NORWOOD ABBEY CENTURION SES EPIKERATOME

K051486 · Norwood Abbey , Ltd. · HNO · Jul 6, 2005 · Ophthalmic

Device Facts

• Record ID: K051486
• Device Name: NORWOOD ABBEY CENTURION SES EPIKERATOME
• Applicant: Norwood Abbey , Ltd.
• Product Code: HNO · Ophthalmic
• Decision Date: Jul 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Norwood Abbey 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.

Device Story

The Centurion SES Epikeratome is an AC-powered ophthalmic surgical device used to separate the corneal epithelium. It consists of a console, separator drive assembly, suction ring assembly (9.0mm and 10.0mm), and a high-speed oscillating PMMA separator. Operated by a surgeon in a clinical setting, the device uses a foot pedal to control vacuum and drive mechanisms. The suction ring secures the cornea, allowing the oscillating separator to incise the epithelium at a predetermined location and diameter. This process prepares the cornea for subsequent surgical procedures. The device provides a consistent and reproducible method for epithelial removal.

Clinical Evidence

Bench testing only. Functional testing demonstrated that the system drives the separator assembly to remove epithelium in a consistent and reproducible manner.

Technological Characteristics

AC-powered; high-speed oscillating separator made of PMMA; suction ring assembly (9.0mm and 10.0mm); console-controlled vacuum and drive mechanism; foot pedal operation.

Indications for Use

Indicated for patients requiring corneal epithelial separation 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

• Johnanch OEO Epikeratome

Submission Summary (Full Text)

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K051486

## Summary of Safety & EFFECTIVENESS

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 | Norwood Abbey Limited<br>63 Wells Road<br>Chelsea Heights<br>Victoria 3196<br>Australia |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Paul Clark<br>Manager Quality Assurance and Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Trade Name: | Centurion SES™ Epikeratome |
| Classification Name: | AC Powered Keratome<br>Battery-Powered Corneal Burr |
| Device Classification and<br>Product Code | Class 1 per 21 CFR §886.4370, HNO |

#### SUBSTANTIAL EQUIVALENCE:

The new Centurion SES Epikeratome with modified console is substantially equivalent to The new Johnanch OEO Epikeratome. Both designs have the same intended use and basic scientific technology.

Bench testing has demonstrated that the new console is functionally equivalent to the Denin tosting has dombinetiated inor differences between the modified device and the predicate device do not affect safety or effectiveness.

#### DESCRIPTION OF THE DEVICE:

The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used The Norwood Abbey Ocharish 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: console, The device separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps and an epithelial separator.

#### INDICATIONS FOR USE:

The Norwood Abbey 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.

#### TECHNICAL CHARACTERISTICS:

The Norwood Abbey Centurion SES Epikeratome contains a Head Unit Assembly (with The Norwood Abbey Container sizes) that allows the cornea to protrude through the ഴിയ വിവിധ വാടിനിന് caction is suspended from the end of the separator drive assembly

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housing that is moved by a drive mechanism along a forward path inside the suction ring nousing that is moved by a unve mechannel and vacuum for the suction ring are provided by user command via the console and foot pedal.

#### PERFORMANCE DATA:

Functional test results demonstrate that the Centurion SES system with new console r unfollowar tost Toodko "device console does to drive the separator assembly to remove epithelium in a consistent and reproducible way.

#### CONCLUSION:

Based on the qualification testing, it can be concluded that the new Norwood Abbey Dased on the qualified console is equivalent to the predicate Ochturion SES Epikeratome with respect to intended use and technological characteristics.

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Image /page/2/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 stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 6 - 2005

Norwood Abbey, LTD. c/o Mr. Paul Clark Quality & Regulatory Affairs Manager 63 Wells Road Chelsea Heights, Victoria 3196 Australia

Re: K051486

Trade/Device Name: Centurion SES™ Epikeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: June 2, 2005 Received: June 6, 2005

Dear Mr. Clark:

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) rms reter notification. The FDA finding of substantial equivalence of your device to a legally premated 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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# Change to Centurion SES Epikeratome Console

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510(k) Number (if known): K051486

Device Name: CENTURION SES™ EPIKERATOME

Indications for Use:

The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of The Norwood Abbey Centunon OLO Epikelatorie is intention of subsequent surgical procedures on the denuded cornea.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Roscioli 7/5/2005

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

K05/4

510(k) Number K051486

Prescription Use
(21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)