M-PACT CORNEAL LIGHT SHIELD

K993883 · M-Pact Corp. · HOZ · Dec 21, 1999 · Ophthalmic

Device Facts

• Record ID: K993883
• Device Name: M-PACT CORNEAL LIGHT SHIELD
• Applicant: M-Pact Corp.
• Product Code: HOZ · Ophthalmic
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4790
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Corneal Light Shield is a sterile sponge that is not absprbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.

Device Story

The M-Pact Corneal Light Shield is a sterile, non-absorbable PVA sponge designed for ophthalmic procedures. Placed on the corneal surface by a physician, the device acts as a physical barrier to shield the retina from excessive illumination. The sponge features an interconnected cell structure that resists fiber shedding and tearing, is nonabrasive, and absorbs approximately 15 times its weight in fluid. It is intended for transient, single-use only and is discarded after the procedure. The device provides a protective benefit to the patient by preventing retinal damage from light exposure during surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Polyvinyl alcohol (PVA) sponge. Features: Interconnected cell structure, nonabrasive, tear-resistant. Performance: Absorbs ~15x weight in fluid. Sterilization: Gamma or e-beam irradiation. Packaging: Moisture barrier. Form factor: Compressed and dried sponge.

Indications for Use

Indicated for use by physicians during ophthalmic procedures to shield the patient's retina from excessive illumination. Intended for short-term, transient, single-use on the corneal surface.

Regulatory Classification

Identification

An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic 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 the limitations in § 886.9.

Predicate Devices

• Merocel Corneal Sponge

Submission Summary (Full Text)

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DEC 2 1 1999

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# A - 510(k) SUMMARY OF SAFETY AND EFFICACY

DATE PREPARED:

SUBMITTER:

November 2, 1999

M-Pact Corp. 1040 OCL Parkway Eudora, KS 66025 PH: 785-542-2920 ext. 112 800-255-4152 Fax: [phone]

CONTACT PERSON:

TRADE (PROPRIETARY) NAME:

M-Pact Corneal Light Shield

And Quality Assurance.

Corneal Light Shield

Class II

Merocel -

Al Boedeker, Manager of Regulatory Affairs

COMMON NAME:

DEVICE CLASSIFICATION:

PREDICATE DEVICE:

DESCRIPTION OF DEVICE:

The M-Pact Corneal Light Shield is designed to be placed on the surface of the cornea during ophthalmic procedures to shield the retina from excessive illumination. The Corneal Light Shield is transient to minimal short-term use only. The Shield is nonabrasive, and is formulated to resist tearing or shedding of fibers.

STATEMENT OF INTENDED USE:

The Corneal Light Shield is a sterile sponge that is not absprbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.

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## TECHNOLOGICAL CHARACTERISTICS:

The M-Pact Corneal Light Shield has similar technological characteristics compared to the predicate device. The features are given in the Substantial Equivalence Table below.

### SUBSTANTIAL EQUIVALENCE TABLE

| FEATURES | M-pact Corneal Light Shield | Merocel Corneal Sponge |
|----------------------------------------------------------------|-----------------------------|------------------------|
| Made of PVA Sponge<br>Bio-compatible and non-toxic | YES | YES |
| shields the retina from laser<br>illumination | YES | YES |
| Foam is compressed and<br>dried prior to packaging | YES | YES |
| Sterilized by Gamma or<br>e-beam irradiation | YES | YES |
| Stored with moisture barrier<br>packaging | YES | YES |
| Interconnected cell structure<br>that prevents loose particles | YES | YES |
| Tear resistant | YES | YES |
| Nonabrasive | YES | YES |
| Absorbs about 15 times its<br>weight in fluid | YES | YES |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

M-Pact Corporation Mr. Al Boedeker Manager of Regulatory Affairs and Quality Assurance 1040 OCL Parkway Eudora, KS 66025

Re: K993883 Trade Name: Corneal Light Shield (ophthalmic sponge) Regulatory Class: II Product Code: 86 HOZ Dated: November 11, 1999 Received: November 15, 1999

Dear Mr. Boedeker:

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 current Good Manufacturing Practice requirements, 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 - Mr. Al Boedeker

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 marked 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.gov/cdrh/dsmamain.html".

Sincerely vours.

A. Ralph Rosenthal

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

Enclosure

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510(k) Number (if known): __ K993883

CORNEAL LIGHT SHEILD Device Name:

#### INDICATIONS FOR USE:

The Corneal Light Shield is a sterile sponge that is not absorbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.

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Concurrence of CDRH, Office of Device Evaluation (ODE) vision Sign-Off) Division of Ophthalmic Devices 510(k) Number_K993883 Prescription Use OR Over-The Counter OR Over-The-Counter Use Prescription Use (Optional Format 1-2-96) (Per 21 CER 801.109)