FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be flowing or merging together. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 25, 2014 OmniGuide Incorporated Ms. Nicole Rasmussen Senior Regulatory Specialist One Kendall Square, Suite B1301 Cambridge, Massachusetts 02139 Re: K140378 Trade Name: OmniGuide Laser System with FlexGuide™ Ultra Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 29, 2014 Received: September 2, 2014 Dear Mr. Rasmussen: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K140378 Device Name OmniGuide Laser System with FlexGuide™ Ultra ### Indications for Use (Describe) The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical special laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the OmniGuide Surgical logo. The logo consists of the words "OmniGuide" in black text, with the word "SURGICAL" in smaller blue text underneath. To the left of the text is a blue circular graphic. There are two light blue and gray curved lines in the background. ## 510(k) Summary This 510(k) summary is being submitted in accordance with 21 CFR 807.92 #### 1. Submitter's Information | Name: | OmniGuide, Inc. | |----------|-----------------------------------------------------------------------------------------------------------------------------| | Address: | OmniGuide, Inc.<br>One Kendall Square<br>Suite B1301<br>Cambridge, MA 02139<br>Phone: (617) 551-8426<br>Fax: (617) 551-8445 | | Contact: | Nicole Boeyink | Contact: Nicole Rasmussen Sr. Regulatory Affairs Specialist Date Prepared: September 24, 2014 ### 2. Device Information | | Trade/Proprietary Name: OmniGuide Laser System with FlexGuide™ Ultra | |----------------------|------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Fiber Optic Handpiece<br>CO2 Laser Powered Surgical Instrument | | Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology (21 CFR § 878.4810) | | Product Code: | GEX | #### 3. Predicate Devices ## Handpiece: See Tables 1 & 2 OmniGuide, Inc. OmniGuide BeamPath Fiber Optic Handpiece System & Sterilization Tray K081939 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for OmniGuide Surgical. The logo consists of two concentric blue circles on the left, with the text "OmniGuide" in black to the right of the circles. Below "OmniGuide" is the word "SURGICAL" in blue, written in a smaller font. There is a registered trademark symbol to the right of the word "Guide". ## Laser: No Changes OmniGuide, Inc. OmniGuide BeamPath FELS 25A CO2 Laser System K093251 ### Fibers: No Changes, see Table 1. OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGuide Fiber K070157 OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGuide Fiber w/Low Loss Tip K093451 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image features the logo for OmniGuide Surgical. The logo consists of a stylized "O" formed by two concentric blue circles, with the text "OmniGuide" in black to the right of the circle. Below "OmniGuide" is the word "SURGICAL" in smaller, uppercase letters. The background includes two curved, gradient bands in shades of blue and gray, adding a modern and clean aesthetic to the overall design. #### Intended Use 4. The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical specialties: general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures. ### Device Description న. The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece are used together to perform the intended use above. The FELS 25A Laser and BeamPath Fibers remain unchanged. Additionally, the BeamPath fibers that deliver the laser energy, are cleared for laparoscopic use. The BeamPath Fiber Optic Handpiece (K081939) has been modified to the FlexGuide™ Ultra handpiece, which includes a sterilization tray and are sold as non-sterile reusable devices. The FlexGuide Ultra is a flexible handpiece that consists of three main sections: the proximal rear sealing cap, handpiece body/cannula and distal tip. The material of the FlexGuide Ultra handpiece is stainless steel. The OmniGuide BeamPath fiber (K070157, K093451) is inserted through the flexible handpiece proximal rear sealing cap and is fixated so that it is visualized through two site holes at the handpiece distal tip. The OmniGuide FELS 25A Laser System (K093251) still generates the