(36 days)
No
The summary does not mention AI, ML, deep learning, neural networks, or any related terms. The functionality described is image processing, visualization, and template overlay, which are not inherently AI/ML technologies.
No
The device is a software package for scanning, storing, importing, visualizing, analyzing, and reporting dental images, primarily for planning dental implants and facilitating communication. It does not directly treat or diagnose a disease or condition.
Yes
The device aids in surgical decisions, including planning for dental implants and visualization of various imaging modalities, which falls under the scope of diagnostic assistance.
No
The device description explicitly states it is used "together with the existing STARPACS solution," which is a system (K031013). While the new component is software, its functionality is dependent on and integrated with an existing system that likely includes hardware components for image capture and storage. The input imaging modalities also mention "direct digital capture using a solid state sensor," implying a hardware component is involved in the image acquisition process that the software utilizes.
Based on the provided information, the StarPACS Dental™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- StarPACS Dental™ function: The description clearly states that StarPACS Dental™ is a software package that processes and visualizes medical images (dental images from direct capture and DICOM images). It's used for planning and visualization related to dental procedures, not for analyzing biological specimens.
The device falls under the category of medical imaging software and planning tools, which are distinct from IVDs.
N/A
Intended Use / Indications for Use
StarPACS Dental™ device is a software package that scans (using direct digital capture using a solid state sensor) and stores those images. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.
Product codes
LLZ
Device Description
STARPACS Dental™ is a new software application that has been developed to handle digital templates for dental implants, which are placed over digital dental images. The overlay of digital templates onto digital dental images is useful in planning dental implants. The software is used together with the existing STARPACS solution (one of the predicate devices K031013). In addition to imaging and workflow features, STARPACS Dental allows dental implants simulations for dental implanting with the digital template library. STARPACS Dental is not intended to replace the skill and the experience of a qualified medical practitioner but to assist in surgical decisions and possibly to shorten surgery time.
STARPACS Dental software must be used by users who have the appropriate training and experience in the specialized field. Users should be aware of the limitations in the accuracy and correctness of the digital template displayed on the screen or printed from the PiViewSTAR PACS workstation. The quality of the digital template is dependent of the correct calibration and settings of display device or printer, and the digital template.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
direct digital capture using a solid state sensor, DICOM images from volumetric data sets
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians, nurses, and technicians.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 2 - 2005
Image /page/0/Picture/2 description: The image shows the word "INFINITT" in bold, black letters. The letters are slightly slanted to the right, giving the word a dynamic appearance. Above the word "INFINITT", there is some smaller text that is difficult to read due to its size and resolution. The overall impression is a logo or brand name, with "INFINITT" being the prominent and recognizable element.
Page 1
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
March 18, 2003
Submitter's Information: 21 CFR 807.92(a)(1)
INFINITT Co., Ltd. Mr. Samuel Choi, Director Research & Development Department TaeSuk Bldg. 9F, 275-5, Yangjae-Dong Seocho-Gu, Seoul, Korea 137-943 Direct : +82-2-2194-1613 Fax : +82-2-2194-1688
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: STARPACS Dental™ Picture Archiving Communications System Common Name: Device Classification: 892.2050 Product Code: LLZ Classification Name: System, Image Processing
Predicate Device: 21 CFR 807. 92(a)(3)
| Predicate 1 | Predicate 2 | |
|---|---|---|
| 510(k) Number | K031013 | K041078 |
| Product Code | LLZ | LLZ |
| Product Name | INFINTT CO., LTD. | |
| STARPACS™ SYSTEM | SurgPLAN™ and PanPlan™ | |
| Decision Date | 04/17/2003 | 12/23/2004 |
Device Description: 21 CFR 807 92(a)(4)
STARPACS Dental™ is a new software application that has been developed to handle digital templates for dental implants, which are placed over digital dental images. The overlay of digital templates onto digital dental images is useful in planning dental implants. The software is used together with the existing STARPACS solution (one of the predicate devices K031013). In addition to imaging and workflow features, STARPACS Dental allows dental implants simulations for dental implanting with the digital template library. STARPACS Dental is not intended to replace the skill and the experience of a qualified medical practitioner but to assist in surgical decisions and possibly to shorten surgery time.
STARPACS Dental software must be used by users who have the appropriate training and experience in the specialized field. Users should be aware of the limitations in the accuracy and correctness of the digital template displayed on the screen or printed from the PiViewSTAR PACS workstation. The quality of the digital
1
Image /page/1/Picture/0 description: The image shows the word "INFINITT" in bold, black letters. The font is sans-serif and slightly slanted. Above the word, there are some faint, blurry dots, possibly artifacts from the image scanning or printing process. The overall impression is of a logo or heading, likely from a document or advertisement.
Page 2
template is dependent of the correct calibration and settings of display device or printer, and the digital template.
Indications for Use: 21 CFR 807 92(a)(5)
StarPACS Dental™ device is a software package that scans (using direct digital capture using a solid state sensor) and stores those images. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for STARPACS Dental™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices. STARPACS Dental™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the potential hazards have been classified as "Minor".
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the stylized image of an eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
INFINITT Co., Ltd. % Mr. Carl Alletto Official Correspondent OTech, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K051715
AUG 2 - 2005
Trade/Device Name: StarPACS Dental™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: April 27, 2005 Received: June 27, 2005
Dear Mr. Alletto:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms totter notification. The FDA finding of substantial equivalence of your device to a legally prematics notificate 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 Part 801), please 11 you don't the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Ov : : - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "INFINITT" in large, bold, black letters. Above the word "INFINITT" are the words "PACS, RIS, 3D and Beyond" in a smaller font size. The text is centered horizontally. The image appears to be a logo or title for a company or product related to medical imaging or healthcare technology.
Page 1 of -1
(Indications for Use Form)
510(k) Number: Kos 1715
$\frac{1}{2} \cdot \frac{2}{3} \cdot \frac{3}{4} \cdot \frac{4}{5} \cdot \frac{5}{6} = $
Device Name: INFINITT Co. Ltd. StarPACS Dental™ device
Indications for Use:
StarPACS Dental™ device is a software package that scans (using direct digital capture using a solid state sensor) and stores those images. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Nancy Brogdon
ivision of Reproductive, and Radiological Devices 510(k) Number __