OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP

K093451 · Omniguide, Inc. · GEX · Nov 20, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K093451
• Device Name: OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
• Applicant: Omniguide, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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 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 Story

Flexible fiber assembly accessory for CO2 laser systems; delivers CO2 laser energy (10.6 um wavelength) for minimally invasive surgery. Features photonic bandgap reflector lining hollow core; includes 14 mm internally coated stainless steel distal tip. Tip configuration reduces heating, enabling continuous wave mode operation. Used in OR/clinic settings by physicians; attaches to OmniGuide Laser Adapter. Enables incision, excision, ablation, vaporization, and coagulation of soft tissues. Benefits patient via minimally invasive access to surgical sites.

Clinical Evidence

Bench testing only. Evaluated laser power output and beam quality per FDA 1995 Laser Guidance. No clinical trials conducted; device utilizes same technology and intended use as predicate devices.

Technological Characteristics

Optical fiber assembly; 1-2 m length. Photonic bandgap reflector lining hollow core; 14 mm internally coated stainless steel distal tip. Transmits 10.6 um CO2 laser wavelength. Single-use, sterile. Standalone accessory for CO2 laser systems.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues (including intra-oral) across general, plastic, oral/maxillofacial, dental, dermatological, gynecological, ENT, gastroenterological, neurosurgical, urological, and pulmonological specialties. Used in open or endoscopic minimally invasive procedures (e.g., laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy, bronchoscopy).

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 III WaveGuide Fiber (K070157)
• OmniGuide BeamPath CO2 Mark III WaveGuide Fiber With Low Profile Tip (K073313)

Submission Summary (Full Text)

{0}------------------------------------------------

# 1093451

Image /page/0/Picture/1 description: The image shows the logo for OmniGuide. The logo consists of two concentric circles, with the word "OmniGuide" written in a sans-serif font across the center of the circles. The text is black, and the circles are also black.

NOV 2 0 2009

## 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 Beam Path CO2 Mark III WaveGuide Fiber<br>with 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 plastic<br>surgery 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

{1}------------------------------------------------

#### 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.

#### Intended 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 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.

#### 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.

Image /page/1/Picture/10 description: The image shows the text "Page 15 of 72". This indicates that the image is a page from a document. The document has a total of 72 pages. The current page being displayed is page 15.

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

Image /page/2/Picture/0 description: The image shows a black and white graphic of what appears to be a water droplet. The droplet is connected to a larger, irregular black shape on the left side of the image. The droplet is round and smooth, while the shape on the left is jagged and uneven.

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.

{3}------------------------------------------------

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

{4}------------------------------------------------

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 [phone] or [phone] 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

{5}------------------------------------------------

### 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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number K093451

Page 13 of 72