(60 days)
Duralastic Anatomical Chin Implant, Seare Biomedical Chin Implant
Not Found
No
The device description and intended use clearly describe a physical silicone implant for surgical augmentation, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as an implant for cosmetic augmentation and reconstruction of the chin, which is primarily an aesthetic and structural purpose, not a therapeutic one aimed at treating a disease or condition.
No
The device is a chin implant used for augmentation and reconstruction, not for identifying or diagnosing a disease or condition.
No
The device description clearly states the device is a physical implant made from a medical grade silicone elastomer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "augmentation and reconstruction of the chin or anterior mandibular contour." This describes a surgical procedure performed directly on the patient's body for structural or cosmetic purposes.
- Device Description: The device is a physical implant made of silicone elastomer, designed to be surgically inserted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
The intended use for the AART Chin Implant is augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.
The intended use for the AART Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.
Product codes
FWP
Device Description
The AART Chin Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped convex implants. They are provided in seven styles with dimensions varying in length, width, and height. The AART Chin Implants are intended to be used for augmentation and reconstruction of the chin or anterior mandibular contour. The surface characteristic of the implant is smooth. The AART Chin Implants will be offered sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chin or anterior mandibular contour
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Duralastic Anatomical Chin Implant, Seare Biomedical Chin Implant
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ATTACHMENT 5
510(k) Summary
April 29,2002
| Contact Information: | Aesthetic and Reconstructive Technologies, Inc. (AART)
3545 Airway Drive, Suite 108
Reno, NV 89511
(775) 853-6800 / FAX (775) 853-6805
Winston A. Andrews |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | AART Chin Implant |
| Common Name: | Silicone Elastomer Chin Implant |
| Classification Name: | Prosthesis, Chin, Internal |
Substantial Equivalence: The AART Chin Implant is substantially equivalent in function, design, performance and materials to the Duralastic Anatomical Chin Implant marketed by Allied Biomedical Corporation of Ventura, CA and the Seare Biomedical Chin Implant marketed by Seare Biomedical Corp. of Salt Lake City, Utah.
Device Description: The AART Chin Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped convex implants. They are provided in seven styles with dimensions varying in length, width, and height. The AART Chin Implants are intended to be used for augmentation and reconstruction of the chin or anterior mandibular contour. The surface characteristic of the implant is smooth. The AART Chin Implants will be offered sterile and non-sterile.
Intended Use: The intended use for the AART Chin Implant is augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.
Predicate Device: The AART Chin Implant is substantially equivalent in material, design, function, and performance to the Duralastic Anatomical Chin Implant marketed by Allied Biomedical Corp. and the Seare Biomedical Chin Implant marketed by Seare Biomedical Corp. All products have identical intended uses and are offered in similar shapes and sizes.
Sterilization Cycle: The AART Chin Implant will be sterilized by Gamma radiation. The sterilization cycle will be determined and validated following the ANSI/AAMI/ISO 11137-1994 standard "Sterilization of health care products - Requirements for validation and routine control -Radiation sterilization".
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The profiles are arranged in a way that they form the body and wing of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food .and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Aesthetic and Reconstructive Technologies, Inc. c/o Ms. Catherine Riple 3545 Airway Drive, Suite 108 Reno, Nevada 89511
Re: K021417 Trade Name: AART Chin Implant Regulation Number: 878.3550 Regulation Name: Prosthesis, Chin Implant Regulatory Class: II Product Code: FWP Dated: April 29, 2002 Received: May 3, 2002
Dear Ms. Riple:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Catherine Riple
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (Misbranding by reference to premarket notification( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 443-6597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stypt Rhode
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
AMENUMEN 1
Page / of
| 510(k) NUMBER (IF KNOWN) : | K021417 |
|---|---|
| DEVICE NAME: | AART Chin Implant |
INDICATIONS FOR USE:
The intended use for the AART Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
્વાર
Over-The-Counter-Use er The Councer 650-96)
Styph Rurdee
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZ 1417 510(k) Number_