ML MICROKERATOME

K981071 · Med-Logics, Inc. · HNO · Jul 23, 1998 · Ophthalmic

Device Facts

• Record ID: K981071
• Device Name: ML MICROKERATOME
• Applicant: Med-Logics, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Jul 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ML Microkeratome is used to perform lamellar keratoplasty procedures. This procedure is to remove a thin circular corneal cap.

Device Story

ML Microkeratome is a surgical instrument used by ophthalmologists to perform lamellar keratoplasty. The device functions by mechanically resecting a thin, circular corneal cap from the patient's eye. It is intended for use in a clinical or surgical setting. The device assists the surgeon in achieving precise corneal tissue removal, which is a critical step in lamellar keratoplasty procedures. By facilitating the creation of the corneal flap, the device enables the surgeon to proceed with the necessary corneal reconstruction or transplantation, potentially improving patient outcomes in corneal surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical instrument for corneal resection. No electronic, software, or energy-based components described.

Indications for Use

Indicated for patients undergoing lamellar keratoplasty procedures requiring the removal of a thin circular corneal cap.

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

JUL 23 1998

Ms. Betty Ross President MED-LOGICS, INC. 30251 Golden Lantern, # E- 207 Laguna Niguel, CA 92677

Re: K981071 Trade Name: ML Microkeratome Regulatory Class: I Product Code: 86 HNO Dated: June 26, 1998 Received: July 7, 1998

Dear Ms. Ross :

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 - Ms. Betty Ross

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. Roerl. lorentthal

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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K981071

:

510(k) Number (if known):

ML Microkeratome Device Name:

Indication For Use:

The ML Microkeratome is used to perform lamellar keratoplasty procedures. This procedure is no I he ML MICrokeratome is used to perform athin circular corneal cap.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------|---------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K981071 |

| Prescription Use | <i>i</i> |
|--------------------|----------|
| Per 21 CFR 801.109 | |

OR

| Over-The-Counter Use | |
|----------------------|--|
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