VMATE MODEL VMM1000

K030948 · Howard Instruments, Inc. · HQE · Jun 17, 2003 · Ophthalmic

Device Facts

• Record ID: K030948
• Device Name: VMATE MODEL VMM1000
• Applicant: Howard Instruments, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Jun 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

Device Story

VMate Vitreous Cutting System is an electrically powered ophthalmic device; designed for vitreous aspiration and cutting. Used by ophthalmologists in surgical settings to remove vitreous matter from the vitreous cavity. Device functions via mechanical cutting and aspiration mechanism; controlled by surgeon to facilitate vitrectomy procedures. Benefits include precise removal of vitreous tissue during ocular surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Electrically powered vitreous aspiration and cutting instrument. Class II device (21 CFR 886.4150). Product code HQE.

Indications for Use

Indicated for the removal of vitreous matter from the vitreous cavity in patients undergoing ophthalmic surgery.

Regulatory Classification

Identification

A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

Special Controls

*Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2003

Howard Instruments, Inc. c/o Jack Howard President 4749 Appletree Lane Tuscaloosa, AL 35405-5747

Re: K030948

Trade/Device Name: VMate TM Vitreous Cutting System Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: Class II Product Code: HQE Dated: March 17, 2003 Received: March 26, 2003

Dear Mr. Jack Howard:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act . or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

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

Enclosure

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4.

510(k) Number (if known):

Device Name: VMate™ Vitreous Cutting System

Indication for use:

An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>✓</div> |
|--------------------|---------------------------------|
| Per 21 CFR 801.109 | |
| | OR |
| | Over-The-Counter Use __________ |

| | <i>signature</i> |
|--|---------------------------------------------------|
| | Division of Ophthalmic Ear,<br>and Throat Devises |

| 510(k) Number | K030948 |
|---------------|---------|
|---------------|---------|