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

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

AI/ML Overview

The Clinicon WaveGuide Platform with Interconnect for Luxar Accessories (K014236) is an accessory for CO2 laser systems designed to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory with minimal beam degradation. The specific indications for use are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.

The provided document does not contain a detailed study report with specific acceptance criteria and performance data in a format suitable for the requested table. This submission primarily focuses on establishing substantial equivalence to predicate devices (K992472 and K960475) based on technological characteristics and intended use.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria or provide detailed performance data from a dedicated study. The information below is inferred from the description of substantial equivalence and device characteristics.

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Beam Degradation (Minimal)	Delivers CO2 laser energy with "minimal beam degradation"
Beam Characteristics (Luxar Interconnect)	Duplicates the termination end & laser beam characteristics of the Standard Luxar Fiber. Has the same beam divergence and multimode character as the output of the Luxar Fiber cable.
Compatibility	Can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon and Luxar accessories.
Wavelength Range	Functions over the wavelength range of 9 - 11 um.
Length Availability	Available in standard lengths between 0.5 m and 3.0 m.
Material/Construction	Hollow silica fiber with internal coating, flexible protective outer cover.
Connectors	FSMA 905 series fiber optic connectors on each end.

2. Sample Size for the Test Set and Data Provenance

The document does not report on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The substantial equivalence claim is based on technological characteristics, intended use comparison to predicate devices, and likely internal engineering tests, rather than a clinical or performance study with a defined test set of patients or medical scenarios.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts or the establishment of ground truth in the context of a performance study for the K014236 device. This type of evaluation is not typically required for a device like a CO2 laser accessory where performance is primarily measured through engineering specifications and functional testing rather than interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Since no specific test set requiring expert interpretation is described, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or reported. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance. This device is a surgical instrument accessory, not a diagnostic tool requiring human interpretation of output.

6. Standalone Performance Study

The document describes the device's technological characteristics and its intended function (delivering laser energy with minimal degradation and maintaining specific beam characteristics). While implicit in the design and engineering, the document does not present a formal "standalone" performance study report in the manner of a clinical trial for a diagnostic or therapeutic device. The "proof" is largely based on demonstrating that its technical specifications and functional output are equivalent to the predicate devices and meet its stated purpose.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., pathology, expert consensus) is not applicable to this submission. The validation evidence for this device would rely on engineering measurements (e.g., laser power output, beam divergence, fiber transmission efficiency, material compatibility, sterile barrier integrity) and functional testing to confirm it performs as intended and is equivalent to the predicate devices.

8. Sample Size for the Training Set

No training set is mentioned or applicable as this device is a physical CO2 laser accessory, not an AI/machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for an AI/machine learning algorithm.

Summary

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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 Corporation5825 Avenida EncinasCarlsbad, CA 92008
Contact person:	Sean M. Curry16787 Bernardo Center Drive, Suite ASan Diego, CA 92128
Phone:	(858) 675-8200
FAX:	(858) 675-8201
Proprietary name:	Clinicon WaveGuide Platform with Interconnect for LuxarAccessories
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 andin dermatology.

Substantial equivalence claimed to:

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

Description:

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 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 (301) 594 1037. The newslangy, liance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Over-the-Counter Use

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.