The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

List of components
a) Power unit
b) Motor
c) Suction rings
d) Applanator lenses
e) Footswitches
f) Keratome head with pre-inserted Keratome blade

AI/ML Overview

The M2 SINGLE USE microkeratome is intended for use in creating a corneal flap for LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

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

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the M2 SINGLE USE microkeratome. Instead, it relies on demonstrating equivalence to predicate devices and qualitative performance. The reported performance is based on in-vivo and in-vitro studies:

Acceptance Criteria (Inferred)	Reported Device Performance
In-vitro:
Flap thickness consistency	Demonstrated in in-vitro studies on porcine eyes.
Safety of corneal resections	Demonstrated in in-vitro studies on porcine eyes.
Good quality of corneal resections	Demonstrated in in-vitro studies on porcine eyes.
In-vivo:
Safety in human eyes	"M2 SINGLE USE microkeratome is a safe Keratome" (based on in-vivo studies on 72 human eyes).
Ability to create circular lamellar resection	"able to create... circular lamellar resection" (based on in-vivo studies on 72 human eyes).
Ability to create resection of predetermined diameter	"able to create... of a predetermined diameter" (based on in-vivo studies on 72 human eyes).
Ability to create resection of predetermined thickness	"able to create... of a predetermined... thickness" (based on in-vivo studies on 72 human eyes).
Bed smoothness	"and bed smoothness" (based on in-vivo studies on 72 human eyes).
Equivalence to predicate device (CARRIAZO BARRAQUER products)	"able to create, equivalently to the predicate device, circular lamellar resection of a predetermined diameter and thickness and bed smoothness." (based on in-vivo studies on 72 human eyes compared to the predicate device CARRIAZO BARRAQUER SINGLE USE Microkeratome (K003594) and CARRIAZO BARRAQUER II Microkeratome (K002191)). (The document implies this equivalence is for all listed in-vivo performance metrics).

2. Sample Size and Data Provenance

Test Set Sample Size:
- In-vitro: Not specified, but stated as "in-vitro studies on porcine eyes."
- In-vivo: 72 human eyes.
Data Provenance: The document does not explicitly state the country of origin. Given the submitter's location (MORIA S.A. in France), it is plausible the studies were conducted in Europe, but this is not confirmed. The studies are implicitly prospective for the M2 SINGLE USE microkeratome as they are conducted to demonstrate its performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts or their qualifications used to establish ground truth for either the in-vitro or in-vivo studies. The "Discussion of tests and results" section simply states what was "demonstrated" by the studies.

4. Adjudication Method

The document does not mention any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The study compares the M2 SINGLE USE microkeratome to predicate devices, but there is no indication of human readers improving with or without AI assistance, as AI is not a component of this device.

6. Standalone Performance

Yes, the studies described are for the standalone performance of the M2 SINGLE USE microkeratome, as it is a physical device and not an AI algorithm requiring human-in-the-loop interaction. The performance metrics listed describe the device's inherent ability to create corneal flaps.

7. Type of Ground Truth Used

In-vitro studies (porcine eyes): The ground truth for flap thickness consistency, safety, and quality of corneal resections would likely be based on direct measurements, microscopic examination, and qualitative assessment by trained surgical or pathology personnel.
In-vivo studies (human eyes): The ground truth for safety, ability to create circular lamellar resection, predetermined diameter and thickness, and bed smoothness would be assessed directly by the operating surgeon and through post-operative clinical evaluations, possibly including imaging techniques for flap dimensions and quality. This primarily relies on expert assessment/clinical observation.

8. Sample Size for the Training Set

This information is not applicable as the M2 SINGLE USE microkeratome is a mechanical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable for the reason stated above (it's not an AI/machine learning device).

