SURGISIS OCULAR GRAFT

K053622 · Iop, Inc. · NXM · Mar 15, 2006 · Ophthalmic

Device Facts

• Record ID: K053622
• Device Name: SURGISIS OCULAR GRAFT
• Applicant: Iop, Inc.
• Product Code: NXM · Ophthalmic
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.

Device Story

Surgisis Ocular Graft is a biologic implant derived from porcine small intestinal submucosa (SIS); supplied as sterile, dry, lyophilized sheets of varying sizes/thicknesses. Intended for surgical implantation by clinicians to reinforce and support eyelid soft tissue reconstruction. Device acts as a scaffold for tissue repair. Benefits include structural support for eyelid defects. No electronic or software components.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility, viral inactivation, and mechanical performance testing.

Technological Characteristics

Material: Processed porcine small intestinal submucosa (SIS). Form: Sterile, dry, lyophilized sheets. Sterilization: Ethylene Oxide. Single-use. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring reinforcement and reconstruction of eyelid soft tissue.

Regulatory Classification

Identification

An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

Predicate Devices

• Surgisis Soft Tissue Graft (K980431)
• SIS Plastic Surgery Matrix (K034039)
• SIS Facial Implant (K050246)

Reference Devices

• ProKera™ Ophthalmic Conformer with Amniotic Membrane (K032104)

Submission Summary (Full Text)

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## MAR 1 5 2006

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: KOS 3622

| Contact Person: | Jason Malecka<br>President<br>IOP, Inc.<br>3184-B Airway Ave.<br>Costa Mesa, CA 9262 |
|-----------------|--------------------------------------------------------------------------------------|
| | Phone: [phone]<br>FAX: [phone] |

December 22, 2005 Date Prepared:

Device Name and Classification

| Proprietary Name: | SURGISIS Ocular Graft |
|----------------------|----------------------------------------------------------|
| Common Name: | Ophthalmic Implant Biologic |
| Classification Name: | Prosthesis, Eyelid Spacer Graft, Biologic |
| Classification: | Class II (Exempt from Premarket notification procedures) |
| Product Code: | NXM |
| Classification No.: | 21 CFR 886.3130 |

### Device Description

The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system

#### Indications for Use

The Surgisis Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.

### Summary of Testing

The Surgisis ocular graft is identical in material composition to predicate Surgisis devices and has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction and repair.

#### Substantial Equivalence Claim

Surgisis Ocular Graft is similar with respect to intended use, materials and technical characteristics to predicate devices.

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## Predicate Device Equivalence

:

| Company | Innovative<br>Ophthalmic<br>Products Inc. | Cook Biotech Inc. | Bio-Tissue, Inc. |
|------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name(s) | SURGISIS Ocular<br>Graft | Surgisis Soft Tissue Graft<br>SIS Plastic Surgery Matrix<br>SIS Facial Implant | ProKera™ Ophthalmic Conformer with<br>Amniotic Membrane |
| 510(k) | Applied For | K980431<br>K034039<br>K050246 | K032104 |
| Product Specifications | | | |
| Material | Processed porcine<br>submucosa | Processed porcine<br>submucosa | Amniotic Membrane with ophthalmic<br>conformer used as an epithelial insert |
| Indications for Use | General<br>reconstruction of<br>the eyelid.<br>Eyelid Spacer<br>Graft | Implantation to reinforce<br>soft tissue where weakness<br>exists in patients requiring<br>soft tissue repair or<br>reinforcement in face and<br>head and plastic and<br>reconstructive surgery | Intended for use in eyes in which the<br>ocular surface cells have been damaged<br>or underlying stoma is inflamed and<br>scarred. The device in inserted<br>between the eyeball and eyelid to<br>maintain space in the orbital cavity and<br>prevent closure or adhesions |
| Supplied | Sterile | Sterile | Unknown |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Unknown |
| Recommended<br>Usage | Single Use | Single Use | Single Use |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

IOP, Inc. Mr. Jason Malecka, President 3184 Airway Avenue, Bldg. B Costa Mesa, CA 92626

Re: K053622

Kooso22
Trade/Device Name: Prosthesis, eyelid spacer/graft, biologic Regulation Number: 21 CFR 886.3130 Regulation Name: Ophthalmic Conformer Regulatory Class: Class II Product Code: NXM Dated: December 22, 2005 Received: December 28, 2005

Dear Mr. Malecka:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared on (d the device is substantially equivalent (for the indications ferenced above and have sure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimer of pror to ria) 2011-12-12, 10:00 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter For (110) market the device, subject to the general controls provisions of the Act. The r ou may, diere, mains 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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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/industry/support/index.html.

Sincerely yours,

MB Egelund - MT

Malvina B. Eydelman, M.D. Acting Division Director Division of Ophthalmic and Ear, Nosc and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 - Mr. Jason Malecka

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K053622

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Usc (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A

(Division Sign-Off) Division of Ophthalmig Ear, Nose and Throat Devises

510(k) Number K053622

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