The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.

Device Description

The Epi Separator System is designed exclusively for use with the Zyoptix XP Microkeratome. The Zyoptix XP Separator System, which consists of the Epi Head and single use Epi separator, are optional accessories for the Zyoptix XP microkeratome.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Zyoptix XP Epi Separator System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional study with acceptance criteria and performance metrics for a novel medical device. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert adjudication as one might see for an AI/algorithm-based device is not present.

However, based on the provided text, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy) is not explicitly defined because this submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance. The "performance" is implicitly tied to the device's ability to safely and effectively perform its intended use as compared to its predicate.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Substantial Equivalence and Safety/Effectiveness Sections)	Reported Device Performance and How it Meets Criteria (Inferred)
Safety	No additional unacceptable known risks compared to the predicate device.	"The Medical Device Risk Analysis was performed comparing the changes made to the Zyoptix XP Microkeratome. The analysis concluded there are no additional unacceptable known risks." (Section 6 & 8 - Safety)
Effectiveness/Functionality	Compliance to design requirements and specifications for its intended use (partial or complete delamination of the corneal epithelium).	"Design verification was conducted to demonstrate compliance to design requirements and specifications for the Zyoptix XP Epi Separator System. Sufficient objective evidence was collected to conclude that the design met the requirements outlined in the product requirements and technical specifications." (Section 8 - Effectiveness)
Material Equivalence	Use of same or substantially equivalent materials as the predicate device.	Materials (Stainless Steel, Low Carbon Stainless Steel) are identical to the predicate device. (Section "Substantial Equivalence Summary Table")
Operating Principle	Same operating principle (electrically driven oscillating blade across the cornea within controlled parameters) as the predicate.	Operating Principle is identical to the predicate device. (Section "Substantial Equivalence Summary Table")
Sterilization	Same sterilization method (EtO) as the predicate device.	Sterilization (EtO) is identical to the predicate device. (Section "Substantial Equivalence Summary Table")

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

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/algorithm. The evaluation is based on design verification, risk analysis, and comparison to a predicate, not clinical trials with "test sets" in the AI sense.

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

Not applicable. There is no "ground truth" established by experts in the context of clinical data for this type of submission. The evaluation is engineering-focused on design and safety, and comparison to an existing device.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" and thus no adjudication method as understood in AI/clinical studies.

5. 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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the traditional sense of clinical outcome data or expert consensus on images. The "ground truth" here is compliance with engineering design specifications and safety standards, and functional equivalence to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/algorithm device.

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

Not applicable. There is no training set.

Summary

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510(k) SUMMARY for

SEP - 6 2006

Zyoptix XP Epi Separator System Prepared 23 May, 2006

1. Submitter Information

Sponsor:	Bausch & Lomb, Inc.
	1400 North Goodman Street
	Rochester, NY 14609

Contact Person:	Ned Luce
	Director, Global Regulatory Affairs
Telephone No.:	(585) 338-6368
Fax No.:	(585) 338-0702

2. Device Name

Classification Name:	Keratome21 CFR 886.4370HNO
Proprietary Name:	Zyoptix XP Epi Separator System

3. Predicate Device

Zyoptix XP Microkeratome

K040204

4. Description of Device

5. Indications for Use

The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.

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6. Description of Safety and substantial equivalence

The Medical Device Risk Analysis was performed comparing the changes made to the Zyoptix XP Microkeratome. The analysis concluded there are no ad ditional unacceptable known risks.

7. Basis of Equivalence

The Zyoptix XP Epi Separator System is substantially equivalent to the Zyoptix XP Microkeratome cleared under 510(k) K040204 on March 22, 2004. A substantial equivalence Summary Table follows.

8. Safety and Effectiveness

Safety:

The Risk analysis applies to the changes made from the existing Zyoptix XP Microkeratome to the Zyoptix XP Epi Separator System. The analysis concluded there are no unacceptable risks known. A copy of the Risk Analysis is included in the appendix.

Effectiveness:

Design verification was conducted to demonstrate compliance to design requirements and specifications for the Zyoptix XP Epi Separator System. Sufficient objective evidence was collected to conclude that the design met the requirements outlined in the product requirements and technical specifications.

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10, ... ر PREMARKET NOTIFICATION
Cyoptix XP Epi Separator System

Substantial Equivalence Summary Table

SIMILARITIES

Characteristics	Zyoptix XP Microkeratome	Zyoptix XP Microkeratome with Zyoptix XP Epi Separator System
Operating Principal	Electrically driven oscillating blade housed in a head, which guides the blade across the cornea within controlled parameters.	Electrically driven oscillating blade housed in a head, which guides the blade across the cornea within controlled parameters.
Patient Contact Portion	Suction Ring Microkeratome Head Blade	Suction Ring Microkeratome Head Blade
Materials	Stainless Steel Stainless Steel Low Carbon Stainless Steel	Stainless Steel Stainless Steel Low Carbon Stainless Steel
Keratome Mechanism	Single port annular suction fixation DC powered 6 to 9 volts Footswitch Blade oscillation XP Blades EtO Instructions are in chapter 3 of the Operator's manual	Single port annular suction fixation DC powered 6 to 9 volts Footswitch Blade oscillation Epi Separators EtO (same cycle as XP blades) Same instructions for the Epi
Suction Ring
Electric motor
Control Mechanism
Cutting Principal
Sterilization
Cleaning, disinfection, sterilization by user
	DIFFERENCES
Characteristics	Zyoptix XP Microkeratome	Zyoptix XP Microkeratome with ZyoptixXP Epi Separator System
Intended Use	Lamellear resection of the corneapreceding Lasik surgery or othertreatment requiring initial lamellarresection of the cornea, where the flapis created in the Stromal layer	Partial or complete delamination of the cornealepithelium in preparation for subsequentsurgical procedures on the denuded cornea.
Microkeratome head thickness plate	3 interchangeable heads with fixedthickness	1 interchangeable head designed to separateepithelium layer from Bowman's layer
Microkeratome blade	Blade edge designed to cut a flap inthe Stromal layer	Blade edge designed to separate epitheliumlayer from Bowman's layer
Microkeratome head	Two piece design	One piece design

11-3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Bausch & Lomb, Inc. 1400 North Goodman St. Rochester, NY 14609 Attn: Ned Luce

Re: K062465

Trade/Device Name: Zyoptix XP Epi Separator System Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome, AC-Powered Regulatory Class: Class I Product Code: HNO Dated: August 24, 2006 Received: August 24, 2006

Dear Mr. Luce:

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) 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

MB. Egdelmisi mD

Malvina B. Eydelman, 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) PREMARKET NOTIFICATION Zyoptix XP Epi Separator System

510(K) Number- K062465

Device Name: Zyoptix XP Epi Separator System

Indications for Use:

The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.

(Please do not write below this line – continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR Over-the-Counter Use
(Division Sign-Off)	Clay R. Buttemess
	(Division Sign-Off)

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number _

510(K) Number_KO62465

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.