The Microspecialties, Inc., 500500 and 400400 keratome blades are designed for use with other manufacturer's keratome. The 500500 blade is for use in the Chiron Keratome while the 400400 blade is used in the S.C.M.D. Keratome.

Device Description

The 500500 and the 400400, keratome blades are single-use, disposable. The 500500 blade is for use in the Chiron keratome while the 400400 blade is used in the S.C.M.D. unit. Both blades are packages in a plastic "clamshell" for protection and then double pouched. Each blade will be sold in single units.

AI/ML Overview

The provided text is a 510(k) summary for Disposable Keratome Blades. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria and results for the new device. Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from this document.

The document discusses the device's design, materials, sterilization, and intended use, and compares it descriptively to predicate devices. It does not contain data from an analytical or clinical performance study.

Here's why I cannot provide the requested information based on this document:

No Acceptance Criteria or Performance Results: The document does not list any specific acceptance criteria (e.g., blade sharpness, cutting efficiency, durability) or present performance data against such criteria.
No Performance Study: The document's purpose is to demonstrate substantial equivalence through descriptive comparison and shared characteristics with predicate devices, not by conducting independent performance testing detailed with sample size, ground truth, or expert adjudication.
Focus on Equivalence, Not Independent Performance: The 510(k) process often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (K972727 and K962661 in this case), meaning it is as safe and effective. This typically involves comparing design, materials, sterilization, and intended use, and less often involves extensive de novo performance studies with quantitative acceptance criteria unless there are significant technological differences or new intended uses.

Therefore, the requested table and details about the study, sample sizes, ground truth, and expert involvement are not available in the provided text.

Summary

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510K Summary MICROspecialties.Inc. Disposable Keratome Blades

MAY 1998

Ref. K980508

MICROspecialties, Inc. 16 Higgins Drive Milford, CT 06460 Tel: 203-874-1832 Fax: 203-877-3762

Submitters Name:

Churla Vanilla

Charles Vassallo

9 Mac 98

Date

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, which an equivalence determination could be based. There are two blade styles as part of this submission, which have very slight differences in width dimension. The catalog number 500500 blade is designed to fit Chiron Keratomes, the 400400 blade will fit S.C.M.D. Keratomes. Both blades are manufactured out of the same materials, packaged and sterilized using the same methods.

Trade/Proprietary Name:	Disposable Keratome Blade
Common/Usual Name:	Keratome Blade
Classification Name:	Keratome
Establishment Registration Number:	In process at FDA

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K980508

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

Descriptive Comparison:

The 500500 blade is equivalent to the Med-Logics ML Lasik Blade and the Howard Instruments CBALK-1000 Blade. The 400400 blade is designed for use in the S.C.M.D. Keratomes of Arizonia.

Characteristics:

ं.

The 500500 and the 400400, keratome blades are single-use, disposable. The 500500 blade is for use in the Chiron keratome while the 400400 blade is used in the S.C.M.D. unit.

Both blades are packages in a plastic "clamshell" for protection and then double 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 500500 or 400400 blade.

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 outer pouch will indicate MICROspecialties name, address, product identification, lot number, sterilization notes, single use, and federal law statements. The inner pouch will bear the catalog number and lot number.

The blades could be relabeled for sale for other companies. These include Oasis Medical, Howard Instruments, Eye-Med, Insight Technologies Instruments, and S.C.M.D.

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

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K980508

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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

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: K980508 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl lorentthal

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

¥980508 510(k) Number (if known):

Device Name: Disposable Keratome Blades

Daryl Kaufman
(Division Sign-Off)

Division of Ophthalmic Devices 510(k) Number_ 1980508

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

X Prescription Use __ (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 886.4370 Keratome.

(a)
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.(b)
Classification. Class I.