FRAG COMMANDER

K973749 · Scieran Technologies, Inc. · HQC · Dec 8, 1997 · Ophthalmic

Device Facts

• Record ID: K973749
• Device Name: FRAG COMMANDER
• Applicant: Scieran Technologies, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in fragmentation and aspiration of the human lens

Device Story

Frag Commander is a phacofragmentation device used by ophthalmologists during cataract surgery. It functions by fragmenting and aspirating the human lens. The device is intended for prescription use in a clinical or surgical setting. It assists the surgeon in lens removal, facilitating the surgical procedure and potentially improving patient outcomes by enabling efficient lens extraction.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Phacofragmentation device designed for lens fragmentation and aspiration. Technical specifications and materials are not detailed in the provided documentation.

Indications for Use

Indicated for fragmentation and aspiration of the human lens during ophthalmic surgery.

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

DEC - 8 1997

Rod Ross President Scieran Technologies 27071 Cabot Rd., Suite 127 Laguna Niguel, Ca 92653

Re: K973749 Trade Name: Frag Commander Regulatory Class: II Product Code: 86 HQC Dated: September 30, 1997 Received: October 1, 1997

Dear Mr. 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 - Mr. Rod 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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K973749 510(k) Number (if known):

Frag Commander™ Phacofragmentation Device Device Name: Indication For Use:

For use in fragmentation and aspiration of the human lens

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Dessis L. McCarthy

(Division Sign-Off)
Division of Ophthalmic Devices

510(k) Number

Prescription Use Per 21 CFR 801.109

Over-The-Counter Use_