(222 days)
No
The description focuses on patient-specific design based on anatomical data and surgeon input, with no mention of AI or ML algorithms being used in the design process.
No.
The device is a bone plate used for stabilization, fixation, and reconstruction of skeletal regions, which is a structural and mechanical function rather than a therapeutic one (i.e., treating a disease or condition).
No
The device is a patient-specific bone plating system for stabilization, fixation, and reconstruction of skeletal regions, not for diagnosing medical conditions.
No
The device description explicitly states it is a "metal bone plate" that is "additively manufactured" and "provided non-sterile," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a physical implant (a metal bone plate) used for the stabilization, fixation, and reconstruction of bone. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to provide structural support and fixation to bone, not to analyze biological specimens for diagnostic information.
The device uses patient anatomical data (CT, CBCT, or MRI scans) to create a custom-designed implant, but this data is used for the design and manufacturing of the physical device, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.
Product codes
JEY
Device Description
The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal bone plate used in conjunction with commercially available, non-locking metal bone screws for the fixation to bone in orbital, midface / maxillofacial, and non-continuity mandibular operations. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The subject device is not intended to be bent or modified in surgery. If for any reason the surgeon chooses not to use the subject device in surgery, they may use any of the commercially available plates to complete the surgery. The subject device is additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non-sterile, must be sterilized prior to use, and is intended for single use only. Plates are fastened to bone using commercially available non-locking bone screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging from 3.5mm to 22mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan, CBCT scan, or MRI
Anatomical Site
maxillofacial / midface and mandibular skeletal regions, orbital
Indicated Patient Age Range
adolescents (greater than 12 to 21 years of age) and adults.
Intended User / Care Setting
Not Found
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)
- Biocompatibility Testing: Conducted in accordance with international standard ISO 10993-1. ISO10993-5, 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". Results adequately address biocompatibility.
- Sterilization Validation: Conducted in accordance with international standard ISO 17665-1, ISO 17665-2, and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" to a sterility Assurance Level (SAL) of 10-6. All test method acceptance criteria were met.
- Non-Clinical Performance Testing:
- Static and Dynamic Bending per ASTM F382: The subject device was shown to have equivalent bending strength and fatigue life as the reference device (K953385).
- Axial Screw Pushout per ASTM F543: The subject device plate / screw interface was shown to have equivalent axial screw pushout strength as the reference device (K953385).
- Fit and Form Validation: The subject device patient specific design process was shown to produce devices that aligned with the approved surgical plan.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K191028 KLS Martin Individual Patient Solutions
Reference Device(s)
K953385 Walter Lorenz Surgical, Inc. Lorenz System, K210731 KLS Martin Individual Patient Solutions, K203282 Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific Maxillofacial System, K170272 Materialize N.V. TruMatch CMF Titanium 3D Printed Implant System, K192282 MedCAD® AccuPlan® System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
9/26/23
MedCAD % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickorv Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K230398
Trade/Device Name: MedCAD® AccuPlate® 3DTi Patient-Specific Plating System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: August 28, 2023 Received: August 28, 2023
Dear Justin 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Sherrill L'athrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230398
Device Name
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
Indications for Use (Describe)
The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.
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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4
K230398 510(k) SUMMARY:
| Date Prepared | September 26, 2023 |
|---|---|
| Sponsor Contact | MedCAD |
| 501 S 2nd Ave, Suite A-1000 | |
| Dallas, TX 75226 | |
| (214) 453-8864 | |
| 510(k) Contact(s) | 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 | |
| Trade Name | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System |
| Code – | |
| Classification | Classification Name: Bone Plate (21 CFR 872.4760) |
| Regulatory Class: II | |
| Product Code: JEY | |
| Primary | |
| Predicate | K191028 KLS Martin Individual Patient Solutions |
| Reference | |
| Devices | K953385 Walter Lorenz Surgical, Inc. Lorenz System |
| K210731 KLS Martin Individual Patient Solutions | |
| K203282 Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific | |
| Maxillofacial System | |
| K170272 Materialize N.V. TruMatch CMF Titanium 3D Printed Implant | |
| System | |
| K192282 MedCAD® AccuPlan® System | |
| Device | |
| Description | The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal |
| bone plate used in conjunction with commercially available, non-locking | |
| metal bone screws for the fixation to bone in orbital, midface / | |
| maxillofacial, and non-continuity mandibular operations. The design and | |
| dimensions of each plate within the envelope specification is based upon | |
| the patient's anatomical data (CT scan, CBCT scan, or MRI), and the | |
| intended anatomy to be fixated as determined from input provided by the | |
| surgeon. The subject device is not intended to be bent or modified in | |
| surgery. If for any reason the surgeon chooses not to use the subject device | |
| in surgery, they may use any of the commercially available plates to | |
| complete the surgery. The subject device is additively manufactured from | |
| Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non- | |
| sterile, must be sterilized prior to use, and is intended for single use only. | |
| Plates are fastened to bone using commercially available non-locking bone | |
| Indications for | |
| Use Statement | The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is |
| intended for use in the stabilization, fixation, and reconstruction of the | |
| maxillofacial / midface and mandibular skeletal regions in adolescents | |
| (greater than 12 to 21 years of age) and adults. |
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
from 3.5mm to 22mm.
screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging
5
Comparison of Technological Characteristics
The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is substantially equivalent to and are as safe and effective as its predicate device (K191028 KLS Martin Individual Patient Solutions). Table 1 compares the subject, predicate, and reference devices.
