SYNTEC VITMAN

K980480 · Syntec, Inc. · HQC · May 4, 1998 · Ophthalmic

Device Facts

• Record ID: K980480
• Device Name: SYNTEC VITMAN
• Applicant: Syntec, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: May 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of: Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies; Opacity Inflammation Endophthalmitis Bacterial Fungal Uveitis Removal of lens remnants after cataract surgery; · Remove vitreous traction under the retina producing localized or complete retinal detachment; Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis; Treatment of vitreous loss during cataract surgery; Clean vitreous strands from the cataract wound; Perform emulsification of cataractous lens and its removal by aspiration and irrigation; Provide internal illumination for vitreous surgery; Provide air pressure for maintaining intraocular pressure for retinal surgery.

Device Story

Syntec VitMan is an ophthalmic surgical system used in clinical settings by ophthalmologists. Device functions include vitreous removal, cataract lens emulsification/aspiration/irrigation, internal illumination, and air pressure maintenance for intraocular pressure. System supports complex retinal and cataract surgeries. Clinician operates device via console controls to manage surgical parameters. Output provides mechanical assistance for tissue removal and visualization, enabling surgeons to treat retinal detachments, hemorrhages, and post-surgical complications. Benefits include restoration of vision and management of ocular trauma/disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ophthalmic surgical system providing aspiration, irrigation, emulsification, and illumination. Operates as a multi-functional surgical console for vitreous and cataract procedures. Technical specifications and materials not detailed in provided text.

Indications for Use

Indicated for ophthalmic surgical procedures including vitreous removal (cloudiness, hemorrhage, trauma, inflammation, endophthalmitis, uveitis), lens remnant removal, retinal detachment repair, diagnostic vitreous sampling, vitreous loss management, cataract wound cleaning, phacoemulsification, internal illumination, and intraocular pressure maintenance.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 MAY

Mr. James Easely Director of Engineering Syntec, Inc. 733 Mansion Road Winfield, MO 63389

Re: K980480

> Trade Name: Syntec Vitman Vitrectomy System Regulatory Class: II Product Code: 86 HQE Dated: January 30, 1998 Received: February 3, 1998

Dear Easely :

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. James Easely

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,

ARalph lorentbal

A. Ralph Rosenthal, M.I Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures:

Removal of vitreous in cases of:

Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies; Opacity Inflammation Endophthalmitis Bacterial Fungal Uveitis

Removal of lens remnants after cataract surgery;

· Remove vitreous traction under the retina producing localized or complete retinal detachment;

Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;

Treatment of vitreous loss during cataract surgery;

Clean vitreous strands from the cataract wound;

Perform emulsification of cataractous lens and its removal by aspiration and irrigation;

Provide internal illumination for vitreous surgery;

Provide air pressure for maintaining intraocular pressure for retinal surgery.

Prescription Use
(Per 21 CFR 801.109)

Massha P. Burke Nicholas

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