MSI SA ELECTRODES

K030996 · Medsphere International, Inc. · GEI · May 30, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030996
• Device Name: MSI SA ELECTRODES
• Applicant: Medsphere International, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MSI SA Electrode is intended for coagulation of soft tissue This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Disposable electrosurgical needle electrode; used for soft tissue coagulation. Percutaneous, laparoscopic, or intraoperative application. Device comprises needle electrode, handle, and insulated cannula. Temperature-monitoring models include integrated thermocouple. Connects to external electrosurgical generator via handle connector. Operated by trained medical personnel. Output provides thermal coagulation of tissue; temperature-sensing models provide feedback for monitoring. Benefits include controlled tissue coagulation during surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable electrosurgical needle electrode; insulated cannula; handle with electrical connector. Temperature-sensing models include integrated thermocouple. Energy source: external electrosurgical generator.

Indications for Use

Indicated for coagulation of soft 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.

Predicate Devices

• MSI TA Electrodes

Submission Summary (Full Text)

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# 030996

## Section E - 510(k) Summary

Submitted by:

MedSphere International, Inc.

48511 Warm Springs Blvd., Suite 212, Fremont, CA 94539

Fax: [phone] Tel: [phone]

#### Contact Person:

Eric Kao, Vice President of Quality and Regulatory Affairs

#### Date Summary Prepared:

March 28, 2003

#### Name of the Device:

Trade / Proprietary Name: MSI SA Electrodes

Common / usual Name: Electrosurgical electrode

Classification Name: Electrosurgical cutting and coagulation device (21CFR878.4400)

#### Predicate Devices:

MSI TA Electrodes

#### Description:

The MSI SA series of disposable electrodes are electrosurgical devices used for coagulation of soft tissue. These devices are designed for percutaneous, laparoscopic or intraoperative use. The device consists of a needle electrode and a handle. For temperature measurement model, the needle contains a thermocouple for monitoring tissue temperature. The needle electrode is housed in an insulated cannula. The handle incorporates an electrical connector for interconnecting to an electrosurgical generator.

#### Statement of Intended Use:

MSI SA Electrode is intended for coagulation of soft tissue

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

#### Comparison to Predicate Devices:

MSI SA Electrode has been compared to previously 510(k) cleared device with respect to intended use and technological characteristics. Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI SA Electrode is substantially equivalent to predicate device and is safe and effective in its intended use.

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Image /page/1/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping faces or heads, and three curved lines above the heads.

Public Health Service

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Eric Kao Vice President of Quality and Regulatory Affairs MedSphere International, Inc. 48511 Warm Springs Boulevard, Suite 212 Fremont, California 94539

Re: K030996

Trade/Device Name: MSI SA Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 28, 2003 Received: March 31, 2003

Dear Mr. Kao:

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. Eric Kao

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 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

l. Mark N. Milkman

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section D - Statement of Indications for Use K030996

### Indications for Use

| Applicant: | MedSphere International, Inc. |
|---------------------------|---------------------------------------------------------------------------------------------------------|
| | 48511 Warm Springs Blvd., Suite 212, Fremont, CA 94539 |
| 510(k) Number (if known): | |
| Device Name: | MSI SA Electrodes |
| Indications For Use: | Indicated for coagulation of soft tissue |
| | These devices are intended for use by qualified medical personnel trained in the use of electrosurgery. |

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

(Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| 510(k) Number | K030996 |
|---------------|---------|
|---------------|---------|

| Prescription Use <img alt="checkmark" src="checkmark.png"/> | OR Over-the-Counter Use |
|-------------------------------------------------------------|-------------------------|
| | (Per 21 CFR 801.109) |

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