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.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study proving device performance:

The provided document is a 510(k) Premarket Notification for the OmniGuide Laser System with FlexGuide™ Ultra. It aims to demonstrate substantial equivalence to previously cleared devices, not to establish new performance claims against defined acceptance criteria in the traditional sense of a clinical trial. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance metrics) is not applicable or not explicitly provided in this type of regulatory submission. The focus is on demonstrating that the modified device is as safe and effective as its predicate devices.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, explicit "acceptance criteria" against numerical performance metrics for a new claim are not presented. Instead, the acceptance is based on demonstrating that the modified device (FlexGuide™ Ultra handpiece) does not raise new issues of safety or effectiveness compared to its predicate. The "performance" reported is a qualitative assessment of similarity.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (FlexGuide™ Ultra)
Similar Intended Use: The modified device should have the same or very similar indications for use as the predicate device(s).	The FlexGuide™ Ultra has the same indications for use as the predicate OmniGuide BeamPath® Fiber Optic Handpiece System (K081939) regarding incision, excision, ablation, vaporization, and coagulation of body soft tissues (including intra-oral tissues) in general laparoscopic, gynecologic laparoscopic, urologic, and otorhinolaryngology surgical procedures.
Similar Operating Principles: The fundamental way the device functions should remain the same.	The operating principle of the FlexGuide™ Ultra, like its predicate, is "To enable precision control and to stabilize surgeon hand motion." The mechanism of action is also identical: "Handpiece is used to guide and protect BeamPath® fibers."
Similar Technical Characteristics: Key design features, materials, and functional aspects should be comparable.	Handpiece Lumen Material: 304 Stainless Steel (same as predicate).Lumen Length: 50cm (vs. Up to 60cm for predicate, indicating a slight difference but within acceptable range for the modified design).Handpiece Design: Distal tip, handpiece body/cannula, rear sealing cap (same as predicate).Distal Tip Function: Used in either non-contact mode or contact mode, and may be used to enable tissue manipulation (same as predicate).The FELS 25A Laser and BeamPath Fibers remain unchanged from their predicate versions. The change focuses on the handpiece modification.
No New Concerns of Safety or Effectiveness: Testing should demonstrate that the modifications do not introduce new risks or reduce effectiveness.	"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.""...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."
Performance Data (Demonstrate Equivalence): Data should support the claim that the modified device performs comparably to the predicate.	"Results from the testing shows similar performance profiles when comparing the modified flexible handpiece to the original handpiece design."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as a number of distinct "tests" or "patients." The performance testing is described as "Engineering analysis and bench testing." This implies a series of laboratory or functional tests, not a clinical trial with human subjects.
Data Provenance: Not explicitly stated, but likely internal laboratory data from OmniGuide, Inc. (Cambridge, Massachusetts, USA). The study is retrospective in the sense that it evaluates the modified device against an existing predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. Ground truth as typically established by experts (e.g., for diagnostic accuracy) is not relevant for this type of engineering and bench testing. The evaluation is against engineering specifications and functional performance.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This is not a study involving human interpretation of results requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a surgical handpiece, not an AI diagnostic tool that assists human readers.
Effect Size of AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable in the traditional sense. The "ground truth" for the engineering and bench testing would be successful operation according to the predicate's established performance parameters and the device's design specifications. This would involve objective measurements (e.g., mechanical integrity tests, energy delivery verification) rather than human interpretation or pathology.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K140378

Device Name OmniGuide Laser System with FlexGuide™ Ultra

Indications for Use (Describe)

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)

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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.One Kendall SquareSuite B1301Cambridge, MA 02139Phone: (617) 551-8426Fax: (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 HandpieceCO2 Laser Powered Surgical Instrument
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand 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

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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

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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.

