PRIZM KERATOME BLADE, MODEL MK8512M2

K033236 · Surgin Surgical Instrumentation, Inc. · HNO · Mar 26, 2004 · Ophthalmic

Device Facts

• Record ID: K033236
• Device Name: PRIZM KERATOME BLADE, MODEL MK8512M2
• Applicant: Surgin Surgical Instrumentation, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Prizm Keratome Blade VII is to be used as a replacement blade for the blade in the non-disposable Moria M2 keratome for lamellar resection of the cornea.

Device Story

Prizm Keratome Blade VII functions as a disposable replacement component for the non-disposable Moria M2 keratome system. Used by ophthalmologists during lamellar corneal resection procedures. Device provides the cutting edge necessary for the keratome to perform precise corneal tissue removal. Benefits include maintaining sharpness and sterility of the cutting interface for each procedure, reducing risks associated with blade reuse. Operates within the clinical setting as part of the standard keratome assembly.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable stainless steel blade designed for compatibility with the Moria M2 keratome system. Mechanical cutting principle. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a replacement blade in the Moria M2 keratome for lamellar corneal resection in patients undergoing refractive surgery.

Regulatory Classification

Identification

A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

Reference Devices

• Moria M2 keratome

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Public Health Service

MAR 2 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgin, Inc. c/o Mr. Don W. Haar QA/ Regulatory Manager 14762 Bentley Circle Tustin, CA 92680

Re: K033236

Trade/Device Name: Prizm Keratome Blade VII Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: February 9, 2004 Received: February 9, 2004

Dear Mr. Haar:

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 - Mr. Don W. Haar

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 vours.

A. heyl 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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## Surgin, Inc

14762 Bentley Circle Tustin. CA 92680 Tcl: 714 832 6300

## INDICATIONS FOR USE STATEMENT

510(k) Number แหล่งข้อ Ko33236

Device Name: Pluzen KEIKTORE BLADE VIL

Indications For Use:

The Prizm Keratome Blade VII is to be used as a replacement
blade for the blade in the pon-disposable M. H. Mac blade for the blade in the non-disposable Moria M2 keratome
for lanellar resection of the corner for lamellar resection of the non-disportion

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------------------|---------|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K033236 |

| Prescription Use | <div> <span style="text-decoration: underline;">✓</span> </div> |
|----------------------|-----------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)