Summary

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MORIA S.A. M2 SINGLE USE microkeratome

July 2nd, 2002 Premarket Notification KOZZ560

SEP 2 7 2002

Section 4 page 1

510(k) SUMMARY

1. Submitter's identification

a. MORIA S.A. 15, rue Georges Besse 92160 ANTONY France Tel: (33-1) 46 74 46 36 Fax: (33-1) 46 74 46 70
- Contact person: Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager

E mail: mrenaud@moria-int. com

July 2nd, 2002 C. Date Summary Prepared:

2. Device name

M2 SINGLE USE microkeratome Trade Name:

3. Classification name

Keratome (per CFR 886.4370)

4. Substantial equivalence

Substantial equivalence is being claimed to the following legally marketed devices:

Device name: CARRIAZO BARRAQUER SINGLE USE Microkeratome Company name: MORIA S.A. Document control number: K003594

And

Device name: CARRIAZO BARRAQUER II Microkeratome Company name: MORIA S.A. Document control number: K002191

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Section 4 page 2

5. Device description

List of components

a) Power unit
b) Motor
c) Suction rings
d) Applanator lenses
e) Footswitches
f) Keratome head with pre-inserted Keratome blade

Power unit a)

The power unit used for the M2 SINGLE USE microkeratome is the same as the power unit used for the predicate devices CARRIAZO BARRAQUER SINGLE USE Microkeratome (K003594) & CARRIAZO BARRAQUER II Microkeratome (K002191) already legally marketed in the USA by our company.

The power unit includes pumps for producing vacuum.

The power unit has been designed to operate the Keratome by means of electric motor or by means of a gas turbine motor.

Only one of the above power options can be selected at the time by means of a 2 position switches in the front panel.

The front panel has several displays and features:

Vacuum pressure gauge, -
Gas pressure gauge, -
-Battery level indicator,
Battery charge indicator, -
-Connectors:
- . DC motor outlet,
- . Gas outlet.
- Vacuum outlet, ●

The back panel has several displays and features:

-Connectors:
- Gas inlet,
- . Foot pedals,
- . Battery charger.

All connectors are of different type for preventing connecting mistakes.

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Section 4 page 3

b) Keratome motor

Option 1: Turbine motor

The turbine motor is gas powered. The recommended gas is medical grade nitrogen. The turbine has been marketed by MORIA since six years (see predicate device PLANCON MICROLAMELLAR KERATOME K970377).

Option 2: The electrical motor

The drive system has two built-in electrical motors (one motor for the blade oscillation and one motor for the advance of the microkeratome).

Keratome head C)

The Keratome head includes the blade that is moved by the motor.

Different heads are available in order to adjust the thickness of the cut.

d) Suction rings

The suction rings are used to fixate and pressurize the eye and provide a base for the microkeratome.

e) Applanator lenses

The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.

They are used with the rings to control disk diameter before the cut.

The upper face is convex for magnification.

The base face (contact face) is plane, with an engraved and calibrated reticule diameter.

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Section 4 page 4

f) Keratome blade

The blade is made of two parts: the blade edge in low carbon steel, and the blade holder, which is not in contact with the patient's eye.

6. Statement of intended use

The M2 SINGLE USE microkeratome is intended for use in making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

7. Discussion of tests and results

Keratomes have been used for lamellar keratoplasty for more than 30 years.

In-vitro studies on porcine eyes demonstrated:

-The flap thickness consistency,
The safety of corneal resections, -
The good quality of corneal resections. -

In-vivo studies on 72 human eyes showed that the M2 SINGLE USE microkeratome is a safe Keratome able to create, equivalently to the predicate device, circular lamellar resection of a predetermined diameter and thickness and bed smoothness.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MORIA S.A. c/o Mrs. Melanie Renaud-Samiri Ouality Assurance & Regulatory Affairs Manager 15, Rue Georges Besse 92160 Antony France

Re: K022560

Trade/Device Name: M2 Single Use microkeratome Regulation Number: 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HMY Dated: July 2, 2002 Received: August 2, 2002

Dear Mrs. Renaud-Samiri:

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 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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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 and additionally 21 CFR Part 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" (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 (800) 638-2041 or (301) 443-6597 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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Section 5 page 1

510(k) Number (if known):

Device Name:

M2 SINGLE USE microkeratome

Indications for use:

The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

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

Concurrence of CDRH, Office of Qevice Eyaluation (ODE)

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

510(k) Number_ ( 0 2 2 5 6 0 2 2 5 6 0 -

Prescription Use V (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.