BLADEWORKS MICROKERATOME BLADE

K993225 · Blade Works, Inc. · HNO · Mar 20, 2000 · Ophthalmic

Device Facts

• Record ID: K993225
• Device Name: BLADEWORKS MICROKERATOME BLADE
• Applicant: Blade Works, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Mar 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Bladeworks BW 9000 Microkeratorne Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Hansatome microkerutome, is used to perform lamellar keratoplasty procedures.

Device Story

Bladeworks Microkeratome Blades (BW 9000 and BW 1011) are surgical cutting instruments designed for use with specific microkeratome systems (Chiron ACS and Chiron Hansatome). These blades are used by ophthalmologists during lamellar keratoplasty procedures to create corneal flaps. The device functions as a mechanical cutting edge; it is integrated into the microkeratome assembly to perform precise corneal tissue resection. The blades facilitate the surgical procedure, enabling the surgeon to achieve the necessary corneal geometry for refractive or therapeutic outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical blade; stainless steel construction; designed for integration with Chiron ACS and Hansatome microkeratome systems; sterile, single-use.

Indications for Use

Indicated for patients undergoing lamellar keratoplasty procedures requiring the use of Chiron ACS or Chiron Hansatome microkeratomes.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2000

Mr. Gary S Mocnik Regulatory Consultant Bladeworks Inc. 107 South Covington Street Hillsboro, TX 76445

Re: K993225 Trade Name: Bladeworks Microkeratome Blade Regulatory Class: I Regulation: 886.4370 Product Code: 86 HNO Dated: September 20, 1999 Received: September 29, 1999

Dear Mr. Mocnik:

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 - Mr. Gary S Mocnik

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,

A. Ralph 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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510(k) Number (if known):

K993225

Dovicc Namc: Bladeworks Microkeratome Blade

## Indication For Use:

The Bladeworks BW 9000 Microkeratorne Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Hansatome microkerutome, is used to perform lamellar keratoplasty procedures.

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Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Usc 1, l'cr 21 CFR 801.109

OK

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

HXB Nicholas

510(k) Numb