Fox Q-810: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology.

Fox Q-980: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Fox Q-1064: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Device Description

Fox Q-810, Q-980 and Q-1064 are standard diode medical lasers with 810, 980nm and 1064nm wavelength, respectively

AI/ML Overview

The provided text is related to a 510(k) summary for the Fox Q-810, Q-980, and Q-1064 Lasers. It outlines regulatory compliance and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, device performance from a study, sample sizes, expert involvement, or specific ground truth methods as would be found in a clinical or performance study report for an AI/ML medical device.

The document is a regulatory submission for a traditional medical device (diode laser) and focuses on demonstrating substantial equivalence to previously cleared devices and compliance with established performance standards (e.g., 21CFR 1040.10, IEC 60601-1). It deals with the inherent physical safety and performance of the laser itself, not an AI algorithm.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: The device complies with "performance requirements of 21CFR 1040.10 and 1040.11, with permissible deviations defined in Laser Notice 50, dated July 26, 2001." It also complies with "IEC 60601-1:1998 including amendment 1, IEC 60601-2-22:1995, and IEC 60825-1:1993 including amendments 1 and 2." These are general safety and performance standards for lasers and medical electrical equipment, not specific criteria for an AI/ML algorithm's diagnostic or predictive performance.
Reported Device Performance: The document states the device "generates energy in the 980 nm range" (and 810 nm, 1064 nm for other models) and "Fibers deliver energy to the tissue." It doesn't report specific performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcome statistics) that would necessitate an acceptance criterion table as requested for an AI/ML study. The "performance" here refers to meeting safety and output specifications according to the listed standards.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a study involving a test set of data for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving a test set of data for an AI/ML algorithm or ground truth established by experts in that context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 laser surgical instrument, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical laser, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its physical specifications and safety compliance, not medical diagnostic outcomes.

8. The sample size for the training set: Not applicable. This device is a physical laser, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

Criteria / Aspect	Description from Document
Acceptance Criteria	Regulatory and Performance Standards Compliance: - 21CFR 1040.10 and 1040.11 (with deviations from Laser Notice 50, dated July 26, 2001) - IEC 60601-1:1998 (including amendment 1) - IEC 60601-2-22:1995 - IEC 60825-1:1993 (including amendments 1 and 2)
Reported Device Performance	The device "uses diodes to generate energy in the [specified] nm range" (e.g., 980 nm, 810 nm, 1064 nm) and "Fibers deliver energy to the tissue." The performance is implied by its adherence to the above-listed standards, ensuring its safety and intended function as a medical laser. No specific quantitative performance metrics (e.g., accuracy, reliability in a clinical setting) are provided as would be for an AI/ML device.
Study Type to Prove Acceptance	The document indicates a substantial equivalence (510(k)) review process, not a specific performance study in the context of AI/ML. The conclusion explicitly states: "The Fox 810, 980 and 1064 Lasers are substantially equivalent to the predicate devices. They have similar intended uses and comply with the same safety and performance standards." This implies that compliance with safety and performance standards was demonstrated through testing against those standards and comparison to predicate devices, rather than a clinical study evaluating diagnostic or predictive performance.
Sample size (test set)	Not applicable. (No AI/ML test set)
Data provenance (test set)	Not applicable. (No AI/ML test set)
Number of experts for ground truth	Not applicable. (No AI/ML ground truth)
Adjudication method	Not applicable. (No AI/ML test set)
MRMC comparative effectiveness study	No.
Standalone performance study	Not applicable. (No AI/ML algorithm)
Type of ground truth used	For a laser, "ground truth" relates to its physical specifications, power output, wavelength accuracy, and safety features meeting established engineering and regulatory standards. Not expert consensus on medical images or patient outcomes in the context of performance study.
Sample size (training set)	Not applicable. (No AI/ML training set)
How ground truth for training set was established	Not applicable. (No AI/ML training set)

Summary

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K073322

510(k) SUMMARY – Fox Q-810, Q-980 and Q-1064 Laser

Applicant Name:	A.R.C. Laser GmbHBessemerstr. 14, D-90411 Nurnberg, Germany
Contact Person:	Reinhardt Thyzel, President
Date Prepared:	February 8, 2008
Device Trade Name:	Fox Q-810, Q-980 and Q-1064 Lasers
Device Common Name:	Diode Laser
Classification Name:	Laser Surgical Instrument
Predicate Devices:	Fox Q-810 (K062619), Ceralas 980 (K072106) andLaserscope 1064 (K990903)
Device Description:	Fox Q-810, Q-980 and Q-1064 are standard diodemedical lasers with 810, 980nm and 1064nmwavelength, respectively
Intended Use:	Fox Q-810:indicated for surgical applications requiring the ablation,vaporization, excision, incision, hemostasis, orcoagulation of soft tissues in medical specialtiesincluding dermatology, dentistry, gastroenterology,general surgery, neurosurgery, otolaryngology,ophthalmology, and pulmonology.
	Fox Q-980:indicated for surgical applications requiring the ablation,vaporization, excision, incision, hemostasis, orcoagulation of soft tissues in medical specialtiesincluding dermatology, dentistry, gastroenterology,general surgery, genitourinary, gynecology,neurosurgery, otolaryngology, orthopedics,
Device TechnologicalCharacteristics andComparison to PredicateDevice(s):	The Fox Q-980 uses diodes to generate energy in the980 nm range. (Commercially available) Fibers deliverenergy to the tissue. The Fox Q-1064 Laser is the samesystem, but generates energy in the 1064 nm range.The new Fox Q-810 is also the same, producing energyin the 810 nm range.
	Predicates: The Fox Q-810 Laser (cleared underK062619) is the same system, but generates energy inthe 810 nm range (at a lower output than the new 810nm device). The Ceralas 980 is also a diode laserproducing energy in the 980 nm range, and theLaserscope system produces energy in the 1064 nmrange.
Performance Standards:	The Fox Q-810, Q-980 and Q-1064 Lasers comply withthe performance requirements of 21CFR 1040.10 and1040.11, with permissible deviations defined in LaserNotice 50, dated July 26, 2001. The diode lasers alsocomply with IEC 60601-1:1998 including amendment 1,IEC 60601-2-22:1995, and IEC 60825-1:1993 includingamendments 1 and 2.
Conclusion:	The Fox 810, 980 and 1064 Lasers are substantiallyequivalent to the predicate devices. They have similarintended uses and comply with the same safety andperformance standards.

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ophthalmology, pulmonology, and thoracic surgery.

Fox Q-1064:

indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.

FEB 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A.R.C. Laser GmbH % PPD Medical Device Ms. Kirsten H. Paulson 3202 Tower Oaks Blvd. Rockville, MD 20852

Re: K073322 Trade/Device Name: Fox 1-980, Fox Q-1064, Fox Q-810 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: November 21, 2007 Received: November 26, 2007

Dear Ms. Paulson:

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 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 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.

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Page 2 - Ms. Kirsten H. Paulson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark N Millican

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): ____________________________________________________________________________________________________________________________________________________ K073322

Device Name: Fox Q-810, Q-980 and Q-1064 Diode Laser Indications for Use:

Image /page/4/Picture/3 description: The image shows a document with a signature and some text. The signature appears to read "Mark A Miller". Below the signature, the text indicates that this is a "Division Sign-Off" for the "Division of General, Restorative, and Neurological Devices". The 510(k) Number is listed as K073322.

Fox Q-810:

indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology , general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology .

Fox Q-980:

indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Fox Q-1064:

Prescription Use X	AND/OR	Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.