(143 days)
Each Pillar Chin Implant is indicated for the augmentation or reconstruction of facial chin deformities, congenital or acquired by trauma or disease.
The Pillar Chin Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
The provided text is a 510(k) summary for a chin implant, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of device performance against specific acceptance criteria.
Therefore, the document does not contain the information requested to complete the table and answer the questions regarding acceptance criteria, device performance, study details, ground truth, or sample sizes for a scientific study.
The primary claims for the Pillar Chin Implant are:
- Substantial Equivalence: It is substantially equivalent to the Silimed Chin Implants.
- Material Equivalence: Made from identical liquid elastomer materials and manufacturing processes as the predicate device.
- Intended Use Equivalence: Intended to augment or reconstruct facial chin deformities caused by facial trauma or congenital defects, and implanted using the same accepted surgical methods of the predicate device.
- Physical/Chemical Properties Equivalence: Physical properties are the same as the predicate device, using equivalent materials (Nusil's MED 4211 unrestricted silicone fluid). Durometer (shore A) ranges from 5 to 30, appearance is clear to opaque, tensile strength averages 700 psi, and percent elongation is over 400 percent. Raw materials are certified and tested to comply with manufacturer requirements.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a logo and a date. The logo says "PILLAR SURGICAL" with the word "PILLAR" underlined. The date is "NOV 22 1999".
510(k) Summary
Substantial Equivalence
The Pillar Chin Implant is substantially equivalent to the Silimed Chin Implants, marketed by Silimed, LLC. The Pillar Chin Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device.
Intended Use
The intended use of the Pillar Chin Implant is to augment or reconstruct facial chin deformities caused by facial trauma or congenital defects. The Pillar Chin Implant is implanted using the same accepted surgical methods of the predicate device.
Labeling
The labeling for this device will comprise a label for the inner package and a label for the outer box. Catalog numbers and sizes will be clearly displayed on the labels. A "Package Insert" will contain instructions for sterilization and indications for use. Product promotional material will depict size, shape and material firmness of the implant.
Physical and Chemical Properties
The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent. Raw material are certified and tested to comply with the requirements of the manufacturer. For more information, see FDA master-file MAF 612.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 1999
Mr. Rob Fritzenkotter Pillar Surgical P.O. Box 8141 La Jolla, California 92038-8141
K992239 Re: Trade Name: Chin Implant Regulatory Class: II Product Code: FWP Dated: November 4, 1999 Received: November 5, 1999
Dear Mr. Fritzenkotter:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2 - Mr. Rob Fritzenkotter
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Neil R.P. Ogden for
James E. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
| KNOWN) : | K442234 |
|---|---|
| ---------- | --------- |
DEVICE NAME:
510 (k) NUMBER (IF
INDICATIONS FOR USE:
Each Pillar Chin Implant is indicated for the augmentation or Each Pillar Chin Implant is indicated for the adgated on acquired by trauma or disease.
Nao fr
(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devic 510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2
§ 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.