HANSATOME EXCELLUS MICROKERATOME

K021640 · Bausch & Lomb, Inc. · HNO · Jun 19, 2002 · Ophthalmic

Device Facts

• Record ID: K021640
• Device Name: HANSATOME EXCELLUS MICROKERATOME
• Applicant: Bausch & Lomb, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Jun 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Story

Hansatome Excellus Microkeratome is a precision instrument for lamellar corneal resection during LASIK or similar ophthalmic surgeries. Device utilizes an electrically driven oscillating blade housed in a head that rotates about a pivot pin; propulsion is achieved via a rolling gear engaging an arcuate gear rack on a suction ring. The Power/Suction Supply Unit includes a vacuum regulator for pre-surgical setting, a vacuum tank for reserve suction during power/pump failure, and a battery backup for the motor. The system features an LCD with back-lit display for low-light visibility. Operated by physicians in clinical settings, the device provides controlled corneal resection. Safety features include reserve vacuum and battery backup to mitigate risks during power interruptions, ensuring consistent performance for the surgeon and improved patient safety during the procedure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Stainless steel. Principle: Electrically driven oscillating blade. Energy: DC powered (6-9 volts), battery backup. Connectivity: Standalone. Features: Vacuum regulator, vacuum reserve tank, back-lit LCD. UL listed power/suction supply unit.

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 Microkeratome (K972808)
• Hansatome Microkeratome (K010260)

Submission Summary (Full Text)

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K021640

# JUN 1 9 2002

#### Hnasatome Excellus Microkeratome

### 510(k) SUMMARY (per 21 CFR §807.92)

| Submitter's Name:<br>Address: | Bausch & Lomb<br>3365 Tree Court Industrial Blvd.<br>St. Louis, MO 63122 |
|-----------------------------------|--------------------------------------------------------------------------|
| Telephone #:<br>Fax #: | [phone]<br>[phone] |
| Official Correspondent: | Dennis PozZO<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | May 15, 2002 |
| Device Name/<br>Proprietary name: | Hansatome® Excellus™ Microkeratome |
| Classification/Common Name | Keratome |
| Class: | I |
| Panel: | Ophthalmic |
| Product Code: | ΗΝΟ |

The marketed device(s) to which substantial equivalence is claimed: Hansatome® Microkeratome

#### PRODUCT DESCRIPTION:

The Hansatome® Excellus™ Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. It functions identically to the existing Hansatome Microkeratome in that the cutting head rotates about a piyot pin. Propulsion is via a rolling gear within the head which engages with an arcuate gear rack affixed to the suction ring. In addition, the Hasatome Excellus Power/Suction Supply Unit includes 1) a vacuum regulator to allow the physician to set vacuum prior to surgery, 2) a vacuum tank that provides reserve vacuum in the event the vacuum pump fails or power is interrupted during the course of surgery, and 3) a battery pack back-up power supply to the microkeratome motor in the event power is interrupted during the course of surgery. The microkeratome's LCD also contains a back-lit display so the User can read the LCD display in low/no light conditions.

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### Substantial Equivalent Basis

The Hansatome® Excellus™ Microkeratome is substantially equivalent to the Hansatome® Microkeratome (K972808 and K010260), see Comparison Martix below.

| COMPARISON MATRIX | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| and and and the management of the commendent of the promotive of the promotive of the management of the manufactures and the manufacturer of the comments of the contraction o | |

### SIMILARITIES

| CHARACTERISTICS | Current Hansatome<br>Microkeratome | PROPOSED Hansatome Excellus<br>Microkeratome |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Lamellar resection of the cornea<br>preceding LASIK surgery or other<br>treatment requiring initial lamellar<br>resection of the cornea | Lamellar resection of the cornea<br>preceding LASIK surgery or other<br>treatment requiring initial lamellar<br>resection of the cornea |
| Operating Principle | Electrically driven oscillating blade<br>housed in a head which guides the<br>blade ascross the cornea within<br>controlled parameters. | Electrically driven oscillating blade<br>housed in a head which guides the<br>blade ascross the cornea within<br>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 arcuate gear rack with temporal pivot pin 3 interchangable heads with fixed thickness DC powered 6-9 volts Footswitch Blade oscillation | Single arcuate gear rack with temporal pivot pin 3 interchangable heads with fixed thickness DC powered 6-9 volts Footswitch Blade oscillation |

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## COMPARISON MATRIX

## DIFFERENCES

| CHARACTERISTICS | Current Hansatome<br>Microkeratome | PROPOSED Hansatome Excellus<br>Microkeratome |
|---------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Power Switch | Power Switch is on front of power<br>supply | Power Switch is on back of power<br>supply |
| Front Panel Labeling | Symbology and verbiage on front<br>panel. | Symbology only on front panel. |
| Vacuum Pump | Less efficient pump, can only<br>operate at elevations up to 6500 feet<br>above sea level. | More efficient pump, can operate at<br>elevations up to 7000 feet above sea<br>level. |
| | The vacuum pump is listed with<br>safety agencies. | The vacuum pump is not listed with<br>safety agencies. |
| Power/Suction Supply Unit | Not UL Listed | UL Listed |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. 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 one behind the other. The profiles are rendered in a simple, abstract manner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 9 2002

Bausch & Lomb, Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 3655 Tree Court Industrial Blvd. St. Louis. MO 63122-6694

Re: K021640

> Trade/Device Name: BAUSCH & LOMB Hansatome® Excellus™ Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: 86 HNO Dated: May 17, 2002 Received: May 20, 2002

Dear Mr. Pozzo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

A. Ralph 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

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510(K) Number

510(K) Number -

Device Name: Hansatome® Excellus™ Microkeratome

### Indications for Use:

The Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring 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 __ V ____ OR Over-the-Counter Use __________________________________________________________________________________________________________________________ R. Binfa hickotons

(Division Sign-Off)

510(k) Number KOR 1640

Bausch & Lomb Surgical