The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform 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.

Device Description

The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers.

The objectives of the hand-piece are to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the hand-piece and fixated so that it is observed at the hand-piece's distal tip. The surgeon wields the hand-piece as a pencil, and advances the hand-piece so that its distal tip is in close proximity to the target tissue to exert the desired effect of the waveguide fiber: incision. excision, ablation, vaporization and coagulation. The surgeon may use the hand-piece distal tip in either non-contact mode or contact mode, and may use the distal tip to enable tissue manipulation.

The sterilization tray is purchased from SYMMETRY MEDICAL USA INC. and sold as a storage and sterilization tray for use with the OmniGuide Fiber Optic Handpieces,

The handpieces consist of a handle and sealing cap consisting of either SS or aluminum, a silicone rubber fiber gripper and a lumen to guide the fiber made of SS hypodermic tubing. The handle/lumen are welded or adhesive bonded to for the unit. Lumen may be bent or straight to facilitate the aiming of the fiber. The tip is may be beveled or straight to improve the fiber visibility, fiber tip protection and blunt dissection.

AI/ML Overview

The provided text describes a 510(k) submission for the OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical trials with predefined acceptance criteria.

Therefore, the requested information regarding acceptance criteria, specific test set details (sample size, provenance, expert number/qualifications, adjudication, MRMC studies), standalone performance, training set details, and ground truth establishment cannot be fully extracted as these are typically part of a more rigorous clinical study design, which was "not deemed necessary" for this particular submission.

Here's a breakdown of what can be inferred or directly stated from the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) submission is substantial equivalence to an existing predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device that does not require premarket approval.

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance
Safety and Effectiveness	"The intended use and major performance parameters of the OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray are similar or equivalent to the characteristics of above mentioned legally marketed device."
Similar Technology	"The handpieces consist of a handle and sealing cap consisting of either SS or aluminum, a silicone rubber fiber gripper and a lumen to guide the fiber made of SS hypodermic tubing."
Comparable Performance Characteristics	"The performance of the OmniGuide BeamPath® Fiber Optic HandPiece and similar related parameters of predicate device are comparable."
Identical Intended Use	"The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues..." - This matches the general indications of the predicate device.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The submission relies on "testing and bench top testing" and comparison to a predicate device, not on a formal clinical test set with a specified sample size.
- Data Provenance: Not specified. The testing was likely conducted in-house by OmniGuide.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as formal clinical trials with expert-adjudicated ground truth were not conducted.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 instrument, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware device requiring human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical test set in this 510(k) submission. The "ground truth" for demonstrating equivalence largely comes from engineering and performance testing data showing the device functions as intended and similarly to the predicate.
The sample size for the training set:
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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081939

1 =4 3 รุ

AUG 1 2 2008

Image /page/0/Picture/3 description: The image shows the logo for OmniGuide. The logo consists of the word "OmniGuide" in a sans-serif font, with the first letter "O" being stylized as two concentric circles. The word "OmniGuide" is placed in the center of the circles.

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® Fiber Optic HandPiece System andSterilization Tray
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:

K952006, ACCU-Beam Fiber Optic Handpeice K040223 PolyVac Surgical Instrument Delivery System

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N 16081939

Description:

The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers.

The sterilization tray is purchased from SYMMETRY MEDICAL USA INC. and sold as a storage and sterilization tray for use with the OmniGuide Fiber Optic Handpieces,

Intended Use:

Summary of Technological Characteristics:

Performance Data:

Non-clinical Performance Data: OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray performance characteristics have been evaluated through testing and bench top testing. The handpieces are used to allow the physician to manipulate the flexible fiber through a surgical endoscope . The performance of the OmniGuide BeamPath® Fiber Optic HandPiece and similar related parameters of predicate device are comparable.

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® Fiber Optic HandPiece System and

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K - 319 - 319 11

Sterilization Tray are similar or equivalent to the characteristics of above mentioned legally marketed device. The sterilization tray used is the identified predicated device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2008

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

Re: K081939

Trade/Device Name: OmniGuide BeamPath® Fiber Optic HandPiece System and Steril Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: July 26 2008 Received: July 28, 2008

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 such 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); 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.

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Page 2 Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milburn

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

Enclosure

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K081939

Indications for Use

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

Device Name: OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray

Indications For Use:

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)

Mark A. Millenson

sion Sign-Of and Neurological

510(k) Number

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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.