(60 days)
Duralastic Anatomical Nasal Implant, Seare Biomedical Nasal Implant
Not Found
No
The description focuses on the material, shape, and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device description clearly states its intended use is for "cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty," indicating an aesthetic rather than therapeutic purpose.
No
Explanation: The device is an implant for cosmetic and reconstructive surgery of the nose, not a device used to diagnose medical conditions.
No
The device description explicitly states the device is manufactured from a medical grade silicone elastomer and is provided in various physical shapes and sizes, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty." This is a surgical procedure performed on a patient's body.
- Device Description: The device is a physical implant made of silicone elastomer, designed to be inserted into the nasal area.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The intended use for the AART Nasal Implant is augmentation and reconstruction of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
The intended use of the AART Nasal Implant is for cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
Product codes
FZE
Device Description
The AART Nasal Implants are manufactured from a medical grade silicone elastomer that has been molded into various "L" or straight shapes with concave convex dorsal aspects which reach from the alar cartilage to the radix. They are provided in seven styles with dimensions varying in length, width, and height. Titanium Oxide and Iron Oxide pigments may be added to the silicone to make the implant opaque if requested by the physician. These pigments are widely used in cosmetic surgery implant applications and will be lot tested for cvtotoxicity. The AART Nasal Implants are intended to be used for augmentation and reconstruction of the nasal contour during rhinoplasty. The surface characteristic of the implants is smooth. The AART Nasal 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
nasal / nose
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 Nasal Implant marketed by Allied Biomedical Corporation of Ventura, CA, Seare Biomedical Nasal Implant marketed by Seare Biomedical Corp. of Salt Lake City, Utah
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.
0
JUL - 2 2002
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: Common Name: Classification Name: AART Nasal Implant Silicone Elastomer Nasal Implant Prosthesis, Nose, Internal
Substantial Equivalence: The AART Nasal Implant is substantially equivalent in function, design, performance and materials to the Duralastic Anatomical Nasal Implant marketed by Allied Biomedical Corporation of Ventura, CA and the Seare Biomedical Nasal Implant marketed by Seare Biomedical Corp. of Salt Lake City, Utah.
Device Description: The AART Nasal Implants are manufactured from a medical grade silicone elastomer that has been molded into various "L" or straight shapes with concave convex dorsal aspects which reach from the alar cartilage to the radix. They are provided in seven styles with dimensions varying in length, width, and height. Titanium Oxide and Iron Oxide pigments may be added to the silicone to make the implant opaque if requested by the physician. These pigments are widely used in cosmetic surgery implant applications and will be lot tested for cvtotoxicity. The AART Nasal Implants are intended to be used for augmentation and reconstruction of the nasal contour during rhinoplasty. The surface characteristic of the implants is smooth. The AART Nasal Implants will be offered sterile and non-sterile.
The intended use for the AART Nasal Implant is augmentation and Intended Use: reconstruction of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
Predicate Device: The AART Nasal Implant is substantially equivalent in material, design, function, and performance to the Duralastic Anatomical Nasal Implant marketed by Allied Biomedical Corp. and the Seare Biomedical Nasal Implant marketed by Seare Biomedical Corp. All products have identical intended uses and are offered in similar shapes and sizes.
Sterilization Cycle: The AART Nasal 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 shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized graphic. The graphic depicts three human profiles facing right, represented by curved lines. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesthetic and Reconstructive Technologies, Inc. c/o Ms. Catherine Riple 3545 Airway Drive, Suite 108 Reno, Nevada 89511
JUL = 2 2002
Re: K021418 Trade Name: AART Nasal Implant Regulation Number: 878.3680 Regulation Name: Prosthesis, Nasal Implant Regulatory Class: II Product Code: FZE 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 (OS) 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,
L. Stipt. Clude
Célia 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
AMENDMENT 1
Page of
| NUMBER (IF KNOWN) : | K021418 |
|---|---|
| --------------------- | --------- |
AART Nasal Implant
DEVICE NAME:
510 (k)
INDICATIONS FOR USE:
The intended use of the AART Nasal Implant is for cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96
Stypt Awode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021418