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, 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 Norwood Abbey 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 (now with 10.0 and 9.0mm sizes), a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator.

AI/ML Overview

The provided document describes the safety and effectiveness summary for the Norwood Abbey Centurion SES™ Epikeratome, specifically the 9.0mm suction ring. This submission is for a Class I device (regulated under 21 CFR 886.4370, Product Code 86 HNO, Keratome, AC - Powered) to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported (Demonstrated) Device Performance
Functional Equivalence/Substantial Equivalence:
Same intended use as predicate device.	The new 9.0mm Centurion SES Epikeratome suction ring has the "same intended use" as the predicate device (CIBA Vision/Norwood Abbey Centurion SES Epikeratome 10.0mm suction ring). The indications for use are identical: separation of epithelium from the cornea for subsequent surgical procedures, and making a corneal flap for LASIK or other lamellar resection.
Same basic scientific technology as predicate device.	Both devices utilize "suction to the cornea and oscillation principles to separate the epithelium from the cornea."
Functionally equivalent to predicate device.	"Bench testing has demonstrated that the new 9.0mm Centurion SES suction ring is functionally equivalent to the predicate Centurion SES 10.0mm suction ring." The device "removes epithelium in a consistent and reproducible way and is equivalent to the predicate device."
Minor differences between modified and predicate device do not affect safety or effectiveness.	"any minor differences between the modified device and the predicate device do not affect safety or effectiveness."
Biocompatibility: (for 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."
Consistency and Reproducibility: (of epithelium removal)	Functional test results demonstrate that the Centurion SES suction ring and separator assembly "removes epithelium in a consistent and reproducible way."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Bench testing" and "Functional test results" but does not specify the sample size for these tests. It also does not directly state the data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) summary for a Class I device and the focus is on "bench testing" and "functional equivalence" to a predicate, the testing would typically be conducted in a controlled lab environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth. The evaluation relied on demonstrable functional equivalence through bench testing.

4. Adjudication Method for the Test Set

Since no experts were used to establish ground truth (as per point 3), there was no adjudication method described or necessary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not mentioned or performed. The study focused on demonstrating functional equivalence through bench testing, not on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is a mechanical epikeratome, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The "performance data" refers to the mechanical function of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this submission appears to be derived from the demonstrated functional characteristics and performance of the predicate device. The new device's performance was compared against the known and accepted performance of the predicate in terms of its ability to separate epithelium consistently and reproducibly. It is based on engineering/bench test results showing direct functional equivalence, rather than a clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

This device is a hardware product, not an AI model. Therefore, the concept of a "training set" is not applicable.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI model, the concept of a "training set" and establishing its ground truth is not applicable.

Summary

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

1. 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.

510(K) NUMBER:	K042810
APPLICANT:	Norwood Abbey Limited63 Wells RoadChelsea HeightsVictoria 3196Australia
OFFICIALCORRESPONDENT:	Paul ClarkManager Quality Assurance and Regulatory AffairsTel: +613 9782 7308Fax: +613 9782 7335e-mail: pclark@norwoodabbey.com.au
TRADE NAME:	NORWOOD ABBEY Centurion SES™ Epikeratome
REGULATION NO.	21 CFR 886.4370, Keratome
REGULATORY CLASS:	Class I
PRODUCT CODE	86 HNO, Keratome, AC - Powered

SUBSTANTIAL EQUIVALENCE:

The new Centurion SES Epikeratome 9.0mm suction ring is substantially equivalent to the CIBA Vision (now Norwood Abbey) Centurion SES Epikeratome 10.0 mm suction ring cleared under K032978. Both the 9.0mm and 10.0mm Suction Ring for the Centurion SES™ Epikeratome has the same intended use and basic scientific technology.

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 new 9.0mm Centurion SES suction ring is functionally equivalent to the predicate Centurion SES 10.0mm suction ring and that any minor differences between the modified device and the predicate device do not affect safety or effectiveness.

DESCRIPTION OF THE DEVICE:

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

The device consists of the following main components and accessories: the drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly (now with 10.0 and 9.0mm sizes), a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator.

INDICATIONS FOR USE:

TECHNICAL CHARACTERISTICS:

The Norwood Abbey Centurion SES Epikeratome contains a suction ring (now with both 10.0 and 9.0mm sizes) 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 test results demonstrate that the Centurion SES suction ring and separator assembly 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 new Norwood Abbey Centurion SES Epikeratome 9.0mm Suction Ring is equivalent to the predicate CIBA Vision (now Norwood Abbey) Centurion SES Epikeratome 10.0mm Suction Ring with respect to intended use and technological characteristics.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract human profiles or figures, resembling a family or group, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2004

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

Re: K042810

Trade/Device Name: Centurion SES™ Epikeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: October 8, 2004 Received: October 12, 2004

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.

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

Page 2- Mr. Paul Clark

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. Kalipi 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

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

510(k) Number (if known): K042810

Device Name: CENTURION SES™ ЕРІКЕРАТОМЕ

Indications for Use:

The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the comea 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 comea.

(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	K042810

Prescription Use ✓	OR	Over-The-Counter Use _____
(Per 21 CFR 801.109)

Page 1 of 1

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.