The Gyrus Endourology System 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 prostatectomy (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.

Device Description

The Gyrus Endourology System is comprised of four key components: the Electrode, the Connector Cable, an Axipolar Resectoscope and an electrosurgical generator called the Controller. The Connector Cable connects the Controller to the Electrode. The Electrode is provided in a variety of models, ranging in size from 5 Fr. to 24 Fr. A system specific Resectoscope is provided for use with one of the Electrode models. Other Electrode models are available for use with available cystoscopes with a 5Fr or larger operating channel. The Electrode is supplied sterile and intended for single patient use. The Connector Cable is designed for a number of sterilizations and the Resectoscope for repeat sterilizations using steam autoclaving methods. The Controller is an electronic radio frequency generator. The Gyrus Endourology System is bipolar, incorporating a return electrode as a part of the electrode tip. This means that a return pad is not required for system operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Gyrus Endourology System. This type of FDA submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials with acceptance criteria.

Therefore, the document does not contain the following information typically associated with a study proving a device meets specific acceptance criteria:

A table of acceptance criteria and the reported device performance: This document focuses on demonstrating equivalence to predicate devices, not meeting pre-defined performance thresholds.
Sample size used for the test set and the data provenance: No new performance data specific to the Gyrus Endourology System is presented from a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant to a substantial equivalence demonstration for this type of device.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrosurgical device, not an AI/algorithm-based system.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as there's no mention of a training set for an algorithm.
How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

Identical intended use: The Gyrus Endourology System's indications for use are described and implicitly compared to those of the predicate devices.
Similar technological characteristics: The document explicitly states, "The technological characteristics of the Gyrus Endourology System are the same as those of the Scuba (Gynecare Versapoint™) Electrosurgery System, Electrodes (K962482, K982738) and its dedicated Resectoscope and accessories (K982771). The devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization."
Safety and effectiveness demonstrated by predicate devices: The submission asserts that "Equivalent monopolar and bipolar electrosurgery devices have been cleared via 510(k), such as those manufactured by Erbe (K933002) and COMEG (K971881). These devices have been demonstrated to be safe and effective in removing tissue during urological surgery." By demonstrating equivalence to these devices, the Gyrus system is presumed to also be safe and effective.

The provided text does not contain any information about specific acceptance criteria or performance studies in the way you've outlined for an AI/algorithm-based device. It is a regulatory submission focused on comparing the new device to existing, legally marketed devices.

Summary

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GYRUS MEDICAL DOCUMENT No. 814064

ardiff CE3 01 T 11K 510(k) Premarket Notification February, 1999

XIII. 510(K) SUMMARY K990628 Pg 1 of 7

Name Of Device 1.

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

2. Equivalence

Device	PremarketNotification
Scuba (Gynecare Versapoint™) System	K962482
Scuba (Gynecare Versapoint™) System G-VAP Electrode	K982738
Gyrus Hysteroscopic Resectoscope	K982771
Erbe ERBOTOM ICC 350	K933002
COMEG Urological Electrosurgical Equipment	K971881

3. Device Description

The Gyrus Endourology System is bipolar, incorporating a return electrode as a part of the electrode tip. This means that a return pad is not required for system operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

4. Indicated Use

Several manufacturers have marketed equivalent monopolar electrosurgical generators, electrodes and accessories in the USA since the 1950's.

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K 990628

GYRUS MEDICAL DOCUMENT No. 814064

February 1990

Equivalent monopolar and bipolar electrosurgery devices have been cleared via 510(k), such as those manufactured by Erbe (K933002) and COMEG (K971881). These devices have been demonstrated to be safe and effective in removing tissue during urological surgery.

Technological Characteristics 5.

The technological characteristics of the Gyrus Endourology System are the same as those of the Scuba (Gynecare Versapoint™) Electrosurgery System, Electrodes (K962482, K982738) and its dedicated Resectoscope and accessories (K982771). The devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization.

6. Summary

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

7. Requiatory 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 OLT United Kingdom

Tel: +44 (0) 1222 300100 Fax: +44 (0) 1222 300101

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Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure.

JUN 2 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Kay Director, Regulatory Affairs and Quality Assurance Gyrus Medical LTD. Fortran Road St. Mellons Cardiff CF3 OLT United Kingdom

Re: K990628 Gyrus Endourology System Dated: April 12, 1999 Received: April 15, 1999 Requiatory Class: II 21 CFR §876.1500/Procodes: 78 FJL; 78 FDC 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, 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 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 requlations.

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) 594-4613. 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 requlation 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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510(k) Number (if known):

K990628

Device Name:

Gyrus Endourology System

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

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Gvrus Endouroloov 510/k) Premarket Notification

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).