(70 days)
The DenLaser 800 Plus is indicated for the procedures of removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, plastic surgery, urology, gynecology, and plastic surgery.
The DenLaser 800 Plus is a device for delivering laser energy to human soft tissue for a variety of surgical procedures. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option. The working end of the delivery fiber is contained within metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
The provided text is a 510(k) Summary for the DenLaser 800 Plus, an 810nm Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards, rather than presenting a clinical study with detailed acceptance criteria and performance data in the typical sense for AI/software devices.
Here's an analysis based on the information provided:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria and reported device performance in the manner one would expect for a diagnostic or AI-driven device clinical study (e.g., sensitivity, specificity, AUC, etc.). Instead, the "acceptance criteria" are implied by compliance with various performance standards and demonstrated substantial equivalence to predicate devices. The "reported device performance" is described qualitatively through its technical characteristics and intended uses.
Acceptance Criterion (Implied) Reported Device Performance Substantial Equivalence to Predicate Devices (K050453, K032864, K993285) The DenLaser 800 Plus shares similar indications for use on soft tissue (cutting, lesions, photocoagulation), design features (wavelength, operating controls, laser delivery), control systems, safety features, performance monitoring, power output, energy type, and applications to soft tissue with the predicate devices. Compliance with 21 CFR 1040.10 and 1040.11 (Laser Product Performance Standards) Device complies with these standards, with permissible deviations relative to Laser Notice 50. Compliance with IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance) Device complies with this standard. Compliance with IEC 60601-2-22 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) Device complies with this standard. Compliance with IEC 60825-1 (Safety of laser products - Equipment classification and requirements) Device complies with this standard. Compliance with 47 CFR 15 and 18 (FCC rules for radio frequency devices) Device complies with these standards. Compliance with ETSI 301-489-1 (Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements) Device complies with this standard. Safe and Effective for Intended Use The device delivers laser energy at 810 ± 20nm for a maximum of 5 watts, via a proprietary optical fiber system, with a 630nm aiming beam, adjustable power, and continuous/pulsed delivery option. It is intended for removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue across several medical fields. -
Sample size used for the test set and the data provenance:
The document explicitly states "Clinical Performance Data" as a heading on page 2 but then provides no content under it, only moving directly to the "Conclusion" on page 3. This indicates that no clinical performance study, test set, or specific data provenance was used or reported in this 510(k) summary. The substantial equivalence argument relies on comparison to predicate devices and adherence to recognized performance standards. This type of submission generally does not require a specific clinical test set if substantial equivalence can be demonstrated through other means (e.g., technological characteristics, bench testing, and adherence to standards).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. As no clinical test set was reported, there was no need for experts to establish ground truth.
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Adjudication method for the test set:
Not applicable. No clinical test set was reported.
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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/diagnostic software. No MRMC study was performed or is relevant for this type of device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device (surgical laser), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No clinical study requiring ground truth was reported. The "ground truth" for this submission are the established performance standards and the characteristics of legally marketed predicate devices.
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The sample size for the training set:
Not applicable. This is a hardware device, not an AI/machine learning algorithm, so there is no training set in that context.
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How the ground truth for the training set was established:
Not applicable. As above, no training set for an algorithm was used.
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510(k) Summary of Safety and Effectiveness
CAO Group, Inc. 4628 West Skyhawk Drive West Jordan. UT 84084 Tel: 801-256-9282 Fax: 801-256-9287
Robert Larsen, Preparation Date: August 15, 2006
NUV 1 4 2006
KO62619
Device Name:
| Trade Name: | DenLaser 800 Plus |
|---|---|
| Common Name: | 810nm Diode Laser |
| Product Classification: | Laser Instrument, Surgical |
Legally Marketed Predicate Devices for Substantial Equivalence:
Odyssey 2.4G Diode Laser, manufactured by Ivoclar Vivadent, Inc. (K050453)
Ceralas D 810 Diode Laser, manufactured by Biolitec, Inc. (K032864)
Aurora SL Diode Laser, manufactured by Premier Laser Systems, Inc. (K993285)
Rationale for Substantial Equivalence:
The aforementioned laser devices and their accompanying delivery systems share similar indications for use on soft tissue with the submitted device for cutting soft tissue, affecting lesions, and photocoagulation. The predicate devices and submitted device share similar design features including wavelength, operating controls, and laser delivery method. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output and energy type. The devices share similar applications to soft tissue.
Description of Submitted Device:
The DenLaser 800 Plus is a device for delivering laser energy to human soft tissue for a variety of surgical procedures. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by
{1}------------------------------------------------
errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option.
The working end of the delivery fiber is contained within metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
Intended Uses of the DenLaser 800 Plus diode laser system:
The device is intended to be used for a variety of surgical procedures on soft tissue. See Indications for Use on page 2-1.
Technological Characteristics and Substantial Equivalence:
The Odyssey 2.4G Diode Laser uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 630nm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emission. The device features a wireless foot switch for actuating the working beam. The maximum output of the working beam is 5 watts.
The Ceralas D 810 Diode Laser uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 635nm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emission. The maximum output of the unit is 15 watts.
The Aurora SL Diode Laser uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 630-680nm aiming beam and features controls that allow for adjusting the output of the working beam. The maximum output of the unit is 6 watts.
Performance Standards:
The DenLaser 800 Plus diode laser complies with the performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated July 26, 2001. The device also complies with IEC 60601-1:1998+A1, IEC 60601-2-22:1995, IEC 60825-1:1993+A1+A2, 47 CFR 15 and 18, and ETSI 301-489-1.
Clinical Performance Data
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Conclusion
The DenLaser 800 Plus is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CAO Group, Inc. % Mr. Robert K. Larsen Operations Director 4628 West Skyhawk Drive West Jordan, Utah 84084
NOV 1 4 2006
Re: K062619 Trade/Device Name: DenLaser 800 Plus 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: August 15, 2006 Received: September 6, 2006
Dear Mr. Larsen:
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 rcclassified 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 - Mr. Robert K. Larsen
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) 276-0115. 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,
Sincerely yours,
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): | K062619 |
|---|---|
| --------------------------- | --------- |
Device Name: DenLaser 800 Plus
Indications For Use:
The DenLaser 800 Plus is indicated for the procedures of
removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation
on soft tissue in the fields of
otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, plastic surgery, urology, gynecology, and plastic surgery.
| Prescription Use | X | AND/OR Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (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 | L06219 | Page 1 of 1 |
|---|---|---|
| --------------- | -------- | ------------- |
2-1
§ 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.