(90 days)
Not Found
Not Found
No
The summary describes a physical adapter system for connecting laser fibers to lasers and contains no mention of software, algorithms, or AI/ML terms.
No
The device is an adapter system designed to connect laser fibers to lasers; it does not directly treat a medical condition or disease.
No
The device is an adapter system designed to connect laser fibers to lasers. Its purpose is to facilitate the use of different laser peripherals, not to diagnose medical conditions.
No
The device description is not found, but the intended use clearly describes a "FiberChoice™ Adapter System" which is a physical adapter for connecting laser fibers. This indicates a hardware component.
Based on the provided information, the LS-905 FiberChoice™ Adapter System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an adapter system for connecting laser fibers to lasers for surgical procedures. This involves direct interaction with the patient during a medical procedure, not the examination of specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The LS-905 FiberChoice™ Adapter System is a medical device used in surgical settings to facilitate the connection of different laser components.
N/A
Intended Use / Indications for Use
The LS-905 FiberChoice™ Adapter System is indicated for use for non-standard laser output ports for lasers manufactured by Laserscope. The LS-905 FiberChoice™ Adapter System is designed to allow owners of Laserscope lasers to connect Laser Peripherals, Inc. 510(k) cleared laser fibers to their lasers. The adapter may be used in each surgical specialty or procedure along with Laser Peripherals laser fibers for which compatible Laserscope lasers have received regulatory clearance.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1998
Ms. Nancy L. Arnold President Laser Peripherals, Incorporated 5484 Feltl Road Minnetonka, Minnesota 55343
Re: K974229 Trade Name: LS-905 FiberChoice Adapter System Regulatory Class: II Product Code: GEX Dated: November 7, 1997 Received: November 12, 1997
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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
1
Page 2 - Ms. Arnold
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
The LS-905 FiberChoice™ Adapter System is indicated for use for non-standard laser output ports for lasers manufactured by Laserscope. The LS-905 FiberChoice™ Adapter System is designed to allow owners of Laserscope lasers to connect Laser Peripherals, Inc. 510(k) cleared laser fibers to their lasers. The adapter may be used in each surgical specialty or procedure along with Laser Peripherals laser fibers for which compatible Laserscope lasers have received regulatory clearance.
Prescription Use
(Per 21 CFR 801.109)
Accevedo