The Bausch & Lomb Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated for creating a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

The Zyoptix™ XP Microkeratome is an automated pivoting keratome that is connected to, and driven by the translational drive mechanism to create a corneal flap of a predetermined diameter and thickness. The same options are available as with the Hansatome® Excellus™ Microkeratome including flap depths of 160, 180 and 200 microns, 8.5 mm or 9.5 mm flap diameter, and two sizes of suction rings, a 19 mm and 20 mm suction ring. The device is designed to provide the same suction ring-to-eye interface geometry as the Hansatome® Excellus™ Microkeratome.

The translation drive has been changed from a rack and pinion gear drive to a two-link pivot mechanism that provides an identical motion. Corresponding modifications have been made to cutting head and suction ring that supports the two-link offset. The new cutting head is also easier for the operator to handle and the component parts were designed for ease of manufacture, assembly, interchangeability, and improved reliability.

The Zyoptix™ XP Blade is produced by a more exacting manufacturing process and is designed to be used exclusively with the Zyoptix™ XP Microkeratome. This manufacturing process reduces the tolerance of blade extension variation. An analysis of the dimensional specifications based on 3-D CAD Modeling (3 dimensional computer aided design) established that the average thickness of the corneal flap produced by the Zyoptix™ XP Microkeratome and the Hansatome® Excellus™ Microkeratome are equivalent.

AI/ML Overview

The provided text in the 510(k) summary for the Zyoptix™ XP Microkeratome does not describe a study with acceptance criteria and device performance results in the typical sense of a clinical trial or performance study for a new device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (the Hansatome® Excellus™ Microkeratome).

Therefore, the "acceptance criteria" and "device performance" are primarily framed around proving that the new device is as safe and effective as the predicate device, despite some mechanical design changes.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the concept of substantial equivalence, meaning the Zyoptix™ XP Microkeratome should perform equivalently to the Hansatome® Excellus™ Microkeratome in creating corneal flaps.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance/Evidence
1. Equivalent Corneal Flap Quality (Diameter and Thickness): The device should produce corneal flaps with dimensions (diameter and thickness) equivalent to those produced by the predicate device (Hansatome® Excellus™ Microkeratome). This is the core functional output of the device.	"An analysis of the dimensional specifications based on 3-D CAD Modeling (3 dimensional computer aided design) established that the average dimensions of the corneal flap produced by the Zyoptix™ XP Microkeratome and the Hansatome® Excellus™ Microkeratome are equivalent."
2. Equivalent Indications for Use: The device should be safely and effectively used for the same clinical application as the predicate device.	"The Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated for creating a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea." This is identical to the predicate device's stated indications.
3. Equivalent Operating Principle: The fundamental mechanism of action should remain the same.	"Electrically driven oscillating blade housed in a head, which guides the blade across the cornea within controlled parameters." (Identical to predicate)
4. Equivalent Patient Contact Portions and Materials: The parts of the device that contact the patient should be the same, with comparable biocompatibility.	"Suction Ring Microkeratome Head Blade" (Identical). Materials: "Stainless Steel Stainless Steel Low Carbon Stainless steel" (Identical).
5. Safety and Risk Profile is Acceptable: Any changes introduced should not introduce new, unacceptable risks, and the overall safety profile should be comparable to the predicate.	"The Medical Devices Risk Analysis applies to the changes made from the existing Hansatome® Excellus™ Microkeratome to the proposed Zyoptix™ XP Microkeratome. The analysis concluded there are no unacceptable risks known."
6. Manufacturing Precision (specifically blade extension variation): Improvements in manufacturing should reduce variability impacting performance. This isn't a direct "acceptance criterion" in the same way as flap dimensions, but it's a supportive claim for equivalence or improvement.	"The Zyoptix™ XP Blade is produced by a more exacting manufacturing process and is designed to be used exclusively with the Zyoptix™ XP Microkeratome. This manufacturing process reduces the tolerance of blade extension variation."

Study Details (Based on the provided information)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a prospective clinical study involving patient samples. The primary evidence for flap dimensions was based on "dimensional specifications" and "3-D CAD Modeling." This suggests a computational analysis rather than a physical test set on biological samples for the primary equivalence claim.
- Data Provenance: The data related to flap dimensions came from "3-D CAD Modeling" (computer-aided design). This is a retrospective analysis of design specifications and theoretical performance, not a prospective study on patient data. No country of origin for this "data" is specified beyond the company's location (Rochester, NY, USA).
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 the flap dimension equivalence was established through engineering analysis (3-D CAD Modeling), not through expert review of physical outcomes or images.
Adjudication method for the test set:
- Not applicable. There was no test set in the sense of a collection of cases requiring adjudication by experts.
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. This is a mechanical device (microkeratome), not an AI diagnostic tool. Therefore, an MRMC study is not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. The 3-D CAD modeling could be considered a "standalone" computational analysis of the device's theoretical mechanical output.
The type of ground truth used:
- The primary ground truth for the equivalence of flap dimensions was derived from engineering specifications and theoretical calculations via 3-D CAD modeling. This is a design-based ground truth or computational ground truth as opposed to a clinical or pathological ground truth from actual surgical outcomes.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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MAR 2 2 2004

510(k) SUMMARY

FOR

Zyoptix™ XP Microkeratome

1. SUBMITTER INFORMATION

Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609

Debra Ketchum Contact Person: Manager, Regulatory Affairs Telephone No.: (585) 338-8638 (585) 338-0702 Fax No.:

DEVICE NAME 2.

