MACROPORE SURGICAL BARRIER FILM

K023643 · Macropore Biosurgery, Inc. · MTZ · Feb 21, 2003 · Ophthalmic

Device Facts

• Record ID: K023643
• Device Name: MACROPORE SURGICAL BARRIER FILM
• Applicant: Macropore Biosurgery, Inc.
• Product Code: MTZ · Ophthalmic
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbiral implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

Device Story

MacroPore Surgical Barrier Film is a resorbable, malleable sheet made of polylactides (PLA). Used in enucleation surgery, the film acts as a protective wrap for orbital implants. Surgeons cut the film to the desired shape and size; it becomes fully malleable when heated to approximately 55°C, allowing for three-dimensional contouring to anatomical structures. The device is provided in various dimensions and thicknesses, with options for solid or porous sheets. By covering the implant, the film protects surrounding orbital tissue from the implant surface. The device is intended for use by surgeons in a clinical setting.

Clinical Evidence

Bench testing only. Testing included evaluation of inherent viscosity after heating to 60°C, aging studies, and mechanical strength testing (tensile and suture pull-out) compared to predicate devices.

Technological Characteristics

Resorbable sheet manufactured from polylactides (PLA). Dimensions: 30mm x 30mm to 200mm x 200mm; thickness 0.05mm to 1.0mm. Malleable at ~55°C. Available in solid or porous configurations (pore size 0.5mm to 3.0mm).

Indications for Use

Indicated for use as an orbital implant wrap to cover orbital implants during enucleation surgery to protect surrounding orbital tissue from the implant surface.

Regulatory Classification

Identification

An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Bio-Vascular Ocu-Guard
• Bio-Eye II Orbital Implant

Submission Summary (Full Text)

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| FEB 21 2003 |
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| K023643 SUMMARY | MacroPore Surgical Barrier Film | Page 1 of 3 |
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| ADMINISTRATIVE INFORMATION | | |
| Manufacturer Name: | MacroPore Biosurgery, Inc.<br>6740 Top Gun Street<br>San Diego, CA 92121 | |

Official Contact:

Kenneth K. Kleinhenz Director of Regulatory Affairs Telephone [phone] Fax [phone]

DEVICE NAME

Implant, Eye Sphear Classification Name:

Trade/Proprietary Name:

MacroPore Surgical Barrier Film

### ESTABLISHMENT REGISTRATION NUMBER 2031733

## DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 886.3320, an eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball. These devices are classified as Class II. Eye sphere implants have been assigned Product Code HP2.

## INTENDED USE

The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbiral implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

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### DEVICE DESCRIPTION

#### Design Characteristics

MacroPore Surgical Barrier Film is a resorbable implant in sheet form manufactured from polylactides (PLA). MacroPore Surgical Barrier Film can be cut with scissors to the desired shape and size. MacroPore Surgical Barrier Film is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation.

The MacroPore Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater

#### Material Composition

The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).

### In Vitro Testing

Because the MacroPore Surgical Barrier Film is intended to be heated in the surgical suite to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60°C on inherent viscosity. The testing demonstrates that viscosity stayed within an appropriate range over 120 minutes. Therefore, the relatively brief exposure anticipated during the surgical preparation of MacroPore Surgical Barrier Film is not expected to have a significant effect on its mechanical properties.

Aging testing was performed on MacroPore Surgical Barrier Film. Testing demonstrated that the MacroPore Surgical Barrier Film is strong enough for the indications for use.

Mechanical testing was performed on the MacroPore Surgical Barrier Film which determined the MacroPore Surgical Barrier Film to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.

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# EQUIVALENCE TO MARKETED PRODUCT

MacroPore Surgical Barrier Film shares indications and design principles with the following predicate devices, which have been determined by FDA to be substantially equivalent to the following pre-amendment devices: Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant: Class II medical devices that were cleared for marketing in the United States.

#### Indications For Use

MacroPore Surgical Barrier Film shares identical indications for use principles with the predicate devices as both the MacroPore Surgical Barrier Film and the predicate devices are indicated for the same surgical procedures.

#### Design and Materials

The physical designs of MacroPore Surgical Barrier Film and the predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant) are substantially equivalent, consisting of thin semirigid sheets. The MacroPore Surgical Barrier Film and the bovine pericardium predicates also share design features of allowing for contouring. The MacroPore Surgical Barrier Film is fully contourable when heated to approximately 55°C. The dimensions of the predicate devices are also comparable to the MacroPore Surgical Barrier Film as both devices are provided in rectangular sheets that are several centimeters in size. The mechanical characteristics of the MacroPore Surgical Barrier Film are substantially equivalent to the predicate devices with respect to mechanical strength as measured by tensile and suture pull out testing. In addition to physical characteristics, both the predicate device and the MacroPore Surgical Barrier Film can be cut to specific shapes and sizes by the end user.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

MacroPore Biosurgery, Inc. c/o Kenneth K. Kleinhenz 6740 Top Gun St. San Diego, CA 92121

Re: K023643

Trade/Device Name: MacroPore Surgical Barrier Film Regulation Name: Eye Sphere Implant Regulation Number: 21 CFR 886.3320 Regulatory Class: Class II Product Code: MTZ Dated: January 22, 2003 Received: January 23, 2003

Dear Mr. Kleinhenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Kenneth K. Kleinhenz

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kalpi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Device Name: MacroPore Surgical Barrier Film

## Indications for Use:

The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Oph
Nose and Thro:
510(k) Number K0 23643