(116 days)
Not Found
No
The description focuses on patient-specific design based on imaging and manufacturing processes, with no mention of AI or ML for analysis, design, or manufacturing. The software mentioned is for translating imaging into a digital model and creating design files, which is standard CAD/CAM functionality, not necessarily AI/ML.
No.
The device is described as an implant for augmentation, reconstructive, and cosmetic surgery of the facial regions, primarily serving as a space-occupying device to form a contoured feature, which are structural and aesthetic purposes rather than therapeutic treatment of a disease or condition.
No
The device is an implant used for augmentation, reconstructive, and cosmetic surgery, not for diagnosing conditions.
No
The device is a physical implant made of medical grade silicone elastomer. While software (VSP® Software) is used in the design and manufacturing process, the final device is a tangible hardware product.
Based on the provided information, 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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Customized Contour Implant is a physical implant designed to be surgically placed inside the patient's body for augmentation, reconstruction, or cosmetic purposes. It is a space-occupying device.
- Intended Use: The intended use is for surgical implantation in facial regions.
- No Specimen Testing: The device itself does not perform any tests on biological specimens. While it is based on patient imaging (CT scans), the imaging is used for design and manufacturing, not for diagnostic testing by the device itself.
Therefore, the Customized Contour Implant falls under the category of a surgically implanted medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.
Product codes (comma separated list FDA assigned to the subject device)
FWP, KKY
Device Description
The Customized Contour Implant is a patient-matched for augmentation, reconstructive and cosmetic surgery of the facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.
The patient's own medical imaging (e.g., Computerized Tomography (CT) scan) is translated into a digital model of the patient's skull using VSP® Software from 3D Systems. At the recommendation of the surgeon, the VSP® Software is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or silicon kits, or to create a digital implant model as an STL file. Implantech Associates manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by 3D Systems, using plaster molds or 3D-printed molds as appropriate. The Customized Contour Implant is manufactured from the customized molds and provided to the surgeon, sterile or non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computerized Tomography (CT) scan
Anatomical Site
facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / 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)
Non-clinical tests were performed:
- Sterilization validation per ISO 17655-1 and ANSI/AAMI/ISO 20857
- Packaging validation per ISO 11607
- Shelf life validation with accelerated and real time aging studies
- Cytotoxicity testing per ISO 10993-5
- Bacterial endotoxins testing per ANSI/AAMI ST72
- 3D printer validation: Fortus 360MC 3D Printer and its ancillary equipment were validated to accurately print a 3D image of a predetermined shape (1 inch cube, 1 inch diameter sphere) using STL file inputs. STL file creation using the VSP® software was validated prior to the 3D printer validation.
Key results: The results of these tests indicate that the Customized Contour Implant is substantially equivalent to the predicate device.
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
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(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.
August 23, 2019
Implantech Associates Inc. % Pierre Bounaud, Ph.D. Senior Consultant AcKnowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K191130
Trade/Device Name: Customized Contour Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin prosthesis Regulatory Class: Class II Product Code: FWP, KKY Dated: April 25, 2019 Received: June 5, 2019
Dear Dr. Bounaud:
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.
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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 and Part 809); 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.
For David Krause, Ph.D. Acting Division Director Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191130
Device Name Customized Contour Implant
Indications for Use (Describe)
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.
| 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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510(k) Summary K191130
DATE PREPARED
August 2, 2019
MANUFACTURER AND 510(k) OWNER
Implantech Associates, Inc. 6025 Nicolle St., Suite B, Ventura, CA 93003, USA Telephone: Fax: +1 (805) 339-9414 Official Contact: Craig Arthur, RA Global Compliance Manager
REPRESENTATIVE/CONSULTANT
Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: pbounaud@acknowledge-rs.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Customized Contour Implant |
|---|---|
| Common Name: | Elastomer, Silicone Block |
| Regulation Number: | 21 CFR 878.3550 |
| Class: | II |
| Product Code: | FWP, KKY |
| Review Panel: | General and Plastic Surgery |
PREDICATE DEVICE IDENTIFICATION
The 3D Accuscan Facial Contour Implant is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K913761 | 3-D Accuscan Facial Implants / Implantech Associates | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
The Customized Contour Implant is a patient-matched for augmentation, reconstructive and cosmetic surgery of the facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized
4
implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.
The patient's own medical imaging (e.g., Computerized Tomography (CT) scan) is translated into a digital model of the patient's skull using VSP® Software from 3D Systems. At the recommendation of the surgeon, the VSP® Software is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or silicon kits, or to create a digital implant model as an STL file. Implantech Associates manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by 3D Systems, using plaster molds or 3D-printed molds as appropriate. The Customized Contour Implant is manufactured from the customized molds and provided to the surgeon, sterile or non-sterile.
Image /page/4/Figure/3 description: The image shows a diagram of the process for creating customized implants. The process starts with the surgeon's specifications, which are then used to create a solid model or digital file. This file is then used to create a mold, which can be a plaster mold or a 3D printed mold. Finally, the mold is used to create a customized implant, which can be sterile or non-sterile.
INDICATIONS FOR USE
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device has the same intended use, target population, design, and materials as the device cleared in K913761.
Unlike the predicate device cleared in K913761, manufacturing of the Customized Contour Implant includes two additional routes involving the use of 3D printing technology to create patient-specific molds and implant models derived from CT scans of a patient. VSP® Software by 3D Systems provides the transfer of the patient's medical imaging to a digital format appropriate for 3D printing of patient-specific molds and implant models.
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Image /page/5/Picture/1 description: The image shows the logo for "Implantech Superior Patient Aesthetics". The word "Implantech" is in a bold, italicized font, with the "I" being much larger than the other letters. Below "Implantech" is the phrase "Superior Patient Aesthetics" in a smaller, less bold font. The logo is in white against a black background.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Customized Contour Implant. The following non-clinical tests were performed in order to demonstrate safety based on current industry standards:
- . Sterilization validation per ISO 17655-1 and ANSI/AAMI/ISO 20857
- Packaging validation per ISO 11607
- Shelf life validation with accelerated and real time aging studies
- Cytotoxicity testing per ISO 10993-5
- Bacterial endotoxins testing per ANSI/AAMI ST72
- 3D printer validation: Fortus 360MC 3D Printer and its ancillary equipment were validated to accurately print a 3D image of a predetermined shape (1 inch cube, 1 inch diameter sphere) using STL file inputs. STL file creation using the VSP® software was validated prior to the 3D printer validation.
The results of these tests indicate that the Customized Contour Implant is substantially equivalent to the predicate device.
CONCLUSION
Based on the testing performed, including bioburden testing, cytotoxicity testing, and physicochemical testing, it can be concluded that the subject device does not raise different questions of safety or effectiveness when compared to the predicate device. The similar indications for use and technological characteristics for the proposed Customized Contour Implant are assessed to be substantially equivalent to the predicate device.