VELOCITY ADVANTAGE

K023939 · Visioncare Devices, Inc. · HQE · Apr 17, 2003 · Ophthalmic

Device Facts

• Record ID: K023939
• Device Name: VELOCITY ADVANTAGE
• Applicant: Visioncare Devices, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Apr 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Velocity Advantage would be used by a physician in conjunction with standard vitrectomy equipment to cut and remove vitreous and other intraocular tissue.

Device Story

Velocity Advantage is a surgical instrument used by physicians during vitrectomy procedures. It functions as an accessory to standard vitrectomy equipment to facilitate the cutting and removal of vitreous humor and intraocular tissue. The device is operated by a surgeon in an operating room setting. By enabling precise tissue removal, it assists in ophthalmic surgical interventions, potentially improving patient outcomes in vitreoretinal procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vitreous aspiration and cutting instrument; class II device (21 CFR 886.4150); product code HQE. Designed for integration with standard vitrectomy surgical systems.

Indications for Use

Indicated for use by physicians in conjunction with standard vitrectomy equipment for the cutting and removal of vitreous and other intraocular tissue.

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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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VisionCare Devices, Inc. c/o Chet Cracchiolo President 1246 Redwood Boulevard Redding, Ca 96003

> K023939 Trade/Device Name: Velocity Advantage Regulation Number: 886.4150 Regulation Name: Vitreous Aspiration & Cutting Instrumentt Regulatory Class: II Product Code: HQE Dated: March 4, 2003 Received: March 4, 2003

Dear Mr. Cracchiolo:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

APR 1 7 2003

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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## Page 2 - Mr. Chet Cracchiolo; President

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. halpi 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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Page I of I

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K023939

Velocity Advantage Console Device Name:

Indications For Use:

The Velocity Advantage would be used by a physician in conjunction with standard vitrectomy equipment to cut and remove vitreous and other intraocular tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

h.K.B. Nicholas

ion of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K023939

Prescription Use
lizze Nicholas
(Per 21 CFR 801.109)

(Optional Format 3-10-98)