KERATOME BLADE 200200 & 600600

• K Number: K020482
• Device Name: KERATOME BLADE 200200 & 600600
• Manufacturer: MICROSPECIALTIES, INC.
• Date Cleared: 2002-12-16 ( 306 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The MICROspecialties, keratome blades are designed to produce a corneal flap when used with the following Moria microkeratomes:

• MICROspecialties 200200 Blade for use on Moria LSK Microkeratome .
• MICROspecialties 600600 Blade for use on Moria CB Microkeratome

Device Description

The disposable 200200 microkeratome blade is designed to be used with the Moria LSK microkeratome system. The disposable 600600 microkeratome blade is designed to be used with the Moria CB microkeratome system. Both of these blades are designed to produce a corneal flap. The blades are packaged in plastic cases to protect the cutting edge and the placed in a Tyvek/poly pouch. They are sold as ten blades per box or in larger quantities of thirty (three ten-packs). Labeling identifies each quantity per box. The blades are then gamma radiation sterilized.
The blades are made from medical grade stainless steel with a single cutting edge. They are assembled with their compatible head and driver systems.

AI/ML Overview

The provided text describes a 510(k) summary for two styles of microkeratome blades, but it is not a study report that would include detailed acceptance criteria and performance data in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions a "nonclinical evaluation" and "design validation" but does not provide the specific quantitative details needed to fill out a table of acceptance criteria and reported device performance, nor does it detail the methodology of a formal study with the requested elements.

Therefore, I cannot generate the requested table and detailed study information. However, I can extract the available information regarding the evaluation performed:

Summary of Device Evaluation Information from the Document:

• Acceptance Criteria and Reported Device Performance: This information is not provided in a quantitative or systematic way in the document. The text generally states that "Engineering, manufacturing and inspection specifications were finalized based on this evaluation," and "The blades go through 100% inspection to insure that they meet the product specification and follow design controls of MICROspecialties." No specific numerical criteria or performance metrics are given.
• Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Independent physicians and clinics were used to evaluate the performance," but does not give a specific sample size for the test set or the country of origin. It appears to be a nonclinical evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The document mentions "Independent physicians and clinics," but does not specify how many, their specialties, or their years of experience.
• Adjudication method: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned or described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (surgical blade), not an AI algorithm.
• The type of ground truth used: Not explicitly defined in terms of a formal ground truth process. The evaluation included "package handling, ease of use, performance on the respective Moria microkeratomes" and "appearance, compatibility with the Moria microkeratomes and performance within these systems." This suggests observation-based feedback and functional testing.
• The sample size for the training set: Not applicable and not mentioned. This is a medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable and not mentioned.

Conclusion:

The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain the detailed, quantitative study data typically found in a scientific paper or a comprehensive test report that would describe explicit acceptance criteria, performance metrics, ground truth establishment, or statistical methods. It largely relies on a risk analysis, design validation, manufacturing controls, and qualitative user feedback to support its claims of safety and effectiveness relative to a predicate device.

Summary

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MICROspecialties,Inc. 264 Quarry Road, Milford, CT 06460

Tel: [phone]

Fax: [phone]

DEC 1 6 2002

K020482 510(k) Summary (ref. 807.87h)

This summary of the 510(k) safety and effectiveness information is being submitted for two styles of microkeratome blades for use on Moria microkeratome systems. The MICROspecialties 200200 Blade is designed for use on the Moria, Model LSK microkeratome and the MICROspecialties 600600 Blade for use on the Moria, Model CB microkeratome.

The blades are manufactured using the same materials and packaging. The method of sterilization is commonly used in these devices and their packaging.

Content and Format of a 510(k) Summary (807.92a)

• 1. Submitter: Gaston Levesque, President MICROspecialties, Inc. 264 QUARRY Road Milford. CT 06460 Phone: [phone] Fax: [phone]
• 2. Keratome Blade
• 3. 200200 Keartome Blade 600600 Keratome Blade
• 4. The disposable 200200 microkeratome blade is designed to be used with the Moria LSK microkeratome system. The disposable 600600 microkeratome blade is designed to be used with the Moria CB microkeratome system. Both of these blades are designed to produce a corneal flap. The blades are packaged in plastic cases to protect the cutting edge and the placed in a Tyvek/poly pouch. They are sold as ten blades per box or in larger quantities of thirty (three ten-packs). Labeling identifies each quantity per box. The blades are then gamma radiation sterilized.

The blades are made from medical grade stainless steel with a single cutting edge. They are assembled with their compatible head and driver systems.

• 5. The 200200 and 600600 keratome blades are designed to produce a corneal flap. This is part to correct correct vision of a surgical procedure in the the the adult population.

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MICROspecialties, Inc. 264 Quarry Road, Milford, CT 06460

Tel: [phone]

510(k) Summary - cont. (ref. 807.87h)

• 5. The MICROspecialties 200200 and 600600 keratome blades are designed for use with Moria Microkeratome systems. The 200200 blade is for use with the Moria, Model LSK Microkeratome and the 600600 for use with the Moria, Model CB Microkeratome.
     A risk analysis was performed to provide a systematic approach to the evaluation of hazards associated with the keratome blades.

Independent physicians and clinics were used to evaluate the performance of the 200200 and 600600 microkeratome blades as part of a nonclinical evaluation The evaluation included package handling, ease of use, performance on the respective Moria microkeratomes.

Engineering, manufacturing and inspection specifications were finalized based on this evaluation. A design validation was conducted to validate the appearance, compatibility with the Moria microkeratomes and performance within these systems. The blades go through 100% inspection to insure that they meet the product specification and follow design controls of MICROspecialties.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles three overlapping, curved lines.

DEC 16 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MICROspecialties, Inc. c/o Ms. Leigh Ayres, Director Quality Assurance and Regulatory Affairs 264 Quarry Road Milford, CT 06460

K020482 Re:

Trade/Device Name: MICROspecialties 200200 Blade for the Moria LSK Microkeratome MICROspecialties 600600 Blade for the Moria CB Microkeratome

Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: November 20, 2002 Received: November 21, 2002

Dear Ms. Ayres:

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

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Page 2 - Ms. Leigh Ayres, Director

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. 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]. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
A. Ralph 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

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Indications for Us MICROspecialties. Inc. Disposable Keratome Blades

Page 1 of 1

K020482 510(k) Number (if known):

Device Name: Disposable Keratome Blades for use on Moria Microkeratomes

The MICROspecialties, keratome blades are designed to produce a corneal flap when used with the following Moria microkeratomes:

• MICROspecialties 200200 Blade for use on Moria LSK Microkeratome .
• MICROspecialties 600600 Blade for use on Moria CB Microkeratome

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ar Callaway

(Bivision Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

K020482 510(k) Number_

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

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.