PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD

K033182 · Surgin Surgical Instrumentation, Inc. · HNO · Jan 30, 2004 · Ophthalmic

Device Facts

• Record ID: K033182
• Device Name: PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
• Applicant: Surgin Surgical Instrumentation, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

SURGIN'S PRIZM BLADES ARE DESIGNATED AS REPLACEMENT BLADES FOR THE BECTON DICKINSON BD-3000 MICROKERATOME SYSTEM, TO BE USED FOR LAMELLAR RESECTION OF THE CORNEA

Device Story

The PRIZM Keratome Blade is a replacement blade component for the Becton Dickinson BD-3000 microkeratome system. It is used by ophthalmic surgeons during corneal surgery to perform lamellar resection of the cornea. The device functions as a mechanical cutting instrument integrated into the existing microkeratome system. It does not involve electronic processing, software, or automated analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical cutting blade designed for compatibility with the Becton Dickinson BD-3000 microkeratome system. No electronic, software, or energy-based components.

Indications for Use

Indicated for lamellar resection of the cornea using the Becton Dickinson BD-3000 microkeratome system.

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.

Predicate Devices

• Becton Dickinson BD-3000 Microkeratome System

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgin, Inc. c/o Don Harr RA/OA Manager 14762 Bentley Circle Tustin, CA 92680

Re: K033182

Trade/Device Name: PRIZM Keratome Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: December 16, 2003 Received: January 5, 2004

Dear Mr. Harr:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have a rowed your 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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drag, 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 r our may, merere, mans 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 rr your device is exactive (tional controls. Existing major regulations affecting your device can may or subject to back as 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 cquivalence determination does not mean I lease be actised that I Dr vistian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny redorm statutes the 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 ford in the quand cyerol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

JAN 30 2004

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Page 2 - Don Harr

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,

Alegi 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 Tel: [phone]

## INDICATIONS FOR USE STATEMENT

K033182 510(k) Number (il known): Device Name: Purzu Barac Indications For Use: SUREN'S PM BUNDES AND DESIGNATI AS NEPLACEMENT Burdes For 7 The BESTON DICKINSON BD - 3000 MICH SHATUALE SYSTEM", To BE USED FOR CANECLAR PESEGENON OF THE CORNEA

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

| Concurrance of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|---------|----------------------|
| <div><img alt="signature" src="signature.png"/></div> | | |
| (Division Sign-Off) | | |
| Division of Ophthalmic Ear, Nose and Throat Devices | | |
| 510(k) Number | K033182 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |

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