Classification Name: Keratome

Zyoptix™ XP Microkeratome Proprietary Name:

PREDICATE DEVICES 3.

Hansatome® Excellus™ Microkeratome

K021640

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4. DESCRIPTION OF DEVICE

The Zyoptix™ XP Microkeratome is an automated pivoting keratome that is The Zyoptix comected to, and outronious by the translational drive mechanism to across the corneal flap of a predetermined diameter and thickness. The create a filmgod ournour hap oth the Zyoptix™ XP Microkeratome as with the Same Options are available than and including flap depths of 160, 180 and Hansatome® Exocilias - Mi8.5 mm or 9.5 mm flap diameter, and two sizes of suction rings, a 19 mm and 20 mm suction ring. The device is designed to Suction Thigs, a 15 min and Eu-n Baction ring-to-eye interface snarsetry as the Hansatome® Excellus™ Microkeratome.

The translation drive has been changed from a rack and pinion gear drive to a two-link pivot mechanism that provides an identical motion. Corresponding two-lifications have been made to cutting head and suction ring that supports the modifications neve boommatic to ew cutting head is also easier for the operator two-link offe hounding the component parts were designed for ease of ത onfacture, assembly, interchangeability, and improved reliability.

The Zyoptix™ XP Blade is produced by a more exacting manufacturing process and is designed to be used exclusively with the Zyoptix™ XP Microkeratome. and is assigriou to a ufacturing process reduces the tolerance of blade extension variation. An analysis of the dimensional specifications based on 3-D CAD Modeling (3 dimensional computer aided design) established that the average Modoling (of the corneal flap produced by the Zyoptix™ XP Microkeratome and the Hansatome® Excellus™ Microkeratome are equivalent.

5. INDICATIONS FOR USE

The Bausch & Lomb Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated for creating a corneal flap in patients undergoing LASIK inotrery or other treatment requiring initial lamellar resection of the cornea.

6. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE

The Medical Devices Risk Analysis applies to the changes made from the existing Hansatome® Excellus™ Microkeratome to the proposed Zyoptix™ XP The analysis concluded there are no unacceptable risks Microkeratome. known.

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7. SUBSTANTIAL EQUIVALENCE

Substantial Equivalence Summary Table

SIMILARITIES

Characteristics	Current Hansatome ExcellusMicrokeratome	Proposed Zyoptix XP Microkeratome
Intended Use	Lamellar resection of the cornea precedingLASIK surgery or other treatment requiringinitial lamellar resection of the cornea	Lamellar resection of the cornea precedingLASIK surgery or other treatment requiringinitial lamellar resection of the cornea
Operating Principle	Electrically driven oscillating blade housedin a head, which guides the blade acrossthe cornea within controlled parameters.	Electrically driven oscillating blade housed ina head, which guides the blade across thecornea within controlled parameters.
Patient contact portion	Suction Ring Microkeratome Head Blade	Suction Ring Microkeratome Head Blade
Materials Suction ring Microkeratome Head Blade	Stainless Steel Stainless Steel Low Carbon Stainless steel	Stainless Steel Stainless Steel Low Carbon Stainless steel
Keratome Mechanism Suction ring Microkeratome head thickness plate Electric motor Control mechanism Cutting Principle	Single port annular suction fixation 3 interchangeable heads with fixed thickness DC powered 6 to 9 volts Footswitch Blade oscillation	Single port annular suction fixation 3 interchangeable heads with fixed thickness DC powered 6 to 9 volts Footswitch Blade oscillation
DIFFERENCES
Characteristics	Current Hansatome ExcellusMicrokeratome	Proposed Zyoptix XP Microkeratome
Components	Matched	Interchangeable
Left/Right Procedure Set-Up	Left/Right Adaptor	Selector Switch
Gear Box	Hand built gearbox	Integrated motor and gearbox
Head to Hand piece Interface	Screws into head	Snaps into head
Translation Drive	Rack and pinion	Two-link pivot mechanism

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meccocures

: 上一

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Substantial Equivalence

SubStantial Equivaloree Excellus ™ Microkeratome cleared in the Premarket Notification K021640 on June 19, 2002.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2004

Bausch & Lomb Surgical, Inc. c/o Debra L. B. Ketchum Manager Global Regulatory Affairs 1400 N. Goodman Street Rochester, NY 14609

Re: K040204

Trade/Device Name: Zyoptix™ XP Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 2, 2004 Received: March 3, 2004

Dear Ms. Ketchum:

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 - Debra L. B. Ketchum

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,

Akepe lorentthal

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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Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609

Indications for Use Statement

510(k) Number (if known): K040204

Zyoptix™ XP Microkeratome Device Name:

Indications for Use:

The Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated The Zyoptix - XI Microkeratorie is a procleronic is undergoing LASIK surgery or other for aso in orealing initial lamellar resection of the 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)
Division of Ophthalmic Ear,

510(k) Number K040204

Nose and Throat Devise

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.