AMADEUS II EPIKERATOME

K043150 · Sis Ltd., Surgical Instrument Systems · HNO · Jan 31, 2005 · Ophthalmic

Device Facts

• Record ID: K043150
• Device Name: AMADEUS II EPIKERATOME
• Applicant: Sis Ltd., Surgical Instrument Systems
• Product Code: HNO · Ophthalmic
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

Device Story

The Amadeus II Epikeratome is a surgical instrument used by ophthalmologists to perform lamellar corneal resections, specifically for Epi-LASIK procedures. The device consists of a handpiece, a control unit with a touch-screen interface, and two footswitches. During operation, a suction ring is placed on the eye and vacuum is applied to increase intraocular pressure. An oscillating blade within the handpiece advances across the cornea, similar to a carpenter's plane, to separate the epithelium from the underlying stroma. The control unit manages cutting parameters and vacuum levels. The device is used in a clinical or surgical setting. By creating a precise epithelial flap, the device facilitates subsequent corneal surgeries, potentially improving patient outcomes in refractive procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence was demonstrated through design controls, including risk assessment, design verification, and design validation.

Technological Characteristics

The device is a mechanical keratome system comprising a handpiece, control unit, and footswitches. It utilizes a vacuum-based suction ring to stabilize the cornea and an oscillating blade for resection. Disposable components include a sterile plastic blade and vacuum tubing. The system is designed for one-handed operation by the surgeon. The control unit features a touch-screen interface for parameter management. Sterilization is supported by an autoclavable instrument tray.

Indications for Use

Indicated for the separation of epithelium from the cornea 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

• Amadeus Microkeratome (K993190)

Submission Summary (Full Text)

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# AN 3 1 2005

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# 510(k) Summary for the Amadeus II Epikeratome

### Name and Address of Sponsor

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: [phone] Fax: [phone] Email: [e-mail]

### Name and Address of Manufacturer

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: [phone] Fax: [phone] Email: [e-mail]

### Name and Address of Official Correspondent

Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127 Phone: [phone] Fax: [phone] Email: [e-mail]

#### Device Name

Device trade name: Amadeus II Epikeratome Common/Classification name: Keratome

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# Classification, Panel and Product Code

Device Classification: Reviewing Panel:

Class I (reserved), HNO Ophthalmic Devices

## Intended Use

The Amadeus II Epikeratome is intended for use in performing lamellar corneal resections. This is the same intended use as previously cleared for the Amadelis microkeratome, K993190.

## Indications for Use

The Amadeus II Epikeratome is intended for use in the separation of epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea.

### Substantial Equivalence

The Amadeus II Epikeratorne is substantially equivalent to the Amadeus Microkeratorne, K993190. 02/10/2000.

### Device Description

The Amadeus II Epikeratome is a modification of the ACCM/Amadeus Microkeratome, which is firmly established in the market for several years. In the course of a product update, the designs of blade and blade holder have been modified to provide surgeons with the option to perform Epi-LASIK.

The surgical principles of the Amadeus II Epikeratome and its predicate device are essentially identical. To perform a lamellar corneal resection, the cornea is held in position by means of a suction ring, and vacuum is applied to increase intraccular pressure to a level allowing the epikeratorne blade to move across the cornes in a mode similar to that of a carpenter's plane. The corneal flap is made by the same open ating principle as in the predicate device, i.e., a blade is advancing and simultane opelva oscillating horizontally and perpendicular to the advancement direction. A Control Unit provides power and a controlled vacuum for fixing the eye.

The comeal flap created by the epikeratorne consists of the entire epithelium, while in the predicate device it consists of the entire epithelium plus parts of the stroma. This difference in flap structure is obtained by modifications of the blade and thre hlade holder.

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Like its predicate device, the Amadeus II Epikeratome comprises three major groups of components:

- a) A Handpiece, incorporating the Suction Unit, the Blade Holder, the Epikeratome Epi-A handpiece, IntoSperating theit. The Handpiece offers several safety features designed to prevent product malfunction or incorrect use, and allows the surgeon to handle the Epikeratome with only one hand.
- b) A Control Unit with touch-screen interface, managing the epikeratome's cutting A Gontrol Only With toutic documentation of the chosen cutting parameters and user interface dialogs.
- c) Two footswitches that serve to actuate and discontinue the epikeratome cutting r wo rocedure. The standard actuation footswitch serves to initiate suction and the epikeratome cutting action.

Disposable components of the Amadeus II Epikeratome system are 1) a sterile plastic epikeratome blade and 2) a sterile vacuum tubing kit. Additionally, an autoclavable instrument tray is provided for sterilization.

#### Performance Data:

Design controls (e.g., risk assessment, design verification and design validation), as well Design controls (c.g., nonimal study, were used to demonstrate that the changes made to the device are safe and effective.

# Rationale for Substantial Equivalence

- Intended use of the Amadeus II Epikeratome is the same as that of the predicate . device.
- The operating principle of the Amadeus II Epikeratome is very similar to the one of . the predicate device and based on the same cutting kinematics.
- The safety features of the Amadeus II Epikeratorne are the same as those offered by . the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 31 2002

SIS Surgical Instrument Systems Ltd. c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127

Re: K043150

Trade/Device Name: Amadeus II Epikeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: January 11, 2005 Received: January 12, 2005

Dear Mr. Walls:

We have reviewed your Scction 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 Cosinctic 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 fisting (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 - Kevin Walls, 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/industry/support/index.html.

Sincerely yours,

A. Ralph 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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# Indications for Use Statement

510(k) Number (if known):

Device Name: Amadeus II Epikeratome

Indications For Use: The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

i/c/w/e X. Juhki huchita
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

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