Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery.
And
Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

Device Description

The Pilot Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid state diodes capable of producing laser energy at 810 ± 20nm for a maximum of 9 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 a 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Pilot Diode Laser and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific clinical study with granular performance metrics against a defined acceptance criterion.

Therefore, many of the requested elements for describing a study that proves the device meets acceptance criteria are not explicitly present in the provided text.

However, I can extract the available information and highlight what is missing.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Criterion	Reported Device Performance
Output Wavelength	Consistent with predicate devices (810nm range).	810 ± 20nm
Maximum Energy Output	Sufficient for intended uses and comparable to predicate devices.	Maximum of 9 watts of energy output.
Delivery System	Optical fiber system for safe transmission.	Proprietary optical fiber system, contained within a metal handpiece with a disposable single-use tip.
Aiming Beam	Present and adjustable.	Switchable 630nm aiming beam, adjustable power output for both working beam and aiming beam.
Delivery Mode	Continuous or pulse delivery option.	Continuous delivery or pulse delivery option.
Activation Method	Foot-actuated switch.	Foot-actuated switch.
Applicable Standards Compliance	Compliance with relevant federal and international safety and performance standards (e.g., 21 CFR 1040.10, 1040.11, IEC 60601-1, etc.).	Complies with 21 CFR 1040.10 and 1040.11 (with permissible deviations relative to Laser Notice 50, July 26, 2001). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, UL60601-1, 47 CFR 15 and 18, and ETSI 301-489-1.
Effectiveness for Indications for Use	Deliver laser energy necessary for the specified indications (soft tissue procedures and temporary relief of minor pain/stiffness/etc.).	"This device was tested and found to deliver laser energy necessary for the temporary relief of minor muscle and joint pain, etc. as described in the device's Indications for Use. The device was tested and passed CAO Group internal requirements for construction and performance." The document further states, "The Pilot Diode Laser 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 implies it also meets effectiveness for "Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue" by virtue of substantial equivalence to predicate devices with these indications.

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., "power output must be 9W +/- 0.5W") nor detailed quantitative performance data for these criteria beyond general statements like "deliver laser energy necessary." It refers to compliance with standards and internal requirements, but the specifics of those are not detailed here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "The Pilot Diode Laser tested as compliant" and "This device was tested and found to deliver laser energy necessary," but it does not describe a clinical study with a test set of data or participants. The testing appears to be based on engineering and safety compliance rather than clinical performance data.

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)

This information is not applicable/not provided. The assessment described in the document is primarily about device specifications, safety standards, and functional characteristics rather than diagnostic or therapeutic efficacy requiring expert ground truth on a test set of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided, as no clinical test set requiring adjudication is described.

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

This information is not applicable/not provided. The device is a surgical/therapeutic laser, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study related to human reading performance is not relevant.

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

This information is not applicable/not provided. The device is a physical laser system, not an algorithm. Its performance is inherent to its output and delivery, not an autonomous algorithmic decision.

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

The document does not describe a clinical study that would require a ground truth of these types. The "ground truth" implicitly used for the performance claims appears to be adherence to engineering specifications and regulatory standards, and the ability to emit laser energy suitable for the stated indications, as verified by internal testing and compliance with external standards.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as this is a physical device, not a machine learning model.

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

This information is not applicable/not provided, as there is no "training set."

Summary of the "Study" (as described in the document):

The document primarily describes a technical compliance and substantial equivalence study.

