(55 days)
Dental, oral, and soft tissue surgery including: Sulcular debridement of diseased or fiberous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown lengthening Operculectomy Frenectomy Photocoagulation
The DenLaser 800 Plus is a device for delivering laser energy to surfaces within the oral cavity. 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 allow for the safe transmission of laser energy to the sire 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 630mm aiming beam, adjustable power output for both the working bearn 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 format requested.
Therefore, many of the requested details cannot be extracted directly from this document. The document states "See Part 7: Performance Data" for Clinical Performance Data, but Part 7 is not included in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Standards: Compliance with: - 21 CFR 1040.10 and 1040.11 (with permissible deviations relative to Laser Notice 50, dated July 26, 2001) - IEC 60601-1:1998+A1 - IEC 60601-2-22:1995 - IEC 60825-1:1993+A1+A2 - 47 CFR 15 and 18 - ETSI 301-489-1 | The document states: "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." The reported performance is an assertion of compliance with these specified standards, implying the device met the criteria outlined within those standards. Specific quantitative acceptance criteria (e.g., "power output must be within X% of Y") and the actual measured performance values are not detailed in this summary. |
| Substantial Equivalence: Similar intended uses, similar functional and performance characteristics to predicate devices. | The document concludes: "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." This is a qualitative statement of meeting the criteria for substantial equivalence. |
| Soft tissue surgical procedures within the oral cavity (as per "Indications for Use") | The device is intended for these uses. The provided document does not include a study demonstrating the device's efficacy or safety specifically for each of these procedures. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided 510(k) summary does not describe a clinical test set with a specific sample size. It mentions "Clinical Performance Data" but directs the reader to a section ("Part 7") that is not included. The document focuses on compliance with technical standards and substantial equivalence, which typically rely on bench testing and comparisons to existing devices rather than a dedicated clinical trial with a "test set" in the context of diagnostic accuracy.
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. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
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 or imaging tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The provided document does not describe a study involving a "ground truth" in this context. The "truth" evaluated is compliance with performance standards and similarity to predicate devices.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this device does not involve machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set."
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
CAO Group, Inc. 86863 South 700 West Sandy, UT 84070 Tel: 801-256-9282 Fax: 801-256-9287
【JUL 1002006
Robert Larsen. Preparation Date: May 8, 2006
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
DenLaser 800. Manufactured by CAO Group, Inc.
Cynosure Accolade Laser
Rationale for Substantial Equivalence:
The aforementioned laser devices and their accompanying delivery systems share similar indications for use in the oral environment, 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 surfaces within the oral cavity. 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 allow for the safe transmission of laser energy to the sire 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
. . . . . ...
{1}------------------------------------------------
630mm aiming beam, adjustable power output for both the working bearn 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 within the oral cavity. 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 DenLaser 800 uses solid state diodes to generate laser energy in the 810mm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 630mm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsedmode laser emission. The maximum output of the unit 5 watts.
The Cynosure Accolade Laser uses an excited Alexandrite crystal to generate a laser wavelength of 755nm. The system uses and optical fiber to deliver laser energy to the surgical site. The system also features a 635mm aiming beam. The system is used to apply laser energy to cutaneous and subcutaneous pigmentations, whether naturally occurring or artificially applied. The discolorations absorb the laser energy causing the discoloration to become altered such that the color is removed. The maximum output of the unit is 1.8J at a pulse width of 60 nanoseconds.
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.
{2}------------------------------------------------
Clinical Performance Data
See Part 7: Performance Data
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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES" are arranged in a circular pattern around the left side of the eagle. The letters "USA" are on the right side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 10 2006
CAO Group, Inc. % Mr. Robert Larsen Operations Director 8683 South 700 West Sandy, Utah 84070
Re: K061366
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: May 8, 2006 Received: May 16, 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 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 complics 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
{4}------------------------------------------------
Page 2 -- Mr. Robert 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 vours.
Hulut lemerno
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
| 510(k) Number (if known): | K 061366 |
|---|---|
| --------------------------- | ---------- |
Device Name: DenLaser 800 Plus
Indications For Use:
Dental, oral, and soft tissue surgery including:
Sulcular debridement of diseased or fiberous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown lengthening Operculectomy Frenectomy Photocoagulation
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)
Hulbert Leeman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
Kobisble 510(k) Number_
§ 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.