CO2 laser energy, which is transmitted through the fiber. During the procedure the surgeon grasps and holds the distal tip of the FlexGuide Ultra with a grasper. The FlexGuide Ultra distal tip may be used in either non-contact mode or contact mode. The surgeon may also use the distal tip to enable tissue manipulation. ### Performance Testing 6. Performance testing has validated the FlexGuide Ultra handpiece. Engineering analysis and bench testing concluded that the FlexGuide Ultra can be grasped, manipulated and confirmed the modified handpiece does not affect its purpose and performance when compared to the OmniGuide predicate handpiece. Additionally, the review of the technical characteristics, indications for use, risk analysis, {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features the logo for OmniGuide Surgical. The logo consists of a circular design with the word "OmniGuide" in bold, black letters, with the word "SURGICAL" in smaller, blue letters underneath. The logo is positioned on the left side of the image, with two curved, light blue and gray lines extending horizontally to the right. verification and validation information provided in this 510(k) Premarket Notification demonstrates the OmniGuide FlexGuide Ultra handpiece, when used in conjunction with OmniGuide BeamPath fibers, are as safe and effective as its predicate device. #### 7. Substantial Equivalence The FlexGuide Ultra Handpiece is substantially equivalent to its predicate device when used according to its intended use. This statement is based on the information provided in this 510(k) Premarket Notification which demonstrates the FlexGuide Ultra handpiece shares the similar intended uses, operating principles, similar technical characteristics and incorporates the same basic handpiece design when compared to the original cleared handpiece. The handpiece also shares a similar intended use as the predicate fibers, which are used in conjunction with the FlexGuide Ultra to transmit CO2 laser energy to the treatment site. | | OmniGuide Laser<br>System with<br>FlexGuide™ Ultra<br>(K140378 pending) | OmniGuide<br>BeamPath Fiber<br>Optic Handpiece<br>System<br>(K081939) | OmniGuide Beam<br>Path CO 2 Mark III<br>WaveGuide Fiber<br>(K070157) | OmniGuide<br>BeamPath CO2<br>Mark III<br>WaveGuide Fiber<br>w/Low Loss Tip<br>(K093451) | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | The OmniGuide<br>Laser System with<br>FlexGuide™ Ultra,<br>which includes the<br>FELS 25A Laser,<br>BeamPath Fibers<br>and the FlexGuide™<br>Ultra handpiece, is<br>indicated for use to<br>enable the surgeon<br>to perform incision,<br>excision, ablation,<br>vaporization and<br>coagulation of body<br>soft tissues<br>including intra-oral<br>tissues. This system<br>is intended for use<br>with a grasper in the<br>following medical<br>specialties: general<br>laparoscopic | The OmniGuide<br>BeamPath® Fiber<br>Optic Handpiece<br>System and<br>Sterilization Tray is<br>indicated for use in<br>conjunction with<br>OmniGuide's<br>waveguide fibers to<br>enable the surgeon to<br>perform incision,<br>excision, ablation,<br>vaporization and<br>coagulation of body<br>soft tissues including<br>intra-oral tissues. It is<br>indicated in the<br>medical specialties of<br>general and plastic<br>surgery,<br>oral/maxillofacial<br>surgery, dentistry, | The OmniGuide<br>Mark Ill WaveGuide<br>Fiber is indicated for<br>the incision, excision,<br>ablation, vaporization<br>and coagulation of<br>body soft tissues<br>including intra-oral<br>tissues. It<br>is indicated in the<br>medical specialties of<br>general and plastic<br>surgery,<br>oral/maxillofacial<br>surgery, dentistry,<br>dermatology,<br>gynecology,<br>otorhinolaryngology,<br>gastroenterology,<br>neurosurgery,<br>urology, and<br>pulmonology. and | The OmniGuide<br>Beam Path CO 2<br>Mark II WaveGuide<br>Fiber with Low<br>Profile/Low Loss<br>Tip is indicated for<br>the incision, excision,<br>ablation, vaporization<br>and coagulation of<br>body<br>soft tissues including<br>intra-oral tissues. It is<br>indidated in the<br>medical specialties of<br>general<br>and plastic surgery,<br>oral/maxillofacial<br>surgery, dentistry,<br>dermatology,<br>gynecology,<br>otorhinolaryngology,<br>gastroenterology. | | | Table 1. Predicate Device