(27 days)
Not Found
Not Found
No
The summary describes a silicone implant for surgical augmentation and reconstruction, with no mention of software, data processing, or AI/ML terms.
No
The device is a silicone implant used for augmentation and reconstructive surgery, which reshapes the body and minimizes defects, but it does not treat or cure a disease or medical condition.
No
The device is described as an implant used for augmentation and reconstructive surgery, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical implant made from silicone elastomer, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The AART Calf Implant is a physical implant made of silicone elastomer that is surgically placed inside the body for augmentation and reconstruction.
- Intended Use: The intended use is for surgical procedures to reshape the calf, not to perform diagnostic tests on bodily samples.
Therefore, based on the provided information, the AART Calf Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for the AART Calf Implant (Silicone Carving Block) is for Intended Use: 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 (comma separated list FDA assigned to the subject device)
MIB
Device Description
The AART Calf Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in two styles with dimensions varying in length, width, height and initial shape. The AART Calf 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
ATTACHMENT 7
510(k) Summary
July 25, 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 Calf Implant |
| Common Name: | Silicone Carving Block |
| Classification Name: | Elastomer, Silicone Block |
Substantial Equivalence: The AART Calf Implant (Silicone Carving, Block) is substantially equivalent in function, design, performance and materials to the Silimed Calf Implant marketed by Silimed LLC.
Device Description: The AART Calf Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in two styles with dimensions varying in length, width, height and initial shape. The AART Calf Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.
The intended use for the AART Calf Implant (Silicone Carving Block) is for Intended Use: 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 Calf Implant (Silicone Carving Block) is substantially equivalent in material, design, function, and performance to the Silimed Calf 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 Calf 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 Calf 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or other bird-like figure, represented by three stylized profiles facing to the right.
AUG 26 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesthetic and Reconstructive Technologies, Inc. c/o Čatherine Riple 5871 Lone Pine Place Paso Robles, California 93446
Re: K022511
Trade/Device Name: AART Calf Implant Regulation Number: 874.3620 Regulation Name: Ear, Nose and Throat synthetic polymer material Regulatory Class: Class II Product Code: MIB Dated: July 25, 2002 Received: July 30, 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, 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" (21 CFR 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,
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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ATTACHMENT 1
Page 1 of 1
) 2 510(k) Number (if known):
AART Calf Implant (Silicone Carving Block) Device Name:
Indications For Use:
The intended use of the AART Calf 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 NOTWRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K022511
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Oplional Formal 1-2-96