(42 days)
Not Found
Not Found
No
The summary describes a physical silicone implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The "Intended Use" clearly states it is for "augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects," which falls under aesthetic or reconstructive purposes rather than treating or curing a medical condition.
No
Explanation: The device is a silicone implant used for augmentation and reconstructive surgery, which is a therapeutic rather than a diagnostic function. It is meant to minimize muscular defects through body contouring.
No
The device description clearly states it is a physical implant made from silicone elastomer, 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 augmentation and reconstructive surgery, which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a silicone implant, designed to be surgically placed within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in a laboratory setting.
IVDs are used to perform tests on samples taken from the body, not devices implanted into the body for structural or cosmetic purposes.
N/A
Intended Use / Indications for Use
The intended use for the AART Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.
Product codes
MIB
Device Description
The AART Gluteal Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or round shapes. They are provided in four styles with dimensions varying in length, width, height and initial shape. The AART Gluteal Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Silimed Gluteal Implant
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
JUL 16 2002
ATTACHMENT 7
510(k) Summary
K02 1839
May 31, 2002
| Applicant: | Aesthetic and Reconstructive Technologies, Inc. (AART) |
|---|---|
| 3545 Airway Drive, Suite 108 | |
| Reno, NV 89511 | |
| (775) 853-6800 / FAX (775) 853-6805 | |
| Contact Person: | Catherine Riple |
| Consultant for AART, Inc. | |
| (805) 239-1059 | |
| Proprietary Name: | AART Gluteal Implant |
| Common Name: | Silicone Carving Block |
| Classification Name: | Elastomer, Silicone Block |
Substantial Equivalence: The AART Gluteal Implant (Silicone Carving Block) is substantially equivalent in function, design, performance and materials to the Silimed Gluteal Implant marketed by Silimed LLC.
Device Description: The AART Gluteal Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or round shapes. They are provided in four styles with dimensions varying in length, width, height and initial shape. The AART Gluteal Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.
Intended Use: The intended use for the AART Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.
Predicate Device: The AART Gluteal Implant (Silicone Carving Block) is substantially equivalent in material, design, function, and performance to the Silimed Gluteal Implant marketed by Silimed LLC. of Crofton, MD. All products have identical intended uses and are offered in similar shapes and sizes.
Packaging: The AART Gluteal Implant (Silicone Carving Block) will be offered non-sterile, The implants will be individually packaged in an autoclavable peel pouch and labeled on the plastic side with appropriate identification for traceability. They will then be boxed in a SSB chipboard box along with a package insert and labeled for inventory and shipment.
Sterilization: The AART Gluteal Implants (Silicone Carving Blocks) are offered non-sterile. Recommended autoclave cycles are stated in the Package Insert which is included with each product.
1
Image /page/1/Picture/2 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 symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it. The logo is black and white.
JUL 16 2002
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
Re: K021839 Trade Name: AART Gluteal Implant Regulation Number: 874.3620 Regulation Name: Ear, nose and throat synthetic polymer material Regulatory Class: II Product Code: MIB Dated: May 31, 2002 Received: June 4, 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 http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stupt Rhodes
lia 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
ATTACHMENT 1
AART Gluteal Implant (Silicone Carving Block) Ko21839
Page
DEVICE NAME:
INDICATIONS FOR USE:
SIO (k) NUMBER (IF KNOWN) :
The intended use of the AART Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.
(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
O
Over-The-Counter-Use_ (Optional Format 1-2-
Stephen Rurder
OR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KOZ1839