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 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

Here's an analysis of the provided documents regarding the acceptance criteria and supporting study for the Endius Bipolar Sheath:

This submission (K012488) is a 510(k) Pre-Market Notification, which is a regulatory pathway for demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. For such submissions, the primary "study" is often a comparison to the predicate device based on design, materials, intended use, and performance characteristics (often bench testing results). A formal clinical trial with specific acceptance criteria in the way one might expect for a novel drug or a high-risk device requiring PMA is generally not presented in full here.

Based on the provided text, the core of the "study" is the demonstration of substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly not different from the predicate device in terms of fundamental performance (e.g., ability to coagulate, electrical safety, material compatibility). The "performance" is demonstrated by showing that the device has similar design features, materials, and operating principles to the predicate.

Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (as demonstrated by comparison to predicate)
Intended Use: Coagulate soft tissue during surgical procedures.	The Endius Bipolar Sheath is intended to be used to coagulate soft tissue during various spinal surgical procedures. (Similar to predicate's use in ENT and orthopedic procedures)
Material Composition: Biocompatible and suitable for intended use.	Materials are Stainless Steel, FEP coating, plastics, adhesives. (Comparable to predicate's Stainless Steel/polyethylene)
Sterilization Method: Effective for single use.	Sterilized by gamma irradiation. (Predicate uses 100% Ethylene Oxide - difference noted but deemed acceptable)
Physical Dimensions/Design: Suitable for surgical application.	Length: 6-12 cm (Predicate: 8.1 cm); Exposed Tip Size: 3.5-4.5mm (Predicate: 1.5mm electrode); Sizes: 3.5-4.5mm (Predicate: 3mm-5mm) (Similar ranges, with minor variations deemed acceptable for equivalence)
Operating Mode: Compatible with ESU Generator in Bipolar Mode.	To be used with ESU Generator in Bipolar Mode. (Identical to predicate)
Electrical Safety/Performance: Appropriate energy transmission for coagulation.	Connected to Valley Lab's Force 2, FX, or EZ generator using Bipolar Sheath Adapter to decrease maximum voltage from 800V to 100V, ensuring appropriate energy level. (This demonstrates specific engineering to match performance expectations for coagulation within safe limits, analogous to predicate's expected electrical performance).

Additional Information on the "Study" (Substantial Equivalence)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical performance study. For substantial equivalence, the "test set" is essentially the device itself and its specifications, which are compared against the predicate device's specifications. There is no mention of a particular number of units tested beyond what would be typical for design verification and validation (e.g., electrical tests, material tests), but a specific "sample size" for a comparative clinical test set is not provided or required for this type of submission.
- Data Provenance: The data comes from the design and manufacturing specifications of the Endius Bipolar Sheath and the publicly available information/previous 510(k) submissions (K981041, K984018) for the predicate SLT Bipolar Sheath. This is retrospective in the sense that it relies on existing design information and previous predicate approvals, rather than new prospective clinical trials. The country of origin of the data is the USA (Endius, Inc. and Surgical Laser Technologies are US companies).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study that involves expert review or ground truth establishment from medical images or clinical outcomes in the way a diagnostic AI might. The "ground truth" for substantial equivalence is the predicate device's performance and safety, which has already been established and regulated by the FDA. The experts involved would be the engineers and regulatory affairs personnel who prepared the submission and the FDA reviewers who assessed it.
Adjudication method for the test set:
- Not applicable. There is no test set in the sense of clinical cases requiring adjudication. The assessment is a regulatory review process by the FDA.
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 a surgical instrument (bipolar sheath), not an imaging or diagnostic AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the legally marketed predicate device(s) as determined by the FDA. The new device must be shown to be as safe and effective as the predicate.
The sample size for the training set:
- Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

Summary

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Ko12488

AUG 3 0 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 SLT Bipolar Sheathmanufactured by Surgical Laser Technologies (Montgomery, PA)
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, FX, or EZ,generator by using the Bipolar Sheath Adapter that is intended to decrease the
7.7
DeviceIndications andIntended use	The Endius Bipolar Sheath is intended to be used in conjunction with theEndius XPS Microdebrider System to coagulate soft tissue during variousspinal 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.

()

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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

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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.

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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 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

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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

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.