(287 days)
Not Found
No
The description focuses on the material, manufacturing process (3D printing), and design based on CT data and surgeon input. There is no mention of AI or ML being used in the design or manufacturing process.
No.
The device is an implant designed to fill a bony void or defect in the cranial skeleton, not to treat a disease or medical condition in a therapeutic manner.
No
The device, VSP PEEK Cranial Implant, is described as an implantable device used to fill bony voids or defects in the cranial skeleton. It is a therapy device, not a diagnostic device, as it does not diagnose medical conditions.
No
The device is a physical implant made of PEEK material, designed and manufactured using CT data and 3D printing. While software is used in the design process, the final product is a tangible medical device, not software itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The VSP PEEK Cranial Implant is a physical implant designed to fill a bony void in the cranial skeleton. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to fill a bony defect, not to analyze a specimen from the body.
- Input Data: While it uses CT imaging data for design, this data is used to create the physical implant, not to perform a diagnostic test on a biological sample.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cranial skeleton of patients 21 years of age and older.
Product codes
GWO
Device Description
The VSP PEEK Cranial Implants are non-load bearing, single use devices showing the following characteristics:
• The implants are designed individually for each patient to correct defects in cranial bone.
- The implants are 3D printed using material extrusion technology.
- The implants are manufactured using Polyetheretherketone (PEEK) implantable grade filament (i.e., Evonik VESTAKEEP® i4-3DF).
- The VSP PEEK Cranial Implants are designed using CT imaging data and surgeon input.
- · The implant size is ranging from 35 mm x 35 mm to 150 mm x 150 mm, and its thickness is constant, ranging from 3 mm to 6 mm with a nominal thickness of 3 mm.
- If minor intra-operative adjustments are required, the implants can be modified by the surgeon with standard surgical burrs.
- The implants are fixed to the native bone using commercially available cranial fixation screws and/or systems
- The implants are provided non-sterile for sterilization prior to implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging data
Anatomical Site
cranial skeleton
Indicated Patient Age Range
21 years of age and older
Intended User / Care Setting
surgeons / 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
The performance testing included:
Biocompatibility Testing: Evaluated compliance according to ISO-10993. Tests included Chemical Characterization and Toxicological Evaluation (ISO 10993-18 and ISO 10993-17), Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), Pyrogenicity (ISO 10993-11), Acute Systemic Toxicity (ISO 10993-11), Implantation effects (ISO 10993-6), and Genotoxicity (ISO/TR 10993-33). All results were found to be within acceptance criteria, concluding acceptable safety margins, non-sensitizing, non-irritating, non-pyrogenic, non-toxic, no unexpected implantation results, and non-mutagenic.
Performance Bench Testing:
Mechanics: Static compression testing and dynamic impact testing of extreme geometries (including screw fixation testing). All samples passed acceptance criteria.
Anatomical fit: Size accuracy and usability surgeon questionnaire following implantation on anatomical models. The size accuracy and usability of the VSP PEEK Cranial Implant was acceptable to surgeons.
Verification and Validation Testing: Technical and Biomechanical Specifications. All samples compliant with specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
April 4, 2024
Image /page/0/Picture/1 description: The image contains the logo of 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
3D Systems, Inc. Ashley Dawson Director, Regulatory Affairs 5381 South Alkire Circle Littleton, Colorado 80127
Re: K231834
Trade/Device Name: VSP PEEK Cranial Implant Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: March 5, 2024 Received: March 5, 2024
Dear Ashley Dawson:
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" (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).
1
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 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2024.04.04, and the time is 16:48:51 -04'00'.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231834
Device Name VSP PEEK Cranial Implant
Indications for Use (Describe)
The VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cramial skeleton of patients 21 years of age and older.
| 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) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY: K231834
| Applicant | |
|---|---|
| Name: | 3D Systems, Inc. |
| Address: | 5381 South Alkire Circle |
| Littleton, CO 80127 USA | |
| Phone: +1 (720) 643-1001 | |
| Official Contact: | Ashley Dawson, PhD |
| Director, Regulatory Affairs, Healthcare | |
| Date Prepared: | April 3rd, 2024 |
| Device | |
| Trade Name: | VSP PEEK Cranial Implant |
| Common Name: | Cranial Implant |
| Classification Name: | Preformed alterable cranioplasty plate |
| Classification: | Class II, 21 CFR 882.5320 |
| Product Code: | GWO |
Predicate Device
Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI), Kelynium Global Inc. (K182711)
Device Description
The VSP PEEK Cranial Implants are non-load bearing, single use devices showing the following characteristics:
• The implants are designed individually for each patient to correct defects in cranial bone.
- The implants are 3D printed using material extrusion technology.
- The implants are manufactured using Polyetheretherketone (PEEK) implantable grade filament (i.e., Evonik VESTAKEEP® i4-3DF).
5
- The VSP PEEK Cranial Implants are designed using CT imaging data and surgeon input.
- · The implant size is ranging from 35 mm x 35 mm to 150 mm x 150 mm, and its thickness is constant, ranging from 3 mm to 6 mm with a nominal thickness of 3 mm.
- If minor intra-operative adjustments are required, the implants can be modified by the surgeon with standard surgical burrs.
- The implants are fixed to the native bone using commercially available cranial fixation screws and/or systems
- The implants are provided non-sterile for sterilization prior to implantation.
Indications for Use Statement
The VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cranial skeleton of patients 21 years of age and older.
