SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS

K980156 · Surgical Laser Technologies, Inc. · GEX · Feb 27, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980156
• Device Name: SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
• Applicant: Surgical Laser Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector.

Device Story

Fiber delivery system and contact tips designed for surgical laser applications; transmits laser energy to target tissue. Input: laser energy (532-1064 nm) from external laser source. Transformation: fiber optic delivery of energy to contact tip for precise tissue incision, excision, vaporization, and coagulation. Output: focused laser energy at surgical site. Used in OR/clinical settings by surgeons. Device connects to existing laser systems via universal SMA-905 connector. Benefits: enables versatile use of SLT fiber systems across multiple laser platforms; provides precise tissue effects for various surgical specialties.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Fiber delivery system with contact tips; utilizes universal SMA-905 connector for laser coupling. Compatible with 532-1064 nm wavelength lasers, CW or Quasi-CW modes, and numerical apertures ≤ 0.39. Mechanical delivery of laser energy.

Indications for Use

Indicated for use in general surgery, urology, gynecology, ENT, head and neck, gastroenterology, neurosurgery, thoracic surgery, pulmonology, plastic surgery, and orthopedics for incision, excision, vaporization, and coagulation of tissue. Compatible with laser systems operating at 532-1064 nm in CW or Quasi-CW mode with numerical aperture ≤ 0.39 and SMA-905 connector. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## FEB 2 7 1998

The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector.

Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used. The comparison of intended use and technological features of this device to other legally marketed devices taken together with validation results indicate that this device is substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use.

The intended use of this device is the same as the intended use of other laser fiber delivery systems and identical to the proprietary SLT Products currently marketed to provide the same tissue effects. Therefore, all aspect of this device have predicates which are well accepted in the clinical community. This product simply provides the ability to use the SLT fiber delivery systems with any 532 to 1064 nm wavelength laser system which accepts the SMA-905 connector.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 1998

Ms. Monica Ferrante Regulatory Affairs Surgical Laser Technologies 147 Kevstone Drive Montgomeryville, Pennsylvania 18936-9638

Re : K980156 Trade Name: SLT Select Fiber Delivery System and Contact Tips Requlatory Class: II Product Code: GEX Dated: January 1998 Received: January 16, 1998

Dear Ms. Ferrante:

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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 requlatory In addition, FDA may publish further announcements action. 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. Ferrante

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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K980156

## INDICATIONS FOR USE

The SLT Select Fiber Delivery Systems and Contact Tips are indicated for use in General Surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic Surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems and tips to be used with any laser system meeting the following requirements:

Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-905 connector.

Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached.

This device is a prescription device.

Signature

(Division Sian-Off) Division of General and Restorative Devices

510(k) Number __ K980156

**Prescription Use**
(Per 21 CFR 801.109)