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

Device Description

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. 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. 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.

AI/ML Overview

This 510(k) submission (K980570) for the MICROspecialties, Inc. Disposable Keratome Blades with Holder is a traditional medical device submission, not an AI/ML-driven device. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., MRMC studies, standalone algorithm performance, AI vs. human performance metrics, training/test set details, ground truth establishment methods) are not applicable here.

This submission focuses on establishing substantial equivalence to existing predicate devices based on design, materials, manufacturing, and intended use, rather than demonstrating a specific performance metric beyond the predicates.

Here's an analysis based on the provided text, highlighting what is applicable and explaining why other sections related to AI/ML are not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (from text)
Design and Function Equivalence:	"The MICROspecialties disposable keratome blade is similar in design construction, and function to the devices as marketed by: Howard Instruments, Inc. (K972727) and Med-Logics, Inc. (K962661)." "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."
Material Equivalence:	"Components that come in direct contact with tissue are made of surgical stainless steels commonly used in other surgical blades." "The material used in the blade is a 400 Series Stainless Steel" (This is a common surgical grade stainless steel, implying equivalence to other surgical blades).
Sterilization Method Equivalence/Validation:	"Presterilized by ethylene oxide gas in accordance with ANSVAAMI/ISO 11135-1994, Medical Device-Validation and Routine Control, Ethylene Oxide Sterilization." (Demonstrates adherence to recognized standards for sterilization, implying safety and effectiveness comparable to similarly sterilized devices).
Intended Use Equivalence:	"The Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other (Insight Technologies Instruments, Model K-SERIES Keratome)." (Indicates the device is intended for the same purpose as the predicate blades, which are used within a keratome system).
Safety:	"When used according to the keratome manufacturers' instructions, there are no adverse safety indications for the either the blades." (A general statement asserting safety, often backed by material biocompatibility and sterilization validation).
Performance (Blade Depth Dimensions):	"The three (3) blades depths dimensions that control the depth of cut on the cornia are; 135 microns, 160 microns, and 200 microns." (These specific depths directly relate to the claimed function and match the range of what would be expected for keratome blades in this application).

2. Sample size used for the test set and the data provenance

Not Applicable in the context of an AI/ML device. This submission does not involve a "test set" of patient data for algorithm performance evaluation.
The evaluation is based on comparison of product specifications, materials, manufacturing processes, sterilization, and intended use with legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. There is no "ground truth" in the AI/ML sense, as there's no diagnostic or predictive output being evaluated against expert consensus or pathology.
The "experts" involved would be regulatory bodies (FDA reviewers) assessing the provided documentation and comparing it to predicate devices and relevant standards.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication process as defined for AI/ML performance evaluation occurred.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted device, so no MRMC study or AI improvement metrics were performed or are relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical surgical blade, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. No explicit "ground truth" in the AI/ML sense is mentioned or required for this type of device submission. The primary "truth" the FDA assesses is whether the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective. This is based on objective comparison of characteristics and adherence to standards.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or "ground truth" in the AI/ML context.

Summary of "Study" and Evidence for Substantial Equivalence:

The "study" in this context is the 510(k) premarket notification process, where MICROspecialties, Inc. presented a detailed comparison of their Disposable Keratome Blades with Holder to existing predicate devices.

Evidence presented for substantial equivalence:

Descriptive Comparison: Explicitly stating similarity in "design, construction, and function" to specific predicate devices (Howard Instruments, Inc. Cbalk-1000 LASIK Blade K972727 and Med-Logics, Inc. ML Microkeratome Blade K962661). The key difference (integrated holder) is identified and implied to not fundamentally alter the safety or effectiveness.
Material Specification: Using 400 Series Stainless Steel, a common surgical material, implying biocompatibility and mechanical properties consistent with predicate devices.
Sterilization Validation: Adherence to recognized international standards (ANSVAAMI/ISO 11135-1994) for ethylene oxide sterilization, demonstrating sterility assurance comparable to other medical devices.
Performance Characteristics: Specification of blade depths (135, 160, 200 microns) which are directly related to the intended use of creating corneal flaps of specific thicknesses, consistent with the functionality of similar keratome blades.
Intended Use Statement: Clear indication that the blades are for use with specific keratoome instruments (Insight Technologies Instruments, Model K-SERIES Keratome), aligning their application with that of predicate blades.

Conclusion from the FDA: The FDA's letter (K980510) indicates that based on the submitted information, the device was found to be substantially equivalent to devices marketed prior to May 28, 1976, or to lawfully reclassified devices. This finding signifies that the device meets the regulatory "acceptance criteria" for market entry in terms of safety and effectiveness being equivalent to already approved devices.

Summary

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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: 203-874-1832 Fax: 203-877-3762

Churles Vassalla

Submitters Name:

Charles Vassallo

Date

MAG

300/ H800

Ref: 510K Premarket Notification

To: Document Control Clerk:

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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with three heads, which are stylized and abstract. The eagle is facing to the left.

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 (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. 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)

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.