ZYOPTIX XP MICROKERATOME

K040204 · Bausch & Lomb, Inc. · HNO · Mar 22, 2004 · Ophthalmic

Device Facts

• Record ID: K040204
• Device Name: ZYOPTIX XP MICROKERATOME
• Applicant: Bausch & Lomb, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Mar 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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 Story

Automated pivoting keratome; creates corneal flaps for LASIK or lamellar resection. Device uses suction ring to fixate to eye; electrically driven oscillating blade housed in head moves across cornea. Translation drive utilizes two-link pivot mechanism; replaces rack and pinion. Operator uses footswitch to control blade oscillation. Device features interchangeable heads and suction rings for specific flap diameters/depths. Used by surgeons in clinical settings. Output is a precise corneal flap; facilitates subsequent refractive surgery. Benefits include improved reliability, easier assembly, and simplified component interchangeability compared to predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing, 3-D CAD modeling of dimensional specifications, and risk analysis comparing subject device to predicate.

Technological Characteristics

Materials: Stainless steel, low carbon stainless steel. Mechanism: Electrically driven (6-9V DC) oscillating blade; two-link pivot translation drive. Components: Interchangeable heads, suction rings (19mm, 20mm). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients undergoing LASIK surgery or other procedures requiring initial lamellar resection of the cornea.

Regulatory Classification

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.

Predicate Devices

• Hansatome® Excellus™ Microkeratome (K021640)

Submission Summary (Full Text)

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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.: [phone] [phone] 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 Excellus<br>Microkeratome | Proposed Zyoptix XP Microkeratome |
|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Lamellar resection of the cornea preceding<br>LASIK surgery or other treatment requiring<br>initial lamellar resection of the cornea | Lamellar resection of the cornea preceding<br>LASIK surgery or other treatment requiring<br>initial lamellar resection of the cornea |
| Operating Principle | Electrically driven oscillating blade housed<br>in a head, which guides the blade across<br>the cornea within controlled parameters. | Electrically driven oscillating blade housed in<br>a head, which guides the blade across the<br>cornea 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 Excellus<br>Microkeratome | 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 [phone]. 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 [phone] or [phone] 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 | <div> <span style="text-decoration: overline;">✓</span> </div> |
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| | |
| | OR |
| | Over-The-Counter-Use ________ |
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, | |

510(k) Number K040204

Nose and Throat Devise

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