OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER

K063141 · Omniguide, Inc. · GEX · Nov 29, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063141
• Device Name: OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
• Applicant: Omniguide, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber 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 Story

OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber is a sterile, single-use accessory for CO2 laser systems. It consists of a 1.5m fiber assembly featuring a hollow core with a photonic bandgap reflector lining to guide CO2 laser energy (10.6 µm wavelength). The device includes a distal lens transparent to the laser beam and a sensor at the tip to detect lens obstruction by debris. It functions by propagating laser beams while venting cooling gases outside the body. Used in clinical settings (OR, endoscopic, or open procedures) by physicians to perform soft tissue surgery. The device output is the directed laser energy used for tissue interaction; the physician monitors the procedure and the sensor-based obstruction feedback to ensure effective delivery. Benefits include precise tissue incision, excision, and coagulation.

Clinical Evidence

Bench testing only. Performance evaluated through analysis of laser power output and beam quality in accordance with FDA Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995). No clinical trials were conducted as the device utilizes the same technology and intended use as the predicate devices.

Technological Characteristics

Optical fiber assembly, 1.5m length. Core technology: photonic bandgap reflector lining in a hollow core. Tip includes a laser-transparent lens and an integrated debris-obstruction sensor. Transmits CO2 laser energy at 10.6 µm. Single-use, sterile. Standalone accessory for CO2 laser systems.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues in general, plastic, oral/maxillofacial, gynecological, otorhinolaryngological, gastroenterological, neurosurgical, and pulmonary surgery, as well as dentistry and dermatology. Use is dependent on the specific cleared indications of the host laser system.

Regulatory Classification

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.

Predicate Devices

• OmniGuide Beam Path CO2 Mark I Laser Beam Delivery System (K050541)
• OmniGuide Highland Beam Delivery System (K061909)

Submission Summary (Full Text)

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K063/41

Image /page/0/Picture/1 description: The image shows the logo for OmniGuide. The logo consists of the word "OmniGuide" in a simple sans-serif font, positioned to the right of two concentric circles. The circles are not complete, with a break in the upper right and lower left quadrants, giving the impression of a stylized "O" shape.

NOV 2 9 2006

.

# 510(k) Summary

| Submitter: | OmniGuide, Inc.<br>One Kendall Square, Building 100 3rd Floor<br>Cambridge, MA 02139 |
|-------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person:<br>Telephone: | Douglas W. Woodruff<br>617-551-8404 |
| Fax: | 617-551-8445 |
| Proprietary Name: | OmniGuide Zero Flow ZF-T 150 Waveguide Fiber |
| Common Name: | CO2 Laser Powered Surgical Instrument |
| Classification: | 878.4810 |
| Product Code: | GEX |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology. |

### Substantial Equivalence Claimed To:

.

:

:

K050541, OmniGuidc Beam Path CO2 Mark I Laser Beam Delivery System K061909, OmniGuide Highland Beam Delivery System

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#### Description:

The OmniGuide Zero Flow ZF-T 150 WaveGuide fiber is an accessory for CO2 laser systems. It consists of a fiber assembly that propagates CO2 laser beams and vents the cooling gases outside of the body. The OmniGuide ZF-T 150 wave guide fiber is supplied sterile and is intended for single procedure use.

#### Intended Use:

The OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber 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.

#### 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. The fiber incorporates a lens at the tip which is transparent to the laser beam. The fiber also incorporates a sensor on the fiber tip that allows physicians to determine when the lens becomes obstructed by debris. The fiber assembly is 1.5 m long and transmits at the CO2 laser emission wavelength of 10.6 gm.

#### Performance Data:

Non-clinical Performance Data: The OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber 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 Zero Flow ZF-T 150 WaveGuide Fiber and related parameters of 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 predicate devices.

#### Conclusions Drawn from Tests and Analysis:

The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber are similar or equivalent to same characteristics of above mentioned legally marketed devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV 2 9 2006

Re: K063141 Trade/Device Name: OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber 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: November 10, 2006 Received: November 13, 2006

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 gencral 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

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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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for Pso
Mark N. Melkerson

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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## Indications for Use

510(k) Number (if known): Not yet assigned Device Name: OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber

Indications for Use:

The OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber 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.

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)

Division of General, Restorative, - and Neurological Devices

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