(159 days)
No
The summary describes software for image processing and manipulation by trained employees with physician input, and additive manufacturing. There is no mention of AI or ML.
No.
The system is used for pre-operative planning and producing anatomical models, surgical guides, and dental splints, which are tools to support surgery, not direct therapeutic interventions themselves.
No
Explanation: The device is described as a software system and associated additive manufacturing equipment used for transferring imaging information, segmenting images, and planning/simulating surgical treatments (pre-operative). It produces outputs like anatomical models, surgical guides, and dental splints. While it processes medical images, its primary intent is not to diagnose conditions but to assist in surgical planning and produce physical aids for surgery. It is explicitly stated as a "pre-operative software tool for simulating / evaluating surgical treatment options".
No
The device description explicitly states that the system is a "collection of software and associated additive manufacturing equipment" and produces "physical outputs including anatomical models, surgical guides, and dental splints." This indicates the system includes hardware components beyond just software.
Based on the provided text, the MedCAD® AccuPlan® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MedCAD® AccuPlan® System's Function: The system processes medical imaging data (CT, CBCT, 3D scans) and physical models to create outputs like anatomical models, surgical guides, and dental splints. These outputs are used in vivo (within the body) during surgery or for pre-operative planning and simulation.
- Lack of Specimen Analysis: The system does not analyze biological specimens from the patient. Its input is imaging data and physical models, not bodily fluids or tissues.
Therefore, the MedCAD® AccuPlan® System falls under the category of a medical device used for surgical planning and the creation of patient-specific surgical aids, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MedCAD® AccuPlan® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the MedCAD® AccuPlan® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial surgery. The surgical guides and dental splints are intended to be used for the maxillofacial bone in maxillofacial surgery. The MedCAD® AccuPlan® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
Product codes (comma separated list FDA assigned to the subject device)
DZJ, LLZ
Device Description
The MedCAD® AccuPlan® System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy or stone castings made from the patient anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, dental splints, surgical guides, and patient-specific case reports.
Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), and/or 3-D scan images from patient physical models (stone models of the patient's teeth) to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. While the process and dataflow vary somewhat based on the requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.
The MedCAD® AccuPlan® System is made up of 4 individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), dental splints, surgical guides, and patient-specific planning reports for reconstructive surgery in the maxillofacial region.
The MedCAD® AccuPlan® System requires an input 3-D image file from medical imaging systems (i.e. - CT) and/or implant file. This input is then used, with support from the prescribing physician to provide the following potential outputs to support reconstructive surgery. Each system output is designed with physician input and reviewed by the physician prior to finalization. All outputs are used only with direct physician involvement to reduce the criticality of the outputs.
System outputs include:
- Anatomical Models
- Surgical Guides
- Dental Splints
- Patient-Specific Case Reports
The purpose of this submission was to add titanium cutting / drilling guides to the family of available patient specific outputs. Cutting and drilling instruments can only be used with titanium cutting / drilling guides. Polymer guides are to be used for marking and positioning of anatomy only.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT based system, Computed Tomography (CT), Cone Beam CT (CBCT), and/or 3-D scan images from patient physical models (stone models of the patient's teeth)
Anatomical Site
maxillofacial bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained employees utilized Commercial Off-The-Shelf (COTS) software / trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session. / trained personnel with active support from the surgeon.
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)
Performance Testing:
- Test: Wear Debris Testing
- Test Method Summary: Cutting / drilling instruments were used on a worst-case titanium surgical guide. The quantity of wear debris generation was characterized.
- Results: PASS. The wear debris generated by the subject device is less than that reported in the literature to be safe.
- Test: Fit and Form Validation
- Test Method Summary: Subject devices from historical cases were manufactured. The manufactured devices were optically scanned to verify alignment with the 3D model. Evaluation of fit was also validated by fitting the guide over the corresponding defect in a representative anatomical model.
- Results: PASS. All samples met the predetermined acceptance criteria.
