MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE

K964779 · Quantum Loop, Inc. · GEI · Aug 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964779
• Device Name: MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE
• Applicant: Quantum Loop, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The RF Passive Attenuator/Splitter Model I 100 I 200 and Cutting/Coagulating Electrode Model R 10 is indicated for the cutting and coagulation of the tissue. This device is intended for use by qualified medical personnel in the use of electrosurgery.

Device Story

Device consists of RF Passive Attenuator/Splitter (Models I 100, I 200) and Loop/Cutting/Coagulating Electrode (Model R 10). Used in electrosurgery to facilitate tissue cutting and coagulation. Operated by qualified medical personnel in clinical settings. Attenuator/Splitter manages RF energy delivery; electrode serves as the surgical interface. Output affects tissue via electrosurgical effect; assists physicians in surgical procedures. Benefits include controlled tissue management during surgery.

Technological Characteristics

RF electrosurgical accessory system comprising passive attenuator/splitter units and cutting/coagulating electrodes. Operates via RF energy transmission. Class II device (Product Code GEI).

Indications for Use

Indicated for cutting and coagulation of tissue during electrosurgical procedures performed by qualified medical personnel. Contraindicated when electrosurgical procedures are contrary to the patient's best interest.

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

Thomas C. Wehman, Ph.D.
President and Chief Operating Officer
Advanced Closure Systems
910 W. Maude Avenue
Sunnyvale, California 94086

AUG 27 1997

Re: K964779
Trade Name: Model I 100 and 200 RF Passive Attenuator/Splitter (PAS) and Model
QL 10 Loop Electrode
Regulatory Class: II
Product Code: GEI
Dated: May 28, 1997
Received: June 2, 1997

Dear Dr. Wehman:

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

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Page 2 - Thomas C. Wehman, Ph.D.

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,


Cella 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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Advanced Closure Systems, Inc.
510(k) RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10.

# INDICATIONS FOR USE

510(k) Number (if known): K 964779

Device name: RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10.

## Indications for Use:

The RF Passive Attenuator/Splitter Model I 100 I 200 and Cutting/Coagulating Electrode Model R 10 is indicated for the cutting and coagulation of the tissue.

This device is intended for use by qualified medical personnel in the use of electrosurgery.

## Contraindications for Use:

The use of the RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10 is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best of the interest of the patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ OR Over-The-Counter Use ☐
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division Sign-Off
Division of General Restorative Devices 6964779
510(k) Number 150-100259 Rev. 1

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Advanced Closure Systems, Inc.