STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION

K991291 · Conway Stuart Medical, Inc. · GEI · Jul 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991291
• Device Name: STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
• Applicant: Conway Stuart Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Stretta Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration is an electrosurgical device. It utilizes an inflatable basket design to position needle electrodes for the coagulation of tissue. Operated by qualified medical personnel trained in electrosurgery, the device delivers energy to target tissue sites. The aspiration feature allows for fluid removal during the procedure. The device is used in clinical settings to achieve tissue coagulation, potentially benefiting patients by providing a controlled method for electrosurgical intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical catheter featuring an inflatable basket mechanism and integrated needle electrodes. Includes aspiration capability. Designed for use by trained medical personnel. Operates via electrosurgical energy delivery.

Indications for Use

Indicated for coagulation of tissue. Intended for use by qualified medical personnel trained in electrosurgery.

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

JUL 14 1999

Thomas C. Wehman, Ph.D. Regulatory Affairs Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086

K991291 Re:

> Trade Name: Stretta Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration Regulatory Class: II Product Code: GEI Dated: April 5, 1999 Received: April 15, 1999

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 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.

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

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.

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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## Indications for Use Statement 10.3

## Indications for Use

510(k) Number (if known):

K991291

Device Name:

Conway Stuart Medical Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration

Indications for Use:

Indicated for coagulation of tissue

These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

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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 1-2-06)

(Division) Sign-Off Division of General Restorative D 510(k) Number