(55 days)
General
SureFlex™ and AccuFlex™ are intended for use in laser-based surgical applications, including but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, abaltion, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
While designed primarily for holmium (Ho:YAG) lasers, SureFlex™ and AccuFlex™ fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.
Not Found
This document is a 510(k) premarket notification FDA clearance letter for a medical device (SureFlex™ and AccuFlex™ Laser Lithotripsy Fibers). It does not contain the acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states that the FDA has reviewed the premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means the device's safety and effectiveness are considered comparable to devices already on the market, rather than requiring a new, independent study to demonstrate specific performance criteria.
Therefore, I cannot provide the requested information from the provided text as it is not present in this type of FDA document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Steve Griffin, Ph.D. Vice President Technology InnovaQuartz, Inc. 23030 North 15th Avenue Phoenix, Arizona 85027
Re: K050108
K030108
Trade/Device Name: SureFlex™ and AccuFlex™ Laser Lithotripsy Fibers 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: December 30, 2004 Received: January 18, 2005
Dear Dr. Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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 for use stated in the encrosale) (o regary to regard) ( the Medical Device Amendments, or to continered provision to may 20, 1978, the encordance with the provisions of the Federal Food, Drug. de rices that have been require approval of a premarket approval application (PMA). and Cosmette Act (110) market the device, subject to the general controls provisions of the Act. The r ou may, dierelove, mains of the Act include requirements for annual registration. Ilisting of general controls provisions or ractice, 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 If your device is elasonica (soo as courols. Existing major regulations affecting your device can may oe subject to subject to submitted and egulations, 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 that I Drivial statutes and regulations administered by other Federal agencies. You must or any I edelul station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It far 007); accems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Steve Griffin, Ph.D.
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 11 you debile of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
R. Mark H. Milliman
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050108
Device Name: SureFlex And AccuFlex Laser Lithotripsy Fiber
Indications for Use:
General
SureFlex™ and AccuFlex™ are intended for use in laser-based surgical applications, including but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, abaltion, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
While designed primarily for holmium (Ho:YAG) lasers, SureFlex™ and AccuFlex™ fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.
Specific, by Surgical Specialty (most common use first), Next Page
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
b. Mark A. Millkeess
al Restornerve and Neurological Devi
Page 1 of 2
510(k) Number K050198
§ 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.