ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE

K974484 · Ximed/Prosure/Injectx · GEI · Feb 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974484
• Device Name: ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
• Applicant: Ximed/Prosure/Injectx
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrosurgical probes and devices are to be used with commercially available R.F. Generators, endoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.

Device Story

Salinetrode™ is an isolated electrosurgical probe designed for use with standard R.F. generators, endoscopes, and suction/irrigation systems. Device functions by delivering R.F. energy to soft tissue to facilitate coagulation, ablation, or vaporization. Used by surgeons in OR or clinical settings during laparoscopic, hysteroscopic, endoscopic, or open procedures. Output is controlled by the surgeon via the R.F. generator interface. Benefits include precise tissue management during minimally invasive and open surgeries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical probe; isolated design; compatible with standard R.F. generators, endoscopes, and suction/irrigation systems. Energy source: external R.F. generator. Sterilization: not specified.

Indications for Use

Indicated for soft tissue removal via coagulation, ablation, or vaporization using R.F. energy during laparoscopic, hysteroscopic, endoscopic, and open surgical procedures. For use by clinicians in prescription settings.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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

Mr. Ashvin Desai
President
Ximed Medical System
2195 Trade Zone Boulevard
San Jose, California 95131

FEB 10 1998

Re: K974484
Trade Name: Isolated Electrosurgical Probes and Devices-Salinetrode™
Regulatory Class: II
Product Code: GEI
Dated: November 25, 1997
Received: November 26, 1997

Dear Mr. Desai:

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 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

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Page 2 - Mr. Desai

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,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known): K974484

Device Name: Isolated Electrosurgical Probe/Device-Salinetrode TM

Indications For Use:

The electrosurgical probes and devices are to be used with commercially available R.F. Generators, endoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.

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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)