(434 days)
Not Found
No
The summary describes image processing and surgical planning software, but there is no mention of AI, ML, or related terms. The performance studies focus on traditional software and manufacturing validation.
No
The device is a software system and associated manufacturing equipment used for pre-operative planning, simulation, and producing anatomical models, surgical guides, and dental splints, rather than directly treating a condition.
No
The device is intended for surgical planning, simulation, and the creation of surgical aids (models, guides, splints), rather than diagnosing a disease or condition.
No
The device description explicitly states it is a "collection of software and associated additive manufacturing equipment" and produces physical outputs like anatomical models, surgical guides, and dental splints. The performance studies also mention equipment qualification and mechanical performance evaluations, indicating hardware components are part of the system.
Based on the provided information, the MedCAD® AccuPlan® System 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.
- MedCAD® AccuPlan® System Function: The MedCAD® AccuPlan® System is a software and manufacturing system that uses medical imaging data (like CT scans) to create physical models, surgical guides, and dental splints. It's a tool for surgical planning and execution, not for analyzing biological samples to diagnose or monitor a patient's health status.
- Intended Use: The intended use clearly states its purpose is for transferring imaging information, processing it, and producing outputs like anatomical models and surgical guides for use in maxillofacial surgery. This is a surgical planning and execution aid, not a diagnostic test.
Therefore, the MedCAD® AccuPlan® System falls under the category of a medical device used for surgical planning and manufacturing, 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, surgical quides, dental splints, 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 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 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 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 ●
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 of the patient's teeth
Anatomical Site
maxillofacial bone, maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained MedCAD employees, physician, trained personnel
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)
The performance data indicates that the verification and validation testing performed on the MedCAD® AccuPlan® system successfully demonstrates that design outputs meet design inputs.
The performance testing for the device includes processes validation methods such as IQ, OQ. and PQ to ensure that the manufacturing process can effectively produce patient matched devices. Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, dental splints, and anatomical models meet production needs. Dental splints and surgical quides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."
Additionally, a dimensional analysis was performed to ensure the proper fit of the final output. Mechanical performance evaluations assessing dynamic compressive strength and ligature wire pullout testing were conducted on final, finished devices demonstrating they are equivalent to the predicate device.
Software System Validation:
In order to ensure the off-the-shelf software packages are operating correctly and any necessary file conversions will not negatively impact the final output, software verification and validation activities include:
- Verification of each independent software subsystem against defined requirements
- Verification of compatibility between software subsystems against defined requirements
- Validation of fully integrated system including all subsystems against overall system requirements
Sterilization Validation:
Sterilization 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 1x10-9. All test method acceptance criteria were met.
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.
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
§ 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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October 29, 2020
MedCAD % Linda Braddon, Ph.D. President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K192282
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: October 2, 2020 Received: October 2, 2020
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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K192282 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 including anatomical models, surgical guides, and dental splints for use in maxillofacial 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 preoperative software tool for simulating / evaluating surgical treatment options.
Type of Use (Select one or bothas applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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510(k) Summary MedCAD® AccuPlan® Svstem K192282
October 29, 2020
Sponsor
MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 (214) 453-8864 x305
Contact
Secure BioMed Evaluations Linda Braddon, Ph.D. 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 Requlatory@SecureBME.com
Name of Device and Classification Name
Device Name: MedCAD® AccuPlan® System Regulation Name: Bone Cutting Instruments and Accessories Requlation Number: 872.4120 Product Code: Primary - DZJ; Secondary - LLZ Classification Panel: Dental
Predicate Device
VSP® System, Medical Modeling, Inc. (K120956)
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.
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
4
Med C
original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, surgical quides, dental splints, 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 of the patient's teeth) to create patientspecific 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 thev 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 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 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 ●
Performance Data
The performance data indicates that the verification and validation testing performed on the MedCAD® AccuPlan® system successfully demonstrates that design outputs meet design inputs.
Device Performance Validation
The performance testing for the device includes processes validation methods such as IQ, OQ. and PQ to ensure that the manufacturing process can effectively produce patient matched devices. Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, dental splints, and anatomical models meet production needs. Dental splints and surgical quides are manufactured based on
5
recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."
Additionally, a dimensional analysis was performed to ensure the proper fit of the final output. Mechanical performance evaluations assessing dynamic compressive strength and ligature wire pullout testing were conducted on final, finished devices demonstrating they are equivalent to the predicate device.
Software System Validation
In order to ensure the off-the-shelf software packages are operating correctly and any necessary file conversions will not neqatively impact the final output, software verification and validation activities include:
- · Verification of each independent software subsystem against defined requirements
- Verification of compatibility between software subsystems aqainst defined . requirements
- Validation of fully integrated system including all subsystems against overall . system requirements
Sterilization Validation
Sterilization 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 1x10-9. All test method acceptance criteria were met.
Biocompatibility Validation
Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 and FDA quidance 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.
Substantial Equivalence
MedCAD® AccuPlan® system is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, 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 creation of 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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| COMPARISON OF TECHNOLOGICAL CHARACTERISITICS | ||
|---|---|---|
| MedCAD® AccuPlan® System | VSP® System Medical | |
| Modeling Inc. | ||
| 510(k) number | K182282 | K120956 |
| 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 Medical Modeling VSP® | |
| 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 VSP® | ||
| 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, templates, and surgical | ||
| guides for use in maxillofacial | ||
| surgery. The VSP® 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 anatomical models, | |
| templates, and surgical guides | ||
| Physical outputs | Dental splints, surgical guide, | |
| anatomical models, and patient-specific | ||
| case reports | Templates, surgical guides, and | |
| anatomical models | ||
| Materials | Biocompatible polymers | Biocompatible polymers |
| Sterilization | Subject device is provided non-sterile | |
| and is steam sterilized by the end-user | Predicate device is provided non- | |
| sterile and is steam sterilized by | ||
| the end-user | ||
| Manufacturing Method | Additive Manufacturing | Additive Manufacturing |
| Patient Contact | Guides: Surface Contacting - Tissue | |
| / Bone / Mucosal Membrane Limited | ||
| ( |