OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY

{0}------------------------------------------------ MAY - 9 2005 Image /page/0/Picture/1 description: The image shows the logo for OmniGuide communications. The logo consists of the word "OmniGuide" in a sans-serif font, with the word "communications" in a smaller, italicized font below it. To the left of the text is a graphic of two concentric circles. 人心之心之小! # 510(k) Summary | Submitter: | OmniGuide Communications Inc.<br>One Kendall Square, Building 100 3rd Floor<br>Cambridge, MA 02139 | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person:<br>Telephone: | Irina Kulinets<br>617-551-8404 | | Fax: | 617-551-8445 | | Proprietary Name: | OmniGuide BeamPath CO2 Mark I Laser Beam Delivery<br>System | | Common Name: | CO2 Laser Powered Surgical Instrument | | Classification: | 878.4810 | | Product Code: | GEX | | Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology. | | Substantial Equivalence Claimed To: | K992472 Clinicon SureGuide CO2 Laser Beam<br>Delivery System.<br>K014048 Clinicon Universal WaveGuide<br>Handpiece and Fiber Tips<br>K924664 Surgilase Fiberlase CO2 Laserwave Guide<br>K921671 Surgilase Fiberlase V CO2 Laser<br>Waveguide<br>K896478 Luxar LX-20 Minilase CO2 Surgical Laser<br>K031440 Cynosure Smart CO2 Medical Laser<br>System<br>K963189 ERBE APC 300 Argon Plasma Coagulator<br>K032969 Helica "TC" Laparoscopic Cutting<br>and Cauterizing Accessories | {1}------------------------------------------------ #### Description: The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is an accessory for CO2 laser systems that can be retrofitted to Luxar LX-20 or Lumenis NovaPulse laser systems. It consists of an adapter and a fiber assembly that propagate CO2 laser beams. The OmniGuide BeamPath CO2 Mark I Fiber Assembly is supplied sterile and is intended for single procedure use. #### Intended Use: The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is intended for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached #### Summary of Technological Characteristics: The device contains the optical fiber assembly and the adapter for connecting the fiber to the laser. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy. The fiber assembly is 1.5 m or 2.0 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The adapter links the fiber assembly and the CO2 laser. ### Performance Data: Non-clinical Performance Data: The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System performance characteristics have been evaluated through testing and analysis of laser power output and beam quality. This type of testing complies with the respective section of the FDA Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995) and is similar to the predicate device tests. The performance of the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System and related parameters of predicate devices (as specified in comparison table) are comparable, The OmniGuide BeamPath CO2 Mark I Fiber Assembly has passed biocompatibility testing as performed by an independent laboratory in accordance with ISO 10993-1:2003 Standards. Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as predicate devices. However, the device was used in a compassionate use per FDA permission. No adverse effects were noticed, the device performed as intended. {2}------------------------------------------------ Conclusions Drawn from Tests and Analysis: The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System are similar or equivalent to same characteristics of above mentioned legally marketed devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health and Human Services, USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged around the emblem in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 9 2005 Ms. Irina Kulinets Director Regulatory Affairs and Quality Assurance OmniGuide Communications One Kendall Square, Building 100 3rd Floor Cambridge, Massachusetts 02139 Re: K050541 K00091 Trade/Device Name: OmniGuide BeamPath CO² Mark I Laser Beam Delivery System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: February 25, 2005 Received: March 2, 2005 Dear Ms. Kulinets: We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or 10 commerce proc to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de vices that have been receasined in quire approval of a premarket approval application (PMA). and Costicle 710 (110) market the device, subject to the general controls provisions of the Act. The r ou may, mercere, mance are as act include requirements for annual registration, listing of gencial controls provisions of ractice, 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 your device is classified (665 a00 -0) trols. Existing major regulations affecting your device it may be subject to stan additions, Title 21, Parts 800 to 898. In addition, FDA ean oc found in the Ovaouncements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not nean I lease of advisou that i Drivistian that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must of any I ederal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, n.c., and manufacturing practice requirements as set Of It Fart 607), adoning (21 CFR Part 820); and if applicable, the electronic (2006) 1959 forth in the quality bybents (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 – Ms. Irina Kulinets This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse ough finding of substantial equivalence of your device to a legally premarket notification: "The PDts 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 If you desire specific at not as (240) 276-0115 . Also, please note the regulation entitled, Connact the Office of Complains market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour represent Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, _ Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K050541 Device Name: OmniGuide BeamPath CO2 Mark | Laser Beam Delivery System Indications For Use: The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery, pulmonary surgery for surgical and aesthetic applications. The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached Nil R.P. Ogle ion of General, **Restorative** Neurological Devices K0J0541 Prescription Use _Yes (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use No (21 CFR 801 Subpart C) (Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)