Objective: To demonstrate that the Pilot Diode Laser is substantially equivalent to legally marketed predicate devices without raising new issues of safety or effectiveness.
Methodology:
- Comparison to Predicate Devices: Analysis of design features, wavelength, control systems, safety features, performance monitoring, power output, applications, and indications for use against three predicate devices (Velure Family of Diode Lasers, DenLaser 800 Plus, THOR VR Single Diode Laser Treatment Probe).
- Compliance Testing: The device was tested for conformity to various international and federal standards:
  - 21 CFR 1040.10 and 1040.11 (with permissible deviations per Laser Notice 50)
  - IEC 60601-1
  - IEC 60601-1-2
  - IEC 60601-2-22
  - IEC 60825-1
  - UL60601-1
  - 47 CFR 15 and 18
  - ETSI 301-489-1
- Internal Performance Testing: "The device was tested and passed CAO Group internal requirements for construction and performance."
"Acceptance Criteria" (Implicit):
- Meet or be comparable to the technical specifications and safety features of predicate devices.
- Comply with all listed regulatory and performance standards.
- Demonstrate the ability to deliver laser energy necessary for the specified indications for use.
"Results": The device was "tested as compliant" with the listed standards and "found to deliver laser energy necessary for the temporary relief of minor muscle and joint pain, etc. as described in the device's Indications for Use." The conclusion was that the device is "substantially equivalent" to the predicate devices.

Summary

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K 100143

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 AUG 1 3 2010

く

Robert Larsen, Preparation Date: July 16, 2010

Device Name:

"ﺑ "

Trade Name:	Pilot Diode Laser
Common Name:	810nm Diode Laser
Product Classification:	Powered Laser Surgical Instrument

Legally Marketed Predicate Devices for Substantial Equivalence:

Velure Family of Diode Lasers, manufactured by Lasering S.R.L. (K063396)

DenLaser 800 Plus, manufactured by CAO Group, Inc. (K062619)

THOR VR Single Diode Laser Treatment Probe, manufactured by Thor International (K070024)

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, similal indications for use on son took too will are therapy for soft tissue relaxation and temporary relief of pain. The predicate devices and submitted device share similar allo telliporary rener of pain. The prounded and laser delivery method. The design leatures including warelengan, of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output montoning. The devices share similar applications to soft tissue and indications for use.

Description of Submitted Device:

The Pilot Diode Laser is a device for delivering laser energy to human soft tissue The Pliot Drocedures and treatments. This energy is generated by solidfor a variety of surgical procedures and treaments. The councy of laser energy at 810 ±

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20nm for a maximum of 9 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 a 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 Pilot Diode Laser system:

The Pilot Diode Laser is indicated for the procedures of

1. Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery.
  And
1. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

Technological Characteristics and Substantial Equivalence:

The Velure Family of Diode Lasers 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 635nm aiming beam and features oners's that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emission with pulse emissions adjustable from 0.1 - 20 Hz. The maximum output of the working beam is 15 watts.

The DenLaser 800 Plus 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 Surgical site: The system and Isation beam, and switching between a continuous anow for adjusting the carpar of the device features a wireless foot switch for actuating of pursed mode not The maximum output of the working beam is 5 watts.

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The THOR VR Single Diode Laser Treatment Probe uses solid state diodes to generate laser energy in the 810nm range. This system employs direct emissions from a handpiece containing the laser diode to transmit laser energy to the surgical site. The system features controls that allow for adjusting the pulse rate of the beam from 2.5 -20,000 Hz. The maximum output of the unit is 0.45 watts.

Conformity to Standards:

The Pilot 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 the entirety of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, UL60601-1, 47 CFR 15 and 18, and ETSI 301-489-1.

Performance Data

The Pilot Diode Laser tested as compliant with 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated July 26, 2001 and constructional requirements of IEC 60601-1. This device was tested and found to deliver laser energy necessary for the temporary relief of minor muscle and joint pain, etc. as described in the device's Indications for Use. The device was tested and passed CAO Group internal requirements for construction and performance.

Conclusion

The Pilot Diode Laser 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the right.

Public Health Service

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

CAO Group, Inc. % Mr. Robert K. Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, Utah 84084

AUG 1 3 2010

Re: K100143

Trade/Device Name: Pilot 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, ILY Dated: August 09, 2010

Received: August 13, 2010

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. 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. Robert K. Larsen

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,

Mark M. Millhusan

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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K100143

Indications for Use

AS 1 8 2010

510(k) Number (if known):

Device Name: Pilot Diode Laser

Indications For Use:

The Pilot Diode Laser is indicated for the procedures of

1. Removal of Iesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery.
  And
1. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.
  x Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ryden formxm

(Division of Surgical, Orthopedic, and Restorative Devices

Page I of of 1 -

510(k) Number K100143

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.