ONEUSE- PLUS MICROKERATOME

K040297 · Moria SA · HMY · Mar 31, 2004 · Ophthalmic

Device Facts

• Record ID: K040297
• Device Name: ONEUSE- PLUS MICROKERATOME
• Applicant: Moria SA
• Product Code: HMY · Ophthalmic
• Decision Date: Mar 31, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

The OneUse-Plus Microkeratome is a surgical instrument used by ophthalmologists to create corneal flaps during LASIK or lamellar keratoplasty. The system consists of a power unit, motor, suction rings, applanator lenses, footswitches, a keratome head, and a blade. The power unit provides vacuum pressure to fixate the eye via suction rings. Two built-in electrical motors drive the blade oscillation and the advancement of the microkeratome head across the cornea. Applanator lenses are used to verify disk diameter prior to the cut. The device is operated by a physician in a clinical setting. By creating a precise, consistent lamellar resection, the device facilitates the surgical procedure, potentially improving patient outcomes in refractive surgery.

Clinical Evidence

Clinical evidence includes in-vitro studies on porcine eyes demonstrating flap thickness consistency and safety/quality of corneal resections. In-vivo clinical study on 54 human eyes confirmed the device is safe and capable of creating circular lamellar resections with predetermined diameter, thickness, and bed smoothness equivalent to the predicate device.

Technological Characteristics

System includes a power unit with vacuum/gas pressure gauges and battery indicators, dual-motor drive (oscillation and advancement), suction rings, and keratome heads. Materials include methylmethacrylate (applanator lenses), stainless steel (handles), and low carbon steel (blades). Operates via electric motor and vacuum suction. Connectivity is limited to physical connectors for motors, gas, and foot pedals. No software-based algorithms or digital connectivity described.

Indications for Use

Indicated for patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Regulatory Classification

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.

Predicate Devices

• One Up Disposable keratome Head (K981742)
• CARRIAZO BARRAQUER II Microkeratome (K002191)

Submission Summary (Full Text)

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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: [phone] 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 [phone]. 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 [phone] or [phone] 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)