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
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
March 7, 2023
MedCAD % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K223024
Trade/Device Name: MedCAD® AccuPlan® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: February 6, 2023 Received: February 7, 2023
Dear Linda Braddon:
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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 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) K223024
Device Name MedCAD® AccuPlan® System
Indications for Use (Describe)
The MedCAD® AccuPlan® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the MedCAD® AccuPlan® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial surgery. The surgical guides and dental splints are intended to be used for the maxillofacial bone in maxillofacial surgery. The MedCAD® AccuPlan® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
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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Image /page/3/Picture/0 description: The image shows the logo for MedCAD. The logo is composed of the word "Med" in a serif font, followed by "CAD" in a sans-serif font. The "CAD" portion of the logo is in a teal color and is slightly offset from the "Med" portion.
K223024 510(k) Summary MedCAD® AccuPlan® System
March 7, 2023
Sponsor
MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 (214) 453-8864 x305
Contacts
Secure BioMed Evaluations Linda Braddon, Ph.D. Justin Gracyalny, MSE 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory(@SecureBME.com
Name of Device and Classification Name
Device Name: MedCAD® AccuPlan® System Regulation Name: Bone Cutting Instruments and Accessories Regulation Number: 872.4120 Product Code: Primary - DZJ; Secondary - LLZ Classification Panel: Dental
Predicate Device(s)
MedCAD® AccuPlan® System (K192282)
Reference Device(s)
KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) MedCAD® AccuShape® Titanium Patient-Specific Cranial Plate (K220357)
Indication for Use:
The MedCAD® AccuPlan® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the MedCAD® AccuPlan® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial surgery. The surgical guides and dental splints are intended to be used for the maxillofacial bone in maxillofacial surgery. The MedCAD® AccuPlan® System is also intended as a pre-operative software tool for simulating /evaluating surgical treatment options.
4
Image /page/4/Picture/0 description: The image shows the logo for MedCAD. The word "Med" is in a serif font and is black. The word "CAD" is in a sans-serif font, is white, and is on a blue-green background. There is a registered trademark symbol in the upper right corner of the blue-green background.
Device Description
The MedCAD® AccuPlan® System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy or stone castings made from the patient anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, dental splints, surgical guides, and patient-specific case reports.
Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), and/or 3-D scan images from patient physical models (stone models of the patient's teeth) to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. While the process and dataflow vary somewhat based on the requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.
The MedCAD® AccuPlan® System is made up of 4 individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), dental splints, surgical guides, and patient-specific planning reports for reconstructive surgery in the maxillofacial region.
The MedCAD® AccuPlan® System requires an input 3-D image file from medical imaging systems (i.e. - CT) and/or implant file. This input is then used, with support from the prescribing physician to provide the following potential outputs to support reconstructive surgery. Each system output is designed with physician input and reviewed by the physician prior to finalization. All outputs are used only with direct physician involvement to reduce the criticality of the outputs.
System outputs include:
- Anatomical Models ●
- Surgical Guides
- Dental Splints ●
- Patient-Specific Case Reports .
The purpose of this submission was to add titanium cutting / drilling guides to the family of available patient specific outputs. Cutting and drilling instruments can only be used with titanium cutting / drilling guides. Polymer guides are to be used for marking and positioning of anatomy only.
Sterilization Validation
Sterlization validation was conducted in accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." to a sterility Assurance Level (SAL) of 1x10". All test method acceptance criteria were met.
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Image /page/5/Picture/0 description: The image shows the logo for MedCAD. The text "Med" is in a large, bold, black serif font. To the right of "Med" is "CAD" in a smaller, white sans-serif font, set against a teal, rectangular background. A registered trademark symbol is in the upper right corner of the teal rectangle.
Biocompatibility Validation
Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the output devices and their intended use.
