(25 days)
No
The document describes traditional image processing, measurement, and simulation tools for dental applications, with no mention of AI or ML algorithms.
No
This device is for capturing, storing, presenting, and analyzing medical images and assisting in diagnosis and treatment planning. It does not directly perform or administer any therapeutic action.
Yes
The "Intended Use / Indications for Use" states that the software assists in "case diagnosis," and the "Device Description" explicitly mentions that it provides "diagnostics" capabilities and allows dentists to "accurately diagnose and treatment plan."
Yes
The device description explicitly states "Dolphin Imaging 12.0 software" and details various software modules and functionalities. There is no mention of accompanying hardware components that are part of the medical device itself. While it processes images from external modalities (2D/3D images and x-rays), the device being cleared is the software suite.
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.
- Dolphin Imaging 12.0 Functionality: The description clearly states that Dolphin Imaging 12.0 software is used for capturing, storing, presenting, and analyzing patient images and x-rays. It assists in treatment planning and case diagnosis based on these images.
- Lack of Biological Sample Analysis: There is no mention of the software analyzing any biological samples from the patient. Its input is imaging data, not biological specimens.
The software is a medical device used for image processing, analysis, and treatment planning in a clinical setting, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Dolphin Imaging 12.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Product codes
LLZ
Device Description
Dolphin Imaging 12.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Dolphin Imaging 12.0 software provides imaging, diagnostics, and case presentation capabilities for dental specialty professionals. The Dolphin Imaging 12.0 suite of software products is a collection of modules that together provide a comprehensive toolset for the dental specialty practitioner. Users can easily manage 2D/3D images and x-rays; accurately diagnose and treatment plan, quickly communicate and present cases to patients and can work efficiently with colleagues on multidisciplinary cases. The below functionalities make up the medical device modules:
- Cephalometric Tracing: Digitize landmarks on a patient's radiograph, trace cephalometric structures, view cephalometric measurements, superimpose images for analysis and perform custom analysis.
- Treatment Simulation (VTO): Simulate orthodontic and surgical treatment results using Visual Treatment Objective (VTO) and growth features.
- Arnett/Gunson FAB Analyses: Perform face, airway, bite (FAB) analysis and simulate treatment for orthodontic and surgical cases based on the methodologies of Dr. William Arnett.
- McLaughlin Dental VTO: Analyze and evaluate orthodontic and surgical visual treatment objective (VTO) based on the theories of Dr. Richard McLaughlin.
- Implanner™: Plan dental implant procedures in 2D.
- Dolphin 3D: Plan, diagnose and present orthodontic and surgical cases, airway analysis, study models, implant planning and surgery treatment simulation in 3D.
Dolphin Imaging 12.0 is a software of Moderate level of concern. Dolphin Imaging maintains all the same key medical device functionality as the predicate Dolphin Imaging 11.5 (K110430). Usability enhancements to the Cephalometric Tracing and Analysis, Treatment Simulation (VTO), and Dolphin 3D modules are included in Dolphin Imaging 12.0, as well as system updates to allow use with current operating software and hardware capabilities
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D/3D images and x-rays
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
specialized dental practices
Orthodontic, oral maxillofacial surgery, and dental-specialty practices.
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
No clinical testing was required to support substantial equivalence.
Non-Clinical Performance Testing:
Dolphin Imaging 12.0 complies with applicable FDA recognized standards:
- Usability (IEC): IEC 62366 Medical devices- Part 1: Application of usability engineering to medical devices
- Software (IEC): ANSI/AAMI/IEC 62304: 2006 & A1:2016 Medical device software- Software life cycle process
- DICOM (NEMA): NEMA PS 3.1-3.20 (2016) Digital Imaging and Communications in Medicine (DICOM)
- Risk Management: ISO 14971:2019 Medical devices- Application of risk management to medical devices
Dolphin Imaging 12.0 design and performance verification involved the following tests:
- Performance Testing
- Manual Testing/ Integration Testing
- System and Regression testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not applicable
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
August 8, 2022
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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Patterson Dental Supply, Inc. % Ms. Erin Daly Sr. Regulatory Manager Dolphin Imaging & Management Solutions 9200 Oakdale Avenue, Ste 500 CHATSWORTH CA 91311
Re: K222072
Trade/Device Name: Dolphin Imaging 12.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 13, 2022 Received: July 14, 2022
Dear Ms. Daly:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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,
Laurel Burk, 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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Dolphin Imaging 12.0
Indications for Use (Describe)
Dolphin Imaging 12.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
Dolphin Imaging 12.0 K22072
Administrative Information
| Date Prepared: | 13 July 2022 |
|---|---|
| Submitter's Name and Address: | Patterson Companies |
| 1031 Mendota Heights Road | |
