KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)

K980510 · Micro Specialties, Inc. · HNO · May 1, 1998 · Ophthalmic

Device Facts

• Record ID: K980510
• Device Name: KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
• Applicant: Micro Specialties, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other These blades are for use in the Insight Technologies Instruments, Model Kmanufacture's keratome. SERIES Keratome.

Device Story

Disposable surgical keratome blades; designed for use with Insight Technologies Instruments keratomes; available in three blade depths (135, 160, 200 microns). Blades feature integrated holders to simplify assembly to keratome drivers. Used by ophthalmic surgeons in clinical settings to perform corneal incisions. Single-use, sterile, stainless steel construction. Integrated holder color-coded for depth identification. Benefits include improved convenience and ease of assembly compared to blades supplied without holders.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through design similarity to legally marketed predicate devices and adherence to manufacturing standards.

Technological Characteristics

400 Series Stainless Steel blades; single-use; ethylene oxide sterilization per ANSI/AAMI/ISO 11135-1994; color-coded integrated holders; available in 135, 160, and 200 micron depths; mechanical interface for Insight Technologies Instruments keratomes.

Indications for Use

Indicated for use in ophthalmic surgery as a cutting component for Insight Technologies Instruments keratomes. Intended for prescription use only.

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

• Howard Instruments, Inc. Cbalk-1000 LASIK Blade (K972727)
• Med-Logics, Inc. ML Microkeratome Blade (K962661)

Submission Summary (Full Text)

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K980570

## 510K Summary MICROspecialties. Inc. Disposable Keratome Blades with Holder

1 1998 MAY

MICROspecialties, Inc. 16 Higgins Drive Milford, CT 06460 Tel: [phone] Fax: [phone]

Churles Vassalla

Submitters Name:

Charles Vassallo

Date

MAG

300/ H800

18

Ref: 510K Premarket Notification

To: Document Control Clerk:

This summary of 510K safety and effectiveness information is being submitted for the MICROspecialties Disposable Keratome Blades with Holder, which an equivalence determination could be based. There are three blade styles as part of this submission, which have very slight differences in blade depth dimension. All of the blades are designed to fit Insight Technologies Instruments keratomes. The blades are manufactured out of the same materials, packaged and sterilized using the same methods.

Blades without holders are assembled to keratome drivers with reusable holders. Blades with holders that are being submitted have the holder assembled to the blade thereby making the assembly of the keratome system easier and more convenient.

| Trade/Proprietary Name: | Disposable Keratome Blade with Holder |
|------------------------------------|---------------------------------------------------|
| Common/Usual Name: | Keratome Blade |
| Classification Name: | Blade, surgical, saw, general and plastic surgery |
| Establishment Registration Number: | In process at FDA |

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### Performance Standard:

The MICROspecialties disposable keratome blade is similar in design construction, and function to the devices as marketed by:

- Howard Instruments, Inc. . Tuscaloosa, AL 35405 Cbalk-1000 LASIK Blade Reference 510k: K972727
- Med-Logics, Inc. . Temple City, CA 91780 ML Microkeratome Blade Reference 510k: K962661

Although these blades are supplied without holders their function is the same when fully assembled to the keratome.

### Descriptive Comparison:

The blades are equivalent to the Med-Logics ML Lasik Blade and the Howard Instruments CBALK-1000 Blade. The difference is the integration of the holder as part of the blade assembly. The three (3) blades depths dimensions that control the depth of cut on the cornia are; 135 microns, 160 microns, and 200 microns. The holders of these blades will be color coded as a means of additional identification to the labeling.

#### Characteristics:

The keratome blades with holders are single-use, disposable. Both blades are packages in a foam case for protection and then pouched. Each blade will be sold in single units.

#### Certification of Safety and Effectiveness:

When used according to the keratome manufacturers' instructions, there are no adverse safety indications for the either the blades.

Components that come in direct contact with tissue are made of surgical stainless steels commonly used in other surgical blades. The blades will be presterilized by ethylene oxide gas.

#### Labeling:

The pouch will indicate MICROspecialties name, address, product identification, lot number, sterilization notes, single use, and federal law statements. The blades could be relabeled for sale for other companies. These include Oasis Medical, Howard Instruments, Eye-Med, and S.C.M.D.

There will be no advertising using the word "Lasik" in any sales literature, manuals, etc.

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# Sterilization Methodology:

Presterilized by ethylene oxide gas in accordance with ANSVAAMI/ISO 11135-1994, Medical Device-Validation and Routine Control, Ethylene Oxide Sterilization.

# Materials:

The material used in the blade is a 400 Series Stainless Steel.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1998 MAY

Mr. Charles Vassallo MICROspecialties, Inc. 16 Higgins Drive Milford, CT 06460

Re: K980510 Trade Name: Keratome Blade Regulatory Class: I Product Code: 86 HNO Dated: February 6, 1998 Received: February 10, 1998

Dear Mr. Vassallo:

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. Charles Vassallo

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 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 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 yours,

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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## Indications for Use MICROspecialties. Inc. Disposable Keratome Blades with Holder

K980510 510(k) Number (if known):

Device Name: Disposable Keratome Blades with Holder

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Division Sign-Off) Division of Ophthalmic Devices 1980510 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use . (Per 21 CFR 801.109)

OR

Over The Counter Use (Optional Format 1-2-96)