HYDROBRUSH (TM) KERATOME

K971078 · Medjet, Inc. · HQS · Jan 23, 1998 · Ophthalmic

Device Facts

• Record ID: K971078
• Device Name: HYDROBRUSH (TM) KERATOME
• Applicant: Medjet, Inc.
• Product Code: HQS · Ophthalmic
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4070
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Any condition which requires removal of the epithelium from the cornea.

Device Story

HydroBrush Keratome is a surgical instrument used by ophthalmologists to remove corneal epithelium. Device operates as a mechanical tool for epithelial debridement. Used in clinical settings during ophthalmic procedures. Output is the physical removal of tissue, facilitating subsequent corneal surgery or treatment. Benefits include controlled epithelial removal.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical surgical instrument for corneal epithelial debridement. Manual operation.

Indications for Use

Indicated for patients requiring corneal epithelial removal for any clinical condition.

Regulatory Classification

Identification

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Eugène I. Gordon, Ph.D.
Chairman
Medjet Inc.
1090 King Georges Post Road, Suite 301
Edison, NJ 08837

Re: K971078/S2
Trade Name: HydroBrush ™ Keratome
Regulatory Class: I
Product Code: HQS
Dated: March 24, 1997
Received: March 24, 1997

Dear Dr. Gordon:

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.

JAN 23 1998

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Page 2 - Eugene I. Gordon, Ph.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,


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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Page 1 of 1

510(k) Number (if known): K971078

Device Name: HydroBrush™ Keratome

Indications For Use:

Any condition which requires removal of the epithelium from the cornea.

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

Concurrence of CORH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number K971078

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)

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