The Sapphire Plus STM 3W Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; and vestibuloplasty.

Device Description

The Sapphire Plus STM Laser is a plug-in option for the Sapphire Plus Light Source Unit. The Sapphire Plus Light Source Unit contains a xenon arc lamp that, depending on which handpiece is attached, has been cleared for use as either a Curing/Whitening attachment (K081287) or as an adjunct for visual oral tissue examination (K073483). In both cases, these two attachments use different portions of the broad-spectrum xenon arc light's emissions to perform their clinical functions.

Like the other two attachments for the Sapphire Plus Light, the Sapphire Plus STM Laser also plugs into the Sapphire Plus Light. Unlike the other two attachments, however, when the Sapphire Plus STM Diode Laser is attached to the Sapphire Plus Light, only low-voltage DC current -not visible light -- is sent to the Laser. The Sapphire Plus STM Diode Laser is comprised of two basic parts: the control box ("control module") with microprocessor and user interface, and the Laser Handpiece containing the working and aiming beam laser diodes and the laser ON/OFF switch. The Control Module interface allows selection of mode (continuous wave or pulsed) and laser output, provides visual indications of power settings and of the unit's status, and features the unit's footswitch jack and operating key switch and the Emergency STOP button. The Laser Handpiece is found at the end of a six foot long power/communications cord that is plugged into the Control Module's light guide port. The Handpiece houses the 808 ± 5nm laser working beam diode and the 640 ± 10nm aiming beam diode and control board, optics and heat sink, on/off switch, and the disposable fiberoptic tip assembly. An optional footswitch is available that plugs into the control module and can be used to activate the laser working beam instead of the handpiece on/off actuator. The Sapphire Plus STM Laser is powered by a 15W, 5 VDC rechargeable lithium-ion battery that receives its energy from the Sapphire Plus Light Source Unit.

AI/ML Overview

The information provided discusses the substantial equivalence of the Den-Mat Holdings Sapphire Plus STM 3W Diode Laser to predicate devices, focusing on non-clinical performance and a review of existing literature for similar devices. There isn't information present to fill all sections of the requested table.

Here's the information that can be extracted from the provided text:

1. Table of acceptance criteria and reported device performance

The acceptance criterion for laser output accuracy is that the output should vary by less than ± 20% of the setting, as per IEC 60601-2-22.

Acceptance Criterion (IEC 60601-2-22)	Reported Device Performance (Den-Mat Holdings Sapphire Plus STM 3W Diode Laser)
Laser output varies by less than ± 20% of the setting	Average variance: 1.4% in Continuous Wave (CW), 0.5% in Pulsed (P) mode

2. Sample size used for the test set and the data provenance

The document indicates that the Sapphire Plus STM Diode Laser was tested "side-by-side against one of the predicate devices". However, it does not specify the sample size for this comparison.

The data provenance is from non-clinical comparative performance testing conducted by Den-Mat Holdings, LLC, which would be considered prospective for the specific device being tested. No external data provenance like country of origin for a 'test set' in a clinical study is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

There is no mention of experts or ground truth establishment for the non-clinical comparative performance data presented. This section primarily focuses on technical specifications and output accuracy comparisons.

4. Adjudication method for the test set

No adjudication method is described as the available information pertains to non-clinical technical comparisons, not clinical trials requiring expert adjudication.

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

No MRMC comparative effectiveness study was performed or mentioned. The device is a surgical laser, not an AI-powered diagnostic tool, so this type of study is not relevant to its evaluation in this document.

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

A standalone study of the device's technical performance was done. The "NON-CLINICAL COMPARISONS Comparative Performance Data" section describes measurements of the device's output accuracy (variance from set power), which is a standalone assessment of its functional precision.

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

For the technical performance comparison, the "ground truth" used was the device's own set output parameters. The measured output was compared against these set values to determine accuracy, relative to the international standard IEC 60601-2-22.