Similarities to Predicate
The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicate / reference devices. The principles of operation and technological characteristics are either identical or substantially equivalent to the predicate / reference devices. The system has similar technological characteristics including:
- The subject device and the predicate / reference devices have hole features to accommodate ● commercially available non-locking fixation screws.
- . The subject device uses the same patient specific design software and process flow as the reference device (K192282).
- . The subject device design envelope is similar to the predicate / reference devices (K191028, K210731, K203282, K170272).
- The subject device has equivalent mechanical performance to the reference device ● (K953385).
- Sterility assurance level of 1x10-6
Differences to Predicate
The following differences exist between the subject and predicate devices:
- The subject and predicate device may both be additively manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F136. However, the primary predicate device may also be subtractively manufactured from commercially pure titanium per ASTM F67. The absence of this design configuration does not raise new concerns for substantial equivalence.
- The subject device is indicated for both adolescents (greater than 12 to 21 years of age) and adults while the patient population in the predicate device is not specified. The use of patient specific facial implants in adolescent populations in identical to that seen in the reference devices (K210731, K170272). As such, this difference does not raise new concerns for substantial equivalence.
- . The predicate device includes mandibular plates for treatment of continuity mandibular defects while the subject device is only intended to treat non-continuity mandibular defects. This difference is addressed via a design envelope appropriate for the intended use and labeling. As such, this difference does not raise new concerns for substantial equivalence.
6
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with international standard ISO 10993-1. ISO10993-5, 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 plates and their intended use.
Sterilization Validation
A sterilization validation was conducted in accordance with international standard ISO 17665-1, ISO 17665-2, and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" to a sterility Assurance Level (SAL) of 10th All test method acceptance criteria were met.
Non-Clinical Performance Testing
Performance testing for the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is summarized below:
- Static and Dynamic Bending per ASTM F382 The subject device was shown to have . equivalent bending strength and fatigue life as the reference device (K953385).
- Axial Screw Pushout per ASTM F543 The subject device plate / screw interface was . shown to have equivalent axial screw pushout strength as the reference device (K953385).
- . Fit and Form Validation – The subject device patient specific design process was shown to produce devices that aligned with the approved surgical plan.
Conclusions
Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.
7
Table 1 – Comparison of Technological Characteristics
| Trait | Proposed Subject Device
MedCAD AccuPlate® 3DTi
Patient-Specific Plate | Primary Predicate Device
KLS Martin Individual
Patient Solutions
K191028 | Reference Device
Walter Lorenz Surgical,
Inc. Lorenz System
K953385 | Reference Device
KLS Martin Individual
Patient Solutions
K210731 | Reference Device
Industrias Medicas
Sampedro S.A.S.
TECHFIT Patient-Specific
Maxillofacial System
K203282 | Reference Device
Materialize N.V.
TruMatch CMF Titanium
3D Printed Implant System
K170272 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose | Subject Device | Same Indications | Similar Dimensions and
Performance | Similar Dimensions and
Patient Population | Similar Dimensions (Midface
Hole Spacing) | Similar Dimensions (Orbital
Plate Thickness) |
| Product Code | JEY | JEY | JEY | JEY | JEY | JEY |
| Device Class | Class II | Class II | Class II | Class II | Class II | Class II |
| Regulation | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 |
| Indications for
Use | The MedCAD® AccuPlate®
3DTi Patient-Specific Plating
System is intended for use in
the stabilization, fixation, and
reconstruction of the
maxillofacial / midface and
mandibular skeletal regions
in adolescents (greater than
12 to 21 years of age) and
adults. | KLS Martin Individual Patient
Solutions implant devices are
intended for use in the
stabilization, fixation, and
reconstruction of the
maxillofacial / midface and
mandibular skeletal regions. | These devices are
implantable bone plates and
bone screws for facial
procedures including:
- Fractures
- Osteotomies
- Reconstructive
procedures - Revision procedures
where other
treatments or devices
have failed | KLS Martin Individual
Patient Solutions (IPS) is
intended as a pre-operative
software tool for simulating /
evaluating surgical treatment
options as a software 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 IPS
software and the result is an
output data file that may then
be provided as digital models
or used as input in an additive
manufacturing portion of the
system that produces physical
outputs including implants,
anatomical models, guides,
splints, and case reports for
use in maxillofacial, midface,
& mandibular surgery.
KLS Martin Individual
Patient Solutions (IPS)
implant devices are intended
for use in the stabilization,
fixation, and reconstruction
of the maxillofacial / midface
and mandibular skeletal
regions in children (2 years
of age to