(344 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of the implant, with no mention of AI or ML.
Yes
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear, which is a physical restoration of a body part and thus falls under the definition of a therapeutic device.
No
This device is an implant intended for reconstruction of the external ear, not for diagnosing conditions.
No
The device is a physical implant made of silicone and ePTFE, intended for surgical reconstruction of the external ear. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reconstruction of the external ear." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implant designed to be surgically placed within the patient's tissue.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases, monitor health, or screen for conditions. This device is a physical implant for surgical reconstruction.
N/A
Intended Use / Indications for Use
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.
Product codes
FZD
Device Description
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear. It is intended to be a long term, single use implant. Implantation of the device by the surgeon produces a contour to reconstruct the patient's outer ear feature. A surgically created "pocket" at the implantation site is made by the surgeon for placement of the device (typically placed on the skeletal feature below the soft muscle tissue). The ePTFE-Coated Auricular is composed of a silicone elastomer core with an outer layer of ePTFE (expanded polytetrafluoroethylene) and is shaped approximately to that of the external ear. The implant comes in nine sizes and the surgeon has the option to trim the implant to fit the patient's need. The implant is provided sterile or non-sterile, as either the "Left" or "Right" side.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external ear / outer ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
No FDA performance standards have been established for the ePTFE-Coated Auricular Implant. Patient-contacting material was subjected to biocompatibility testing in compliance to ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, implantation, and chemical characterization.
Bond strength between the silicone elastomer and the ePTFE outer layer was evaluated to confirm that the effects of aging, repetitive sterilization (dry heat and steam) and the white pigment in the silicone elastomer do not adversely affect the silicone/ePTFE mechanical bond of the ear implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3590 Ear prosthesis.
(a)
Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.(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 & 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.
July 18, 2018
Implantech Associates Inc. % Ms. Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, California 92104
Re: K172389
Trade/Device Name: ePTFE-Coated Auricular Implant Regulation Number: 21 CFR 878.3590 Regulation Name: Ear prosthesis Regulatory Class: Class II Product Code: FZD Dated: August 2, 2017 Received: August 8, 2017
Dear Ms. Komiyama:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ePTFE-Coated Auricular Implant
Indications for Use (Describe)
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K172389
DATE PREPARED
July 18, 2018
MANUFACTURER AND 510(k) OWNER
Implantech Associates, Inc. 6025 Nicolle St., Suite B, Ventura, CA 93003, USA Telephone: +1 (805) 339-9414 Fax: Official Contact: Craig Arthur, RA/QA Manager
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Pierre Bounaud, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 akomiyama@acknowledge-rs.com Email:
PROPRIETARY NAME OF SUBJECT DEVICE
ePTFE-Coated Auricular Implant
COMMON NAME
Prosthesis, Ear, External
DEVICE CLASSIFICATION
Ear Prosthesis (21 CFR 878.3590, Product Code FZD, Class II)
PREMARKET REVIEW
ODE/DSD/Plastic Surgery Devices Branch One (PRSB1) General & Plastic Surgery
INDICATIONS FOR USE
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.
DEVICE DESCRIPTION
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear. It is intended to be a long term, single use implant. Implantation of the device by the surgeon produces a contour to reconstruct the patient's outer ear feature. A surgically created "pocket" at the implantation site is made by the surgeon for placement of the device (typically placed on the skeletal feature below the soft muscle tissue). The ePTFE-Coated Auricular is composed of a silicone elastomer core with an outer layer of ePTFE (expanded polytetrafluoroethylene) and is shaped approximately to that of the external ear. The implant
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comes in nine sizes and the surgeon has the option to trim the implant to fit the patient's need. The implant is provided sterile or non-sterile, as either the "Left" or "Right" side.
PREDICATE DEVICE IDENTIFICATION
The ePTFE-Coated Auricular Implant is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K863939 | Porex Ear Prosthesis / Porex Medical | |
| K141027 | Implantech ePTFE Facial Implants / Implantech Associates | |
| K002886 | Implantech Composite Facial Implants / Implantech Associates |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the ePTFE-Coated Auricular Implant. Patient-contacting material was subjected to biocompatibility testing in compliance to ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, implantation, and chemical characterization.
Bond strength between the silicone elastomer and the ePTFE outer layer was evaluated to confirm that the effects of aging, repetitive sterilization (dry heat and steam) and the white pigment in the silicone elastomer do not adversely affect the silicone/ePTFE mechanical bond of the ear implant.
EQUIVALENCE TO PREDICATE DEVICES
Implantech believes that the ePTFE-Coated Auricular Implant is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has the same intended use and target population as the Porex Ear Prosthesis device cleared in K863939. The subject device uses similar or identical materials and similar manufacturing processes as the Implantech ePTFE Facial Implants cleared in K141027 and the Implantech Composite Facial Implants cleared in K002886. The main differences in design between the Porex Ear Prosthesis and the subject device include:
- Two-piece design vs one-piece design ।
- -Open framework vs trimmable single-piece design
- -High density propylene vs ePTFE/silicone composite
CONCLUSION
The ePTFE-Coated Auricular Implant is considered substantially equivalent to the predicate devices based on the identical indications for use, and similar technological characteristics. Based on the testing performed on the patient-contacting material, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices.