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 drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly, a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator,

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the CIBA Centurion SES™ Epikeratome, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive details of clinical trials with detailed statistical analysis and performance metrics in the way one might expect for a novel device requiring a PMA. Therefore, some of the requested information (like specific sample sizes for test sets, number of experts for ground truth, or MRMC studies with effect sizes) is not present in this document. The "study" described is primarily a bench testing equivalence study.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Functional Equivalence to Predicate Device	Bench testing demonstrated that the modified Centurion SES device is functionally equivalent to the predicate Centurion SES device.	This is the primary acceptance criterion and the basis for substantial equivalence.
Safety and Effectiveness	Minor differences between the modified device and the predicate device do not affect safety or effectiveness.	Assessed through bench testing comparison with the predicate device.
Biocompatibility	All components that come in direct contact with the patient have a long history of use in ophthalmic medical devices and are biocompatible.	Relies on prior knowledge and use of materials, not a specific new study for this submission.
Consistent and Reproducible Epithelium Removal	Centurion SES separator removes epithelium in a consistent and reproducible way.	Evaluated through functional and electrical safety test results.
Equivalence to Predicate Device (Overall)	The modified CIBA Centurion SES Epikeratome is equivalent to the predicate CIBA Centurion SES Epikeratome with respect to intended use and technological characteristics.	This is the overall conclusion based on all performance testing.

Study Details

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The "test set" here refers to the components and overall device undergoing bench testing. It's likely involved multiple units/components, but a specific number is not provided.
- Data provenance: Bench testing results. Location of testing not specified, but the applicant (CIBA Vision Corporation) is based in Duluth, Georgia, USA. The study is retrospective in the sense that it's a comparison to an existing, cleared device (K031735).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was primarily bench testing for functional equivalence, not a clinical study requiring expert diagnosis or assessment for ground truth. Device function was likely assessed against engineering specifications and pre-defined performance metrics through testing.
Adjudication method for the test set:
- Not applicable. As noted above, this was a bench testing comparison, not a clinical trial with case adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument (keratome) and does not involve "human readers" interpreting images or data where AI assistance would be relevant in the context of diagnostic improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical instrument, not an algorithm. The "functional and electrical safety test results" can be considered a standalone performance assessment of the instrument.
The type of ground truth used:
- For the bench testing, the "ground truth" was likely the technical specifications and established performance characteristics of the predicate device (Centurion SES Epikeratome cleared under K031735), along with engineering design specifications and safety standards for medical devices. The device's ability to "remove epithelium in a consistent and reproducible way" would be assessed against these engineering and functional standards.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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KO32978

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:	1. AC Powered Keratome2. Battery-Powered Corneal Burr
DEVICECLASSIFICATIONAND PRODUCTCODE	1. Class 1 per 21 CFR §886.4370, HNO2. Class 1 per 21 CFR §886.4070, HOG

SUBSTANTIAL EQUIVALENCE:

The modified Centurion SES Epikeratome is substantially equivalent to the Centurion SES Epikeratome cleared under K031735. The modifications made to the device include a separate dedicated handpiece for the epikeratome function. Minor design modifications were made to the suction ring, separator drive assembly, DCU vacuum pump, and DCU software to accommodate the new. The modified Centurion SES™ Epikeratome has the same intended use and basic scientific technology as the original model.

Both devices have the same indication for use statement, and utilize suction to the cornea and oscillation principles to separate the epithelium from the cornea. Bench testing has demonstrated that the modified Centurion SES device is functionally equivalent to the predicate Centurion SES device and that any minor differences between the modified device and the predicate device do not affect safety or effectiveness.

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DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

The CIBA Centurion SES Epikeratome is intended for use in the separation of the enithelium 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 ring that allows the cornea to protrude through the ring. The epithelial separator is suspended from the end of the separator drive assembly housing that is moved by a drive mechanism along a forward path inside the suction ring while oscillating laterally. Drive control and vacuum for the suction ring are provided by user command via the drive 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. Functional and electrical safety test results demonstrate that the Centurion SES separator removes epithelium in a consistent and reproducible way and is equivalent to the predicate device.

CONCLUSION:

Based on the performance testing, it can be concluded that the modified CIBA Centurion SES Epikeratome is equivalent to the predicate CIBA Centurion SES Epikeratome with respect to intended use and technological characteristics.

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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.

OCT 2 0 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 Pkwy. Duluth, GA 30097

Re: K032978

Trade/Device Name: CIBA Vision Centurion SES " Epikeratome Regulation Number: 21 CFR 886.4370; 21 CFR 886.4070 Regulation Name: Keratome; AC-Powered corneal burr Regulatory Class: Class I Product Code: HNO: HOG Dated: September 23, 2003 Received: September 24, 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 (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,

Akagi Korenthal

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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510(k) Number (if known):

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CENTURION SES™ 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)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number	K032978
Date	10-17-2003
Prescription Use
(Per 21 CFR 801.109)
OR	Over-The-Counter Use

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.