GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

K994166 · Gyrus Medical , Ltd. · KNS · Dec 27, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K994166
• Device Name: GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
• Applicant: Gyrus Medical , Ltd.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Dec 27, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Gyrus Axipolar Resectoscope Electrode is a sterile, disposable accessory for the Gyrus Endourology System; functions as a bipolar electrosurgical device. Used by surgeons in urological procedures to ablate or remove soft tissue and achieve hemostasis. Device delivers radio frequency energy to target tissue; bipolar design limits current path to tissue between electrodes, reducing risk of collateral damage. Used in clinical settings (OR); operated by urologists. Output is thermal energy for tissue cutting and coagulation. Benefits include precise tissue removal and effective hemostasis during transurethral surgeries.

Clinical Evidence

No clinical data provided; substantial equivalence demonstrated through design, materials, and functional comparison to predicate device.

Technological Characteristics

Bipolar electrosurgical electrode; sterile, disposable; radio frequency energy source; designed for use with Gyrus Endourology System.

Indications for Use

Indicated for patients undergoing urological surgical procedures requiring soft tissue ablation, removal, or hemostasis, including transurethral prostatectomy (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors, and cystodiathermy.

Regulatory Classification

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.

Predicate Devices

• Gyrus Axipolar Resectoscope Electrode (K990628)

Submission Summary (Full Text)

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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 Resectoscope<br>Electrode | | | | |
|----------------------|----------------------------------------------------------------------|--|--|--|--|
| Common name: | Electrosurgical Generator System | | | | |
| Classification name: | Endoscopic Electrosurgical Unit and Accessories<br>(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: [phone] Fax: [phone]

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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): K99466

Device Name: Gyrus Axipolar Resectoscope Electrode

Indications for Use:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="height: 20px;"></div> |
|----------------------|-----------------------------------|
| (Per 21 CFR 801.109) | <div style="height: 20px;"></div> |

OR

| Over-the-Counter Use | <div style="height: 20px;"></div> |
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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

| 510(k) Number | K994166 |
|---------------|---------|
|---------------|---------|

Gyrus Medical Limited Gyrus Axipolar Resectoscope Electrode (ARE)