants.
Substantial Equivalence
Symbyo Dental LLC. wishes to use the following devices as a predicates: MATERIALISE N.V. Simplant system (K033849) siCAT GmbH & Co. KG Sicat implant (K090119)
The claim of substantial equivalence to the predicate devices is based on both intended use and technology used.
1
.
Predicate Comparison Table
2
Based Upon Intended Used:
IPS and its predicate devices have intended use; which is Visualization and planning simulation that aids the user in the placement of dental implants and planning for dental surgical treatment.
Based Upon Technology Used:
IPS, like the predicate devices, is a pure software device with DICOM data conformance.
The technological characteristics of IPS vs. the predicate devices are summarized below.
Our software conforms to DICOM standard and it has been verified and validated for it.
Validation and verification was performed to demonstrate DICOM conformance
Following test cases were used to validate DICOM conformance:
-
Importing DICOM Data.
-
Sorting DICOM data.
-
Grouping multiple DICOM case
These test cases have been adopted to perform a validation process according to the IPS DICOM Conformance statement. These test cases are performed on the patient's DICOM images to ensure that the IPS application's modules are fully compliant with the DICOM conformance.
Conclusion
The results of all testing demonstrate that IPS does not raise any new issues of safety, effectiveness or performance when compared to the existing predicate devices.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002
Symbyo Dental, LLC. % Mr. Mark Job -- Official Correspondent 1394 25th Street NW Buffalo MN 94305
Re: K113404 Trade/Device Name: Dental 3D Planning Software IPS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2011 Received: November 18, 2011
Dear Mr. Job:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
DEC - 6 2011
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Device Name: Dental 3D Planning Software IPS
Indications for Use:
IPS is prescription use software used by dentists and dental lab technicians for the visualization and image segmentation of DICOM data from medical scanners such as CT. The software aids the user in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
.l.O.D.R.
ostic Device