The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.

Device Description

The, Azuryt Model CTL 1401 CO2 Surgical Laser System is a CO2 laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcontroller and control panel.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Azuryt Model CTL 1401, CO2 Surgical Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving upfront that a new device meets specific performance criteria through extensive clinical studies.

Therefore, the information requested in your prompt related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is largely not applicable or not provided in this specific 510(k) summary.

Here's why and what information can be extracted:

1. A table of acceptance criteria and the reported device performance

Not Applicable in the traditional sense. For a 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This isn't about numerical performance metrics in a clinical study but rather about ensuring the new device has the same intended use, technological characteristics, and raises no new safety or effectiveness issues compared to a device already on the market.
What is provided: The submission states that "The system performs as intended and raises no new safety or effectiveness issues." This is the general conclusion, not a quantified performance report against specific criteria.

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

Not provided. No clinical test set or data provenance is mentioned as this is a device clearance based on substantial equivalence and compliance with standards, not a clinical trial.

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/Not provided. No expert review for ground truth on a test set is discussed.

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

Not applicable/Not provided.

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 device is a surgical laser, not an AI-assisted diagnostic tool. MRMC studies are not relevant.

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

Not applicable. This device is a surgical laser, not a standalone algorithm.

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

Not applicable/Not provided. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with recognized standards.

8. The sample size for the training set

Not applicable. As this is a physical medical device (surgical laser) and not an AI/algorithm, there is no "training set."

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

Not applicable.

Summary of what IS provided regarding "acceptance criteria" and "study":

The "study" or evidence proving the device meets the "acceptance criteria" (which in this context means demonstrating safety, effectiveness, and substantial equivalence) primarily relies on:

Acceptance Criteria & Reported Performance (Based on Substantial Equivalence and Standards Compliance):

Acceptance Criteria (Implied for 510(k))	Reported Device Performance
1. Substantial Equivalence to Predicate Device (K042439)	The Azuryt Model CTL 1401, CO2 Surgical Laser System is "substantially equivalent to the Azuryt Model CTL 1401 cleared under K042439." It has the "same intended uses, with the same technological characteristics" as the predicate.
2. Intended Use and Indications	Indicated for "incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues" across specialties like general/plastic surgery, dentistry, dermatology, etc. This matches the predicate's intended uses. The submission concludes the device "performs as intended."
3. Technological Characteristics	Operates as a CO2 surgical laser with a 10.6 um wavelength. Consists of a power supply, cooling system, laser head, articulated arm, handpiece, microcontroller, and control panel. These characteristics are described as "the same" as the predicate.
4. Safety Standards Compliance	Complies with: - IEC 60825-1 (Safety of laser products) - IEC 60601-2-22 (Safety of diagnostic and therapeutic laser equipment) - IEC 60601-1 (General requirements for safety) - IEC 60601-1-2 (Electromagnetic compatibility) - European Medical Device Directive 92/42/EEC - US Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products (with noted deviations pursuant to Laser Notice No. 50).
5. No New Safety or Effectiveness Issues	The submission concludes that "Based upon the testing and comparison to the predicate devices, the Azuryt Model CTI. 1401... raises no new safety or effectiveness issues."

Study/Evidence:

The "study" that proves the device meets (or rather, satisfies the requirements for) these criteria is primarily through engineering verification and validation based on international and national standards, and a comparison of technological characteristics to a legally marketed predicate device.

Type of "Study": This is a premarket notification (510(k)), which is a regulatory pathway for demonstrating substantial equivalence. It is not a clinical trial or performance study in the way one might evaluate an AI algorithm.
Methodology:
- Comparison to Predicate: Direct comparison of intended use and technological characteristics to the Azuryt Model CTL 1401 (cleared under K042439).
- Compliance with Standards: Verification that the device adheres to a list of specified international and US federal safety and performance standards for laser products and medical electrical equipment (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, European MDD 92/42/EEC, US 21 CFR 1040.10, 21 CFR 1040.11).

In essence, for a 510(k) for a device like a surgical laser, the "acceptance criteria" are regulatory and technical compliance, and the "study" is the demonstrated adherence to these through bench testing, design specifications, and comparison to existing products.

Summary

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K062248

Premarket Notification [510(k)] Summary (per 21 CFR 807.92)

AUG 1 7 2006

Submitted by: 1.

North American Clinical Lasers, Ltd. 2755 S. Amcs Way Denver, CO 80227

Contact Person:	Geoffrey D. Swank
	Vice-President of Operations
	Phone: (303)-263-3307
	Fax: (303) 985-7957

Date Prepared: 31 May 2006

2. Device Name

Trade/Proprietary Name:	Azuryt Model CTL 1401, CO2 Surgical Laser System
Common/Usual Name:	General Surgical Laser System
Classification Name:	Laser Instrument, Surgical, Powered(per 21 CFR 878.4810)

Predicate Device: 3.

The Azuryt Model CTL 1401, CO2 Surgical Laser System described in this submission is substantially equivalent to the Azuryt Model CTL 1401 cleared under K042439.

4. Intended use of the device

5. Description of the Device

The, Azuryt Model CTL 1401 CO2 Surgical Laser System is a CO2 laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcontroller and control panel.

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Summary of the technological characteristics of the device compared to the 6. predicate device.

The Azuryt Model CTL 1401 is a CO2 surgical laser system, utilizing a laser with a wavelength of 10.6 um. Each of these devices contains a power supply, a cooling system, a sealed CO2 laser head delivering a beam with a wavelength of 10.6 um, an arm to deliver the laser beam, a handpiece and a variety of accessories to address specific surgical needs.

7. Testing

The manufacturer of the Azuryt Model CTL 1401 certifies that its device complies with the following international standards:

IEC 60825-1, Safety of laser products Part 1: Equipment classification, . requirements and user's guide.
. IEC 60601-2-22, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for . safety, as amended by amendment 1 (1991) and amendment 2 (1995).
IEC 60601-1-2, Medical Electrical Equipment Part 1: General requirements for . safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests

The device is also complies with the European Medical Device Directive 92/42/EEC and the US Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, except for deviations pursuant to Lascr Notice No. 50, dated 26 July 2001.

8. Conclusions

Based upon the testing and comparison to the predicate devices, the Azuryt Model CTI. 1401 has the same intended uses, with the same technological characteristics as the device described in the previous submission. The system performs as intended and raises no new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 2006

North American Clinical Lasers, Ltd. % Intertek Testing Services Mr. Neil E. Devine, Jr. Senior Staff Engineer 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

Re: K062248

Trade/Device Name: Azuryt Model CTL 1401, CO2 Surgical Laser System 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: August 2, 2006 Received: August 3, 2006

Dear Mr. Devine:

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

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Page 2 - Mr. Neil E. Devine, Jr.

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. 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) 276-0120. 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 Nours.

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):

Device Namc: Azuryt Model CTL 1401, CO2 Surgical Laser System

Indications For Use:

Prescription Use _ X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K062248

Page _ 1_ of 1

Azuryt CTL-1401

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.