(28 days)
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.
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, microcomputer and control panel.
The provided text describes a Premarket Notification [510(k)] Summary for a CO2 Surgical Laser System. This type of device is classified as a medical electrical equipment, and the document outlines its compliance with safety and performance standards rather than presenting a clinical study with acceptance criteria in the context of diagnostic or AI-driven devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC study, standalone performance) are not applicable to this document as it does not describe a study involving human or image data for diagnostic or AI algorithm evaluation.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This device's "performance" is demonstrated by its adherence to established international safety and performance standards for CO2 surgical lasers and its substantial equivalence to predicate devices. The acceptance criteria are essentially the requirements of these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Compliance) |
|---|---|---|
| Safety of Laser Products | EN60825-1 / IEC 60825-1: Equipment classification, requirements and user's guide | Complies |
| Medical Electrical Equipment - Safety Requirements | EN60601-2-22 / IEC 60601-2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment | Complies |
| Medical Electrical Equipment - General Safety Requirements | EN60601-1 / IEC 60601-1 (including amendments): General requirements for safety | Complies |
| Medical Electrical Equipment - Electromagnetic Compatibility | EN60601-1-2 / IEC 60601-1-2: Electromagnetic compatibility - Requirements and tests | Complies |
| European Medical Device Directive | 92/42/EEC | Complies |
| US Federal Performance Standards for Laser Products | 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products (with allowed deviations under Laser Notice No. 50) | Complies |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices (Deka Smart CO2 laser, Lumenis LX-20 CO2 Surgical Laser System) in intended use and technological characteristics. | Azuryt Model CTL 1401 has the same intended uses and similar technological characteristics as the predicate devices. The system performs as intended and raises no new safety or effectiveness issues. |
2. Sample size used for the test set and the data provenance
Not applicable. This document refers to compliance testing against engineering and safety standards, not a clinical test set 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
Not applicable. This is not a study requiring expert ground truth in a clinical context.
4. Adjudication method for the test set
Not applicable.
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 surgical laser system, not an AI-assisted diagnostic or interpretation device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established requirements and specifications within the cited international and federal standards. Compliance with these standards is determined through engineering tests, quality assurance procedures, and comparison of technological characteristics to already approved predicate devices.
8. The sample size for the training set
Not applicable. This is a hardware medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Premarket Notification [510(k)] Summary (per 21 CFR 807.92)
1. Submitted by:
Diamond Age Systems, Inc. 3775 South Laurel Way Chandler, AZ 85249 Phone: (866) 546-5444
Contact Person: Geoffrey D. Swank Vice-President of Laser Operations Phone: (303) 263-3307 Fax: (303) 985-7957
Date Prepared: 29 August 2004
2. Device Name
Trade/Proprietary Name: Common/Usual Name: Classification Name:
Azurvt Model CTL 1401. CO2 Surgical Laser System General Surgical Laser System Laser Instrument, Surgical, Powered (per 21 CFR 878.4810)
3. Predicate Device:
The Azuryt Model CTL 1401, CO2 Surgical Laser System is substantially equivalent to other laser systems on the market, such as the Deka Smart CO2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO2 Surgical Laser System, cleared under K896478, K953074, and K960475.
4. Intended use of the device
The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coaqulation 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.
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Description of the Device 5.
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, microcomputer and control panel.
Summary of the technological characteristics of the device 6. compared to the predicate device.
Like the predicate devices, the Azuryt Model CTL 1401 is a CO2 surgical laser system, utilizing a laser with a wavelength of 10.6 µm. 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 1401certifies that its device complies with the following international standards:
EN60825-1. IEC 60825-1. Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
EN60601-2-22, IEC 60601-2-22, Medical Electrical Equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
EN60601-1. IEC 60601-1. Medical Electrical Equipment - Part 1: General requirements for safety, as amended by amendment 1 (1991) and amendment 2 (1995).
EN60601-1-2, IEC 60601-1-2, Medical Electrical Equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests
The device 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 Laser Notice No. 50, dated 26 July 2001.
8. Conclusions
Based upon the testing and comparison to the predicate devices, the Azuryt Model CTL 1401 has the same intended uses, with similar technological characteristics as the predicate devices. 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Diamond Age Systems, Inc. c/o Mr. Ned E. Devine Entela. Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K042439
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: II Product Code: GEX Dated: September 21, 2004 Received: September 22, 2004
0C1 7 - 2004
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 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. Ned Devine
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in your le FDA finding of substantial equivalence of your device to a legally promated nevice 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 11 you attire 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 other general micronal 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 vours,
Sincerely yours,
Mark A. Millerson
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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Indications for Use
510(k) Number (if known): K042439
Device Name: Azuryt Model CTL 1401, CO2 Surgical Laser System
Indications For Use:
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.
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)
for
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K042439
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§ 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.