(60 days)
The intended use of the AART Malar Implant is for augmentation or reconstruction of the check areas of the face.
The AART Malar Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped concave convex implants. They are provided in four styles in pairs of right and left mirror images with dimensions varying in length, width, and height. The AART Malar Implants are intended to be used for augmentation and reconstruction of the cheek areas of the face. The surface characteristic of the implants is smooth, The AART Malar Implants will be offered sterile and non-sterile.
The provided text is a 510(k) summary and FDA clearance letter for the AART Malar Implant. This type of document establishes substantial equivalence to predicate devices, rather than conducting new studies to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not present in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The 510(k) submission focuses on demonstrating substantial equivalence to already marketed devices, not on proving performance against a specific set of new acceptance criteria through a clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present because no new clinical or performance test set data is described. The submission is based on the characteristics of the device itself and its similarity to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present because no new clinical or performance test set data requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present because no new clinical or performance test set data requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present. The device is an implant, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. The device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present because no new clinical or performance test set data requiring ground truth is described. The "ground truth" for this type of submission would relate to the long-standing safety and effectiveness of the predicate devices.
8. The sample size for the training set
This information is not present because the document does not describe the development or training of any algorithm.
9. How the ground truth for the training set was established
This information is not present because the document does not describe the development or training of any algorithm.
Summary of Device Equivalence (from the document):
The AART Malar Implant is deemed substantially equivalent to the Duralastic Anatomical Malar Implants (Allied Biomedical Corporation) and the Seare Biomedical Malar Implants (Seare Biomedical Corp.). This equivalence is based on:
- Function
- Design
- Performance
- Materials (medical grade silicone elastomer)
- Intended Use (augmentation and reconstruction of the cheek areas of the face)
- Similar shapes and sizes
The sterilization cycle will be determined and validated following ANSI/AAMI/ISO 11137-1994 for radiation sterilization, which is a standard for ensuring sterility, not specific performance criteria for the device's function within the body.
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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 Malar Implant Silicone Elastomer Malar Implant Implant, Malar
Substantial Equivalence: The AART Malar Implant is substantially equivalent in function, design, performance and materials to the Duralastic Anatomical Malar Implants marketed by Allied Biomedical Corporation of Ventura, CA and the Seare Biomedical Malar Implants marketed by Seare Biomedical Corp. of Salt Lake City, Utah.
Device Description: The AART Malar Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped concave convex implants. They are provided in four styles in pairs of right and left mirror images with dimensions varying in length, width, and height. The AART Malar Implants are intended to be used for augmentation and reconstruction of the cheek areas of the face. The surface characteristic of the implants is smooth, The AART Malar Implants will be offered sterile and non-sterile.
Intended Use: The intended use for the AART Malar Implant is augmentation and reconstruction of the cheek areas of the face.
Predicate Device: The AART Malar Implant is substantially equivalent in material, design, function, and performance to the Duralastic Anatomical Malar Implants marketed by Allied Biomedical Corp. and the Seare Biomedical Malar Implants marketed by Seare Biomedical Corp. All products have identical intended uses and are offered in similar shapes and sizes.
Sterilization Cycle: The AART Malar Implant will be sterilized by Gamma radiation. The sterilization cycle will be determined and validated following the ANSUAAMI/ISO 11137-1994 standard "Sterilization of health care products - Requirements for validation and routine control -Radiation sterilization".
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. 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
JUL = 2 2002
Ms. Catherine Riple Consultant Aesthetic and Reconstructive Technologies, Inc. 3545 Airway Drive, Suite 108 Reno. NV 89511
Re: K021419
Trade/Device Name: AART Malar Implant Regulation Number: 878.3550 Regulation Name: Chin prosthesis Regulatory Class: II Product Code: LZK 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 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. Iisting 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.
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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 http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hypt Rhodes
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
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AMENDMENT 1
Page of
| 510 (k) NUMBER (IF KNOWN) : | K021419 |
|---|---|
| DEVICE NAME: | AART Malar Implant |
INDICATIONS FOR USE:
The intended use of the AART Malar Implant is for augmentation or reconstruction of the check areas of the face.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.】 .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter-Use (Optional Format 1-2-
Styph Ruddy
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_ KOZI419
§ 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.