The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191

Device Description

The MICROspecialties, Inc. disposable M2 compatible Microkeratome blade is a replacement stainless steel blade for the Moria M2 Microkeratome blade. Both blades are made of 400 series stainless steel and they are packaged and shipped using the same methods. Both blades are single-use, sterile, and disposable blades.

AI/ML Overview

The provided document describes the MICROspecialties, Inc. Disposable M2 Compatible Microkeratome Blades and its substantial equivalence to the predicate device, the Moria M2 Microkeratome blade (K002191). The study aims to demonstrate that the new device performs comparably to the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating comparability to the predicate device.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (MICROspecialties M2 Compatible Blade)
Intended Use	Same as predicate device (Moria M2 Microkeratome blade)	As indicated (Same as predicate)
Target Population	Same as predicate device	As indicated (Same as predicate)
Performance (General)	Comparable to the M2 Blade (predicate)	Comparable to the M2 Blade (predicate)
Blade Material	Low carbon stainless steel (same as predicate)	Low carbon stainless steel (Same as predicate)
Blade Dimensions	Comparable to the M2 blade (predicate)	Comparable to the M2 blade (Same as predicate)
Physical Measurements	Same as the predicate device	Same as the predicate device
Sharpness	Comparable to the predicate blade	Comparable to the predicate blade
Fit	Same as the predicate blade	Same as the predicate blade
Corneal Resections	Similar accuracy and variability to predicate device	Similar accuracy and variability (demonstrated on porcine eyes)
Sterilization	Sterilized to SAL of 10-6 with validated process to EN 552	Sterilized by exposure to gamma radiation to an SAL of 10-6 with a validated process to EN 552

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document explicitly mentions "Non-clinical testing on porcine eves". However, the exact number of porcine eyes used in this testing is not specified in the provided text.
Data Provenance: The testing was "non-clinical" and likely conducted in a laboratory setting. There is no mention of country of origin for this specific testing or if it was retrospective or prospective. It is implied to be prospective testing for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of human experts or an expert panel to establish ground truth for the non-clinical testing on porcine eyes. The assessment of "corneal resections that had similar accuracy and variability" would likely be performed by technicians or researchers, but their qualifications are not specified.

4. Adjudication Method for the Test Set

Since there's no mention of human experts establishing ground truth or a multi-reader setup, there is no adjudication method described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study focuses on the physical and performance characteristics of the device itself (blade material, sharpness, fit, and corneal resection quality on animal models), not on human reader performance with or without AI assistance. This device is a surgical blade, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This device is a microkeratome blade, a physical surgical instrument, not an algorithm or AI system. Therefore, standalone algorithm-only performance testing is not relevant.

7. Type of Ground Truth Used

The ground truth for the performance testing (specifically for corneal resections) appears to be based on objective measurements and observations of the quality and consistency of corneal flaps created on porcine eyes. This is a form of experimental or laboratory ground truth, comparing new device outcomes to those known to be produced by the predicate device.

8. Sample Size for the Training Set

There is no mention of a training set in this document. As the device is a physical surgical blade and not an AI or machine learning model, a training set as typically understood in AI/ML development is not applicable. The device's design and manufacturing are based on established engineering principles and material science, not data-driven training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a training set is not mentioned and is not relevant for this type of device, the method for establishing its ground truth is also not applicable.

Summary

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K033457

Ref: 510(k) Premarket Notification Summary

MAY 25 2004

To: Document Control clerk

This is to notify you of the intention of MICROspecialties, Inc. to manufacture and market the following device:

Disposable M2 Compatible Microkeratome Blades

Establishment registration number: 1226074

This 510(k) summary of safety and effectiveness for the MICROspecialties, Inc. Microkeratome blade is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF §807.92, and follows the Office of Device Evaluation guidance concerning the presentation and content of a 510(k) summary.

Submitter's name, address, telephone number, contact person, and date the 1. summary was prepared:
Applicant: MICROspecialties, Inc. a. 264 Quarry Road Milford, CT 06460
(203)-874-1832 b. Telephone number:
c. Contact Person: Leigh S. Ayres (Director, Regulatory and Quality)
d. Date summary prepared: 10/23/03
- Name of the device, including trade name, the common or usual name, and the 2. classification
M2 Compatible Microkeratome Blade a. Trade/Proprietary name:
Microkeratome blade b. Common/Usual Name:
c. Classification: Keratome (blade only) - 21CFR §886.4370
86 HNO d. Product code:
e. Classification panel: Ophthalmic
- 3. Identification of legally marketed devices to which equivalence is being claimed:

The MICROspecialties, Inc. disposable M2 Compatible Microkeratome blade is substantially equivalent in design, material, and function to the devices as marketed by:

Company: Moria S. A. Device: Moria M2 Microkeratome blade 510(k) number: K002191

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K033457

Description of the device: 4.
The MICROspecialties, Inc. disposable M2 compatible Microkeratome blade is a replacement stainless steel blade for the Moria M2 Microkeratome blade. Both blades are made of 400 series stainless steel and they are packaged and shipped using the same methods. Both blades are single-use, sterile, and disposable blades.

Certification of safety and effectiveness:

When used according to the Microkeratome manufacturer's instructions, there are no adverse safety indications for the M2 compatible Microkeratome blade.

Sterilization Methodology:

All blades are sterilized by exposure to gamma radiation to a Sterilization Assurance Level (SAL) of 10-6 with a validated process to EN 552.

Labeling:

The pouch will indicate MICROspecialties, Inc. name, address, product identification, lot number, sterilization notes, single use, and federal law statements.

5. Intended Use for the Device:

The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191.

Summary of the Technological Characteristics of the Submitted Device 6. Compared to the Predicate device (§807.92(a)(6) - K002191):

CHARACTERISTICS	M2 Compatible Blade	M2 Blade
Intended use	As indicated	Same
Target population	As indicated	Same
Performance	Comparable to the M2 Blade	Same
Blade Material	Low carbon stainless steel	Same
Blade dimensions	Comparable to the M2 blade	Same

Performance Tests and Conclusions:

1. The physical measurements of the M2 compatible Microkeratome blade is the same as the predicate device made by Moria S. A.
1. The sharpness of the predicate blade made by Moria S. A. and the M2 Compatible Microkeratome blade are comparable.
1. The fit of the predicate blade made by Moria S. A. and the M2 Compatible Microkeratome blade are the same.
1. Non-clinical testing on porcine eves resulted in corneal resections that had similar accuracy and variability.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 2004

Micro Specialties, Inc. c/o Leigh S. Ayres 264 Quarry Road Milford, CT 06460

Re: K033457

Trade/Device Name: M2 Compatible Microkeratome Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: 86 HNO Dated: April 27, 2004 Received: April 29, 2004

Dear Ms. Ayres :

We have reviewed your Section 510(k) premarket notification of intent to market the device w f na re reviewe 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 prov to that if the 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 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.

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Page 2- Ms. Leigh Ayres

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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kaligi 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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Indications for Use

510(k) Number (if known):

Device Name: M2 Compatible Microkeratome Blade (Model 700700)

Indications For Use:

The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191

Prescription Use (Part 21 CFR 801 Subparl D)

AND/OR

Qver-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Don Kevin

(Division sign-om)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(K) Number K0334157

Page 1 of

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.