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,

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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 LaserSystem withFlexGuide™ Ultra(K140378 pending)	OmniGuideBeamPath FiberOptic HandpieceSystem(K081939)	OmniGuide BeamPath CO 2 Mark IIIWaveGuide Fiber(K070157)	OmniGuideBeamPath CO2Mark IIIWaveGuide Fiberw/Low Loss Tip(K093451)
Indicationsfor Use	The OmniGuideLaser System withFlexGuide™ Ultra,which includes theFELS 25A Laser,BeamPath Fibersand the FlexGuide™Ultra handpiece, isindicated for use toenable the surgeonto perform incision,excision, ablation,vaporization andcoagulation of bodysoft tissuesincluding intra-oraltissues. This systemis intended for usewith a grasper in thefollowing medicalspecialties: generallaparoscopic	The OmniGuideBeamPath® FiberOptic HandpieceSystem andSterilization Tray isindicated for use inconjunction withOmniGuide'swaveguide fibers toenable the surgeon toperform incision,excision, ablation,vaporization andcoagulation of bodysoft tissues includingintra-oral tissues. It isindicated in themedical specialties ofgeneral and plasticsurgery,oral/maxillofacialsurgery, dentistry,	The OmniGuideMark Ill WaveGuideFiber is indicated forthe incision, excision,ablation, vaporizationand coagulation ofbody soft tissuesincluding intra-oraltissues. Itis indicated in themedical specialties ofgeneral and plasticsurgery,oral/maxillofacialsurgery, dentistry,dermatology,gynecology,otorhinolaryngology,gastroenterology,neurosurgery,urology, andpulmonology. and	The OmniGuideBeam Path CO 2Mark II WaveGuideFiber with LowProfile/Low LossTip is indicated forthe incision, excision,ablation, vaporizationand coagulation ofbodysoft tissues includingintra-oral tissues. It isindidated in themedical specialties ofgeneraland plastic surgery,oral/maxillofacialsurgery, dentistry,dermatology,gynecology,otorhinolaryngology,gastroenterology.

	Table 1. Predicate Device Indications for Use Comparison

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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,gynecologiclaparoscopicsurgical procedures,urologic surgicalprocedures,otorhinolaryngologysurgical procedures.	dermatology,gynecology,otorhinolaryngology,gastroenterology,neurosurgery,urology, andpulmonology.	can be used in opensurgical proceduresas well as endoscopicminimally invasiveprocedures inconjunction withrigid or flexibleendoscopes, such asin laryngoscopy,gastroscopy,colonoscopy,laparoscopy,thoracoscopy,hysteroscopy andbronchoscopy.The indications foruse for which thedelivery system isused for aredependent upon thecleared indicationsfor use of the lasersystem and thoselaser systemaccessories to whichit is attached.	neurosurgery,urology, andpulmonology, andcan be used in opensurgical proceduresas well as endoscopicminimally invasiveproceduresin conjunction withrigid or flexibleendoscopes, such asin laryngoscopy,gastroscopy,colonoscopy,laparoscopy,thoracoscopy,hysteroscopy andbronchoscopy.The indications foruse for which thedelivery system isused for aredependent upon thecleared indicationsfor use of the lasersystem and thoselaser systemaccessories to whichit is attached.

Table 2. Predicate Handpiece Specification Comparison

	OmniGuide Laser System withFlexGuide™ Ultra(K140378 pending)	OmniGuide BeamPath Fiber OpticHandpiece System(K081939)
HandpieceLumenMaterial	304 Stainless Steel	304 Stainless Steel Hypodermic Tubing
LumenLength	50cm	Up to 60cm
HandpieceDesign	Distal tip, handpiece body/cannula, rearsealing cap	Distal tip, handpiece body/cannula, rearsealing cap

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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 contactmode, and may be used to enable tissuemanipulation.	Used in either non-contact mode or contactmode, and may be used to enable tissuemanipulation.
Mechanism ofAction	Handpiece is used to guide and protectBeamPath® fibers	Handpiece is used to guide and protectBeamPath® fibers
OperatingPrinciple	To enable precision control and to stabilizesurgeon hand motion	To enable precision control and to stabilizesurgeon 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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.