(123 days)
The SLT bipolar sheath is indicated for use with currently marketed cutter systems used in Orthopedic Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.
The SLT HemoSleeve Bipolar Sheath is indicated for use in general surgery procedures to provide coagulation at the distal end of a tissue debrider tip.
The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.
The provided text is a 510(k) summary for the SLT HemoSleeve Bipolar Sheath, which is a medical device. It does not contain information about acceptance criteria, device performance metrics, detailed study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document primarily focuses on:
- Indications for Use
- A general description of the device
- A statement of substantial equivalence to predicate devices based on intended use and technological features, supported by "performance data from device validation" (though the data itself is not presented).
- A formal FDA letter confirming substantial equivalence and market clearance.
Therefore, I cannot provide the requested information from the given text.
The document explicitly states:
"Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used."
This indicates that performance data and validation were conducted, but the details of those studies are not included in this summary. This type of summary typically omits the detailed study results and focuses on the regulatory conclusion.
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3/15/99
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The SLT bipolar sheath is indicated for use with currently marketed cutter systems used in Orthopedic Surgery. The SLT bipolar sheath is intended to
provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.
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 bipolar electrocautery devices marketed to provide the same tissue effects. TTherefore, all aspect of this device have predicates which are well accepted in the clinical community. This product simply provides an alternative to those currently marketed devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Ms. Monica Ferrante Regulatory Affairs Surgical Laser Technologies 147 Keystone Drive Montgomeryville, Pennsylvania 18936
Re: K984018 Trade Name: SLT HemoSleeve Bipolar Sheath Regulatory Class: II Product Code: GEI Dated: January 29, 1999 Received: February 1, 1999
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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Monica 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 (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
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INDICATIONS FOR USE
The SLT HemoSleeve Bipolar Sheath is indicated for use in general surgery procedures to provide coagulation at the distal end of a tissue debrider tip.
This device is a prescription device.
Prescription Use
(Per 21 CFR 801.109)
Acoolefa
(Division Sign-Off) Division of General and Restorative Devices
510(k) Number __ K984018
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.