The document also references a body of literature showing the safety and effectiveness of 808 nm diode lasers in general. This literature would consist of various study types (meta-reviews, clinical studies, in vitro studies, animal studies), implying diverse forms of "ground truth" (e.g., clinical outcomes, histological findings, expert assessment, etc.) but these are for the predicate devices and the general class of lasers, not specifically for establishing a ground truth for the new Sapphire Plus STM 3W Diode Laser's performance.

8. The sample size for the training set

No training set is mentioned. The document describes a medical device (laser), not an AI algorithm that requires training data.

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

Not applicable, as there is no training set mentioned for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo consists of the letters 'dm' in a stylized font, with the word 'DenMat' written below. The address of the company is listed as 2727 Skyway Drive, Santa Maria, CA 93455.

K110079
FEB - 10 2011

510(k) Summary of Safety and Effectiveness

Den-Mat Holding's Sapphire Plus STM 3W Diode Laser

Submitted for:	Den-Mat Holdings, LLC2727 Skyway DriveSanta Maria, CA 93455
Phone:	805-922-8491
Facsimile:	805-347-7940
Contact Person:	Alan B. Matthews, ext. 2927
Date Prepared:	7 December 2010
Device Proprietary Name(s):	Sapphire Plus STM 3W Diode Laser
Common or Usual Name:	808 nm Diode Laser (Class 4 laser)
Product Classification:	Laser instrument, surgical
Product Code:	GEX
Predicate Device(s):	Ivoclar Vivadent, Inc. Odyssey Navigator Diode Laser(K062258); Zap Lasers, LLC Styla MicroLaser/StylaOrthoLaser (K081214); Ivoclar Vivadent, Inc. Odyssey 2.4G(K050453)

Rationale for Substantial Equivalence

Both the subject and predicate laser devices share similar intended uses and indications for use, technical characteristics, features, and specifications. The laser characteristics of the Sapphire Plus STM Laser, including working and aiming beam wavelengths and outputs, laser delivery methods, safety features, and performance specifications are similar to those of the cleared Odyssey Navigator, Odyssey 2.4G, and Styla MicroLaser Diode Lasers. The laser operating system and controls of the subject device are similar to those used by the previously-cleared predicate devices that have proven safety and effectiveness records in the treatment of the claimed indications. Safety and performance test results have been shown to satisfy applicable international standards recognized by the Agency.

Intended Uses and Indications for Use

The Sapphire Plus STM Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas;

{1}------------------------------------------------

soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; and vestibuloplasty.

Device Description

Conformity to International Standards

The Sapphire Plus STM Laser complies with the performance requirements listed in 21 CFR 1040.10 and 1040.11, with permissible deviations pursuant to Laser Notice 50, dated July 26, 2001. Additionally, the subject device has been shown to conform to the same international electrical safety standards for electrical medical devices in general, and lasers in particular, as the predicate devices, including electrical safety and electromagnetic compatibility and resistance to interference (EMC and EMI): IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo consists of the letters 'dm' in a stylized font, with the word 'DenMat' written below. The address '2727 Skyway Drive, Santa Maria, CA 03455' is printed to the right of the logo.

NON-CLINICAL COMPARISONS Comparative Performance Data

The Sapphire Plus STM Diode Laser has been tested side-by-side against one of the predicate devices. Measurements of the output of the subject device's working beam ranging from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings by an average of only 1.4% in CW and 0.5% in P compared to the predicate's variance of 2.2% in CW and 2.7% in P. The intended performance of these devices, based on IEC 60601-2-22, is that laser output should vary from the device's setting by less than ± 20% of the setting. Both the subject and predicate devices have been shown to satisfy this standard, with the subject device demonstrating less variability (more control) than the cleared predicate device.

The Table "Comparison of Lasing Characteristics" immediately following and Table 1 Key Features and Characteristics provide tabular comparisons of the subject device technical and operational characteristics to those of the predicate devices.

