ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE

K974516 · Endolap, Inc. · FAS · Dec 22, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K974516
• Device Name: ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
• Applicant: Endolap, Inc.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endolap Resectoscope Cutting Loop Device is a monopolar electrode designed to deliver radiofrequency energy that is supplied by and electrical generator cleared for medical use. The Endolap Resectoscope Cutting Loop device is indicated for ablation and coagulation of the soft tissue and is intended for use with compatible resectoscopes.

Device Story

Monopolar electrode device; delivers radiofrequency (RF) energy from external cleared generator to soft tissue. Used during resectoscopic procedures for ablation and coagulation. Operated by physicians in clinical/surgical settings. Device interfaces with compatible resectoscopes to facilitate tissue removal or hemostasis. Benefits include precise tissue management during endoscopic surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Monopolar electrode; RF energy source; compatible with standard resectoscopes; manual surgical instrument form factor.

Indications for Use

Indicated for ablation and coagulation of soft tissue in patients requiring resectoscopic surgery. Intended for use with compatible resectoscopes and cleared medical electrical generators.

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}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
DEC 22 1997

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

Re: K974516
ENDOlap™ Resectoscope Cutting Loop 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. Gilstrap:

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 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 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 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 Compliance 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/dsmamain.html".

Sincerely yours,


Enclosure

{1}

Page ___ of ___

510(k) NUMBER (IF KNOWN): K974516

DEVICE NAME: Resectoscope Cutting Loop

INDICATIONS FOR USE:

The Endolap Resectoscope Cutting Loop Device is a monopolar electrode designed to deliver radiofrequency energy that is supplied by and electrical generator cleared for medical use. The Endolap Resectoscope Cutting Loop device is indicated for ablation and coagulation of the soft tissue and is intended for use with compatible resectoscopes.


(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)

R. K. Lathry
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974516