The Gyrus Endourology System, when used with a Gyrus Axipolar Resectoscope Electrode, is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectorny (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.

Device Description

The Axipolar Resectoscope Electrode devices described in this 510(k) are sterile, disposable electrodes designed for use with the Gyrus Endourology System.

AI/ML Overview

The provided document, K994166 "Gyrus Axipolar Resectoscope Electrode (ARE) Special 510(k) Premarket Notification: Device Modification," describes a device modification and asserts substantial equivalence to a predicate device. It does not present a study with specific acceptance criteria and reported device performance metrics in the way one would expect for a new diagnostic or AI-driven device.

This submission is a Special 510(k): Device Modification for an electrosurgical electrode. The focus of such a submission is to demonstrate that a modified device is still substantially equivalent to its original predicate device, often by showing continued compliance with design control requirements and risk analysis procedures, rather than conducting a new, extensive performance study with detailed acceptance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study are not directly applicable or available in this document.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as a formal table of acceptance criteria and performance metrics from a study. As a Special 510(k) for a device modification, the submission likely relies on demonstrating that the modified device continues to meet the safety and effectiveness profile of the original predicate device through design controls and risk analysis, rather than new, quantitative performance testing with explicit acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document makes no mention of a "test set" in the context of performance evaluation as it would for a new diagnostic device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. No "test set" and corresponding "ground truth establishment" by experts is described in this regulatory submission for a device modification.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no described "test set" requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is more relevant for diagnostic devices (especially those involving image interpretation) to assess the impact of AI on human reader performance. This document concerns an electrosurgical system electrode.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was not conducted or described. This document describes a physical medical device (an electrosurgical electrode), not an algorithm or AI system.

7. Type of Ground Truth Used

This information is not applicable/provided. No "ground truth" in the context of diagnostic performance evaluation is mentioned. The "ground truth" for an electrosurgical device's safety and effectiveness would implicitly be adherence to engineering specifications, material biocompatibility, and functional performance (e.g., cutting, coagulation efficiency) which are typically assessed through bench testing and animal/cadaver studies, but specifics are not detailed in this summary.

8. Sample Size for the Training Set

This information is not applicable/provided. The device is an electrosurgical electrode, not an AI or machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided. As explained above, there is no "training set."

Summary of Device in the Context of the Request:

The provided document details a Special 510(k) Premarket Notification for a modification to the Gyrus Axipolar Resectoscope Electrode. The core of this type of submission is to demonstrate substantial equivalence to an existing, legally marketed predicate device (K990628 in this case) despite a modification. This is typically achieved by:

Certification of compliance to 21 CFR 820.30 Design Control requirements: Showing that the design changes were controlled and documented to ensure the device still meets its intended use.
Risk Analysis procedures: Demonstrating that the modifications do not introduce new or increased risks.
Comparison to predicate: Arguing that the modified device maintains the same safety and effectiveness profile as the predicate.

The document explicitly states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Gyrus has provided certification of compliance to 21 CFR 820.30 design Control requirements, and Risk Analysis procedures."

Therefore, the "study" demonstrating the device meets "acceptance criteria" here is primarily the design control and risk analysis process that concludes the modified device remains substantially equivalent and performs as safely and effectively as its predicate. This is a qualitative and process-oriented demonstration rather than a quantitative, performance study with specific metrics and thresholds akin to those expected for a new diagnostic device or AI algorithm.

Summary

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K994166" platl

Gyrus Medical Limited Document No. 814278 Gyrus Axipolar Resectoscope Electrode (ARE) Special 510(k) Premarket Notification: Device Modification December 3, 1999

DEC 27 1999

SECTION 9 510(k) SUMMARY

1. Name Of Device

Trade name:	Gyrus Endourology System: Axipolar ResectoscopeElectrode
Common name:	Electrosurgical Generator System
Classification name:	Endoscopic Electrosurgical Unit and Accessories(21 CFR 876.4300)

2. Equivalence

Device	Premarket Notification
Gyrus Axipolar Resectoscope Electrode	K990628

3. Device Description

The Axipolar Resectoscope Electrode devices described in this 510(k) are sterile, disposable electrodes designed for use with the Gyrus Endourology System.

4. Indicated Use

The Gyrus Endourology System is intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectorny (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.

Safety & Performance 5.

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Gyrus has provided certification of compliance to 21 CFR 820.30 design Control requirements, and Risk Analysis procedures.

6. Summary

By virtue of design, materials, function and indicated use, the Gyrus Endourology System Axipolar Resectoscope Electrode is substantially equivalent to similar devices currently marketed in the USA.

7. Regulatory Contact

Please direct any questions regarding this submission to:

David Kay Director, Regulatory Affairs & Quality Assurance Gyrus Medical Limited, Fortran Road, St Mellons, Cardiff, CF3 0LT, UK Tel: +44 (029) 20 776300 Fax: +44 (029) 20 776301

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Image /page/1/Picture/2 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. In the center of the circle is an abstract symbol that resembles three stylized human figures.

DEC 27 1999

Mr. David Kay Director, Regulatory Affairs and Quality Assurance Gyrus Medical Limited Fortran Road St. Mellons Cardiff CF3 OLT UNITED KINGDOM

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K994166 Gyrus Endourology Electrosurgical System: Axipolar Resectoscope Electrode Dated: December 3, 1999 Received: December 9, 1999 Requiatory Class: II 21 CFR §876.1500/Procodes: 78 FJL; 78 FJC; 21 CFR §876.4300/Procodes: 78 FAS; 78 KNS

Dear Mr. Kay:

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.

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 Compiiance 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/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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of ___________________________________________________________________________________________________________________________________________________________________________ Page 1

510(k) Number (if known): K99466

Device Name: Gyrus Axipolar Resectoscope Electrode

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use
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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

510(k) Number	K994166
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Gyrus Medical Limited Gyrus Axipolar Resectoscope Electrode (ARE)

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).