Indications for Use Comparison | | | |--|----------------------------------------------------------|--|--| | | | | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for OmniGuide Surgical. The logo consists of three concentric blue circles on the left side of the image. To the right of the circles is the word "OmniGuide" in black font, with the word "SURGICAL" in blue font underneath. There is a registered trademark symbol to the right of the word "OmniGuide". | surgical procedures,<br>gynecologic<br>laparoscopic<br>surgical procedures,<br>urologic surgical<br>procedures,<br>otorhinolaryngology<br>surgical procedures. | dermatology,<br>gynecology,<br>otorhinolaryngology,<br>gastroenterology,<br>neurosurgery,<br>urology, and<br>pulmonology. | can be used in open<br>surgical procedures<br>as well as endoscopic<br>minimally invasive<br>procedures in<br>conjunction with<br>rigid or flexible<br>endoscopes, such as<br>in laryngoscopy,<br>gastroscopy,<br>colonoscopy,<br>laparoscopy,<br>thoracoscopy,<br>hysteroscopy and<br>bronchoscopy.<br>The indications for<br>use for which the<br>delivery system is<br>used for are<br>dependent upon the<br>cleared indications<br>for use of the laser<br>system and those<br>laser system<br>accessories to which<br>it is attached. | neurosurgery,<br>urology, and<br>pulmonology, and<br>can be used in open<br>surgical procedures<br>as well as endoscopic<br>minimally invasive<br>procedures<br>in conjunction with<br>rigid or flexible<br>endoscopes, such as<br>in laryngoscopy,<br>gastroscopy,<br>colonoscopy,<br>laparoscopy,<br>thoracoscopy,<br>hysteroscopy and<br>bronchoscopy.<br>The indications for<br>use for which the<br>delivery system is<br>used for are<br>dependent upon the<br>cleared indications<br>for use of the laser<br>system and those<br>laser system<br>accessories to which<br>it is attached. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ## Table 2. Predicate Handpiece Specification Comparison | | OmniGuide Laser System with<br>FlexGuide™ Ultra<br>(K140378 pending) | OmniGuide BeamPath Fiber Optic<br>Handpiece System<br>(K081939) | |--------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------| | Handpiece<br>Lumen<br>Material | 304 Stainless Steel | 304 Stainless Steel Hypodermic Tubing | | Lumen<br>Length | 50cm | Up to 60cm | | Handpiece<br>Design | Distal tip, handpiece body/cannula, rear<br>sealing cap | Distal tip, handpiece body/cannula, rear<br>sealing cap | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for OmniGuide Surgical. The logo consists of a blue circle with the words "OmniGuide" in black letters inside the circle. Below the circle, the word "SURGICAL" is written in blue letters. The logo is simple and modern, and it is likely used to represent a company that specializes in surgical products or services. | Distal Tip | Used in either non-contact mode or contact<br>mode, and may be used to enable tissue<br>manipulation. | Used in either non-contact mode or contact<br>mode, and may be used to enable tissue<br>manipulation. | |------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Mechanism of<br>Action | Handpiece is used to guide and protect<br>BeamPath® fibers | Handpiece is used to guide and protect<br>BeamPath® fibers | | Operating<br>Principle | To enable precision control and to stabilize<br>surgeon hand motion | To enable precision control and to stabilize<br>surgeon hand motion | #### 8. Conclusions OmniGuide conducted device performance non-clinical verification and validation testing. Results from the testing shows similar performance profiles when comparing the modified flexible handpiece to the original handpiece design. As confirmed in this 510(k) submission, testing was performed to confirm the modifications to the flexible handpiece when compared to its predicate device did not raise any new concerns of safety or effectiveness, alter the fundamental scientific technology of the device, nor affect its mode of use. OmniGuide believes the modified handpiece is substantially equivalent to its predicate handpiece based on similar specifications, performance data, intended use, and the handpiece mechanism of action. Thus, the FlexGuide Ultra handpiece is as safe, as effective and performs similar to the predicate handpiece.