Performance Testing
Performance testing for the MedCAD® AccuPlan® System is summarized in the table below:
| Test | Test Method Summary | Results |
|---|---|---|
| Wear Debris | ||
| Testing | Cutting / drilling instruments were used on a | |
| worst-case titanium surgical guide. The quantity | ||
| of wear debris generation was characterized. | PASS | |
| The wear debris | ||
| generated by the subject | ||
| device is less than that | ||
| reported in the literature | ||
| to be safe. | ||
| Fit and Form | ||
| Validation | Subject devices from historical cases were | |
| manufactured. The manufactured devices were | ||
| optically scanned to verify alignment with the | ||
| 3D model. Evaluation of fit was also validated | ||
| by fitting the guide over the corresponding | ||
| defect in a representative anatomical model. | PASS | |
| All samples met the | ||
| predetermined | ||
| acceptance criteria. |
Substantial Equivalence
MedCAD® AccuPlan® System is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, and outputs. Minor differences in the surgical planning and manufacturing processes are verified and validated in the performance data in accordance with the intended use.
The input is images from medical scanners, dental models, and/or implants files. Physical outputs include dental splints and surgical guides. Biocompatible materials are used in the subject devices.
All devices are intended to aid in maxillofacial surgeries. These systems are intended to be utilized by trained employees with the approval by the physician.
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Med CAD
| COMPARISON OF TECHNOLOGICAL CHARACTERISITICS | ||
|---|---|---|
| MedCAD® AccuPlan® System | MedCAD® AccuPlan® System | |
| 510(k) Number | K223024 | K192282 |
| Indications for Use | The MedCAD® AccuPlan® System is | |
| intended for use as a software system | ||
| and image segmentation system for the | ||
| transfer of imaging information from a | ||
| medical scanner such as a CT based | ||
| system. The input data file is processed | ||
| by the MedCAD® AccuPlan® System | ||
| and the result is an output data file that | ||
| may then be provided as digital models | ||
| or used as input to a rapid prototyping | ||
| portion of the system that produces | ||
| physical outputs including anatomical | ||
| models, surgical guides, and dental | ||
| splints for use in maxillofacial surgery. | ||
| The surgical guides and dental splints | ||
| are intended to be used for the | ||
| maxillofacial bone in maxillofacial | ||
| surgery. The MedCAD® AccuPlan® | ||
| System is also intended as a pre- | ||
| operative software tool for simulating / | ||
| evaluating surgical treatment options. | The MedCAD® AccuPlan® System is | |
| intended for use as a software system | ||
| and image segmentation system for the | ||
| transfer of imaging information from a | ||
| medical scanner such as a CT based | ||
| system. The input data file is processed | ||
| by the MedCAD® AccuPlan® System | ||
| and the result is an output data file that | ||
| may then be provided as digital models | ||
| or used as input to a rapid prototyping | ||
| portion of the system that produces | ||
| physical outputs including anatomical | ||
| models, surgical guides, and dental | ||
| splints for use in maxillofacial surgery. | ||
| The surgical guides and dental splints | ||
| are intended to be used for the | ||
| maxillofacial bone in maxillofacial | ||
| surgery. The MedCAD® AccuPlan® | ||
| System is also intended as a pre- | ||
| operative software tool for simulating / | ||
| evaluating surgical treatment options. | ||
| Preoperative software | Yes | Yes |
| Additive manufacturing | ||
| of splints, guides, and | ||
| models | Yes | Yes |
| Data inputs | Images from medical scanners | Images from medical scanners |
| Data outputs | Output for dental splints, surgical | |
| guides, and anatomical models | Output for dental splints, surgical | |
| guides, and anatomical models | ||
| Physical outputs | Dental splints, surgical guides, | |
| anatomical models, and patient-specific | ||
| case reports | Dental splints, surgical guides, | |
| anatomical models, and patient-specific | ||
| case reports | ||
| Materials | Biocompatible polymers and Ti-6Al-4V | |
| ELI Titanium Alloy per ASTM F136 | Biocompatible polymers | |
| Sterilization | Provided non-sterile and is steam | |
| sterilized by the end-user | Provided non-sterile and is steam | |
| sterilized by the end-user | ||
| Manufacturing Method | Additive Manufacturing | Additive Manufacturing |
| Patient Contact | Surgical Guides: Implant - Tissue / | |
| Bone; Limited ( |