(45 days)
Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage. The tissue expander assemblies are designed to be implanted completely under the skin, and filled externally via a syringe. All tissue expandic, incremental inflation with sterile saline for injection, until the desired amount of tissue is developed. The Seare Biomedical Silicone Tissue Expanders are constructed as a unit from silicone elastomer and consist of an expansion envelope with a smooth surface, a silicone connection tube, and a remote injection site. The expanders are available in a wide range of styles and sizes to meet diverse surgical needs.
The provided text is a 510(k) summary for a medical device called "Seare Biomedical Silicone Tissue Expanders." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) summary like this one generally does not include information about acceptance criteria or specific studies proving device performance beyond demonstrating substantial equivalence.
The document explicitly states:
- "Clinical Tests: None"
- "Adverse S&E Information: None" (referring to safety and effectiveness, implying no specific studies were conducted for this submission regarding these aspects for the new device as separate from its predicate.)
Therefore, I cannot provide the requested information because it is not present in the provided text. The submission relies on demonstrating similarity to existing devices already on the market, rather than new performance studies with acceptance criteria.
{0}------------------------------------------------
DEC 1 1998
Image /page/0/Picture/1 description: The image shows a circular shape with a pattern of dark and light areas. The dark areas are irregularly shaped and distributed throughout the circle. The lighter areas fill in the spaces between the dark areas, creating a marbled or camouflage-like effect. The overall impression is that of an abstract design within a defined circular boundary.
SEARE BIOMEDICAL CORPORATION
510(k) Summary
| Contact Information: | Seare Biomedical Corporation3190 Chula Vista CircleSalt Lake City, Utah 84121Telephone: 1(801) 355-5533Facsimile: 1(801) 942-1999 |
|---|---|
| Trade Name: | Seare Biomedical Silicone Tissue Expanders |
| Common Name: | Silicone Tissue Expanders |
| Classification Name: | Expander Skin Inflatable |
Substantial Equivalence: The Seare Biomedical Silicone Tissue Expander configurations are substantially equivalent in material, function, performance, and design to the Silicone Tissue Expanders manufactured and marketed by Specialty Surgical Products, Inc. and McGhan Medical Corporation. The products have comparable indications for use and are offered in the same exact sizes and basic options.
Device Description: Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage. The tissue expander assemblies are designed to be implanted completely under the skin, and filled externally via a syringe. All tissue expandic, incremental inflation with sterile saline for injection, until the desired amount of tissue is developed. The Seare Biomedical Silicone Tissue Expanders are constructed as a unit from silicone elastomer and consist of an expansion envelope with a smooth surface, a silicone connection tube, and a remote injection site. The expanders are available in a wide range of styles and sizes to meet diverse surgical needs.
Indications For Use: Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectorny, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
Predicate Devices: The Seare Biomedical Silicone Tissue Expander configurations are substantially equivalent to the predicate device Silicone Tissue Expanders manufactured and marketed by Specially Surgical Products, Inc. and McGhan Medical Corporation.
Clinical Tests: None
Adverse S&E Information: None
William J. Sears, Jr. M.D.
President & C.E.O.
10/13/94
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three heads facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEC 11 1388
Food and Brug Administration 9200 Corporate Boulevard Rockville MD 20850
William J. Seare, Jr., M.D. President and Chief Executive Officer Seare Biomedical Corporation 3190 Chula Vista Circle Salt Lake City, Utah, 84121
Re: K983792 Trade Name: Seare Biomedical Silicone Tissue Expander Regulatory Class: Unclassified Product Code: LCJ Dated: October 13, 1998 Received: October 27, 1998
Dear Dr. Seare:
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.
{2}------------------------------------------------
Page 2 - William J. Seare, Jr., M.D.
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
{3}------------------------------------------------
510(k) Number (if known):
Device Name: Seare Biomedical Silicone Tissue Expanders
Indications For Use:
Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of General Restorative Devices
510(k) Number K983792
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
N/A