(289 days)
Not Found
No
The summary describes a patient-matched implant made of silicone elastomer, customized based on surgeon specifications. There is no mention of AI, ML, or any computational processing that would suggest the use of these technologies in the design or manufacturing process. The performance studies focus on material and sterilization validation, not algorithmic performance.
No
A therapeutic device is used to treat or cure a disease or condition. This device is intended for augmentation, reconstructive, and cosmetic surgery, which are not considered therapeutic.
No
The device is an implantable medical device used for augmentation, reconstructive, and cosmetic surgery, not for diagnosing conditions. Its purpose is to form a contoured feature in the body.
No
The device description explicitly states the device is a "single use implant intended for long term implantation" and is "made of medical grade silicone elastomer," 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 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 testing is done outside of the body (in vitro).
- Device Description: The Customized Contour Implant is a physical implant intended for long-term implantation inside the body. It is used for augmentation, reconstruction, and cosmetic surgery.
- Intended Use: The intended use clearly describes surgical procedures involving implantation, not laboratory testing of biological samples.
The information provided about the device's intended use, description, and performance studies all point to it being a surgically implanted medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.
Product codes (comma separated list FDA assigned to the subject device)
FWP, KKY, MIB, MIC
Device Description
The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial implants, gluteal implants, calf implants, or pectoralis implants.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon's specification
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)
- 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
- 3D printer validation
Results: The results of these tests indicate that the Customized Contour Implant is substantially equivalent to the predicate devices.
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.
K191130, K052504, K052505, K952708
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.
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December 23, 2020
Implantech Associates Inc. % Pierre Bounaud Senior Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K200610
Trade/Device Name: Customized Contour Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin Prosthesis Regulatory Class: Class II Product Code: FWP, KKY, MIB, MIC Dated: March 5, 2020 Received: March 9, 2020
Dear Mr. 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.
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
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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,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: 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) K200610
Device Name Customized Contour Implant
Indications for Use (Describe)
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.
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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Image /page/3/Picture/2 description: The image shows the logo for "Implantech". The logo is white text on a black background. Below the main logo is the text "Superior Patient Aesthetics".
510(k) Summary
DATE PREPARED
March 5, 2020
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, akomiyama@acknowledge-rs.com Website: www.AcKnowledge-RS.com
DEVICE INFORMATION
| Trade Name/Proprietary Name | Customized Contour Implant |
|---|---|
| Common Name | Elastomer, Silicone Block |
| Classification Name | Classification Regulations | Device Class | Product Code |
|---|---|---|---|
| Chin prosthesis | 21 CFR 878.3550 | II | FWP |
| Polytetrafluoroethylene with carbon fibers | |||
| composite implant material | 21 CFR 878.3500 | II | KKY |
| Ear, nose, and throat synthetic polymer | |||
| material | 21 CFR 874.3620 | II | MIB |
| II | MIC |
OPEQ/OHT4/Infection Control and Plastic Surgery Devices Premarket Review (DHT4B) General & Plastic Surgery Review Panel
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510(k) Summary
PREDICATE DEVICE IDENTIFICATION
The Customized Contour Implant is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K191130 | Customized Contour Implant/Implantech Associates, Inc. | ✓ |
| K052504 | Gluteal Implant, Models RND 5-X, TRD 6-X/Implantech Associates, Inc. | |
| K052505 | Calf Implant, Model EC17-X/Implantech Associates, Inc. | |
| K952708 | Pectoralis Implant/Spirit Ridge Technologies |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. 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.
INDICATIONS FOR USE
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, calf implants, or pectoralis implants.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Implantech Associates believes that the Customized Contour Implant is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has the same intended use (facial, gluteal, calf and pectoral implants for reconstructive and augmentation/cosmetic surgery) and patient population as the devices cleared in K191130 (facial implants), K052504 (gluteal implants), K052505 (calf implants), and K952708 (pectoral implants). The subject device has similar design and identical materials as the devices cleared in K191130, K052504, K052505, and K952708. Subject and predicate devices are all made from the same Nusil silicone elastomers with the same durometer range.
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
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510(k) Summary
Image /page/5/Picture/1 description: The image shows the text "K200610 Page 3 of 3" at the top. Below that is the logo for "Implantech" in a bold, sans-serif font. Underneath the logo is the tagline "Superior Patient Aesthetics" in a smaller font.
- Cytotoxicity testing per ISO 10993-5
- 3D printer validation
The results of these tests indicate that the Customized Contour Implant is substantially equivalent to the predicate devices.
CONCLUSION
Based on the testing performed, including sterilization validation, packaging validation, shelf life validation, cytotoxicity testing, and 3D printer validation, it can be concluded that the subject device does not raise new issues of safety or effectiveness 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 devices.