MODIFICATION TO VISITOME 20-10 MICROKERATOME

K042083 · Biovision AG · HNO · Nov 16, 2004 · Ophthalmic

Device Facts

• Record ID: K042083
• Device Name: MODIFICATION TO VISITOME 20-10 MICROKERATOME
• Applicant: Biovision AG
• Product Code: HNO · Ophthalmic
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Visitome 20-10 Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

Device Story

AC-powered microkeratome for corneal flap creation; used in LASIK or lamellar resection procedures. System includes control unit, surgical handpiece with drive assembly, positioning ring, applanator, and stainless steel blade. Operation: positioning ring secures cornea via vacuum; applanation shoe flattens surface; high-speed oscillating stainless steel blade performs resection at predetermined thickness and diameter. Controlled by physician via foot pedal and control unit. Benefits: enables precise corneal tissue incision for refractive surgery.

Clinical Evidence

Bench testing only. Performance evaluation conducted in pig eyes to validate new blade size and demonstrate equivalence to predicate devices.

Technological Characteristics

AC-powered; stainless steel oscillating blade; vacuum-assisted positioning ring; applanation shoe. Mechanical drive mechanism. No software or electronic algorithm described.

Indications for Use

Indicated for patients undergoing LASIK 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

• Visitome 20-10 Microkeratome (K014000)
• FS Laser Keratome (K031960)

Submission Summary (Full Text)

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### 510(k) SUMMARY NOV 1 6 2004 VISITOME 20-10 MICROKERATOME

#### 1. APPLICANT

| Company Name: | Biovision AG<br>27 Erlenstrasse<br>2555 Brugg, Switzerland |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dale Sadlik<br>Product Director<br>Visitome, Inc.<br>27 Mauchly, Unit 206<br>Irvine, CA 92618<br>Tel: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | November 3, 2004 |

#### 2. DEVICE IDENTIFICATION

| A. | Classification Name: | Keratome, AC-Powered |
|----|-------------------------|------------------------------|
| B. | Trade/Proprietary Name: | Visitome 20-10 Microkeratome |
| C. | Classification: | Class I per 886.4370 |
| D. | Product Code: | HNO |

#### DEVICE DESCRIPTION 3.

The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).

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#### 4. INTENDED USE

The Visitome 20-10 Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

#### 5. SUBSTANTIAL EQUIVALENCE

The Biovision AG Visitome 20-10 Microkeratome is equivalent to the predicate devices listed below. Each of these devices has a similar indication for use and utilizes suction to the cornea. With respect to corneal resections, the Visitome and device uses a stainless steel blade to cut a corneal flap, while the IntraLase device uses a femtosecond laser for cutting/resection created by micro-photodisruption of the corneal tissue. Bench testing demonstrates that the Visitome 20-10 Microkeratome is equivalent to the predicate devices, and that any differences do not affect safety or effectiveness.

| Predicate<br>Device | Applicant | 510(k) No. | Date Cleared |
|---------------------------------|--------------------------|------------|--------------------|
| Visitome 20-10<br>Microkeratome | Biovision AG | K014000 | March 11, 2002 |
| FS Laser<br>Keratome | Intralase<br>Corporation | K031960 | September 29, 2003 |

#### TECHNOLOGICAL CHARACTERISTICS 6.

The Visitome 20-10 Microkeratome contains a positioning ring which allows the cornea to protrude through the ring. The cornea is restrained by an applanation shoe surface, which may be pivoted away. A stainless steel blade is suspended from the end of the positioning ring by a blade support (holder) which is driven by a drive mechanism, so that the blade moves along a forward path between the positioning ring and the applanation shoe while oscillating laterally. Drive control and vacuum for the positioning ring are provided by user command via the control unit and foot pedal.

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#### 7. PERFORMANCE DATA

The Visitome 20-10 Microkeratome has been designed and tested in accordance with applicable electrical safety standards. The new blade size has undergone performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements, and is substantially equivalent to the predicate devices.

#### CONCLUSIONS 8.

Biovision AG has demonstrated through its evaluation of the Visitome 20-10 Microkeratome that the device is equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2004

Biovision AG c/o Mr. Dale Sadlik Visitome, Inc 27 Mauchly, Unit 206 Irvine, CA 92618

> Re: K042083 Trade/Device Name: Visitome 20-10 Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: July 19, 2004 Received: August 3, 2004

Dear Mr. Sadlik:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rQth pe is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosals) to togally to trgans and the Medical Device Amendments, or to commerce proof to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug, devices mar nave been recuire approval of a premarket approval application (PMA). and Cosmetic Treef, market the device, subject to the general controls provisions of the Act. The Tou may, merciole, market the act include requirements for annual registration, listing of general controls provision 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 If your device is classified (500 a00 roy als. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of Pource concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that FDF 3 lobants of your device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must of any I cochar statutes and regulated including, but not limited to: registration and listing comply with an the Act 3 requirements, months.go
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 607), facemig (21 cegulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Dale Sadlik

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.

A halyi korenthal

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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## INDICATIONS FOR USE

510(k) Number:

# (To Be Assigned By FDA)

Device Trade Name:

## VISITOME 20-10 MICROKERATOME

Indications For Use:

The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Doxeylin 11-8-2004

vision Sign-Off Division of Ophthalmic E Nose and Throat Devises

Page 1 of

510(k) Number

November 3, 2004