The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.

The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

Device Description

The OmniGuide OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Acceptance Criteria and Study Details for OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip (K093451)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Laser Power Output	Comparable to predicate devices.
Beam Quality	Comparable to predicate devices.
Tip Heating (Continuous Wave Mode)	Reduced, allowing for continuous wave mode use without heating the tip.
Energy Transmission Levels	Similar or equivalent to legally marketed devices.
Intended Use Equivalence	Similar or equivalent to legally marketed devices.
Technology Equivalence	Uses the same technology as predicate devices.

Explanation of the Acceptance Criteria (Implied):

The document does not explicitly list numerical acceptance criteria. Instead, the "Performance Data" section states that the device's performance characteristics (laser power output and beam quality) were evaluated through testing and analysis. The acceptance for these characteristics is implicitly defined by their comparability to legally marketed predicate devices. The new feature of "Low Profile/Low Loss Tip" specifically addresses tip heating, indicating that its performance in continuous wave mode without excessive heating was a key acceptance point. The overall conclusion reinforces the equivalence of energy transmission levels, beam quality, and intended use as the basis for acceptance.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "testing and analysis of laser power output and beam quality." This suggests a series of technical bench tests on the device itself, rather than a sample of patients or cases.
Data Provenance: The "Non-clinical Performance Data" section implies that the testing was conducted internally by OmniGuide, Inc. (the submitter). The data would therefore be retrospective in terms of being collected prior to the 510(k) submission and for the purpose of demonstrating equivalence. There is no mention of country of origin for this testing, but given the submitter's location (Cambridge, MA), it is highly likely to be United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The "ground truth" for this device's performance is based on engineering specifications and direct measurements of physical properties (laser power output, beam quality, tip temperature). There were no human experts establishing ground truth in the context of clinical interpretation or diagnosis.
Qualifications of Experts: Not applicable for establishing ground truth in this context. The "experts" involved would have been engineers and technicians conducting the non-clinical performance testing.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This was a technical performance study, not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" would have been the comparison of the measured performance data to the established performance characteristics of the predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The document explicitly states: "Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate devices." This indicates that no human-in-the-loop clinical studies were conducted, thus no MRMC study.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this device is a surgical fiber for laser energy delivery, not an AI-assisted diagnostic or interpretative tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Yes, in essence. The "Non-clinical Performance Data" represents a standalone evaluation of the device's physical performance characteristics (laser power output, beam quality, tip heating) against engineering benchmarks and predicate device performance. This assesses the device's function directly without human interaction beyond operating the device for testing purposes.
Description: The study involved "testing and analysis of laser power output and beam quality." The comparison to predicate devices served as the benchmark for "standalone" performance.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used was primarily engineering specifications and measured physical performance data from established predicate devices. The predicate devices' "energy transmission levels" and "beam quality" served as the reference points for comparison. The performance in terms of "reduced tip heating" was also a key physical characteristic that was measured and compared to previous versions or requirements.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a physical medical instrument (laser fiber), not an AI/algorithm-based system that requires a "training set" of data in the machine learning sense. The development and design of the fiber would have relied on engineering principles, materials science, and possibly iterative design and testing, rather than an explicit "training set."

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there is no "training set" for this type of device. The "ground truth" during the device's engineering and development phase would have been established through physics, material science data, prior art, performance standards, and experimental results from prototypes.

Summary

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1093451

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NOV 2 0 2009

510(k) Summary

Submitter:	OmniGuide, Inc.One Kendall Square, Building 100 3rd FloorCambridge, MA 02139
Contact Person:Telephone:	Douglas W. Woodruff617-551-8404
Fax:	617-551-8445
Proprietary Name:	OmniGuide Beam Path CO2 Mark III WaveGuide Fiberwith Low Profile/Low Loss Tip
Common Name:	CO2 Laser Powered Surgical Instrument
Classification:	878.4810
Product Code:	GEX
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology.

Substantial Equivalence Claimed To:

K070157, OmniGuide Beam Path CO2 Mark III WaveGuide Fiber K073313, OmniGuide BeamPath CO2 Mark III WaveGuide Fiber With Low Profile Tip

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Description :

Intended Use:

The indications for use for which the delivery system is used for 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 consists of an optical fiber assembly. 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 and an internally coated, stainless steel waveguide distal tip. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The fiber has 14 mm long, internally coated, stainless steel tip that is coated internally and acts as an efficient continuation of the waveguide. The new tip configuration reduces tip heating allowing the fiber to be used in continuous wave mode without heating the tip.

Performance Data:

Non-clinical Performance Data: The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile /Low Loss Tip 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 OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip and the related parameters of the predicate devices are comparable.

Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate devices.

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Conclusions Drawn from Tests and Analysis: The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip are similar or equivalent to the characteristics of above mentioned legally marketed devices.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with its wings spread, symbolizing the department's mission related to health and human welfare.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OmniGuide, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street NW Buffalo, Minnesota 55313

Re: K093451

Trade/Device Name: OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip 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: November 4, 2009 Received: November 5, 2009

NOV 2 0 2009

Dear Mr. Job:

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.

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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Page 2 - Mr. Mark Job

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark N. Mcllhinney

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Not yet assigned

Device Name: OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip

Indications For Use:

The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical snecialti os of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatlogy, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endosconic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.

The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Neilheblen for mta

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093451

Page 13 of 72

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.