| Saint Paul, MN 55120 | |
| Contact: Erin Daly | |
| Telephone: (608) 345-4888 | |
| Trade or Proprietary Name: | Dolphin Imaging 12.0 |
| Common or Usual Name: | Dental imaging software |
| Classification Name: | Medical image management and processing system |
| CFR Reference: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory Class: | Class II |
| Predicate Device: | K110430 - Dolphin Imaging |
| Reference Device(s): | Not applicable |
| Predicate Device Trade or Proprietary | |
| Name: | Dolphin Imaging 11.5 |
| K110430 | |
| Common or Usual Name: | Dental imaging software |
| Classification Name: | Medical image management and processing system |
| CFR Reference: | 21 CFR 892.2050 |
| Product Code: | LLZ |
Product Description
Regulatory Class:
Dolphin Imaging 12.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Class II
Dolphin Imaging 12.0 software provides imaging, diagnostics, and case presentation capabilities for dental specialty professionals. The Dolphin Imaging 12.0 suite of software products is a collection of modules that together provide a comprehensive toolset for the dental specialty practitioner. Users can easily manage 2D/3D images and x-rays; accurately diagnose and treatment plan, quickly communicate and present cases to patients and can work efficiently with colleagues on multidisciplinary cases. The below functionalities make up the medical device modules:
4
| Module | Overview |
|---|---|
| Cephalometric Tracing | Digitize landmarks on a patient's radiograph, trace cephalometric |
| structures, view cephalometric measurements, superimpose images for | |
| analysis and perform custom analysis. | |
| Treatment Simulation (VTO) | Simulate orthodontic and surgical treatment results using Visual Treatment |
| Objective (VTO) and growth features. | |
| Arnett/Gunson FAB Analyses | Perform face, airway, bite (FAB) analysis and simulate treatment for |
| orthodontic and surgical cases based on the methodologies of Dr. William | |
| Arnett. | |
| McLaughlin Dental VTO | Analyze and evaluate orthodontic and surgical visual treatment objective |
| (VTO) based on the theories of Dr. Richard McLaughlin. | |
| Implanner™ | Plan dental implant procedures in 2D. |
| Dolphin 3D | Plan, diagnose and present orthodontic and surgical cases, airway analysis, |
| study models, implant planning and surgery treatment simulation in 3D. |
Dolphin Imaging 12.0 is a software of Moderate level of concern. Dolphin Imaging maintains all the same key medical device functionality as the predicate Dolphin Imaging 11.5 (K110430). Usability enhancements to the Cephalometric Tracing and Analysis, Treatment Simulation (VTO), and Dolphin 3D modules are included in Dolphin Imaging 12.0, as well as system updates to allow use with current operating software and hardware capabilities
Indications for Use
Dolphin Imaging 12.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Comparison to Predicate
| Parameter | Subject Device | Predicate |
|---|---|---|
| K222072 Dolphin Imaging 12.0 | K110430 – 11.5 Dolphin Imaging | |
| Intended Use | Dolphin Imaging 12.0 software is | |
| designed for use by specialized dental | ||
| practices for capturing, storing and | ||
| presenting patient images and assisting | ||
| in treatment planning and case | ||
| diagnosis. Results produced by the | ||
| software's diagnostic and treatment | ||
| planning tools are dependent on the | ||
| interpretation of trained and licensed | ||
| practitioners. | Dolphin Imaging software is designed | |
| for use by specialized dental practices | ||
| for capturing, storing and presenting | ||
| patient images and assisting in | ||
| treatment planning and case diagnosis. | ||
| Results produced by the software's | ||
| diagnostic and treatment planning tools | ||
| are dependent on the interpretation of | ||
| trained and licensed practitioners. | ||
| Classification | Class II | Class II |
| Classification Code | LLZ | LLZ |
| Type of Use (Rx / OTC) | Rx | Rx |
| User | Orthodontic, oral maxillofacial surgery, | |
| and dental-specialty practices. | Orthodontic, oral maxillofacial surgery, | |
| and dental-specialty practices. | ||
| User Interface/OS | Local PC workstation with 64-bit | |
| Microsoft Windows OS | Local PC workstation with Microsoft | |
| Windows OS | ||
| Medical Device Features |
5
| 2D Image Digitize and
| Measurements | Yes | Yes |
|---|---|---|
| 2D Image Superimposition | Yes | Yes |
| 2D Growth Forecast | Yes | Yes |
| 2D Treatment Simulation | Yes | Yes |
| 2D Custom Analysis Editor | Yes | Yes |
| 3D Image Digitize and | ||
| Measurements | Yes | Yes |
| 3D Airway Analysis | Yes | Yes |
| 3D Image (Volume) | ||
| Superimposition | Yes | Yes |
| 3D Implant Simulation | Yes | Yes |
| 2D/3D Orthognathic Surgical | ||
| Planning | Yes | Yes |
Non-Clinical Performance Testing
Dolphin Imaging 12.0 complies with applicable FDA recognized standards:
| Usability (IEC) | Medical devices- Part 1: Application of usability engineering to |
|---|---|
| IEC 62366 | medical devices |
| Software (IEC)ANSI/AAMI/IEC 62304: 2006 & A1:2016 | Medical device software- Software life cycle process |
| DICOM (NEMA)NEMA PS 3.1-3.20 (2016) | Digital Imaging and Communications in Medicine (DICOM) |
| Risk Management | Medical devices- Application of risk management to medical |
| ISO 14971:2019 | devices |
Dolphin Imaging 12.0 design and performance verification involved the following tests:
- Performance Testing ●
- Manual Testing/ Integration Testing ●
- . System and Regression testing
Clinical Performance Testing
No clinical testing was required to support substantial equivalence.
Conclusions
Dolphin Imaging 12.0 is substantially equivalent to the predicate device, Dolphin Imaging, and differences do not raise any concerns about safety or efficacy of the device.