(160 days)
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No
The summary describes a bipolar sheath for coagulation during ENT surgery, a purely mechanical and electrical device. There is no mention of any computational or data-driven components that would suggest AI/ML.
Yes
The device is intended to coagulate tissue, which is a therapeutic action.
No
Explanation: The device is intended for coagulation of tissue during Ear Nose and Throat surgery, which is a therapeutic function, not a diagnostic one. It provides a means to perform a surgical procedure rather than to identify a medical condition.
No
The device description explicitly mentions a "sheath" and its physical interface with electrosurgical generators, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for coagulation of tissue at the distal end of a debrider tip during Ear Nose and Throat Surgery. This is a surgical procedure performed directly on a patient's body.
- Device Description: The description reinforces its use in surgery with debrider systems and electrosurgical generators.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The SLT bipolar sheath is indicated for use with currently marketed debrider systems used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators. The SLT Bipolar Sheath is indicated for use with currently marketed debrider system tips used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. The sheath which incorporates the bipolar electrodes is designed with a standard interface to allow use with any electrosurgical system which meets the following requirements: Generator must operate in a Bipolar mode Generator must accept a standard banana plug connector and will fit on any debrider tips which meet the following requirements: Debrider tip must be either 3.5mm or 4.0mm in diameter This device is a prescription device.
Product codes
77 ERL, 79 GEI
Device Description
The SLT bipolar sheath is indicated for use with currently marketed debrider systems used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear, Nose, and Throat
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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
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§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The SLT bipolar sheath is indicated for use with currently marketed debrider systems used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider 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. Therefore, 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.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of a human figure with three lines representing the head, body, and legs. The figure is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1998
Monica Ferrante
Regulatory Affairs
147 Keystone Drive
Surgical Laser Technologies
Montgomervville, PA 18936-9638
Re:
K981041 SLT Bipolar Sheath Dated: July 9, 1998 Received: July 13, 1998 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL 21 CFR 878.4400/Procode: 79 GEI
Dear Ms. Ferrante:
We have reviewed your Section 510(k) notification of intent to market the covice 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 reslassified 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 i submission does not affect any obligation you might have under sections 542 of the Act for 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
The SLT Bipolar Sheath is indicated for use with currently marketed debrider system tips used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. The sheath which incorporates the bipolar electrodes is designed with a standard interface to allow use with any electrosurgical system which meets the following requirements:
Generator must operate in a Bipolar mode Generator must accept a standard banana plug connector
and will fit on any debrider tips which meet the following requirements:
Debrider tip must be either 3.5mm or 4.0mm in diameter
This device is a prescription device.
Daniel C. Heffern
(Division Sign-Off) Division of General and Restorative Devices
510(k) Number K981041
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)