The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.

Device Description

List of components

Power unit
Motor
Suction rings
Applanator lenses
Footswitches
Keratome head
Keratome blade

a) Power unit
The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & 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.
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 motors outlets, Gas turbine 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 types for preventing connection mistakes.

b) Keratome 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).

c) Keratome head
In the keratome head, a blade activated by an oscillation motor is inserted.
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 to provide a base for the microkeratome heads.

e) Applanator lenses
The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.
They are used with the rings to check disk diameter before the cut.
The upper part is convex for magnification.
The base part (contact part) is plane, with an engraved and calibrated reticule diameter.

f) Keratome blade
The blade is made of two parts: the metal part in low carbon steel, and the plastic blade holder, which is not in contact with the patient's eye.
Different blades are available in order to adjust the thickness of the cut.

AI/ML Overview

The provided text describes the MORIA S.A. OneUse - Plus Microkeratome and its intended use, but it does not specify explicit acceptance criteria in a quantitative format. Instead, it mentions general performance characteristics demonstrated through studies.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not stated, the table below consolidates the qualitative performance mentioned in the "Discussion of tests and results" section.

Acceptance Criterion (Implicit)	Reported Device Performance
Flap thickness consistency	Demonstrated in in-vitro studies on porcine eyes. In-vivo studies on 54 human eyes showed the device is able to create "circular lamellar resection of a predetermined diameter and thickness."
Safety of corneal resections	Demonstrated in in-vitro studies on porcine eyes. In-vivo studies on 54 human eyes showed the device is "a safe Keratome."
Quality of corneal resections (e.g., bed smoothness)	Demonstrated "good quality of corneal resections" in in-vitro studies on porcine eyes. In-vivo studies on 54 human eyes showed the device makes resections with "bed smoothness."
Equivalence to predicate device for creating lamellar resections	In-vivo studies on 54 human eyes showed the device is able to create, "equivalently to the predicate device, circular lamellar resection of a predetermined diameter and thickness and bed smoothness." (This implies a comparison and meeting the performance standards of the predicate device, but no specific metrics are given).

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

Sample Size for Test Set:
- In-vitro studies: Performed on "porcine eyes." The exact number of porcine eyes is not specified.
- In-vivo studies: 54 human eyes.
Data Provenance:
- The document does not explicitly state the country of origin for the data for either the in-vitro or in-vivo studies.
- The studies were conducted as part of a premarket notification, implying they were prospective safety and performance assessments. However, the exact nature (e.g., fully prospective clinical trial, observational study) is not detailed beyond "in-vivo studies."

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set. It mentions "in-vivo studies on 54 human eyes showed..." and "In-vitro studies on porcine eyes demonstrated...", suggesting clinical or laboratory assessments, but details on expert involvement in defining the "truth" for these assessments are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of an effect size regarding human reader improvement with or without AI assistance. The device is a microkeratome, a surgical instrument, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable as the device is a mechanical surgical microkeratome, not an algorithm or AI system. Its performance is inherently tied to its use by a human surgeon.

7. Type of Ground Truth Used

The "ground truth" for the performance claims would be:

In-vitro studies (porcine eyes): Direct measurements of flap thickness, assessment of corneal resection safety, and quality (bed smoothness) using laboratory techniques.
In-vivo studies (human eyes): Clinical assessment of the quality of the corneal flap, its thickness, safety, and smoothness in a real-world surgical context. This would likely involve post-operative examinations and clinical measurements. The term "equivallently to the predicate device" suggests a comparative clinical outcome as a "ground truth" for equivalence.

8. Sample Size for the Training Set

No information is provided regarding a separate "training set" or its sample size. This is consistent with a mechanical device where performance is typically evaluated through direct testing rather than training a machine learning model.

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

As no training set is mentioned or applicable in the context of this mechanical device, this information is not provided.

Summary

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MORIA S.A. OneUse - Plus Microkeratome

February 5, 2004 Premarket Notification

MAR 3 1 2004

Section 4 page 1

510(k) SUMMARY

1. Submitter's identification

MORIA S.A. a. 15, rue Georges Besse 92160 ANTONY France (33-1) 46 74 46 36 Tel: (33-1) 46 74 46 70 Fax:
Contact person: b.

040297

Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager E mail: mrenaud@moria-int. com

February 5, 2004

Date Summary Prepared: C.

2. Device name

OneUse - Plus Microkeratome Trade Name:

Classification name 3.

Keratome (per CFR 886.4370)

Substantial equivalence 4.

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

Device name:	One Up Disposable keratome Head
Company name:	MORIA S.A.
Document control number:	K981742

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

Power unit ●
Motor .
Suction rings ●
Applanator lenses .
Footswitches .
Keratome head ●
Keratome blade ●

a) Power unit

The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & 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.

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 motors outlets, Gas turbine 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 types for preventing connection mistakes.

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Section 4 page 3

b) Keratome 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).

c) Keratome head

In the keratome head, a blade activated by an oscillation motor is inserted.

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

Suction rings d)

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

e) Applanator lenses

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

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

The upper part is convex for magnification.

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

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Section 4 page 4

Keratome blade f)

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

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

Statement of intended use 6.

The OneUse - Plus Microkeratome is intended for use in making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.

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 54 human eyes showed that the OneUse - Plus 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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2004

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

Re: K040297

Trade/Device Name: OneUse - Plus Microkeratome Regulation Number: 21CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HMY Dated: February 5, 2004 Received: February 9, 2004

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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Page 2 - Mrs. Melanie Renaud-Samiri

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,

Aherl 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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MORIA S.A. OneUse - Plus Microkeratome

February 5, 2004 Premarket Notification

Section 5 page 1

510(k) Number (if known):

K040297

Device Name:

OneUse - Plus Microkeratome

Indications for use:

The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.

3-29-2004

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

510(k) Number. K040297

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﮐﮯ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (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.