DURALASTIC ANATOMICAL MALAR IMPLANT

K973574 · Hanson Medical, Inc. · LZK · Oct 24, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973574
• Device Name: DURALASTIC ANATOMICAL MALAR IMPLANT
• Applicant: Hanson Medical, Inc.
• Product Code: LZK · General, Plastic Surgery
• Decision Date: Oct 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Duralastic Malr implants are intended for use in augmentation and reconstruction of the cheek. They are intended for insertion via an intraoral or cilliary incision.

Device Story

Duralastic Malar implants are crescent-shaped, concave-convex silicone elastomer rubber implants; manufactured in mirror-image pairs. Implants are inserted by surgeons via intraoral or ciliary incisions to augment or reconstruct cheek contours or the maxillary zygoma. Device provides permanent structural support to facial anatomy.

Clinical Evidence

Bench testing only. Material characterization (mutagenicity, biocompatibility, carcinogenicity, cytotoxicity) referenced via Master Files MAF-562 and MAF-612. Sterilization validation performed per ANSI/AAMI/ISO 1137-1994.

Technological Characteristics

Materials: Platinum-cured dimethyl polysiloxane (LSR-30, MED 4211). Physical properties: 30 Shore A durometer, 650% elongation, 950 PSI tensile strength, 150 PSI tear strength (Die C), 1.12 specific gravity. Surface: Smooth and textured. Sterilization: Gamma radiation (2.5-4.2 Megarads) per ANSI/AAMI/ISO 1137-1994.

Indications for Use

Indicated for augmentation or reconstruction of the malar cheek contour or the maxillary Zygoma.

Regulatory Classification

Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

Predicate Devices

• Applied Biomedical malar implants (K952707)

Submission Summary (Full Text)

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K973574

# OCT 24 1997

Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 [phone] 510(k) Submission Malar Implants

#### TAB H

#### 510 (k) SUMMARY

## PRODUCT DESCRIPTION

Duralastic Malar implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been mutagenicity, biocompatibility, tested for thoroughly carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Malar Implants will be provided sterile and nonsterile.

#### SUBSTANTIAL EQUIVALENCE

Under it original 510(k) K952707, Duralastic Malar implants were found SE to the Applied Biomedical malar implants. In fact the very same molds and materials used to produce the Duralastic Malar implants in the sterile form, because these molds were sold to Allied and Allied has not changed raw material suppliers.

#### INTENDED USE

Duralastic Malr implants are intended for use in augmentation and reconstruction of the cheek. They are intended for insertion via an intraoral or cilliary incision.

#### PHYSICAL AND CHEMICAL PROPERTIES

Duralastic Malar implants are manufactured from Applied The Silicone's LSR-30 part # 40029 and Nusil Technologies' MED 4211 MAF 612 which are platinum cured dimethyl polysiloxane systems. All chemical characterizations are found in Applied Masterfile MAF-562 amd Nusil's 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.

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# TAB H Continued

### STERILIZATION CYCLE

Duralastic Malar Implants are sterilized via gamma radiation cycles of 2.5 - 4.2 Megarads. The validation of this cycle was 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. SAL 10 to the minus 6th.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 1997

Ms. Kathy Hanson Richardson Regulatory Affairs Hanson Medical Inc. 19325 58th Place NE Seattle, Washington 98155

Re: K973574

> Trade Name: Duralastic Anatomical Malar Implants Regulatory Class: II Product Code: LZK Dated: September 15, 1997 Received: September 19, 1997

Dear Ms. Richardson:

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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## Page 2 - Ms. Kathy Hanson Richardson

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, yours,

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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### INTENDED USE FORM

Page 1 of 1

510(k) Number - ₩分 长973574

Device Name: Silicone Elastomer Malar Implant

:

To augment or reconstruct the malar cheek Indications For Use: contour or the maxillary Zygoma.

Concurrence of CDRH, Office of Device Evaluat (ODE)

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Division of General Restorative Devices
510(k) Number K973574

Presecription Use √
(Per 21 CFR 801.109)

OR

Over The Counter Use (Optional Format 1-2-96)