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 Description

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.

AI/ML Overview

The provided 510(k) summary for the CIBA Centurion SES Epikeratome describes a medical device, but it does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to predicate devices, supported by bench testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies. This information is typically found in more comprehensive clinical study reports, which are not part of this 510(k) summary.

However, based on the provided text, I can infer and state what was used to establish equivalence:

Acceptance Criteria and Study Summary (Based on Substantial Equivalence and Bench Testing):

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance
Functional equivalence to predicate devices (Biovision Visitome 20-10, Alcon Pallikaris Brush, Amoils Epithelial Scrubber)	Bench testing demonstrates functional equivalence, showing the Centurion SES device is functionally equivalent to the Visitome 20-10. Minor differences between Centurion SES and predicate devices do not affect safety and effectiveness.
Consistent and reproducible epithelium removal	Bench testing demonstrates that the Centurion SES separator removes epithelium in a consistent and reproducible way.
Biocompatibility of patient-contacting components	All components that come in direct contact with the patient have a long history of use in ophthalmic medical devices and are biocompatible.
Equivalence in intended use (separation of epithelium, making corneal flap)	Centurion SES is substantially equivalent to predicate devices with respect to intended use.
Equivalent technological characteristics	Centurion SES has equivalent technological characteristics to predicate devices.

Detailed Study Information (Based on provided 510(k) Summary):

A table of acceptance criteria and the reported device performance: See table above. These are inferred from the 510(k)'s focus on substantial equivalence and bench testing, rather than explicit numerical acceptance criteria.
Sample sized used for the test set and the data provenance: Not specified. The document refers to "bench testing" but does not provide details on sample sizes, specific test protocols, or data provenance (e.g., country of origin, retrospective/prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for showing equivalence was based on functional performance in bench testing relative to predicate devices, not on expert consensus from human data.
Adjudication method for the test set: Not applicable. No human adjudication process is described for performance evaluation; the assessment was based on bench testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document does not mention an MRMC study or any study involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an AC-powered surgical tool, not an algorithm. Its standalone performance was assessed through "functional and electrical" bench testing to demonstrate consistent and reproducible epithelium removal, and equivalence to predicate devices.
The type of ground truth used: The "ground truth" for demonstrating the device's performance was the established functionality and performance of the predicate devices, against which the Centurion SES Epikeratome was quantitatively and qualitatively compared via bench testing. The biocompatibility of materials was also a "ground truth" based on historical use.
The sample size for the training set: Not applicable. This device is a mechanical surgical tool, not an AI or algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

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 Corporation11460 Johns Creek ParkwayDuluth, Georgia 30097, USA
OFFICIALCorrespondent	Penny Northcutt, RACSurgical Regulatory AffairsTel: (678) 415-3214Fax: (678) 415-4024e-mail: penny.northcutt@cibavision.novartis.com
TRADE NAME:	CIBA Centurion SES™ Epikeratome
CLASSIFICATIONNAME:	AC Powered Keratome
DEVICECLASSIFICATIONAND PRODUCT	Class 1 per 21 CFR §886.4370 , HNOClass 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.

Code

(

{1}------------------------------------------------

DESCRIPTION OF THE DEVICE:

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:

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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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

{4}------------------------------------------------

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

Device Name: CENTURION SESTM EPIKERATOME

Indications for Use:

(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 _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

(Optional Format

Regulation Number and Section

§ 886.4370 Keratome.

(a)
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.(b)
Classification. Class I.