MICROKERATOME OR THE MATE

K974598 · Howard Instruments, Inc. · HNO · Apr 22, 1998 · Ophthalmic

Device Facts

• Record ID: K974598
• Device Name: MICROKERATOME OR THE MATE
• Applicant: Howard Instruments, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Apr 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MMK-1000 is designed to produce a corneal flap.

Device Story

The MMK-1000 is a microkeratome used by ophthalmologists in a clinical or surgical setting to create a corneal flap. The device functions as a mechanical surgical instrument. It is operated by a physician to perform precise corneal incisions. The output is a physical corneal flap, which facilitates subsequent refractive surgical procedures. The device benefits the patient by enabling the necessary access for vision correction surgeries.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Mechanical microkeratome for corneal surgery. Device is a Class I surgical instrument. No software, electronic, or complex material specifications provided in the document.

Indications for Use

Indicated for the creation of a corneal flap in patients undergoing ophthalmic surgery.

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

APR 2 2 1998

Mr. Jack Howard Official Correspondent Howard Instrument, Inc. 4749 Appletree Ln. Tuscaloosa, Alabama 35405

K974598 Re: Trade Name: Microkeratome Regulatory Class: I Product Code: 86 HMY, 86 HNO Dated: April 14, 1998 Received: April 20, 1998

Dear Mr. Howard:

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. Jack Howard

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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5 10(k) Number (if known): K 974598

Device Name: _microkeratome

Indications For Use:

The MMK-1000 is designed to produce a corneal flap.

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

| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| Bruce Drum | |
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K974598 |

| Prescription Use | OR | Over the Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)