ENDOLAP RESECTOSCOPE ROLLER ELECTRODE by ENDOLAP, INC.

The Endolap Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrical generator cleared for medical use. The Endolap Resectoscope roller electrode device is indicated for ablation and coagulation of the soft tissue and is intended for use with compatible resectoscopes.

Device Description

The Endolap Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrical generator cleared for medical use.

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "ENDOlap™ Resectoscope Roller Electrode." This type of document does not typically contain the detailed information requested about acceptance criteria, study data, ground truth establishment, or multi-reader multi-case studies, as it is a regulatory clearance based on substantial equivalence to a predicate device, rather than a presentation of a full de novo study.

Therefore, most of the requested information cannot be extracted from this document. However, I can infer some general points related to the device and its intended use.

Here's what can be stated based on the provided text, and what cannot be provided:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not describe specific acceptance criteria (e.g., performance thresholds for sensitivity, specificity, accuracy, etc.) or report detailed device performance metrics from a study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not refer to a test set or study data in this context.

3. 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)

Cannot be provided. The concept of "ground truth" as it relates to clinical study data for algorithm evaluation is not applicable here. This device is a surgical instrument, not an AI or diagnostic algorithm.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. Not applicable to this type of device clearance.

5. 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

Cannot be provided. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Cannot be provided. This is not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. The concept of ground truth in the context of diagnostic or AI performance is not applicable to an electrosurgical device like this. For a surgical instrument, "ground truth" might relate more to the physical properties, safety, and functionality of the device as tested against engineering and biocompatibility standards, rather than clinical diagnostic accuracy.

8. The sample size for the training set

Cannot be provided. This is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

Cannot be provided. This is not an AI or machine learning device.

What the document does tell us:

Device Name: ENDOlap™ Resectoscope Roller Electrode
Regulatory Class: Class II
Product Codes: 78 FAS (Resectoscope, Electrosurgical) and 78 FDC (Electrosurgical Unit, General & Plastic Surgery)
Indications for Use: The ENDOlap™ Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy. It is indicated for ablation and coagulation of soft tissue and is intended for use with compatible resectoscopes.
Regulatory Mechanism: 510(k) Pre-market Notification, cleared on the basis of substantial equivalence to predicate devices marketed before May 28, 1976. This means the device met the FDA's requirements by demonstrating it is as safe and effective as a legally marketed predicate device, rather than submitting extensive de novo clinical trial data. The clearance focuses on general controls provisions, good manufacturing practices, and labeling.

Summary

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Image /page/0/Picture/17 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized symbol that resembles a person with their arms outstretched. The symbol is composed of three curved lines that overlap each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1997

Mr. L. A. Tony Gilstrap Chief Operating Officer ENDOlap™, Inc. 3012 Mercy Drive Orlando, Florida 32808 Re: K974515

ENDOlap™ Resectoscope Roller Electrode Dated: November 15, 1997 Received: December 2, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 FAS 21 CFR §876.1500/Product code: 78 FDC

Dear Mr. Gilstran:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 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 question 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,

W.Liau Yu

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

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Page of

K974515 510(k) NUMBER (IF KNOWN):

Resctoscope Roller electrode DEVICE NAME:

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELCW THIS LINE-CONTINUE ON ANCITER FAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K974515

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).