Predicate Comparison Table
The VSP PEEK Cranial Implant and its predicate device have tunctionality and similar technical data as shown in the table below.
| | Subject Device
VSP PEEK Cranial
Implant | Predicate Device
Customized Craniofacial
Implant (CCI) and Customized
Skull Implant (CSI) | Remark |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | 3D Systems, Inc. | Kelyniam Global Inc. (KGI) | |
| 510K number | K231834 | K182711 | |
| Indications
for Use | The VSP PEEK Cranial
Implant is indicated for
use to fill a bony void or
defect area in the
cranial skeleton of
patients 21 years of age
or older. | The Customized Craniofacial
Implant (CCI) and Customized
Skull Implant (CSI) is intended
to fill a bony void or defect
area in a patient's specific
cranial and craniofacial
skeleton (orbital rim, zygoma, &
adjacent bone). | Indications of use for VSP
PEEK Cranial Implant is
equivalent to the
predicate subject device
Customized Skull Implant
(CSI) |
| Material | Evonik VESTAKEEP® i4
3DF | Invibio Inc PEEK-Optima LT- 1®
and Evonik Vestakeep i4® | Equivalent |
| Technical
specifications | Plate - sized to each
patient using CT scan
data | Plate - sized to each patient
using CT scan data | Same |
| Sterilization | Provided Non-sterile | Provided Non-sterile | Same |
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| Product code | GWO (882.5320, Preformed Alterable Cranioplasty Plate) | GWO (882.5320, Preformed Alterable Cranioplasty Plate) | Same |
|---|---|---|---|
| Classification | Class II | Class II | Same |
Brief Summary of Performance Testing
The impact of the differences in the manufacturing process on the device performances are studied in detail. The performance testing of the VSP PEEK Cranial Implant includes the following tests to evaluate the substantial equivalence of the subject device to the predicate device:
- Biocompatibility Testing ●
- Performance Bench Testing: Mechanics
- Performance Bench Testing: Anatomical fit
Biocompatibility Testing
The VSP PEEK Cranial Implant was biologically evaluated in order to verify compliance according to the technical specifications and standards of ISO-10993 ("Biological Evaluation of Medical Devices Part 1: Evaluation and Testing").
Biocompatibility tests were conducted according to the above-mentioned standards and the results obtained from test specimens were found to be within the acceptance criteria described in the standards.
| Test | Results | Conclusion |
|---|---|---|
| Chemical | ||
| Characterization | ||
| and Toxicological | ||
| Evaluation | ||
| (ISO 10993-18 and | ||
| ISO 10993-17) | Analysis of extractables by | |
| HS-GC-MS, GC-MS, LC-MS, | ||
| and ICP-MS following | ||
| exhaustive extraction | Acceptable Margin of Safety for all | |
| reported extractable substances | ||
| Cytotoxicity | ||
| (ISO 10993-5) | Cell culture treated with test | |
| sample and compared | ||
| dehydrogenase activity to | ||
| control | ||
| Sensitization | ||
| (ISO 10993-10) | In vivo Maximization Test | Non-sensitizing |
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| Irritation
(ISO 10993-23) | In vivo intracutaneous
reactivity test | Non-irritating |
|----------------------------------------------|-------------------------------------------------------------------------------------|-----------------------|
| Pyrogenicity
(ISO 10993-11) | In vivo pyrogenicity test | Non-pyrogenic |
| Acute Systemic
Toxicity
(ISO 10993-11) | Clinical examination
following injection in mouse
model | Non-toxic |
| Implantation effects
(ISO 10993-6) | Implantation within rat
calvarial bone 28 day follow-
up and 90 day follow-up | No unexpected results |
| Genotoxicity
(ISO/TR 10993-33) | Reverse Mutation Assay | Non-Mutagenic |
| Genotoxicity
(ISO/TR 10993-33) | In vitro Mammalian Cell Gene
Mutation Assay | Non-Mutagenic |
Performance Bench Testing
Various performance-bench tests regarding mechanics, including static testing and impact testing, were performed on the VSP PEEK Cranial Implant. The testing protocol was set up based on literature research, since there is no industry accepted standard governing mechanical testing for non-load bearing implantable prosthetic plates. Results indicate that the VSP PEEK Cranial Implant as replacements for bone defects have acceptable mechanical performance following sterilization or when used in combination with common osteosynthesis fixation systems.
Additionally, the size accuracy and usability of the implant was tested performing an anatomical fit test. Simulated surgical procedures were performed on anatomical models on test bench by surgeons. Several implantations were performed using commercially available cranioplasty fixation systems and reviewed by each surgeon. Results indicate that the size accuracy and usability of the VSP PEEK Cranial Implant is acceptable to surgeons.
The VSP PEEK Cranial Implant was bench tested in order to verify compliance according to the technical and biomechanical specifications.
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| Test | Test Method Summary | Results |
|---|---|---|
| Mechanical | ||
| Performance | ||
| Testing | Static compression testing and | |
| dynamic impact testing of | ||
| extreme geometries (including | ||
| screw fixation testing) | All samples passed the | |
| acceptance criteria | ||
| Anatomical Fit | ||
| Testing | Size accuracy and usability | |
| surgeon questionnaire | ||
| following implantation on | ||
| anatomical model | The size accuracy and usability | |
| of the VSP PEEK Cranial Implant | ||
| was acceptable to surgeons | ||
| Verification and | ||
| Validation Testing | Technical and Biomechanical | |
| Specifications | All samples compliant with | |
| specifications. |
CONCLUSION
According to the comparison of the intended use/indications for use and the non-clinical performance testing, it is concluded that the subject device is substantially equivalent to the predicate device.