KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT

K090078 · Iop, Inc. · NXM · May 8, 2009 · Ophthalmic

Device Facts

• Record ID: K090078
• Device Name: KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
• Applicant: Iop, Inc.
• Product Code: NXM · Ophthalmic
• Decision Date: May 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KeraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.

Device Story

KeraSys Bioengineered Lamellar Patch Graft is a sterile, dehydrated ophthalmic implant; constructed from four laminated layers of porcine small intestinal submucosa (SIS). Device is used by surgeons for scleral reinforcement and ocular surface reconstruction. Implant provides a scaffold for tissue repair. Supplied in 1x1.5cm size in double peel pouch; sterilized via ethylene oxide.

Clinical Evidence

No clinical data. Safety and efficacy supported by bench testing, including biocompatibility, viral inactivation, and mechanical testing of the Surgisis device family.

Technological Characteristics

Material: Four-layer laminated porcine small intestinal submucosa (SIS). Form factor: 1x1.5cm dehydrated patch. Sterilization: Ethylene Oxide. Single-use.

Indications for Use

Indicated for patients requiring scleral reinforcement and ocular surface reconstruction. Labeled for single use.

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 Ocular Graft (K053622)
• SIS Facial Implant (K050246)

Submission Summary (Full Text)

{0}------------------------------------------------

K090078

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: | K090078 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Malecka<br>President<br>IOP, Inc.<br>3184-B Airway Ave.<br>Costa Mesa, CA 92626<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | December 29, 2008 |

MAY - 8 2009## Device Name and Classification

ﻣﺴﺮﺣﺎ

| Proprietary Name: | KeraSys Bioengineered Lamellar Patch Graft |
|------------------------------|----------------------------------------------------------|
| Common Name: | Ophthalmic Implant Biologic |
| Regulation Name: | Ophthalmic Conformer |
| Regulatory Class: | Class II (Exempt from Premarket notification procedures) |
| Product Code: | NXM |
| Proposed Classification No.: | 886.3130 |

#### Device Description

The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm

### Indications for Use

The KeraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.

#### Summary of Testing

The Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction.

#### Substantial Equivalence Claim

KcraSys Bioengineered Lamellar Patch Graft is similar with respect to intended use, materials and technical characteristics to predicate devices.

{1}------------------------------------------------

. .

:

# Predicate Device Equivalence

ي المقابل المنتج

من القرن

.

:

| Company | Innovative Ophthalmic<br>Products Inc. | Cook Biotech Inc. | Innovative Ophthalmic<br>Products, Inc. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Name(s) | SURGISIS Ocular Graft<br>tarSys Bioengineered Eyelid<br>prosthesis | SIS Facial Implant | keraSys Bioengineered Patch<br>Graft 1x1.5cm |
| 510(k) | K053622 | K050246 | Applied for 510(k) K090078<br>Pending |
| Product Specifications | | | |
| Material<br>Indications for<br>Use | Processed porcine submucosa<br>The SURGISIS Ocular Graft<br>is intended for implantation to<br>reinforce and aid<br>reconstruction of eyelid and is<br>labeled for single use | Processed porcine submucosa<br>Reinforcement of tissue where<br>weakness exists in patients<br>requiring soft tissue repair or<br>reinforcement in face, head<br>and plastic and reconstructive<br>surgery | Processed porcine submucosa<br>The KeraSys Bioengineered<br>Lamellar Patch Graft is<br>intended for implantation to<br>reinforce sclera and aid the<br>reconstruction of the ocular<br>surface. |
| Supplied | Sterile | Sterile | Sterile |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Recommended<br>Usage | Single Use | Single Use | Single Use |

.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAY - 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

IOP, Inc. c/o Mr. Jason Malecka, President 3184-B-Airway Ave. Costa Mesa, CA 92626

Re: K090078

Trade/Device Name: keraSys Bioengineered Lamellar Patch Graft Regulation Number: 21 CFR 886.3130 Regulation Name: Ophthalmic Conformer Regulatory Class: Class II Product Code: NXM Dated: April 15, 2009 Received: April 17, 2009

Dear Mr. Malecka:

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 Foond, Or ug, 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 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, FTDA 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.

{3}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

M. B. Egleston, MD

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K090078

Device Name: KeraSys Bioengineered Lamellar Patch Graft

Indications For Use:

The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.

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

Over-The-Counter Use (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)

R. S. Rowe

(Division Sign-Off) (Division Sign-OII)
Division of Ophthalmic and Ear, Division of Open Devices

Page 1 of 1

**510(k) Number**