DURALASTIC I AND DURALASTIC II

K971480 · Allied Biomedical Corp. · MIB · May 28, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971480
• Device Name: DURALASTIC I AND DURALASTIC II
• Applicant: Allied Biomedical Corp.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: May 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Duralastic I (Short Term) Nasal Splinting, Wound Dressings, wound covering for gastroschisis, suture bolsters, drains, Scar Coverings, Laboratory Uses, Temporary facilitation of osteogenesis and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joing andrea and other short term uses according to the surgeon's determination. Chalastic II (Long Term) Nonreinforced - Tympanic Membrane Repair, Pural Covering . 005inch, Nasal Septal Repair, Tendon Anatomobile, na ral repair - 007inch. Correction of Strabismus .010inch, Galea Repair Shunt Anchors . 060inch. Reinforced - Facilitation of Osteogenesis 007 hon, repair of urethral strictures .007inch, Staged Repair of mphalocoel . 020inch, Repair of Orbital Floor Fractures .040inch.

Device Story

Duralastic I and II are biocompatible silicone elastomer sheets; available in reinforced (polyester mesh) and non-reinforced forms. Used by surgeons in clinical settings for various reconstructive and repair procedures. Device acts as a physical barrier or structural support in surgical sites. No electronic input/output or software involved. Benefits include biocompatibility and versatility in surgical applications.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on material characterization, biocompatibility testing (meeting USP Class VI standards including Teratogenicity, Mutagenicity, Carcinogenicity, and Toxicity), and physical property testing (durometer, tensile strength, tear strength).

Technological Characteristics

Biocompatible silicone elastomer (dimethylpolysiloxane); peroxide cured. Durometer 45-55 Shore A; tensile strength 1600 psi; tear strength 190 psi; specific gravity 1.16. Available in polyester mesh reinforced or non-reinforced configurations. Sterilized via gamma radiation (2.5 - 4.2 Megarads) per ANSI/AAMI/ISO 11137-1994.

Indications for Use

Indicated for patients requiring short-term (nasal splinting, wound dressings, scar coverings, temporary joint shims) or long-term (nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair, omphalocele repair, extraocular muscle lengthening, tendon/nerve anastomosis, guided tissue regeneration) surgical implantation or application.

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

• Applied Biomaterial Technologies Duralastic Sheeting (K955368)
• Dow Corning Silastic Sheeting (K955370)

Submission Summary (Full Text)

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6971480

Allied Biomedical Corporation 3850 Ramada Drive Paso Robles, CA 93446

MAY 28 1997

### TAB H

# 510 (K) SUMMARY

# PRODUCT DESCRIPTION

Duralastic I and II Silicone Elastomer Sheeting is made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 704

## SUBSTANTIAL EQUIVALENCE

Under it's original 510k K955368 and K955370 Duralastic I and II was found to be SE to Applied Biomaterial Technologies Duralastic Sheeting and Dow Corning's Silastic Sheeting in the Premarket Notification for the nonsterile Duralastic Sheeting. Because Duralastic Sheeting is made from Dow Corning Analogs and made in the same sizes and thicknesses for the same intended use it has been found SE to the predicate devices.

### INTENDED USES

Duralastic I and II are intended for a variety of medical purposes both in short term and long term applications. For short term application this list includes nasal splinting, wound dressings, scar coverings, temporary use in TMJ disease, temporary joint shims, and laboratory uses. For long term use this list includes nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair, staged repair of omphalocoel, lengthening of extraocular muscles, tendon and nerve anastomosis, facilitation of osteogenesis or guided tissue regeneration, and other uses deemed appropriate by the using surgeon. Silicone sheeting has been in use for over 30 years and the uses are myriad. Allied Biomedical advises surgeons to consult the literature before utilizing Duralastic Sheeting for any purpose in the package inserts.

# PHYSICAL AND CHEMICAL PROPERTIES

Duralastic Sheeting is a peroxide cured rubber of a 45 - 55

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#### 510(k) Summary page 2. TAB H

Durometer hardness (Shore A). It has an elasticity of 700 percent with a tensile strength of 1600 psi and a tear strength of 190 psi (Tear Die C). The elasticity is greatly reduced in the polyester reinforced sheets. The specific gravity is 1.16. Chemically Duralastic I and II are made from HCRA-50, an Applied Silicone dimethylpolysiloxane. For details on the foregoing chemical and physical properties consult Masterfile MAF 704

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# STERILIZATION CYCLE

Duralastic I and II sheeting are sterilized via gamma radiation 2.5 - 4.2 Megarads. The validation of this cycle was performed by STI Corporation of Brea California. STI uses Sterigenics Inc. as the contract gamma radiation sterilizer. The validation uses Method 1 Testing as defined in the ANSI/AAMI/ISO 11137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization."

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**MAY 28 1997**

Mr. Gerald Hanson Regulatory Affairs Allied Biomedical Corporation .................. 3850 Ramada Drive Paso Robles, California 93446

Re: K971480

Trade Name: Duralastic I and Duralastic II Silicone Sheeting Regulatory Class: Unclassified Product Code: MIB Dated: April 15, 1997 Received: April 23, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (2) CFR Part 820) and that, through periodic GMP 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 - Mr. Gerald Hanson

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 vour 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,

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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Page_ 1 _of

Number (if known) : K971480 SI . . . K

Device Name: Duralastic I and Duralastic II Silicone Sheeting

Indications For Use:

Duralastic I (Short Term) Nasal Splinting, Wound Dressings, wound covering for gastroschisis, suture bolsters, drains, Scar Coverings, Laboratory Uses, Temporary facilitation of osteogenesis and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joing andrea and other short term uses according to the surgeon's determination.

Chalastic II (Long Term) Nonreinforced - Tympanic Membrane Repair, Pural Covering . 005inch, Nasal Septal Repair, Tendon Anatomobile, na ral repair - 007inch. Correction of Strabismus .010inch, Galea Repair Shunt Anchors . 060inch. Reinforced - Facilitation of Osteogenesis 007 hon, repair of urethral strictures .007inch, Staged Repair of mphalocoel . 020inch, Repair of Orbital Floor Fractures .040inch.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED !

Concurrence of CDRH, Office of Device Evaluation

peralta

(Division Sign-Of)
Division of General Restorative Devigasy 71480
510(k) Number.

Prescription Use

OR

Over - The - Counter Use

(Optional Format 1-2-96)