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 generator by using the Bipolar Sheath Adapter which is intended to decrease the 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.

AI/ML Overview

This document is a 510(k) summary for the Endius Bipolar Sheath, a Bipolar Coagulation Device. The submission focuses on establishing substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria and results as might be found for a novel device.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available in the provided text. The submission primarily addresses the device's technical characteristics and intended use in comparison to a legally marketed predicate.

Here's the information that can be extracted or inferred from the provided text, along with an explanation of why other requested details are not present:

Acceptance Criteria and Reported Device Performance

This 510(k) submission establishes substantial equivalence to a predicate device rather than setting and meeting specific performance acceptance criteria for a novel device. As such, a table of acceptance criteria and reported device performance in the manner of a clinical study is not applicable and not provided in the given text.

The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. The performance is "accepted" if it is shown to be as safe and effective as the predicate.

Study Details (Not Applicable/Not Provided)

The provided text describes a 510(k) submission which focuses on demonstrating substantial equivalence to a predicate device (Everest Bipolar Probes/Forceps, K945975). This type of submission typically relies on comparing technical characteristics and intended use rather than conducting extensive new clinical studies with defined acceptance criteria for the new device's performance. Therefore, the detailed study information requested below is not available within this 510(k) summary.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. This information would typically come from a specific performance study, which is not detailed here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided. Ground truth establishment and expert review are typically part of a performance study, which is not described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool; it's an electrosurgical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided as a specific performance study is not detailed. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device.
The sample size for the training set: Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable/Not provided.

Summary of what is provided:

Acceptance Criteria: The implicit acceptance criterion for this 510(k) is demonstrating "substantial equivalence" to the Everest Bipolar Probes/Forceps (K945975) in terms of intended use, materials, sterilization, and general performance characteristics.
Reported Device Performance: Instead of performance data from a specific study, the submission asserts substantial equivalence by comparing the device's features to the predicate.
- Intended Use: Both the Endius Bipolar Sheath and the Everest Bipolar Forceps are intended to cut and coagulate soft tissue electrosurgically. The Endius device specifies use "in conjunction with the Endius XPS Microdebrider System... during various spinal surgical procedures."
- Materials: Both use Stainless Steel and plastics. The Endius device also lists a Parylene coating, while the predicate lists adhesives and ceramics.
- Sterilization/Labeling: Both are single-use. The predicate uses Ethylene Oxide for sterilization, while the Endius device uses gamma irradiation.
- Sizes: The predicate comes in 3mm and 5mm; the Endius device is 4.5mm.
Safety Feature: The Endius Bipolar Sheath requires an adapter (Bipolar Sheath Adapter) to decrease the maximum voltage of the Valley Lab's Generator from 800 volts to 100 volts, "to ensure that the appropriate level of energy is transmitted to the Bipolar Sheath for the maximum performance." This is a design feature to ensure safe and effective operation within expected parameters.

Summary

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K003897

MAR 2 2 2001

Section 7- 510(k) Summary of Safety and Effectiveness

7.1Statement	This summary of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and CFR 807.92
7.2Submitter	Endius, Inc.23 West Bacon StreetPlainville, MA. 02762
7.3CompanyContact	Susan FinneranDirector Regulatory Affairs508-643-0983
7.4Device Name	Proprietary Name: Endius Bipolar SheathCommon Name: Bipolar Coagulation DeviceClassification Name: Electrosurgical cutting and coagulation device andaccessories
7.5PredicateLegallyMarketedDevices	The Bipolar Sheath is substantially equivalent to the Everest Bipolar Probes,Everest Medical (Minneapolis, MN).
7.6DeviceDescription	The Endius Bipolar Sheath is a stainless Steel tube covered with an insulationmaterial that is intended to fit over an automated tissue removal blade. Thedevice is intended to be connected to the Valley Lab's Force 2 generator byusing the Bipolar Sheath Adapter which is intended to decrease the maximumvoltage of the Valley Lab's Generator from 800 volts to 100 volts. This willensure that the appropriate level of energy is transmitted to the Bipolar Sheathfor the maximum performance.
7.8	The Endius Bipolar Sheath is substantially equivalent to the Everest Bipolar
Substantial	Forceps
Equivalence

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K003847

7.7 The Endius Bipolar Sheath is intended to be used in conjunction with the Device The Endius Diponal Biload Risan Rostem to cut and coagulate soft tissue during Indications and Intended use various spinal surgical procedures.

Table of Substantial Equivalence
Device Name	Everest Bipolar Forcep	Endius Bipolar Sheath and MDSDevice
510k #	K945975	The subject of this submission
Intended use	The Everest Bipolar Forcepsare intended to be used to cutand coagulate soft tissueelectrosurgically.	The Endius Bipolar Sheath isintended to be used in conjunctionwith the Endius XPSMicrodebrider System to cut andcoagulate soft tissue duringvarious spinal surgical procedures.
Materials	Stainless Steel, Plastics,Adhesives, and ceramics	Stainless Steel, Parylene coating,plastics, adhesives
Sterilization/Labeling	Single Use, Sterilized byEthylene Oxide	Single use, Sterilized by gammairradiation
Sizes	3mm and 5mm	4.5mm

Applicant

Date 12/15/00

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2001

Ms. Susan Finneran Director Regulatory Affairs/Clinical Sciences Endius. Incorporated 23 West Bacon Street Plainville, Massachusetts 02762

Re: K003897

Trade Name: Endius Bipolar Sheath and Accessories Regulatory Class: II Product Code: GEI Dated: February 6, 2001 Received: February 7, 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 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 (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.

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Page 2 - Ms. Susan Finneran

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,

Miriam C. Provost

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

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510(k) Number (if known): K003897

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) מילות מיני נושב על המיני במונח במ

Concurence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

iriam C. Provost

(Division Sign-Off) (Division Sigi-Oral, Restorative Division of Neurological Devices

K003897 510(k) Number -

Prescription Use _ (Per 21 CFR 801.109)

Regulation Number and Section

§ 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.