MSI MODEL S-500 RF GENERATOR

K033888 · Medsphere International, Inc. · GEI · Apr 2, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033888
• Device Name: MSI MODEL S-500 RF GENERATOR
• Applicant: Medsphere International, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MSI S-500 RF Generator 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

The MSI S-500 RF Generator is an electrosurgical device designed for soft tissue coagulation. It functions by delivering radiofrequency (RF) energy to target tissue. The device is operated by qualified medical personnel trained in electrosurgical procedures within a clinical setting. By applying RF energy, the generator facilitates controlled coagulation, assisting clinicians in achieving hemostasis or tissue modification during surgical interventions. The output is controlled by the operator to achieve the desired clinical effect, directly impacting surgical decision-making and patient outcomes by managing bleeding or tissue state.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electrosurgical generator for cutting and coagulation (21 CFR 878.4400). Operates via radiofrequency energy delivery. Class II device. Technical specifications and specific materials of construction are not detailed in the provided documentation.

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

• Somnus Model 225 Electro Surgical Generator (K963772)

Submission Summary (Full Text)

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## APR - 2 2004

K033888

### 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:

December 12, 2003

#### Name of the Device:

Trade / Proprietary Name: MSI S-500 RF Generator

Common / usual Name: Electrosurgical Generator and Accessories

- Classification Name: Electrosurgical cutting and coagulation device (21CFR878.4400)
#### Predicate Devices:

Somnus Model 225 Electro Surgical Generator (K963772)

#### Description:

MSI S-500 RF Generator

#### Statement of Intended Use:

MSI S-500 RF Generator 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 S-500 RF Generator 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 S-500 RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use.

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized lines forming the body and wings.

APR = 2 2004

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: K033888

Trade/Device Name: MSI S-500 RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 2, 2004 Received: March 4, 2004

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]. 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 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.

Miriam C. Provost

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

K 033 888

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## Indications for Use

| Applicant: | MedSphere International, Inc. |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | 48511 Warm Springs Blvd., Suite 212, Fremont, CA 94539 |
| 510(k) Number (if known): | |
| Device Name: | MSI S-500 RF Generator |
| 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) | |
| <i>Miriam C. Provost</i> | |
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K6 33888 |
| Prescription Use | <div> ✓ </div> |
| | OR Over-the-Counter Use |
| | (Per 21 CFR 801.109) |
| (Optional format 1-2-06) | |

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