HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS

{0}------------------------------------------------ 3/15/99 K983385 #### 510(K) SUMMARY EXHIBIT 1 . 23 Sept 1998 Submitter: Hutchison International Inc. 7949 Jefferson Hwy Baton Rouge, LA 70809 Telph: 504 927 6800 Fax: 504 927 6874 #### 1. Classification Name: Tissue Expanders Common Name: HUTCHISON Inflatable Silicone Tissue Expanders Proprietary Name: - Establishment Registration Number: 2. HUTCHISON INTERNATIONAL registration: 2320466 - Device Classification: Tissue Expanders are unclassified. 3. - No performance standards have been established under section 514 4. Performance Standards: of the FD&C Act. #### ર. Indications for Use: The HUTCHISON Inflatable Silicone Tissue Expanders are designed for use in: - . Scar/defect revision - Reconstruction of the breast following subcutaneous mastectomy and other suitable . procedures or trauma - Breast underdevelopment and combined breast and chest wall abnormalities . #### Device Description: 6. The HUTCHISON Inflatable Silicone Tissue Expander is currently manufactured and marketed in Europe. The HUTCHISON Inflatable Silicone Tissue Expanders will be sold in the US, sterile for single use only and in double-peel pouches to facilitate aseptic handling during implantation in the patient. Product packaging is designed to allow sterilization gases onto the product and permit proper degassing. The Silicone Tissue Expanders are constructed from silicone elastomer and consist of a silicone connection tube and an injection site. The injection site is a self-sealing dome valve to allow for sterile saline injections for expanding the implant. The HUTCHISON Inflatable Silicone Tissue Expanders will be manufactured and available to physicians with two surface finishes, smooth or textured. {1}------------------------------------------------ Hutchison Silicone Tissue Expanders are available in various designs and sizes to meet the patient and surgeon's needs. A more detailed description of size and volume is provided in Section 3. The available styles are: - . Round - Rectangle . - . Crescent - Cylindrical . - Croissant . - U design . The manufacturer, Biosil Ltd., uses a high-strength silicone dispersion to produce the shell. The silicone materials used in producing the shell and the valve assembly have all received full biocompatibility assessment by the raw materials supplier. - Biosil has conducted extensive tests of the mechanical properties of the silicone shell and the fused 7. joints, including the results from pre and post sterilization studies of elongation, tensile strength, tear resistance, and valve competence. ### Sterility- Biosil has all implants manufactured in a clean room environment and sterilized by the ethylene oxide method to provide a sterility assurance level (SAL) of 106 . {2}------------------------------------------------ Image /page/2/Picture/1 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 left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 5 1999 Hutchison International, Inc. c/o Eduardo March, RAC Senior Consultant AAC Consulting Group, Inc. 7475 Wisconsin Avenue, Suite 850 Bethesda, Maryland 20814 Re: K983385 Trade Name: Hutchison Inflatable Silicone Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: January 19, 1999 Received: January 20, 1999 Dear Mr. March: 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 (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. {3}------------------------------------------------ Page 2 – Mr. Eduardo March 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, 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 {4}------------------------------------------------ র্তা Page 1 1 # 510(k) Number (if known): K9g33385 Device Name: HUTCHISON Inflatable Silicone Tissue Expanders Indications for Use: The HUTCHISON Inflatable Silicone Tissue Expanders are designed for temporary use in: - Scar/defect revision . - Reconstruction of the breast following subcutaneous . mastectomy and other suitable procedures or trauma - Breast underdevelopment and combined breast and chest wall abnormalities ● ## (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: Use: (Per 21 CFR 80.109) OR Over-the-Counter coell eral Restorative Devices K9833BS