← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K012488 # MODIFICATION TO:ENDIUS BIPOLAR SHEATH (K012488) _Endius, Inc. · GEI · Aug 30, 2001 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K012488 ## Device Facts - **Applicant:** Endius, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Aug 30, 2001 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Endius Bipolar Sheath is intended to be used in conjunction with the Endius XPS Microdebrider System to coagulate soft tissue during various spinal surgical procedures. ## Device Story Endius Bipolar Sheath is a stainless steel tube with insulation coating; fits over automated tissue removal blade. Device connects to Valley Lab Force 2, FX, or EZ electrosurgical generators via Bipolar Sheath Adapter. Adapter reduces generator voltage from 800V to 100V to ensure appropriate energy delivery. Used in spinal surgery by surgeons to coagulate soft tissue. Device provides bipolar electrosurgical coagulation capability during procedures involving the Endius XPS Microdebrider System. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Stainless steel tube with FEP coating, plastics, and adhesives. Bipolar electrosurgical coagulation principle. Dimensions: 3.5-4.5mm diameter, 6-12cm length. Sterilized by gamma irradiation. Single-use. Connects to external electrosurgical generators via adapter. ## Regulatory 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. ## Predicate Devices - SLT Bipolar Sheath ([K981041](/device/K981041.md), [K984018](/device/K984018.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Ko12488 ### AUG 3 0 2001 ## Section 7- 510(k) Summary of Safety and Effectiveness | 7.1
Statement | This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the requirements of SMDA 1990 and CFR 807.92 | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 7.2
Submitter | Endius, Inc.
23 West Bacon Street
Plainville, MA. 02762 | | 7.3
Company
Contact | Susan Finneran
Director Regulatory Affairs
508-643-0983 | | 7.4
Device Name | Proprietary Name: Endius Bipolar Sheath
Common Name: Bipolar Coagulation Device
Classification Name: Electrosurgical cutting and coagulation device and
accessories | | 7.5
Predicate
Legally
Marketed
Devices | The Bipolar Sheath is substantially equivalent to the SLT Bipolar Sheath
manufactured by Surgical Laser Technologies (Montgomery, PA) | | 7.6
Device
Description | The Endius Bipolar Sheath is a stainless Steel tube covered with an insulation
material that is intended to fit over an automated tissue removal blade. The
device is intended to be connected to the Valley Lab's Force 2, FX, or EZ,
generator by using the Bipolar Sheath Adapter that is intended to decrease the | | 7.7 | | | Device
Indications and
Intended use | The Endius Bipolar Sheath is intended to be used in conjunction with the
Endius XPS Microdebrider System to coagulate soft tissue during various
spinal surgical procedures. | ಸ್ maximum voltage of the Valley Lab's Generator from 800 volts to 100 volts. This will ensure that the appropriate level of energy is transmitted to the Bipolar Sheath for the maximum performance. 6: () {1}------------------------------------------------ K012488 #### 7.8 Substantial Equivalence The Endius Bipolar Sheath is substantially equivalent to the SLT Bipolar Sheath manufactured by Surgical Laser Technologies (Montgomery, PA) | Table of Substantial Equivalence | | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Device Name | SLT Bipolar Sheath | Endius Bipolar Sheath and MDS Device | | Intended use | K981041: The SLT Bipolar Sheath is intended to be used to coagulate soft tissue during ENT procedures.
K984018: The SLT Bipolar Sheath is intended to be used to coagulate soft tissue during orthopedic procedures. | The Endius Bipolar Sheath is intended to be used coagulate soft tissue during various spinal surgical procedures. | | Materials | Stainless Steel/ polyethylene | Stainless Steel, FEP coating, plastics, adhesives | | Sterilization/ Labeling | Single Use, sterilized by 100% Ethylene Oxide | Single use, Sterilized by gamma irradiation | | Sizes | 3mm - 5mm | 3.5-4.5mm | | Exposed Tip Size | 1.5 mm electrode | 3.5-4.5mm | | Length | 8.1 cm | 6-12 cm | | Operating Mode | To be used with ESU Generator in Bipolar Mode | To be used with ESU Generator in Bipolar Mode | Applicant Date 8/1/01 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 3 0 2001 Ms. Susan Finneran Director Regulatory Affairs, Clinical Sciences Endius, Inc. 23 West Bacon Street Plainville, Massachusetts 02762 Re: K012488 Trade/Device Name: Endius Bipolar Sheath and Accessories Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: August 2, 2001 Received: August 3, 2001 Dear Ms. Finneran: 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 legally marketed predicate 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 (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 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. {3}------------------------------------------------ #### Page 2 - Ms. Susan Finneran This letter will allow you to begin marketing your device as described in your 510(k) premarket I nils lotter will and w you of substantial equivalence of your device to a legally marketed nouthoution. The I Dr 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 11 you desire specific and vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 dditionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on Jour respons and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html". Sincerely yours, Susan Leacock, M.D. FOR Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 510(k) Number (if known): Device Name: Endius Bipolar Sheath and Accessories Indications for Use: The Endius Bipolar Sheath is intended to be used to coagulate soft tissue during various spinal surgical procedures. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) (Posted July 1, 1998) Susan Weberon (Division Sign-Off) (Division Signi-On) Division of General, Restorative Division of General, Devices Division of General, and Neurological Devices 510(k) Number Ko 12 488 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K012488](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K012488) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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