(121 days)
The Fox Q-980 Diode Laser is 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, thoracic surgery and laser assisted lipolysis.
Fox Q-980 is a standard diode medical laser with 980nm wavelength and quartz fibers
This document describes a 510(k) submission for the Fox Q-980 Laser. The submission is primarily focused on demonstrating substantial equivalence to predicate devices, particularly for the added indication of laser-assisted lipolysis.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific performance acceptance criteria or reported device performance metrics in the format of a clinical study or performance data table. The submission relies solely on demonstrating compliance with recognized standards and equivalence to predicate devices, rather than establishing de novo performance targets.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical study with a test set.
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 clinical study with ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a clinical study with an adjudication method.
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 or therapeutic tool that would involve human readers or AI assistance in a diagnostic capacity.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a clinical study requiring ground truth. The primary ground for approval is substantial equivalence to legally marketed predicate devices and compliance with recognized performance standards. In this context, the "ground truth" for the device's safety and effectiveness is implicitly established by the predicate devices and their successful market history, as well as adherence to safety standards.
8. The sample size for the training set
Not applicable. The document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a machine learning algorithm or a training set.
Summary of the 510(k) Submission for Fox Q-980 Laser:
This 510(k) submission for the Fox Q-980 Laser is a declaration of substantial equivalence to previously cleared devices (K073322 and K082721). The key arguments for equivalence are:
- Identical Core Device: The Fox Q-980 is stated to be the "same 980 nm laser cleared under K073322."
- Added Indication Equivalence: The added indication for laser-assisted lipolysis is justified by the fact that the predicate device LaserPro980 (K082721) also has this indication.
- Technological Characteristics: The device utilizes a 980nm diode laser and quartz fibers, similar to the predicate devices.
- Compliance with Standards: The device complies with relevant electrical and laser safety standards (21CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, IEC 60825-1) and sterilization standards (ISO 11135-1 and 2).
The 510(k) process for devices like this typically relies heavily on demonstrating that the new device does not raise new questions of safety or efficacy compared to legally marketed predicate devices, rather than presenting new clinical study data with specific acceptance criteria.
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K09/03-9
510(k) SUMMARY - Fox Q-980 Laser
Applicant Name:
A.R.C. Laser GmbH
Fox Q-980 (K073322), LaserPro980 (K082721),
vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology,
general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics,
Fox Q-980 is a standard diode medical laser with 980nm
Indicated for surgical applications requiring the ablation,
ophthalmology, pulmonology, thoracic surgery and laser
Bessemerstr. 14, D-90411 Nurnberg, Germany
Angela Thyzel, General Manager Contact Person:
July 30, 2009 Date Prepared:
Fox Q-980 Laser Device Trade Name:
AUG 1 3 2009
Device Common Name: Classification Name:
Diode Laser Laser Surgical Instrument
wavelength and quartz fibers
assisted lipolvsis.
Predicate Devices:
Device Description:
Intended Use:
Device Technological Characteristics and Comparison to Predicate Device(s):
Performance Standards:
The Fox Q-980 uses diodes to generate energy in the 980 nm range. It is the same 980 laser cleared under K073322 with the added indication for liploysis. Another commercially available diode laser also indicated for laser assisted lipolysis is the LaserPro 980, cleared under K082721. Fibers deliver energy to the tissue for both laser models.
The Fox Q-980 Laser complies with the performance requirements of 21CFR 1040.10 and 1040.11. with permissible deviations defined in Laser Notice 50, dated July 26, 2001. The diode lasers also comply with IEC 60601-1:1998 including amendment 1, IEC 60601-2-22:1995, and IEC 60825-1:1993 including amendments 1 and 2. Sterilization of the fibers is in compliance with ISO 11135-1 and 2.
Conclusion: The Fox Q- 980 Laser is substantially equivalent to the predicate devices. It is the same 980 nm laser cleared under K073322 and is also indicated for laser assisted lipolysis as is the LaserPro device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
A.R.C. Laser GmbH % PPD Medical Device Ms. Kirsten H. Paulson Manager, Regulatory Affairs 3202 Tower Oaks Boulevard, Suite 300 Rockville, Maryland 20852
AUG 1 8 2009
Re: K091059
Trade/Device Name: Fox Q-980 nm 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: August 4, 2009 Received: August 5, 2009
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 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); medical device reporting (reporting of medical
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Page 2 - Ms. Kirsten H. Paulson
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Millerson
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
510(k) Number (if known): ِ
Device Name: Fox Q-980 nm Diode Laser
Indications for Use:
The Fox Q-980 Diode Laser is 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, thoracic surgery and laser assisted lipolysis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE RELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Divisione Siggenoel of CDRH, Office of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091059
§ 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.