(199 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a manufacturing process based on patient CT data using software identical to the predicate device, with physician approval required for all designs. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes: The device is an implant designed to correct defects/replace bony voids in the cranial skeleton, indicating a therapeutic purpose.
No
The device is a cranial implant designed to correct defects or replace bony voids in the cranial skeleton, not to diagnose a condition.
No
The device is a physical cranial implant made of titanium, not a software-only device. While software is used in the manufacturing process, the device itself is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a physical implant designed to be surgically placed in the cranial skeleton to repair defects. It does not perform any diagnostic testing on biological samples.
- Intended Use: The intended use is to "correct defects / replace bony voids in the cranial skeleton," which is a surgical and reconstructive purpose, not a diagnostic one.
- Device Description: The description details the material, manufacturing process, and physical features of the implant, all of which relate to its function as a medical device for implantation.
Therefore, based on the provided information, the MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.
Product codes
GXN
Device Description
The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a preformed non-alterable cranioplasty plate that cannot be altered or reshaped at the time of surgery and is designed to be implanted in a patient to repair a skull defect. The subject device is composed of commercially pure (CP) Grade 2 titanium per ASTM F67. The manufacturing process is subtractive manufacturing (CNC milled) from models created and developed from patient specific CT Scan Data. The software used in this process is identical to the software used in the predicate device (K110684). The device is designed to have, as requested by the physician, drainage holes over the defect void area, fixation holes over an onlay area, and retractions and other features that fall within the approved design envelope. All designs must be approved by the physician prior to manufacture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient specific CT Scan Data
Anatomical Site
cranial skeleton (skull)
Indicated Patient Age Range
Not Found
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
| Test | Test Method Summary | Results |
|---|---|---|
| MR Compatibility Testing | Per ASTM F2503-20: Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment | The subject device was characterized to be MR Unsafe. This designation is noted in the labeling. |
| Screw Fixation Testing | Verification that fixation retention of the implant at the point of fixation of the screw is at least as strong as the axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model. | PASS The fixation retention of the implant at the point of fixation of the screw is at least as strong as the axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model. |
| Evaluation of Fit Testing | Subject devices using worst case CT data (1.25mm scan thickness) from 3 large defect predicate historical cases (K110684) with known CT scanners and configurations were used. The manufactured implant was optically scanned to verify alignment with the 3D model. Evaluation of fit was also validated by qualified inspectors by fitting the implant over the corresponding defect in a representative anatomical model. | PASS All samples met the predetermined acceptance criteria. |
| Comparative Strength | Identical subject and predicate devices (K110684 AccuShape PEEK) were used for testing. Pre-drilled fixation holes were placed at identical locations on all fixtures to ensure that all test samples were fixated at the same locations. All devices were applied to the same defect (same fit and fixation). A plunger was used to displace the center of each implant until failure. Load / displacement curves were collected. | PASS The subject device was substantially equivalent to the predicate device. |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
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: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
August 26, 2022
MedCAD % Linda Braddon, Ph.D. CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K220357
Trade/Device Name: MedCAD AccuShape Titanium Patient-Specific Cranial Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: July 20, 2022 Received: July 20, 2022
Dear Dr. 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,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220357
Device Name
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
Indications for Use (Describe)
The MedCAD AccuShape Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY: MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant
| Date Prepared | August 26, 2022 | ||
|---|---|---|---|
| Sponsor Contact | MedCAD | ||
| Brian Buss | |||
| 501 S 2nd Ave, Suite A-1000 | |||
| Dallas, TX 75226 | |||
| (214) 453-8864 | |||
| brian@medcad.com | |||
| 510(k) Contact | Secure BioMed Evaluations | ||
| Linda Braddon, Ph.D. | |||
| 7828 Hickory Flat Highway | |||
| Suite 120 | |||
| Woodstock, GA 30188 | |||
| 770-837-2681 | |||
| Regulatory@SecureBME.com | |||
| Trade Name | MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant | ||
| Common Name | Cranial Implant | ||
| Code – | |||
| Classification | Classification Name: Preformed nonalterable cranioplasty plate (21 CFR 882.5330) | ||
| Regulatory Class: II | |||
| Product Code: GXN | |||
| Predicate Device | K110684 MedCAD® AccuShape® PEEK Patient Specific Cranial Implant | ||
| Reference Device | K053199 Synthes Patient Specific Cranial Implant | ||
| K193280 MedCAD® AccuPlate® Patient-Specific Plate | |||
| K192282 MedCAD® AccuPlan® System |
4
| Device Description | The MedCAD® AccuShape® Titanium Patient-Specific Cranial
Implant is a preformed non-alterable cranioplasty plate that cannot be
altered or reshaped at the time of surgery and is designed to be
implanted in a patient to repair a skull defect.
