CENTURION SES EPIKERATOME

K031735 · Ciba Vision Corporation · HNO · Aug 21, 2003 · Ophthalmic

Device Facts

• Record ID: K031735
• Device Name: CENTURION SES EPIKERATOME
• Applicant: Ciba Vision Corporation
• Product Code: HNO · Ophthalmic
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

Device Story

The Centurion SES Epikeratome is an AC-powered surgical instrument used by ophthalmologists to perform corneal lamellar resection or epithelial separation. The device comprises a control unit, handpiece with drive assembly, suction positioning ring, foot pedal, and a PMMA epithelial separator. During operation, the suction positioning ring is applied to the patient's cornea, allowing it to protrude through the ring. The separator, suspended from the ring, is moved by the drive mechanism along a forward path while oscillating laterally to incise the tissue at a predetermined location and diameter. Vacuum and oscillation are controlled by the surgeon via the control unit and foot pedal. The device facilitates precise tissue separation, preparing the cornea for subsequent surgical procedures. It is intended for clinical use in an operating room or surgical setting.

Clinical Evidence

Bench testing only. Functional and electrical testing demonstrated that the device removes epithelium in a consistent and reproducible manner equivalent to predicate devices. No clinical data provided.

Technological Characteristics

AC-powered keratome. Components include a control unit, handpiece, suction positioning ring, and PMMA epithelial separator. Operates via mechanical oscillation and vacuum suction. Biocompatible materials used for patient-contact components. System is controlled by user-commanded drive mechanism and foot pedal.

Indications for Use

Indicated for patients undergoing LASIK or other surgical procedures requiring initial lamellar resection of the cornea or separation of the epithelium from 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

• Biovision Visitome 20-10 (K01400)
• Alcon Pallikaris Brush (K960261)
• Amoils Epithelial Scrubber (K962989)

Submission Summary (Full Text)

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K031735

AUG 2 1 2003

Image /page/0/Picture/2 description: The image shows the logo for CIBA Vision, a Novartis company. The logo features the word "CIBA" in bold, uppercase letters above the word "Vision." The "i" in Vision is replaced with an eye symbol. Below the logo, the text "A Novartis Company" is written in a smaller font.

#### CIBA Vision Corporation

11460 Johns Creek Parkway Duluth, Georgia 30097-1556

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | CIBA Vision Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia 30097, USA |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL<br>Correspondent | Penny Northcutt, RAC<br>Surgical Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| TRADE NAME: | CIBA Centurion SES™ Epikeratome |
| CLASSIFICATION<br>NAME: | AC Powered Keratome |
| DEVICE<br>CLASSIFICATION<br>AND PRODUCT | Class 1 per 21 CFR §886.4370 , HNO<br>Class 1 per 21 CFR §886.4070 , HOG |

#### SUBSTANTIAL EQUIVALENCE:

The Centurion SES Epikeratome is substantially equivalent to the Biovision Visitome 20-10, the Alcon Pallikaris Brush, and the Amoils Epithelial Scrubber. Each of these devices have a similar indication for use, utilizing suction to the cornea and oscillation principles to separate epithelium from the cornea. Bench testing demonstrates that the Centurion SES device is functionally equivalent to the Visitome 20-10 and that any minor differences between the Centurion SES and the predicate device do not affect safety and effectiveness.

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# DESCRIPTION OF THE DEVICE:

The Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA.

The device consists of the following main components and accessories: the control unit. handpiece with drive assembly, suction positioning ring assembly, a foot pedal, a tubinq set with fluid collection assembly (accessory), and a epithelial separator.

## INDICATIONS FOR USE:

The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

### TECHNICAL CHARACTERISTICS:

The CIBA Centurion SES Epikeratome contains a suction positioning ring which allows the cornea to protrude through the ring. The epithelial separator is suspended from the end of the suction positioning ring by a support (holder) that is moved by a drive mechanism, along a forward path between the suction positioning ring while oscillating laterally. Drive control and vacuum for the suction positioning ring are provided by user command via the control unit and foot pedal.

#### PERFORMANCE DATA:

All components that come in direct contact with the patient have a long history of use in ophthalmic medical devices and are biocompatible. This 510(k) notice includes functional and electrical that demonstrate that the Centurion SES separator removes epithelium in a consistent and reproducible way and equivalently to the predicate devices.

#### CONCLUSION:

The Centurion SES is substantially equivalent to the Biovision Visitome 20-10 cleared under 510(k) K01400. Both devices have a equivalent technological characteristics and performance testing demonstrated their equivalence.

The Centurion SES is substantially equivalent to the Alcon Pallikaris Brush cleared under K960261 and the Amoils Epithelial Scrubber cleared under K962989 with respect to intended use - to separate the epithelium from the cornea

Based on the performance testing, it can be concluded that the CIBA Centurion SES Epikeratome with EpiEdge Epithelial Separator has demonstrated equivalence to the predicate devices with respect to intended use and technological characteristics.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

AUG 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CIBA Vision Corporation c/o Penny Northcutt, RAC Surgical Regulatory Affairs 11460 Johns Creek Parkway Duluth, Georgia 30097

Re: K031735

Trade/Device Name: CIBA Vision Centurion SES " Epikeratome Regulation Number: 21 CFR 886.4370; 21 CFR 886.4070 Regulation Name: Keratome, AC-Powered; Burr, Corneal, Battery-Powered Regulatory Class: Class I: Class I Product Code: HNO; HOG Dated: May 30, 2003 Received: June 4, 2003

Dear Ms. Northcutt:

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 - Penny Northcutt, RAC

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,

A. Palagi forentthal

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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510(k) Number (if known): _ K031735

Device Name: CENTURION SESTM EPIKERATOME

Indications for Use:

The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dexie Hesi

(Division Sign vision of Onhthalmic Ea

510(k) Number K031735

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109) 1-2-96)

(Optional Format