TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES

K050488 · Prosurg, Inc. · FAS · Apr 1, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050488
• Device Name: TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
• Applicant: Prosurg, Inc.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Apr 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.

Device Story

TURBT-RF electrodes and electrosurgical devices; used with external RF generators, resectoscopes, and suction/irrigation systems. Designed for endoscopic urological soft tissue procedures; performs resection, ablation, hemostasis, coagulation, and excision. Operates via RF energy in cutting, coagulation, and vaporization modes. Used by physicians in clinical/surgical settings. Output is physical tissue modification; assists surgeons in treating bladder/prostate conditions. Benefits include minimally invasive access for tissue removal and management of urological obstructions/malignancies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic electrosurgical electrodes; compatible with standard RF generators, resectoscopes, and irrigation systems. Operates via RF energy (cutting, coagulation, vaporization modes).

Indications for Use

Indicated for patients requiring endoscopic urological soft tissue surgery, including resection, ablation, hemostasis, coagulation, and excision of prostatic and bladder tissue (e.g., bladder tumors, cancer, BPH, urethral stricture, vesical neck constriction).

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with three curved lines extending from its wing. The logo is black and white and appears to be a scan of a document.

APR - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Inc. 2193 Trade Zone Blvd. SAN JOSE CA 95131

Re: K050488

Trade/Device Name: TURBT-RF electrodes and Electrosurgical devices Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS Dated: February 16, 2005 Received: March 1, 2005

Dear Mr. Desai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow yourto begin manceang of your device of your device to a legally premarket nothleation: "The PDF midnig of our 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), please If you desire specific advice for your device to be on the regulation numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 |
|-----------------|-----------------------------------------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) 240-276-0120 |
| Other | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation onlined, "Association on your responsibilities under the Act from the 807.97). Tou may outlain other general missistance at its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at its toll-free num DIVISION of Sillan Manufactures, Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page

਼ (

510(k) NUMBER (IF KNOWN): KOSO488

TURBT- RF electrodes and Electrosurgical devices DEVICE NAME:

INDICATIONS FOR USE:

TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.

(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)

OR

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

Nancy Broadon

(Division Sign-Off) ( (Division of Reproductive, Abdominal, Division ological Devices 510(k) Number