SEARE BIOMEDICAL SILICONE SHEETING

K983041 · Seare Biomedical Corp. · MIB · Sep 30, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K983041
• Device Name: SEARE BIOMEDICAL SILICONE SHEETING
• Applicant: Seare Biomedical Corp.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Seare Biomedical Silicone sheeting is intended for a variety of uses. For short term applications for use are: nasal splinting; wound dressings; management of hypentrophic or keloid scarring; to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus; temporary joint spacers; and laboratory uses. For long-term application the indications for use are: nasal septal floor reconstruction; tympanic membrane repair; dialysis shunt anchoring: duramater repair of omphalocele; for lengthening extra ocular muscles in select cases of strabismus; as a protective sheathing to help facilitate neural regeneration and tendon anastomosis; as a protective sheathing to help facilitate osteogenesis; guided tissue regeneration between teeth and gingival margin, or example; subcutaneous tissue augmentation; subcutaneous tissue suspentation; facial suspension; muscular and facial reinforcement; and other uses deemed appropriate by the using surgeon. Warning: Not for permanent use in Temporo Mandibular Joint applications.

Device Story

Seare Biomedical Silicone Sheeting consists of flexible, translucent, medical-grade LSR (liquid silicone rubber) elastomer sheets. Available in reinforced (polyester mesh) and non-reinforced configurations with varying thicknesses, textures, and porosity. Designed for surgical implantation or external application; surgeon trims material with scissors or knife to custom-fabricate prostheses intraoperatively. Used in diverse clinical settings (OR, clinic) by surgeons for reconstructive, orthopedic, and soft tissue procedures. Acts as a physical barrier or scaffold to facilitate healing, regeneration, or structural support. No electronic components or automated processing.

Clinical Evidence

No clinical data.

Technological Characteristics

Medical-grade LSR (liquid silicone rubber) elastomer. Available in reinforced (polyester mesh) and non-reinforced forms. Features varying degrees of surface texturing and porosity. Dimensions and shape are custom-trimmed by the surgeon at the point of use. Non-electronic, passive implantable material.

Indications for Use

Indicated for patients requiring surgical implants or dressings, including nasal splinting, wound management, scar treatment, joint spacers, septal/tympanic/duramater repair, dialysis shunt anchoring, strabismus correction, neural/tendon/bone regeneration, and tissue augmentation. Contraindicated for permanent use in Temporo Mandibular Joint (TMJ) applications.

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

• Silicone Elastomer Sheeting (Dow Corning)
• Silicone Elastomer Sheeting (Bentec Medical)

Submission Summary (Full Text)

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K983041

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SEARE BIOMEDICAL CORPORATION

## 510(k) Summary

| Contact Information: | Seare Biomedical Corporation<br>3190 Chula Vista Circle<br>Salt Lake City, Utah 84121<br>Telephone: [phone]<br>Facsimile: 1(801) 942-1999 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Seare Biomedical Silicone Sheeting |
| Common Name: | Silicone Elastomer Sheeting |
| Classification Name: | Elastomer. Silicone Block |

Substantial Equivalence: The Seare Biometical Silicone Sheeting configurations are substantially equivalent in material, function, performance, and design to the Silicone Elastomer Sheeting manufactured and marketed by Dow Corning and Bentec Medical.

Device Description: Seare Biomedical Silicone Sheeting is thate from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer Seare Biomer Sheeting is a flexible, translucent, medical grade silicone elastomer sheeting material designed for a variety of implant applications. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. Surface characteristics will varying degrees of texturing and porosity. The Silicone Sheeting may be readily trimmed with a knife or scissors. This trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable prosthesis for a specific surgical indication.

Indications For Use: Seare Biomedical Silicone sheeting is intended for a variety of uses. For short term applications for use are: nasal splinting; wound dressings; management of hypentrophic or keloid scarring; to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus; temporary joint spacers; and laboratory uses.

For long-term application the indications for use are: nasal septal floor reconstruction; tympanic membrane repair; dialysis shunt anchoring: duramater repair of omphalocele; for lengthening extra ocular muscles in select cases of strabismus; as a protective sheathing to help facilitate neural regeneration and tendon anastomosis; as a protective sheathing to help facilitate osteogenesis; guided tissue regeneration between teeth and gingival margin, or example; subcutaneous tissue augmentation; subcutaneous tissue suspentation; facial suspension; muscular and facial reinforcement; and other uses deemed appropriate by the using surgeon.

Warning: Not for permanent use in Temporo Mandibular Joint applications.

Predicate Devices: The Seare Biomedical Silicone Sheeting configurations are substantially equivalent in material, function, performance, and design to the Silicone Sheeting manufactured and marketed by Dow Corning and Bentec Medical. The products have virtually identical indications for use and are offered in the same basic sizes and options.

Clinical Tests: None

Adverse S&E Information: None

William J. Seare, Jr., M.D.
William J. Seare, V.M.D.

illiam J. Seare. Jr. M.D. President & C.E.O.

August 27, 1998
Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

William J. Seare, M.D. President & C.E.O. Seare Biomedical Corporation 3190 Chula Vista Circle Salt Lake City, Utah 84121

Re: K983041 Trade Name: Seare Biomedical Silicone Sheeting Regulatory Class: Unclassified Product Code: мів Dated: August 27, 1998 Received: August 31, 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 The general controls provisions of the Act 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 (QS) 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 - Dr. William J. Seare

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.qov/cdrh/dsmamain.html".

Sincerely yours,
Cella 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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| 510(k) Number (if known): | K983041 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Seare Biomedical Silicone Sheeting

Indications For Use:

For short term application the indications for use are:

- nasal splinting; .
- wound dressings; .
- management of hypentrophic or kcloid scarring; .
- to prevent soft tissue fibrosis or bony ankylosis following surgical concction of trismus; .
- temporary joint spacers; .
- laboratory uses. .

For long-term application the indications for use are:

- nasal septal repair; .
- orbital floor reconstruction;
- tympanic membrane repair: .
- dialysis shunt anchoring:
- duramater repair:
- staged repair of omphaloccic;
- for lengthening extra ocular muscles in select cases of strabismus;
- as a protective sheathing to help facilitate neural regeneration and tendon anastomosis;
- as a protective sheathing to help facilitate osteogenesis;
- guided tissue regeneration between teeth and gingival margin, or external ear canal for example;
- other uses deemed appropriate by the using surgeon.

Warning: Not for permanent use in Temporo Mundibular Joint applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983011 |

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)