The Sapphire ST Portable 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 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; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.

Device Description

The Sapphire ST Portable Diode Laser is comprised of three basic parts: the control box ("control module") with microprocessor and user interface for selection of mode (continuous wave or pulsed) and laser output to provide visual indications of power settings and of the unit's status, and features the unit's power ON/OFF switch, footswitch jack and key switch; the second component is the corded laser handpiece that houses the laser working beam and aiming beam diodes and control board, optics and harat 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. Electrical power is taken from the AC/DC Power Supply that plugs into a standard electrical outlet and charges a 15W, 5 VDC lithium-ion battery that generates 4 amps used to drive the diode laser.

AI/ML Overview

The provided text describes the Den-Mat Holdings Sapphire ST Portable Diode Laser, a medical device. Here's an analysis of the acceptance criteria and study as requested:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (Sapphire ST Portable Diode Laser)
Laser Output Variability (IEC 60601-2-22 Standard): Laser output should vary from the device's setting by less than ± 20% of the setting.	Continuous Wave (CW) Mode: Average variance of only 1.4% from the unit's settings. Pulsed (P) Mode: Average variance of only 0.5% from the unit's settings. (The predicate device had variances of 2.2% in CW and 2.7% in P)
Wavelength	$808 \pm 5$ nm
Power	0.1 – 3.0 W (CW) & 0.1 – 5.0 W (Pulse)
Aiming Beam	640 nm ($\pm 10$ nm), maximum 2mW (adjustable)
Cooling System	Convection cooled
Pulse Control	Digital emission control
Laser Source	Solid-state diode
Power Requirements	24W 5VDC supplied from 110 – 120 VAC @ 60 Hz or 220 – 240 VAC @ 50 Hz (switchable)
User Interface	Membrane touch pad, LCD Display, LED Indicators
Fiberoptic Tip	Disposable, 400 μm unit dose
Conformity to International Standards	Complies with 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22.

Study Details:

Sample size used for the test set and the data provenance:
- The document mentions "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..." However, it does not specify a numerical sample size for the test set (i.e., how many measurements were taken or how many devices were tested).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). It describes internal testing of the device against predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study is a technical performance comparison of laser output accuracy against a predefined standard (IEC 60601-2-22), not a clinical study requiring expert ground truth in the traditional sense of medical image or diagnosis evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2. The performance data is objective measurement of physical output, not subjective human assessment needing adjudication.
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 document is for a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. See point 4.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation in this context is the international standard IEC 60601-2-22, which specifies that laser output should vary by less than ± 20% of the setting. The measurements taken from the device were compared against this objective standard.
The sample size for the training set:
- Not applicable. This device is a hardware laser instrument, not a machine learning or AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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103667 page ① of ③

510(k) Summary of Safety and Effectiveness

Den-Mat Holding's Sapphire ST Portable Diode Laser

Submitted for:	Den-Mat Holdings, LLC
	2727 Skyway Drive
	Santa Maria, CA 93455
Phone:	805-922-8491
Facsimile:	805-347-7940
Contact Person:	Alan B. Matthews, ext. 2927
Date Prepared:	11 November 2010
Device Proprietary Name(s):	Sapphire ST Portable Diode Laser
Common or Usual Name:	808 nm Diode Laser (Class 4 laser)
Product Classification:	Laser instrument, surgical
Product Code:	GEX

Ivoclar Vivadent, Inc. Odyssey Navigator Diode Laser (K062258); Zap Lasers, LLC Styla MicroLaser/StylaOrtho Laser (K081214); Ivoclar Vivadent, Inc. Odyssey 2.4G (K050453)

Rationale for Substantial Equivalence

Predicate Device(s):

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 ST Portable Diode 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

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103667 page 2 of 3

impression; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.

Device Description

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Conformity to International Standards

The Sapphire ST Portable Diode 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: IEC 60601-1, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22.

Comparative Performance Data

The Sapphire ST Portable 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.

Comparison of Features and Characteristics

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

Table 1.

Den-Mat Holdings,LLC Sapphire STPortable Diode	Ivoclar Vivadent,Inc. OdysseyNavigator Diode	Zap Lasers, Inc.Styla MicroLaserDiode Laser	Ivoclar Vivadent,Inc Odyssey 2.4GDiode Laser
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103667 page (3) of (3)

	Laser		Laser
Wavelength	$808 \pm 5$ nm	$810 \pm 20$ nm	$808 \pm 5$ nm	$810 \pm 20$ nm
Power	0.1 – 3.0 W (CW) &0.1 – 5.0 W (Pulse)	0.1 – 3.0 W (CW &Pulse)	2.0 W maximum	0.1 – 5.0 W (CW &Pulse)
Aiming Beam	640 nm ( $\pm 10$ nm),maximum 2mW(adjustable)	630 – 650 nm,maximum 2 mW(adjustable)	650 nm, maximum5 mW (adjustable)	630 – 650 nm,maximum 2 mW(adjustable)
Cooling System	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	24W 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 display
FiberopticTip	Disposable, 400 μmunit dose	Disposable, 400 μmunit dose	Disposable, 400 μmunit dose	6 meter fibercartridge, 400 μmdiameter
510(k)Number	Pending thisapplication	K062258	K081214	K050453

Conclusion

The subject device shares the same principle of operation as the three predicate devices. All arc 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 fiberoptic tips controlled by trained, experienced clinicians. 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 Sapphire ST Portable Diode Laser device 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 ST Portable Laser is substantially equivalent to the listed predicate laser surgical devices and does not raise any issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUM" is arranged vertically along the left side of the logo.

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

Den-Mat Holdings, LLC % Regulatory Technology Services, LLC Mr. Mark Job 1394 2511 Street. NW Buffalo, Minnesota 55313

DEC 2 9 2010

Re: K103667

Trade/Device Name: Sapphire ST Portable Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 14, 2010 Received: December 15, 2010

Dear Mr. Job:

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. 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.

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Page 2 - Mr. Mark Job

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); medical device reporting (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 yours,

FOR Dothan DR

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

Enclosure

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Indications for Use Statement

510(k) Number (if known):_k|0 2 6 6 7

Device Name: Sapphire ST Portable Diode Laser

Indications for Use:

The Sapphire ST Portable 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 fiberoptic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectorny; frenotomy, gingival incision and excision; 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; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

P. Antonio

(Division Sign-C. T) (Division Sign-C-1, Orthopedic, Division of on of evices

510(k) Number .

DEC 2 9 2010

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.