(314 days)
No
The description focuses on software for image processing, 3D modeling, and manufacturing of physical outputs based on physician input, without mentioning AI or ML algorithms.
Yes.
The device produces physical components like surgical guides for harvesting bone grafts and anatomical models, which directly assist in surgical procedures.
No
Explanation: The device is described as a software system and image segmentation system for pre-operative planning and creating physical outputs like anatomical models and surgical guides, not for diagnosing medical conditions.
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... and surgical guides". This indicates the system includes hardware components beyond just software.
Based on the provided information, the MedCAD® AccuPlan® Orthopedics System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- MedCAD® AccuPlan® Orthopedics System Function: The MedCAD® AccuPlan® Orthopedics System processes medical images (CT scans) to create digital models, physical anatomical models, surgical guides, and patient-specific case reports. These outputs are used for surgical planning and execution, specifically for harvesting bone grafts.
- Lack of Sample Testing: The system does not perform any tests on biological samples from the patient. Its input is imaging data, not biological material.
- Purpose: The purpose of the system is to aid in surgical planning and execution, not to diagnose or monitor a patient's health through laboratory testing.
Therefore, while it is a medical device that uses patient data, it does not fit the definition of an In Vitro Diagnostic device. It falls under the category of a surgical planning and guidance system.
N/A
Intended Use / Indications for Use
MedCAD® AccuPlan® Orthopedics 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 system and the result is an output data file. This file 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 of the fibula and ilium. surgical guides for harvesting bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults.
Product codes (comma separated list FDA assigned to the subject device)
PBF, LLZ
Device Description
The MedCAD® AccuPlan® Orthopedics System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support harvesting of bone to support maxillofacial reconstructive surgeries. The system uses electronic medical images of the patient's anatomy with input from the physician to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system include anatomical models, 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 Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during 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® Orthopedics System is made up of two individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical guides, and patient-specific planning reports for harvesting of bone from the fibula and ilium for use in maxillofacial reconstructive surgeries.
The MedCAD® AccuPlan® Orthopedics System requires an input 3-D image file from medical imaging systems (i.e., CT). This input is then used, with support from the prescribing physician to provide the following potential outputs to support maxillofacial reconstructive surgery. Each system output is designed with physician inout 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
- Patient-Specific Case Reports
Mentions image processing
MedCAD® AccuPlan® Orthopedics 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 system and the result is an output data file.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT based system.
Anatomical Site
fibula and ilium, maxillofacial
Indicated Patient Age Range
adolescents (greater than 12 to 21 years of age) and adults.
Intended User / Care Setting
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.
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 for the MedCAD® AccuPlan® Orthopedics System is summarized in the table below:
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. Wear particles were characterized per ASTM F1877-16.
Results: PASS The quantity and morphology of wear debris generated by the subject device under worst case use conditions aligns with values as reported in the literature to be safe.
Test: Fit and Form Validation
Test Method Summary: Subject devices were manufactured from worst-case CT scan input data. 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
September 20, 2023
Image /page/0/Picture/1 description: The image shows the logo for 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
MedCAD % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K223421
Trade/Device Name: MedCAD® AccuPlan® Orthopedics System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF, LLZ Dated: August 18, 2023 Received: August 18, 2023
Dear Mr. Gracyalny:
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
1
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); 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 (QS) 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 medical devices and radiation-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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223421
Device Name MedCAD® AccuPlan® Orthopedics System
Indications for Use (Describe)
MedCAD® AccuPlan® Orthopedics 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 system and the result is an output data file. This file 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 of the fibula and ilium. surgical guides for harvesting bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K223421 510(k) Summary MedCAD® AccuPlan® Orthopedics System
September 18, 2023
Sponsor
MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 (214) 453-8864 x305
Contacts
Secure BioMed Evaluations Justin Gracyalny, MSE Linda Braddon, Ph.D. 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® Orthopedics System Common Device: Orthopaedic Surgical Planning And Instrument Guide Regulation Name and Number: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 892.2050 Medical image management and processing system Product Code: PBF, LLZ Classification Panel: Orthopedic
Predicate Device CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614)
Reference Devices MedCAD® AccuPlan® System (K192282 / K223024)
Indications for Use:
MedCAD® AccuPlan® Orthopedics 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 system and the result is an output data file. This file 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 of the fibula and ilium, surgical guides for harvesting bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults.
4
K223421
Device Description
The MedCAD® AccuPlan® Orthopedics System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support harvesting of bone to support maxillofacial reconstructive surgeries. The system uses electronic medical images of the patient's anatomy with input from the physician to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system include anatomical models, 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 Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during 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® Orthopedics System is made up of two individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical guides, and patient-specific planning reports for harvesting of bone from the fibula and ilium for use in maxillofacial reconstructive surgeries.
The MedCAD® AccuPlan® Orthopedics System requires an input 3-D image file from medical imaging systems (i.e., CT). This input is then used, with support from the prescribing physician to provide the following potential outputs to support maxillofacial reconstructive surgery. Each system output is designed with physician inout 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
- Patient-Specific Case Reports ●
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 . 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.
5
K223421
Performance Testing
Performance testing for the MedCAD® AccuPlan® Orthopedics 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. | ||
| Wear particles were characterized per ASTM | ||
| F1877-16. | PASS | |
| The quantity and | ||
| morphology of wear | ||
| debris generated by the | ||
| subject device under | ||
| worst case use | ||
| conditions aligns with | ||
| values as reported in the | ||
| literature to be safe. | ||
| Fit and Form | ||
| Validation | Subject devices were manufactured from worst- | |
| case CT scan input data. 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® Orthopedics System is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, and outputs.
| Property | MedCAD® AccuPlan®
Orthopedics System | CenterMed Patient Matched
Assisted Surgical Planning (ASP)
System |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K223421 | K211614 |
| Indications for Use | MedCAD® AccuPlan® Orthopedics
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 system and the
result is an output data file. This file
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 of the fibula and
ilium, surgical guides for harvesting | CenterMed Patient Matched Assisted
Surgical Planning (ASP) 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 ASP system and the
result is an output data file. This file
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 of the Fibula and
Ilium, surgical guides for harvesting |
| Property | MedCAD® AccuPlan®
Orthopedics System | CenterMed Patient Matched
Assisted Surgical Planning (ASP)
System |
| | bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults. | bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. |
| Preoperative software | Yes | Yes |
| Additive
manufacturing of
surgical guides and
models | Yes | Yes |
| Data inputs | Images from medical scanners | Images from medical scanners |
| Data outputs | Output for patient-specific surgical
guides and anatomical models | Output for patient-specific surgical
guides and anatomical models |
| Physical outputs | Patient-specific surgical guides,
anatomical models, and patient-
specific case reports | Patient-specific surgical guides,
anatomical models, and patient-
specific case reports |
| Materials | Biocompatible polymers and
Ti-6Al-4V ELI Titanium Alloy per
ASTM F136 | Polyamide-12 (PA-12) with 316L
stainless steel sleeves when used as
cutting guides |
| Recommended
Temporary Screw
Diameter | 1.5mm – 2.1mm | 1.5mm – 2.1mm |
| Recommended
Temporary Screw
Length | 5mm – 22mm | 5mm – 22mm |
| Recommended
Temporary Screw
Style | Non-Locking | Drill-Free, Tapping-Free |
| Sterilization | Provided non-sterile and is steam
sterilized by the end-user (SAL 10⁻⁶) | Provided non-sterile and is steam
sterilized by the end-user (SAL 10⁻⁶) |
| Manufacturing
Method | Additive Manufacturing | Additive Manufacturing |
| Patient Contact | Implant – Tissue / Bone; Limited (