(21 days)
The ScatterFree™ Lateral Emitting Fiber is intended for use in General, Urological, OB-GYN, Orthopedic and ENT laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.
ScatterFree™ Lateral Emitting Fiber
The provided text is a 510(k) clearance letter from the FDA for the ScatterFree™ Lateral Emitting Fiber. It describes the device's intended use and states that it has been found substantially equivalent to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about ground truth, sample sizes, or expert adjudication.
Therefore, I cannot provide the requested information from the given input. The document is administrative in nature, confirming regulatory clearance, rather than a scientific study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, with a smaller curved line representing the head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1.2 1999
Ms. Nancy L. Arnold President Laser Peripherals, Inc. 5484 Feltl Road Minnetonka, Minnesota 55343
Re: K992083
Trade Name: ScatterFree™ Lateral Emitting Fiber Regulatory Class: II Product Code: GEX Dated: June 18, 1999 Received: June 21, 1999
Dear Ms. Arnold:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Nancy L. Arnold
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia B. Fisher, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT B
Indications for Use Statement
992083
510(k) Number
ScatterFree™ Lateral Emitting Fiber Device Name
The ScatterFree™ Lateral Emitting Fiber is intended for use in Indications General, Urological, OB-GYN, Orthopedic and ENT laser surgical For Use procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K992083 |
|---|---|
| --------------- | --------- |
§ 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.