The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery, pulmonary surgery for surgical and aesthetic applications.

The indications for use for which the delivery system is used 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 BeamPath CO2 Mark I Laser Beam Delivery System is an accessory for CO2 laser systems that can be retrofitted to Luxar LX-20 or Lumenis NovaPulse laser systems. It consists of an adapter and a fiber assembly that propagate CO2 laser beams. The OmniGuide BeamPath CO2 Mark I Fiber Assembly is supplied sterile and is intended for single procedure use.

AI/ML Overview

The provided 510(k) summary for the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System describes non-clinical performance data but explicitly states that formal clinical trials were not deemed necessary. Therefore, an acceptance criteria table and detailed information about a study proving the device meets those criteria, as typically seen with AI/ML devices, are not present.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent due to the nature of the submission (no formal clinical study for acceptance criteria):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical study. The acceptance is based on achieving "comparable" performance to predicate devices in non-clinical tests.
Reported Device Performance:
- "The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System performance characteristics have been evaluated through testing and analysis of laser power output and beam quality."
- "The performance of the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System and related parameters of predicate devices (as specified in comparison table) are comparable." (The comparison table is not included in the provided text).
- "The OmniGuide BeamPath CO2 Mark I Fiber Assembly has passed biocompatibility testing as performed by an independent laboratory in accordance with ISO 10993-1:2003 Standards."
- Conclusion: "The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System are similar or equivalent to same characteristics of above mentioned legally marketed devices."

Acceptance Criteria (Implied)	Reported Device Performance
Comparable laser power output to predicate devices	Evaluated; performance is comparable to predicate devices.
Comparable beam quality to predicate devices	Evaluated; performance is comparable to predicate devices.
Biocompatibility according to ISO 10993-1:2003	Passed biocompatibility testing by an independent laboratory.
No adverse effects during compassionate use	Device performed as intended; no adverse effects noticed.
Similar/Equivalent energy transmission levels to predicate devices	Similar or equivalent to legally marketed devices.
Similar/Equivalent beam quality to predicate devices	Similar or equivalent to legally marketed devices.

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 (Non-clinical): Not specified. The document mentions "testing and analysis of laser power output and beam quality" but does not give specific sample sizes for these tests.
Sample Size (Clinical for Compassionate Use): Not specified. It only states "the device was used in a compassionate use per FDA permission," implying a very small, observational group, but no number is given.
Data Provenance: Not specified for the non-clinical tests. For the compassionate use, it would be prospective, likely in the US given FDA permission, but the exact country is not stated.

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)

Not Applicable. This device is a medical accessory, not an AI/ML diagnostic tool requiring expert-established ground truth for a test set. Evaluation was via non-clinical performance characteristics.

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

Not Applicable. See point 3.

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

No. This is not an AI/ML device, and no MRMC study was performed.

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

Not Applicable. This is not an algorithm or AI device. The device's performance stands alone in its ability to transmit laser energy, evaluated through non-clinical testing.

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

For Non-clinical Testing: The "ground truth" was established by measured physical parameters (laser power output, beam quality) and comparison to established parameters of predicate devices and relevant industry standards (e.g., ISO 10993-1:2003 for biocompatibility).
For Compassionate Use: The "ground truth" was clinical observation of device "performing as intended" and "no adverse effects."

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. See point 8.

Summary

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MAY - 9 2005

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人心之心之小!

510(k) Summary

Submitter:	OmniGuide Communications Inc.One Kendall Square, Building 100 3rd FloorCambridge, MA 02139
Contact Person:Telephone:	Irina Kulinets617-551-8404
Fax:	617-551-8445
Proprietary Name:	OmniGuide BeamPath CO2 Mark I Laser Beam DeliverySystem
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:	K992472 Clinicon SureGuide CO2 Laser BeamDelivery System.K014048 Clinicon Universal WaveGuideHandpiece and Fiber TipsK924664 Surgilase Fiberlase CO2 Laserwave GuideK921671 Surgilase Fiberlase V CO2 LaserWaveguideK896478 Luxar LX-20 Minilase CO2 Surgical LaserK031440 Cynosure Smart CO2 Medical LaserSystemK963189 ERBE APC 300 Argon Plasma CoagulatorK032969 Helica "TC" Laparoscopic Cuttingand Cauterizing Accessories

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Description:

Intended Use:

The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is intended for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues

The indications for use for which the delivery system is used 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 contains the optical fiber assembly and the adapter for connecting the fiber to the laser. 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. The fiber assembly is 1.5 m or 2.0 m long and transmits at the CO2 laser emission wavelength of 10.6 um.

The adapter links the fiber assembly and the CO2 laser.

Performance Data:

Non-clinical Performance Data: The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System 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 the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System and related parameters of predicate devices (as specified in comparison table) are comparable, The OmniGuide BeamPath CO2 Mark I Fiber Assembly has passed biocompatibility testing as performed by an independent laboratory in accordance with ISO 10993-1:2003 Standards.

Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as predicate devices. However, the device was used in a compassionate use per FDA permission. No adverse effects were noticed, the device performed as intended.

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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 BeamPath CO2 Mark I Laser Beam Delivery System are similar or equivalent to same characteristics of above mentioned legally marketed devices.

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health and Human Services, USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2005

Ms. Irina Kulinets Director Regulatory Affairs and Quality Assurance OmniGuide Communications One Kendall Square, Building 100 3rd Floor Cambridge, Massachusetts 02139

Re: K050541

K00091
Trade/Device Name: OmniGuide BeamPath CO² Mark I Laser Beam Delivery System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: February 25, 2005 Received: March 2, 2005

Dear Ms. Kulinets:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or 10 commerce proc to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de vices that have been receasined in quire approval of a premarket approval application (PMA). and Costicle 710 (110) market the device, subject to the general controls provisions of the Act. The r ou may, mercere, mance are as act include requirements for annual registration, listing of gencial controls provisions of ractice, 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 your device is classified (665 a00 -0) trols. Existing major regulations affecting your device it may be subject to stan additions, Title 21, Parts 800 to 898. In addition, FDA ean oc found in the Ovaouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not nean I lease of advisou that i Drivistian that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must of any I ederal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, n.c., and manufacturing practice requirements as set Of It Fart 607), adoning (21 CFR Part 820); and if applicable, the electronic (2006) 1959 forth in the quality bybents (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Irina Kulinets

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse ough finding of substantial equivalence of your device to a legally premarket notification: "The PDts 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 If you desire specific at not as (240) 276-0115 . Also, please note the regulation entitled, Connact the Office of Complains market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour represent Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

_ Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K050541

Device Name: OmniGuide BeamPath CO2 Mark | Laser Beam Delivery System

Indications For Use:

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

Nil R.P. Ogle

ion of General, Restorative
Neurological Devices

K0J0541

Prescription Use _Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (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)

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.