(52 days)
The Caff Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Calf Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
Calf Implant (Silicone Carving Blocks)
The provided text is a 510(k) clearance letter from the FDA for a Gluteal Implant (later identified as a Calf Implant in the "Indications for Use" section). It confirms substantial equivalence to a predicate device.
However, the document does not contain any information about acceptance criteria or the study that proves the device meets those criteria. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting detailed performance study data against specific acceptance criteria in the format requested.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a detailed device specification.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a circular seal for the U.S. Department of Health and Human Services. The seal features the department's name encircling an emblem. The emblem is a stylized representation of an eagle with three stripes extending from its head, symbolizing health and human services.
NOV - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stephen Meade Implantech Associates, Inc. 6025 Nicolle Street. Suite B Ventura, California 93003
Re: K052505
Trade/Device Name: Gluteal Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: MIB Dated: September 9, 2005 Received: September 15, 2005
Dear Mr. Meade:
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.
{1}------------------------------------------------
Page 2 - Stephen Meade
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Soubare BuellD
Mark N. Me kerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
Calf Implant
Indications For Use:
The Caff Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Calf Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Corbare Bneelip
Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K052505
§ 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.