CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES

K014236 · Clinicon Corp. · GEX · Mar 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014236
• Device Name: CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES
• Applicant: Clinicon Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached. The Clinicon Interconnect (Distal Adapter) enables Luxar accessories that are designed to be used with the standard Luxar fiber cables to be connected with the Clinicon WaveGuide Platform.

Device Story

WaveGuide Platform acts as accessory for CO2 laser systems; delivers laser energy from source to surgical accessory. Components include turret adapter (houses focusing lens) and hollow silica fiber cable (internal reflective coating; flexible outer cover). Interconnect (distal adapter) allows attachment of Luxar-compatible accessories. Interconnect contains waveguide segment that scrambles spatial coherence of input beam to match Luxar fiber beam divergence and multimode characteristics. Used in clinical settings by physicians; enables use of various manufacturers' accessories with CO2 laser systems. Benefits include flexible beam delivery with minimal degradation and compatibility with existing Luxar surgical tools.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Hollow silica fiber with internal reflective coating; flexible protective cover. FSMA 905 series fiber optic connectors. Wavelength range 9-11 um. Lengths 0.5 m to 3.0 m. Turret adapter with focusing lens. Interconnect adapter uses waveguide segment to scramble spatial coherence for beam matching.

Indications for Use

Indicated for delivery of CO2 laser energy in general surgery, plastic surgery, and dermatology. Patient population and specific clinical indications are determined by the cleared indications of the host CO2 laser system and attached accessories.

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

• Clinicon's SureGuide CO2 Laser Beam Delivery System (K992472)
• Modified Luxar LX-20 (K960475)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Clinicon Corporation. The logo consists of a stylized "C" shape on the left, followed by the word "Clinicon" in a blocky font. To the right of "Clinicon" is the word "CORPORATION" in a similar font. Below the logo is the address "5825 AVENIDA ENCINAS" followed by "CARLSBAD, CA 92008".

# K014236

## 510(k) Summary

| Submitter: | Clinicon Corporation<br>5825 Avenida Encinas<br>Carlsbad, CA 92008 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact person: | Sean M. Curry<br>16787 Bernardo Center Drive, Suite A<br>San Diego, CA 92128 |
| Phone: | [phone] |
| FAX: | [phone] |
| Proprietary name: | Clinicon WaveGuide Platform with Interconnect for Luxar<br>Accessories |
| Common name: | CO2 Laser Powered Surgical Instrument |
| Classification: | 878.4810 |
| Product Code: | GEX |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and<br>in dermatology. |

# Substantial equivalence claimed to:

K992472, Clinicon's SureGuide CO2 Laser Beam Delivery System K960475, Modified Luxar LX-20

## Description:

The Clinicon WaveGuide Platform (K992472, SureGuide CO2 Laser Beam Delivery System now marketed as Clinicon WaveGuide Platform) is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.

The WaveGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.

The Clinicon Interconnect (Distal Adapter) is an accessory to the WaveGuide Platform that duplicates the termination end & laser beam characteristics of the Standard Luxar

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Fiber. This allows Luxar accessories to be attached to the WaveGuide Platform and used in the same manner.

#### Intended use:

The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.

The Clinicon Interconnect (Distal Adapter) enables Luxar accessories that are designed to be used with the standard Luxar fiber cables to be connected with the Clinicon WaveGuide Platform.

### Summary of technological characteristics:

The Clinicon WaveGuide Platform is an accessory for CQ2 laser systems. Its two primary components are a turret adapter and a fiber cable assembly. A secondary component is the Interconnect accessory.

The fiber cable assembly consist of a hollow silica fiber with an internal coating that reflects and propagates the CO2 laser energy and a flexible protective outer covering. The fiber cable has a fiber optic connector on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories. The fiber cable is available in various standard lengths between 0.5 m and 3.0 m, and functions over the wavelength range of 9 - 11 um.

The Turret Adapter is the interface between the fiber cable and the CO2 laser system, and houses a focusing lens to align the beam from the CO2 laser system into the waveguide.

The Interconnect duplicates the distal termination end and laser beam characteristics of the Standard Luxar Cables. The Clinicon Interconnect contains a segment of the same coherent waveguide used throughout the Clinicon Waveguide Platform. Uniquely in the Interconnect, however, this waveguide segment is held in a manner that "scrambles" the spatial coherence of the input laser beam, so that the output laser beam is spatially incoherent. The particular distortion has been chosen so that the Clinicon Fiber Cable with the Clinicon Interconnect has the same beam divergence and multimode character as does the output of the Luxar Fiber [cable]. This allows Luxar accessories to be used with the Clinicon Fiber Cable plus Clinicon Interconnect.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 6 2002

Clinicon Corporation c/o Mr. Sean Curry Certified Software Solutions, Inc. 16787 Bernardo Center Drive, Suite A San Diego, CA 92128

Re: K014236

Trade/Device Name: Clinicon WaveGuide Platform with Interconnect for Luxar Accessories

Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: December 21, 2001 Received: December 26, 2001

Dear Mr. Curry:

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, Sean Curry

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogen maineng of substantial equivalence of your device to a legally premarket notincation. The PDF maining of castination 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 and IT you desire specific advice to: your avitro diagnostic devices), please contact the Office of additionally 21 CFR Fall 807.10 for in This Chapters on the promotion and advertising of Compliance at [phone]. The newslangy, liance at [phone]. Also, please note the your dones, prease vollaborading by reference to premarket notification" (21CFR Part 807.97). regulation chititied, "Misoranaing of esponsibilities under the Act may be obtained from the Other general information on your respectional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO14236 510(k) Number (if known):

Device Name:

Indications for Use:

The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser The meendou ase of the ennoource to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 dogradulton. - The Waves, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.

The Clinicon Interconnect enables Luxar accessories that are designed to be used with the standard Luxar cables to be connected with the Clinicon WaveGuide Platform.

Miriam C. Provost

ion Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K014236

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

Over-the-Counter Use