Comparison of Lasing Characteristics
DeviceDescription:	Sapphire PlusSTM	OdysseyNavigator	StylaMicroLaser	Odyssey 2.4G
Output range, CW	0.1 - 3.0W	0.1 - 3.0W	2W maximum	0.1 - 5.0 W
Incrementsavailable	0.1W	0.1W	unknown	0.1W
Energy available(per 1 secondemission, CW)	3J	3J	2J	5J
Output range, P	0.1 - 3.0W	0.1 - 3.0 W	0.1 - 2.0 W	0.1 - 5.0W
Incrementsavailable	0.1W	0.1W	0.1W	0.1W
Method for pulsing	Digital emission control	Digital emissioncontrol	Digital emissioncontrol	Digital emissioncontrol
Frequency of pulse	4 Hz	10 Hz	10 Hz	1 Hz
Pulse trainduration	0.125 seconds	0.05 seconds	0.05 seconds	0.5 seconds
Duty cycle	50%	50%	50%	50%
Energy available(per 1 secondemission, CW @maximum output)	3.0J	3.0J	2.0J	5.0J
Fiberoptic tipdiameter	400 μm	400 μm	400 μm	400 μm
Beam diameter	150 μm	unknown	unknown	unknown
Working BeamWavelength (nm)	808 nm (±5nm)	810 (±20 nm)	808 (±5 nm)	810 nm (±20 nm)
Light source	Single emitter solid statediode	Single emitter solidstate diode	Single emitter solidstate diode	Single-emitter solidstate diode
Beam divergenceangle	9° (± 1°)	9° (±1°)	unknown	9° (±1°)
Aiming beampresent?	Yes	Yes	Yes	Yes
If present,wavelength	640 nm (±10nm)	630 - 650 nm	650 nm	630 - 660nm (±15nm)
Output	2mW	2 mW	5 mW	2mW
Adjustable?	Yes, from 0 mW(OFF) to 2 mW	Yes, from 0 mW(OFF) to 2mW	Yes	Yes, from 0 mW(OFF) to 2 mW
Laser medium	GaAIAs Laser Diode	GaAIAs LaserDiode	GaAIAs LaserDiode	GaAIAs LaserDiode
Cooling method	Convection	Convection	Convection	Air cooled fan
Aperture stoppresent?	Yes	Unknown	Unknown	Unknown

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo for DenMat. The logo consists of the letters 'dm' in a stylized font, with the 'd' and 'm' connected at the top. Below the letters 'dm' is the word 'DenMat' in a smaller, sans-serif font. The logo is black and white.

--.

ノ

DEN-MAT HOLDINGS. DRIVE
SANTA MARIA. CA 93455

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo includes the letters 'dm' stacked on top of the word 'DenMat'. To the right of the logo is the text 'DEN-MAT HOLDINGS, LLC' followed by the address '2727 SKYWAY DRIVE, SANTA MARIA, CA 93455'.

Comparison of Features and Characteristics

Table 1, following, lists key Features and Characteristics of the subject and three predicate devices.

œ
4	1	C	L B

	Den-Mat Holdings,LLC Sapphire PlusSTM laser	Ivoclar Vivadent,Inc. OdysseyNavigator DiodeLaser	Zap Lasers, Inc.Styla MicroLaserDiode Laser	Ivoclar Vivadent,Inc Odyssey 2.4GDiode Laser
Wavelength	808 ±5 nm	810 ±20 nm	808 ±5 nm	810 ±20 nm
Power	0.1 – 3.0 W (CW) &(Pulse)	0.1-3.0 W (CW &Pulse)	2.0 W maximum	0.1-5.0 W (CW &Pulse)
Aiming Beam	640 nm (±10 nm),maximum 2 mW(adjustable)	630 – 650 nm,maximum 2 mW(adjustable)	650 nm, maximum5 mW (adjustable)	630 - 650 nm,maximum 2 mW(adjustable)
CoolingSystem	Convection cooled	Fan air cooled	Convection cooled	Fan air cooled
Pulse Control	Digital emissioncontrol	Digital emissioncontrol	Digital emissioncontrol	Digital emissioncontrol
Laser Source	Solid-state diode	Solid-state diode	Solid-state diode	Solid-state diode
PowerRequirements	15W 5VDCsupplied from 110 -120 VAC @ 60 Hzor 220-240 VAC@ 50 Hz(switchable)	100-240 VAC @50-60 Hz, 0.5A(switchable)	100-240VAC @ 50-60 Hz, 0.8A max(switchable)	100-240 VAC @50-60 Hz, 1.5A(switchable)
UserInterface	Membrane touchpad, LCD Display,LED Indicators	LCD Touch Screen	Membrane touchpads, LED Display	Membrane touchpads, LCD display6 meter fibercartridge, 400 μmdiameter
FiberopticTip	Disposable, 400 μmunit dose	Disposable, 400 μmunit dose	Disposable, 400 μmunit dose	Disposable, 400 μmunit dose
510(k)Number	Pending thisapplication	K062258	K081214	K050453

