EPI-K

K043183 · Moria SA · HNO · Mar 25, 2005 · Ophthalmic

Device Facts

• Record ID: K043183
• Device Name: EPI-K
• Applicant: Moria SA
• Product Code: HNO · Ophthalmic
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Epi-K is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

Device Story

The Epi-K is an epikeratome system used by ophthalmologists to create a hinged circular epithelial flap. The system consists of a power unit with vacuum pumps, a motorized handpiece, a disposable head with a blade separator, and suction rings. The power unit provides vacuum to fixate the eye and electrical power to the handpiece. The handpiece contains two motors: one oscillates the blade separator to cleave the epithelium, and the other advances the handpiece across the cornea. Suction rings, available in reusable or disposable versions, stabilize the eye and define the flap diameter. The device is operated by a clinician in a surgical setting. By creating a precise epithelial flap, the device facilitates subsequent corneal surgical procedures, potentially improving patient outcomes compared to manual techniques.

Clinical Evidence

Clinical evidence includes in-vitro studies on porcine eyes and an in-vivo study on 77 human eyes. The in-vitro studies demonstrated the safety and efficacy of the device for creating an epithelial flap and confirmed the quality of the separation. The in-vivo study on 77 human eyes confirmed the device is safe and capable of creating a hinged circular epithelial flap of predetermined dimensions.

Technological Characteristics

The device is a motorized keratome system. Components include a power unit with vacuum pumps, a motorized handpiece, and suction rings. The blade separator is constructed of low carbon steel with a plastic holder. The system uses electrical energy for motor-driven oscillation and advancement. It is designed for ophthalmic surgery. The device is a Class I medical device (Product Code: HNO).

Indications for Use

Indicated for the separation of the corneal epithelium in preparation for subsequent surgical procedures on the denuded 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

• OneUse - Plus Microkeratome (K040297)
• Centurion SEST Epikeratome (K032978)
• EpiTome SYSTEM (K041206)

Submission Summary (Full Text)

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MAR 2 5 2005

# 510(k) SUMMARY

#### Submitter's identification 1.

- થ. MORIA S.A. 15, rue Georges Besse 92160 ANTONY France Tel: [phone] Fax: [phone]
- b. Contact person:

Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager E mail: mrenaud@moria-int. com Or Alain DUPRAT Chief Executive Officer and President

E mail: aduprat@moria-int. com

November 15, 2004

### c. Date Summary Prepared:

2. Device name

..

Epi-K™M Trade Name:

#### 3. Classification name

Keratome (per 21CFR section 886.4370)

#### 4. Substantial equivalence

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

| Trade or Proprietary or Model Name: | OneUse - Plus Microkeratom |
|-------------------------------------|----------------------------|
| Manufacturer: | MORIA S.A. |
| 510(k) number: | K040297 |

Trade or Proprietary or Model Name: Centurion SESTM Epikeratome Manufacturer: CIBA Vision Corporation 510(k) number: K032978

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Section 4 page 2

Trade or Proprietary or Model Name: EpiTome SYSTEM Manufacturer: GEBAUER MEDZINTECHNIK GmbH 510(k) number: K041206

#### న్. Submitted device description

List of components

- Power unit and footswitch .
- Handpiece / submitted device motor .
- Head and blade separator .
- Suction rings .

## a) Power unit and footswitch

The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) 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.

The front panel includes several displays and features:

- . Vacuum pressure gauge, Battery level indicator,
- . Battery charge indicator,
- Connector for the motorized handpiece of the submitted device .
- Vacuum outlet connector .

The back panel includes connectors for footswitches and battery charger

## b) Handpiece / submitted device motor

The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea).

## c) Head and blade separator

The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts:

- > The metal part in low carbon steel, and
- > The plastic holder of the blade separator, which is not in contact with the patient's eye.

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Section 4 page 3

## d) Suction rings

The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions:

- > Reusable
- > Disposable

#### Statement of intended use 6.

The submitted device Epi-K is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

#### 7. Discussion of tests and results

Epi-keratome predicate devices are already legally marketed and have been used to cleave the epithelium from the cornea (CIBA Centurion SESTN Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).

In-vitro studies on porcine eyes with the submitted device Epi-K 11" demonstrated:

- The safety and efficacy of the submitted device for creating an epithelial flap -
- -The quality of the epithelium separation.

In-vivo studies on 77 human eyes showed that the submitted device –Epi-K "" is a safe device able to create a hinged circular epithelial flap of predetermined dimensions.

The intended uses and the operating and separating principles (i.e.; Effectiveness) of the submitted device Epi-K ™ are the same as the predicate devices (CIBA Centurion SEST™ Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).

The operational features of the submitted device Epi-K™ are the same or similar to those offered by the predicate device (MORIA OneUse-Plus Microkeratome K040297).

The safety features of the submitted device Epi-KTM are the same or very similar to those offered by the predicate devices (CIBA Centurion SES 11 Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing shapes, representing health, services, and people. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2005

Moria S.A. c/o Mélanic Renaud-Samiri QA & Regulatory Affairs Manager 15 Rue Georges Besse F 92160 Antony FRANCE

Re: K043183 Trade/Device Name: Epi-KTM Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 16, 2005 Received: March 18, 2005

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 - Mélanie 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/industry/support/index.html.

Sincerely yours.

David M. Whipple

David M. Whipple Acting 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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Section 5 page 1

# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Devicc Name:

Epi-KTM

Indications for use:

The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

Marsha L. Burke hi cholova

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

510(k) Number K042183

Prescription Use V (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)