(49 days)
Duralastic Chin implants are intended for use in augmentation and reconstruction of the chin. They are intended for insertion via an intraoral or submental incision.
To augment or reconstruct the chin or each and class and currentaun indicacionandibular contour.
Chin implants are crescent shaped concave convex Duralastic silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies' MAF 612. The Duralastic Chin Implants will be provided sterile and nonsterile.
The provided text describes a 510(k) submission for a chin implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria. Therefore, the information typically required for a medical device performance study (such as acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRI study results) is not present in this document.
The document primarily covers:
- Product Description: Materials, physical properties, intended use, and sterilization method of the Duralastic Chin Implants.
- Substantial Equivalence: States that the Duralastic Chin implants are substantially equivalent (SE) to Allied Biomedical chin implants (K971478).
- Regulatory Information: A letter from the FDA confirming the finding of substantial equivalence and allowing the device to be marketed.
Since this is a submission for substantial equivalence based on material properties and comparison to a predicate device, a clinical performance study with specific acceptance criteria as you've outlined is not included or required for this type of submission.
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KY15212
NOV - 7 1997
Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 (425) 481 2185 510 (k) Submission Chin Implant
TAB H
510 (k) SUMMARY
PRODUCT DESCRIPTION
Chin implants are crescent shaped concave convex Duralastic silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies' MAF 612. The Duralastic Chin Implants will be provided sterile and nonsterile.
SUBSTANTIAL EQUIVALENCE
Duralastic Chin implants are SE to the Allied Biomedical chin implants K971478. They are soft solid silicone implant grade cresent shaped implants in various sizes and styles.
INTENDED USE
Duralastic Chin implants are intended for use in augmentation and reconstruction of the chin. They are intended for insertion via an intraoral or submental incision.
PHYSICAL AND CHEMICAL PROPERTIES
Duralastic Chin implants are manufactured from Applied The Silicone's LSR-30 part # 40029 which is a platinum cured dimethyl polysiloxane system. All chemical characterizations are found in Applied Masterfile MAF-562 and in Nusil Technologies MAF 612.
The physical properties are: Durometer 30 Shore A, Elongation 650%, Tensile Strength 950 PSI, tear strength Tear Die C 150 PSI, Specific Gravity 1.12, Modulus 300 PSI at 200% Elongation, Surface Smooth and Textured.
STERILIZATION CYCLE
Duralastic Chin Implants will be sterilized via gamma radiation cycles of 2.5 - 4.2 Megarads. The validation of this cycle was
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TAB H 510 (k) Summary
designed and performed by STI of Brea, California. Sterigenics Corporation is the contract gamma sterilizer. The validation used Method i Testing as defined in the ANSI/AAMI/ISO 1137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gerald Hanson Regulatory Affairs Hanson Medical Inc. 19325 58th Place NE Seattle, Washington 98155
NOV - 7 1997
Re: K973575
Trade Name: Duralastic Anatomical Chin Implant Regulatory Class: II Product Code: FWP Dated: September 18, 1997 Received: September 19, 1997
Dear Mr. Hanson:
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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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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 vours.
Acoella
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1973575
Page 1 of 1
510(k) Number - N/A
Device Name: Silicone Elastomer Chin Implant
Indications For Use: To augment or reconstruct the chin or
each and class and currentaun indicacionandibular contour.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 14973575 |
Presecription Use ✓ OR Over The Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
§ 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.