The CO2 Laser System, Model C-LAS is an easily transported table top laser console made of mainly machined aluminum and optics for the transmission of reflection of CO2 laser wave lengths. It is a carbon dioxide laser which emits laser light at 10.6 micrometers and has a RF excited laser tube which produces an output power of about 30 watts. The laser is for used by physicians for cutting and coagulation at a wound during surgery. The physician uses the laser light on tissue via lenses and a focusing hand piece, or via a diamond scalpel which transmits the laser light onto the scalpel.

AI/ML Overview

This document describes a 510(k) premarket notification for a CO2 laser system, Model C-LAS. The information provided heavily focuses on regulatory aspects and comparison to a predicate device, rather than detailed performance studies and acceptance criteria as would typically be seen for a new diagnostic AI device.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative output power ranges with tolerances) for the device's cutting and coagulation abilities. Instead, it relies on substantial equivalence to a predicate device.

The "Performance Characteristics" section in the General Product Information (page 2) refers to "Software Test Procedures and Test Report," but the details of these tests and their criteria are not included in the provided text.

Based on the information given, the primary "acceptance criterion" appears to be Substantial Equivalence to the predicate device K875338: CHRYS™ MODEL MED-MAX.

Here's a table based on the similarities highlighted for substantial equivalence, which serves as a de-facto "performance" comparison in this context:

Acceptance Criterion (Implied by Substantial Equivalence)	Predicate Device (CHRYS™ MODEL MED-MAX) Performance	Reported Device (CO2 Laser, Model C-LAS) Performance
Intended Use (Cutting and Coagulation)	Physicians to cut and coagulate wounds during surgery	Physicians to cut and coagulate wounds during surgery
Laser Type	CO2 sealed	CO2 sealed
Wavelength	10.6 micrometers	10.6 micrometers
Mode	Continuous wave form (TEM00)	Continuous wave form (Gauss)
Output Power	About 30 Watts	About 30 Watts
Accessories / Waveguide	Articulated Arm Waveguide	Flexible Cable Waveguide
Console	Microprocessor	Microprocessor
Laser Operation	Footswitch	Footswitch
Form Factor (Footprint)	Compact (15" by 20")	Compact (12.5"x 13")
Weight	45 pounds	39.6 pounds

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not describe a "test set" in the context of clinical data for performance evaluation. It describes technological similarities to a predicate device. The "Software Test Procedures and Test Report" are mentioned (page 2), but their details, including sample sizes or data provenance, are not provided. Given the nature of a CO2 laser surgical instrument, "data provenance" related to patient data would not typically be applicable in the same way as for an AI diagnostic device.

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 is a medical device (laser surgical instrument), not a diagnostic AI system requiring expert-established ground truth from clinical images or patient data. The "ground truth" for a laser system would be its physical output parameters meeting specifications.

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

Not applicable. No "test set" in the traditional sense of clinical data requiring expert adjudication is described.

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

Not applicable. This is a standalone medical device (CO2 laser), not an AI system designed to assist human readers.

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

The device itself is a standalone laser surgical instrument. Its performance would be evaluated based on engineering specifications and safety, not an algorithm's diagnostic performance. The document indicates that "Software Test Procedures and Test Report" were performed (page 2), implying software testing for the embedded control system, but not clinical "standalone performance" in the AI sense.

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

For this type of device (a CO2 laser surgical instrument), the "ground truth" would be established through:

Engineering specifications and measurements: Verifying output power, wavelength, mode, and other physical parameters meet design requirements.
Performance testing: Demonstrating the device can perform its intended functions (cutting and coagulation on tissue models or in animal studies, though not explicitly detailed here).
Safety testing: Ensuring compliance with electrical safety, laser safety standards, and electromagnetic compatibility.

The document refers to a "Certificate of Conformity" and "Safety Risk Analysis" (page 2), which would cover these aspects.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI system that requires a "training set" of data.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Certified Software Solutions, Inc. The logo consists of the letters "CSS" in a bold, stylized font. The letters are black and have a horizontal line design. Below the letters, the words "Certified Software Solutions, Inc." are written in a smaller, sans-serif font.