The subject device is composed of commercially pure (CP) Grade
2 titanium per ASTM F67. The manufacturing process is
subtractive manufacturing (CNC milled) from models created and
developed from patient specific CT Scan Data. The software used
in this process is identical to the software used in the predicate
device (K110684). The device is designed to have, as requested by the
physician, drainage holes over the defect void area, fixation holes
over an onlay area, and retractions and other features that fall
within the approved design envelope. All designs must be
approved by the physician prior to manufacture. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
Statement | The MedCAD® AccuShape® Titanium Patient-Specific Cranial
Implant is designed individually for each patient and intended to correct
defects / replace bony voids in the cranial skeleton. |
Comparison of Technological Characteristics
| Characteristic | Subject Device
MedCAD® AccuShape®
Titanium Patient-Specific
Cranial Implant | Predicate Device
MedCAD® AccuShape®
PEEK Patient Specific
Cranial Implant
K110684 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | Class II | Class II |
| Product Code | GXN | GXN |
| Indications for Use | The MedCAD®
AccuShape® Titanium
Patient-Specific Cranial
Implant is designed
individually for each patient
and intended to correct
defects / replace bony voids
in the cranial skeleton. | The MedCAD®
AccuShape® PEEK Patient
Specific Cranial Implant is
designed individually for
each patient and intended to
correct defects / replace bony
voids in the cranial skeleton. |
| Material | Commercially pure (CP)
titanium | PEEK |
| Design | Patient Specific Implant | Patient Specific Implant |
| Dimensions | Min: 10mm x 10mm
Max: 200mm x 200mm | Min: 10mm x 10 mm
Max: 200mm x 200mm |
5
| Characteristic | Subject Device
MedCAD® AccuShape®
Titanium Patient-Specific
Cranial Implant | Predicate Device
MedCAD® AccuShape®
PEEK Patient Specific
Cranial Implant
K110684 |
|-------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Maximum Thickness | 5mm | 5mm |
| Attachment Method | Commercially available
fixation systems | Commercially available
fixation systems |
| Modifications | No Modifications allowed | No Modifications allowed |
| Non-Pyrogenic | Yes | Yes |
| Sterility | Provided non-sterile, to be
steam sterilized | Provided non-sterile, to be
steam sterilized |
| Biocompatibility | Implant device with
permanent (>30 days)
contact with tissue and bone | Implant device with
permanent (>30 days) contact
with tissue and bone |
Technological Characteristics
There are no significant technological differences between the subject and predicate device. The subject device uses the same material as the reference device (K053199) and all devices are manufactured using subtractive techniques.
Non-Clinical Performance Testing Summary
Performance testing for the MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is summarized in the table below:
| Test | Test Method Summary | Results |
|---|---|---|
| MR | ||
| Compatibility | ||
| Testing | Per ASTM F2503-20: Standard Practice For | |
| Marking Medical Devices And Other Items For | ||
| Safety In The Magnetic Resonance | ||
| Environment | The subject device was | |
| characterized to be MR | ||
| Unsafe . This | ||
| designation is noted in | ||
| the labeling. | ||
| Screw Fixation | ||
| Testing | Verification that fixation retention of the | |
| implant at the point of fixation of the screw is at | ||
| least as strong as the axial pullout forces | ||
| measured in prior testing of FDA-cleared neuro | ||
| screws in an established cortical bone model. | PASS | |
| The fixation retention of | ||
| the implant at the point | ||
| of fixation of the screw | ||
| is at least as strong as | ||
| the axial pullout forces | ||
| measured in prior | ||
| testing of FDA-cleared | ||
| neuro screws in an | ||
| established cortical bone | ||
| model. |
6
| Test | Test Method Summary | Results |
|---|---|---|
| Evaluation of Fit | ||
| Testing | Subject devices using worst case CT data | |
| (1.25mm scan thickness) from 3 large defect | ||
| predicate historical cases (K110684) with | ||
| known CT scanners and configurations were | ||
| used. The manufactured implant was optically | ||
| scanned to verify alignment with the 3D model. | ||
| Evaluation of fit was also validated by qualified | ||
| inspectors by fitting the implant over the | ||
| corresponding defect in a representative | ||
| anatomical model. | PASS | |
| All samples met the | ||
| predetermined | ||
| acceptance criteria. | ||
| Comparative | ||
| Strength | Identical subject and predicate devices | |
| (K110684 AccuShape PEEK) were used for | ||
| testing. Pre-drilled fixation holes were placed at | ||
| identical locations on all fixtures to ensure that | ||
| all test samples were fixated at the same | ||
| locations. All devices were applied to the same | ||
| defect (same fit and fixation). A plunger was | ||
| used to displace the center of each implant until | ||
| failure. Load / displacement curves were | ||
| collected. | PASS | |
| The subject device was | ||
| substantially equivalent | ||
| to the predicate device. |
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.