Studies from the Literature Showing Safety and Effectiveness of 808 nm Diode Lasers Used in Dental Intraoral Soft Tissue General, Oral Maxilla-facial and Cosmetic Surgery

The literature abounds with studies that describe the safe and effective uses for 810 nm diode lasers for soft tissue indications. This application includes references to articles that describe the use and effectiveness of soft tissue diode lasers in intra-oral applications of the type intended for the Sapphire Plus STM 3W Diode Laser and describes how the Sapphire Plus STM Diode Laser is equivalent to these devices. Included in the Section "Clinical Reviews Related to the Sapphire Plus 3W Diode Laser" are references to meta-reviews, clinical studies, in vitro studies, and animal studies. The studies point to the 808 nm diode laser's affinity for hemoglobin and melanin and describe how this is particularly effective in soft tissue treatments and point to the

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo consists of the letters 'dm' in a stylized font, with the word 'DenMat' written below. The address '2727 Skyway Drive, Santa Maria, CA 93455' is printed to the right of the logo.

device's ability to achieve clinical objectives that are overall less painful and exhibit quicker recovery times than traditional surgical means. The studies support the contention that diode lasers that emit in this approximate wavelength are similarly effective and safe.

Conclusion

The subject device shares the same principle of operation as the three predicate devices, All are diode lasers that emit radiant energy at approximately 808 nm with outputs that range from 0.1 to 5.0W. All deliver collimated laser energy to subject target tissue via 400 um silica optical fibers controlled by trained, experienced clinicians. All offer visible aiming beams that are adjustable and that may be turned off. All share the same indications for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. All have been found to satisfy international safety standards relating to electrical medical devices in general and medical lasers in particular. All share the similar safety labeling, device interlocks, and associated safety features. Both the subject and a predicate device's output were measured and compared to their settings to determine the accuracy of the devices' controls. Both met international standards pertaining to accuracy of output of the working beam, but the difference between the subject device's output and its setting was much less than the predicate's. demonstrating not only conformance to the standard, but also superior control over laser emissions.

The subject and the predicate devices share similar features and characteristics, from working beam lasing characteristics to control interfaces and status indicators. Laser energy for all devices is transferred to patient tissues via 400 um silica optical fibers.

The Sapphire Plus STM Diode Laser shares intended uses, principle of operation, technical attributes, functional capabilities, and performance characteristics with the listed predicate devices. Both the subject and predicate devices have been shown to comply with applicable Federal and international safety and performance standards. The Sapphire Plus STM Laser performs it's surgical function using the same technological means as similar dental soft-tissue lasers whose safety and effectiveness has been reported in the literature. The Sapphire Plus STM Diode Laser is substantially equivalent to the listed predicate laser surgical devices and does not raise any new issues of safety or effectiveness.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and people. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002

Den-Mat Holdings, LLC % Intertek Testing Services Ms. Paula Wilkerson 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

FEB 10 201

Re: K110079

Trade/Device Name: Sapphire Plus STM 3W Diode Laser 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: February 03, 2011 Received: February 07, 2011

Dear Ms. Wilkerson:

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

の 2017年 10:00 PM 2017

{7}------------------------------------------------

Page 2 – Ms. Paula Wilkerson

Please be advised that I'DA'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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kiy B. Reta
kr

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): k//079

Device Name: Sapphire Plus STM 3W Diode Laser

Indications for Use:

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

Page

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilbe Ogden for mxm

Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

. 510(k) Number K110079

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.