K063698

MAR 0 2 2007

510(k) Summary

Submitter/Applicant Name:	Clinicon Corporation
Contact:	Fritz Brauer
Address:	3025-A Industry StreetOceanside, CA 92054
Phone number:	(760) 439-1700
Fax number:	(760) 439-1798
Contact person:	Kim L. Bloom (CSS, Inc.)
Phone number:	(858) 675-8200
Fax number:	(858) 675-8201
Date prepared:	December 11, 2006
Trade name:	C_Las CO2 Laser System
Common name:	CO2 Laser System
Classification name:	II

Substantial equivalence claimed to:

K 875338: CHRYS (20 Watt CO2 Laser, cleared on April 13, 1988. The CHRYS (20 Watt CO2 Laser was cleared as a laser surgical instrument for use in general surgery as well as plastic surgery and in dermatology.

Device Description

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Intended Use

The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:

Cosmetic Surgery .
Dermatology .
General Surgery .
Gynecology .
Head & Neck Surgery .
Neurosurgery .
Oral Surgery .
Orthopedic Surgery .
Otorhinolaryngology .
Pediatric Surgery .
Plastic & Reconstructive Surgery .
Podiatry .
Urology .

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General Product Information

1. Product Names: A.R.C. CO2 Laser System
1. Regulatory Information
- Regulatory Section: 878.4810 a.
- Classification: Class II b.
- Product Code: GEX c.
- d. Panel: General & Plastic Surgery
1. Intended Use:
- Indication(s) for use: Please see page 9 and 12. a.
- b. Special conditions for use statement(s): N/A
- Special instrument requirements: N/A c.
1. Device Description: Please see 510k Summary page 8.
1. Standard/Guidance Document Referenced: Please see pages 20
Performance Characteristics: Please see the Software Test Procedures and Test 6. Report.
1. System description: Please see the Operational's Manual.
Product Safety Standards and Test Results: Please see Certificate of Conformity 8. attachment and Software Test Procedures.

Supporting specifications:

Please see attached validation documents (some of which may also be noted on the last page of this document):

1. Certificate of Conformity
1. Safety Risk Analysis
1. Software Requirements Specification
1. Software Test Procedures
1. Software Test Report
1. C-Las Brochure
1. C-Las Operator's Manual

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Technological Similarities and Differences to Predicate

Substantial equivalence claimed to:

K875338: CHRYS™ MODEL MED-MAX cleared on 04/13/1988 as a laser surgical instrument for use in general surgery as well as plastic surgery and in dermatology.

Summary of technological characteristics:

The following table describes similarities between CO2 Laser, Model C-LAS and the California Laboratories CHRYSTM MODEL MED-MAX (the predicate).

Similarities
Item	Device	Predicate
Name	CO2 Laser, Model C-LAS	CHRYSTM MODEL MED-MAX by CaliforniaLaboratories (K875338)
Intended use	Intended to be used byphysicians to cut andcoagulate wounds duringsurgery.	Intended to be used byphysicians to cut andcoagulate wounds duringsurgery.
Footprint	Compact12.5"x 13"	Compact15" by 20"
Laser	CO2 sealed	CO2 sealed
WaveLength	10.6 micrometers	10.6 micrometers
Mode	Continuous wave form(Gauss)	Continuous wave form(TEM00)
Accessories	Flexible Cable Waveguide	Articulated ArmWaveguide
Output Power	About 30 Watts	About 30 Watts
Weight	39.6 pounds	45 pounds
Console	Microprocessor	Microprocessor
Laser Operation	Footswitch	Footswitch

Based on the intended use and the use of laser technology for cutting and coagulation of wounds during surgery using a waveguide, the CO2 Laser is substantially equivalent to the California Laboratories CHRYS.

000011

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clinicon Corporation % Certified Software Solutions, Inc. Ms. Kim L. Bloom Sr. Software Quality Engineer 16787 Bernardo Center drive, Suite A-1 San Diego, California 92128

MAR 0 2 2007

Re: K063698 Trade/Device Name: CO2 Laser, Model C-LAS 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: February 14, 2007 Received: February 15, 2007

Dear Ms. Bloom:

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 reclassifial 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

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Page 2 - Ms. Kim L. Bloom

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,

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark McMillan

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

(To be determined) 510(k) Number: Device Name: C Las CO2 Laser System

Indications for Use: The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:

Cosmetic Surgery .
Dermatology .
General Surgery .
Gynecology .
Head & Neck Surgery .
Neurosurgery .
Oral Surgery .
Orthopedic Surgery ●
Otorhinolaryngology t
Pediatric Surgery ●
Plastic & Reconstructive Surgery t
Podiatry
Urology

Prescription Use
(Per 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 Sign-Off)
Division of General. Restorative, and Neurological Devices

510(k) Number	L063968
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	Page 12 of 20

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.