SERIES SY DISPOSABLE ELECTROSURGICAL PAD

K082204 · Ventlab Corp. · ODR · Aug 13, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082204
• Device Name: SERIES SY DISPOSABLE ELECTROSURGICAL PAD
• Applicant: Ventlab Corp.
• Product Code: ODR · General, Plastic Surgery
• Decision Date: Aug 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

Device Story

Ventlab Disposable Electrosurgical Pad functions as a return electrode during electrosurgical procedures; provides conductive path for RF current to return to generator. Used in clinical settings by healthcare professionals. Device ensures safe completion of electrosurgical circuit, preventing patient burns at return site. Benefits include safe grounding of high-frequency electrical energy during surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable electrosurgical return electrode. Conductive material interface for RF current return. Passive device; no energy source or software. Designed for single-patient use.

Indications for Use

Indicated for patients undergoing electrosurgical procedures requiring a return electrode for RF current.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 3 2008

Ventlab Corporation % Underwriters Laboratories, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062-2096

Re: K082204

Trade/Device Name: Ventlab Disposable Electrosurgical Pad Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: ODR Dated: August 1. 2008 Received: August 5, 2008

Dear Mr. Devine:

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 (PMA), 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.

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## Page 2 - Mr. Ned Devine

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device advervour (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ventlab Disposable Electrosurgical Pad

Indications for Use:

The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | Page ___ of ___ |
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| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K082209 |