FLAPMAKER DISPOSABLE MICROKERATOME

K981155 · Hawken Industries · HNO · Aug 14, 1998 · Ophthalmic

Device Facts

• Record ID: K981155
• Device Name: FLAPMAKER DISPOSABLE MICROKERATOME
• Applicant: Hawken Industries
• Product Code: HNO · Ophthalmic
• Decision Date: Aug 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.

Device Story

FlapMaker is a disposable microkeratome system for anterior lamellar corneal resections. System comprises a control console (suction pump, electronics) and sterile, single-use disposable microkeratome heads. Principle of operation mimics a carpenter's plane; surgical-grade stainless steel blade oscillates at 12,500 rpm, driven by mechanical transmission cables from the control unit. Device mounts on a suction plate; moves across the cornea at 6.8 mm/sec. Available in fixed resection depths (130/160 microns) and diameters (8.5/10.5 mm). Used by ophthalmologists in clinical settings. No electricity is transmitted to the disposable head. Output is a corneal flap of specific dimensions, facilitating subsequent ophthalmic procedures. Benefits include disposable sterility and automated, consistent resection geometry.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including electrical safety certification and biocompatibility testing of materials in contact with tissue.

Technological Characteristics

Disposable microkeratome head made of biocompatible polycarbonate plastic with surgical-grade stainless steel blade. Blade oscillates at 12,500 rpm; axial drive speed 6.8 mm/sec. Energy source: electric motors in central control unit transmitted via mechanical cables. Resection depths: 130 or 160 microns; diameters: 8.5 or 10.5 mm. Sterilization: gamma radiation. No electrical components in the disposable head.

Indications for Use

Indicated for patients requiring anterior lamellar corneal resections of preselected thickness and diameter.

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

• Chiron Automatic Corneal Shaper (K941550)
• Steinway Micro-Kerato-trephone (K8436646)
• HANSA Automatic Corneal Shaper (K913697)

Submission Summary (Full Text)

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981155

#### Hawken Industries FlapMaker

Page A 3

AUG 1 4 1998

Hawken Industries Inc. FlapMaker Microkeratome 510(k) Submission

510(k) Summary

(1) Submitter Information

Name: Hawken Industries Inc.

Address: 26650 Renaissance Pkwy. Suite 3 Cleveland, Ohio 44128 U.S.A.

Telephone Number: 216-464-1119

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703

Date Prepared: March 19, 1998

(2) Name of Device:

Trade Name: FlapMaker Disposable Microkeratome Common Name: Disposable Microkeratome Classification Name: Keratome, A-C powered

(3) Equivalent legally-marketed devices:

The predicate devices for the FlapMaker are Chiron Automatic Corneal Shaper, K941550, the Steinway Micro-Kerato-trephone K8436646, and the HANSA Automatic Corneal Shaper, K913697.

(4) Description

The device consists of a control console and disposable FLAPMAKER™ microkeratomes. The control console contains a suction pump, electronics, and flexible cables to actuate the disposable microkeratome. The basic system sold consists of the control unit, 20 disposable microkeratomes (sold sterile), 5 practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.

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The FLAPMAKER™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes the blade made from surgical-grade steel. It is sold sterile and is for single use only. Each individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation.

The microkeratome is based upon the principle of the carpenter's plane. The blade, made from surgical stainless steel, oscillates at 12,500 rpm and is controlled by a unique patented flexible cable that is electronically driven. The blade extends a fixed distance from a transparent fixed plate and is at a 26° angle to the plate. Microkeratomes that create resection depths of 130 or 160 microns and resection diameters of 8.5mm and 10.5 mm are available. The microkeratome is mounted in a suction plate and is driven across the suction plate and protruding cornea at 6.8 mm/sec. by a patented flexible cable that is electrically actuated. The plastic suction ring, which supports the unit on the cornea, is made from biocompatible polycarbonate plastic.

The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by mechanical transmission cables. The motors are UL approved. The central unit also supplies the suction. One cable transmits the motion to cause the blade to oscillate, and the other drives the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the connections to the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

(5) Intended Use

The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.

### (6) Performance data

#### (1) Non-clinical tests

The FlapMaker has had electrical safety tests certified by the Canadian Standards Plastic Materials in contact with tissue have been tested for Association. biocompatibility. All motors are UL approved. Blades are surgical-grade stainless steel.

(2) Clinical tests

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# Hawken Industries FlapMaker

This device is identical to the predicate devices, except that the motors have been moved to a central unit and the energy is transmitted by cables. Since there is no change in technology or principles, a clinical test is not required.

# (3) Conclusions

The FlapMaker microkeratome is equivalent in safety and efficacy to the legallymarketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | 4 1998

Hawken Industries c/o George H. Myers, Sc.D Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604

Re: K981155 Trade Name: FlapMaker Disposable Microkeratome Regulatory Class: I Product Code: 86 HNO Dated: July 7, 1998 Received: July 8, 1998

Dear Dr. Myers:

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 Quality System Regulation (QS) 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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#### Page 2 - George H. Myers, Sc.D

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ARalph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Hawken Industries FlapMaker

Page 2011 - of of 1 - 1 1

510(k) Number (if known):

Device Name: Hawken FlapMaker Disposable Microkeratome

Indications for Use:

The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic Devices Ka81155 510(k) Number.

OR

Prescription Use_ 188/1 (Per 21 CFR 810.109) Over-the-Counter Use

(Optional Format 1-2-96)