The OmniGuide BeamPath FELS 25A, CO2 Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties:

. Dermatology
General Surgery .
Gynecology .
Head & Neck Surgery .
Neurosurgery .
Oral Surgery ●
Orthopedic Surgery .
Otorhinolaryngology .
Pediatric Surgery ●
Plastic & Reconstructive Surgery
Podiatry .
· Urology

The OmniGuide BeamPath® FELS 25A, CO2 Laser System intended to be used in conjunction with the OmniGuide BeamPath Adapter and the OmniGuide BeamPath fiber and is intended to be used for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues.

Device Description

The OmniGuide BeamPath FELS 25A, CO2 Laser System, is a Carbon dioxide (CO2) Laser emitting light at a wavelength of 10.6 um. It has an RF excited laser tube which produces a maximum continuous wave (CW) output power of up to 30 watts. Laser energy (CO2), with a wavelength of 10.6 um, has a variety of attractive features for surgical use. Because it is strongly absorbed by water (the main constituent of biological tissue) it does not penetrate into tissue beyond the point of application of the laser energy. This small depth of penetration (0.1-0.2 mm) leads to high cutting precision and minimal thermal damage to adjacent tissue. In addition, the CO2 wavelength has excellent coagulation capabilities.

The laser console is a table top console which can be easily transported from one surgery room to the other. The controls for the physician are part of the console and the parameters are clearly displayed on a large screen display. The laser light is guided through different mirrors and focused via an attached adapter is the interface allowing an OmniGuide BeamPath Fiber or equivalent to attach to the laser.

Materials used are mainly machined aluminum or stainless Steel and standard optics for the transmission or the reflection of the CO2 laser wave length. Only the laser energy from the OmniGuide BeamPath FELS 25A, CO2 Laser System comes in contact with the patient. The energy is guided through a hollow waveguide such as the OmniGuide BeamPath hollow waveguide liber. It is worth noting that all components (mirrors, lenses and the fiber) that the CO2 light travels though are passive and do not alter the wayelength or any other of the fundamental properties or beneficial attributes of the CO2 Laser.

AI/ML Overview

The OmniGuide BeamPath® FELS 25A, CO2 Laser System is a surgical CO2 laser designed for incision, excision, ablation, vaporization, and coagulation of soft tissues. The acceptance criteria and the study proving it meets these criteria are outlined below.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through non-clinical testing and analysis, as formal clinical trials were not deemed necessary. The primary acceptance criterion was substantial equivalence to a predicate device (K063698 C-Las CO2 Laser System).

Acceptance Criteria	Reported Device Performance
Laser Power Output	Evaluated through testing and analysis. "Performance of OmniGuide BeamPath® PELS 25A, CO2 Laser System and related parameters of the predicate device are the same."
Beam Quality	Evaluated through testing and analysis. "Performance of OmniGuide BeamPath® PELS 25A, CO2 Laser System and related parameters of the predicate device are the same."
Technology and Intended Use Equivalence	"using the same technology and intended use as predicate device"
Major Performance Parameters Equivalent	"The intended use and major performance parameters of the OmniGuide BeamPath® FELS 25A, CO2 Lascr System are equivalent to the characteristics of above mentioned legally marketed device."

Study Details:

Sample size used for the test set and the data provenance: Not applicable. The study primarily involved non-clinical performance testing and analysis of the laser's power output and beam quality. There was no test set of patient data, nor was there any human subject data, retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant for this type of non-clinical device testing focused on physical parameters.
Adjudication method for the test set: Not applicable. There was no test set involving human judgment or interpretation.
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: Not applicable. This device is a surgical CO2 laser, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "study" was focused on the standalone performance of the laser system itself, specifically its power output and beam quality. It's an algorithm-only performance in the sense that it's the device operating independently of a human-in-the-loop for its basic function, but it's important to differentiate that it's not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" was established by engineering and physics principles, specifically measurements and analyses of laser power output and beam quality against established standards and comparison to the predicate device's measured parameters.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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OmniGuide

ん093251

OCT 2 9 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 BeamPath® FELS 25A, CO2 Laser System
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:

K063698 C-Las CO2 Laser System

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Description:

Indications for Use:

The OmniGuide BeamPath FELS 25A, CO2 Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties:

. Dermatology
General Surgery .
Gynecology .
Head & Neck Surgery .
Neurosurgery .
Oral Surgery ●
Orthopedic Surgery .
Otorhinolaryngology .
Pediatric Surgery ●
Plastic & Reconstructive Surgery
Podiatry .

{2}------------------------------------------------

· Urology

Intended Use:

Summary of Technological Characteristics:

The device is a 30 watt maximum power CO2 laser, emitting wavelength of 10.6 um. The System incorporates an adapter that allows the connection to CO2 waveguide fibers such as the OmniGuide BeamPath WaveGuide Fiber, to transmit the laser encrgy to the surgical site.

Performance Data:

Non-clinical Performance Data: The OmniGuide BeamPath® FELS 25A, CO2 Laser System performance characteristics have been cyaluated 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 BeamPath® PELS 25A, CO2 Laser System and related parameters of the predicate device are the same.

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

Conclusions Drawn from Tests and Analysis: The intended use and major performance parameters of the OmniGuide BeamPath® FELS 25A, CO2 Lascr System are equivalent to the characteristics of above mentioned legally marketed device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

OCT 2 9 2009

Re: K093251

Trade/Device Name: OmniGuide BeamPath® FELS 25A, CO2 Laser System 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: October 15, 2009 Received: October 16, 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 (sec 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Job

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 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,

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

11 093251 Not vet assigned 510(k) Number (if known):

OmniGuide BeamPath® FELS 25A, CO2 Laser System Device Name:

Indications for Use:

The OmniGuide BeamPath FELS 25A, CO2 Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties:

. Dermatology
General Surgery .
Gynecology .
Head & Neck Surgery .
. Neurosurgery
Oral Surgery .
Orthopedic Surgery �
Otorhinolaryngology .
Pediatric Surgery ●
Plastic & Reconstructive Surgery .
Podiatry .
Urology .

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)

Nil R.P. Gyle- fir mxm

Page 1 of __ 1_

(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093251

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.