MSI S-500L RF GENERATOR

K041980 · Medsphere International, Inc. · GEI · Aug 6, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041980
• Device Name: MSI S-500L RF GENERATOR
• Applicant: Medsphere International, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MSI S-500L 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-500L 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. By applying RF energy, the generator facilitates controlled coagulation, which assists in achieving hemostasis during surgical interventions. The device is intended for clinical use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical generator utilizing radiofrequency (RF) energy for tissue coagulation. Device is classified under 21 CFR 878.4400 as an electrosurgical cutting and coagulation device (Product Code: GEI).

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 S-500 RF Generator (K033888)

Submission Summary (Full Text)

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## K041980

### 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:

July 22, 2004

#### Name of the Device:

Trade / Proprietary Name: MSI S-500L RF Generator

Common / usual Name: Electrosurgical Generator and Accessories

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

#### Predicate Devices:

MSI S-500 RF Generator (K033888)

#### Description:

MSI S-500L RF Generator

#### Statement of Intended Use:

MSI S-500L 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-500L 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-500L 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2004

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

Re: K041980

Trade/Device Name: MSI S-500L RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 22, 2004 Received: July 23, 2004

Dear Mr. Kao:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard change the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been rechasined in assee approval of a premarket approval application (PMA). allu Cosmetic 71ct (71ct) that do not see subject to the general controls provisions of the Act. The 1 ou may, dicierore, market are act recessful and requirements for annual registration, listing of general controls provisions 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 If your device is clusion (sovated with be major regulations affecting your device can Inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dr F 5 rocames a vour device complies with other requirements of the Act that I DA has made a determentlations administered by other Federal agencies. You must of any ireactal statutes and regulations and limited to: registration and listing (21 Comply with an the Act 810 cart 801); good manufacturing practice requirements as set CFR in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic fordt in the quality systems (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) I mis letter will and w you'ls ough finding of substantial equivalence of your device to a legally premaired notincation. The PDF Imaling or castion 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 If you desire specific arrious. Jose [phone]. Also, please note the regulation entitled, Comact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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

fa Cclia 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

### Indications for Use

| Applicant: | MedSphere International, Inc.<br>48511 Warm Springs Blvd., Suite 212<br>Fremont, CA 94539 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K041980 |
| Device Name: | MSI S-500L 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. |
| Prescription Use | X OR Over-the-Counter Use |
| | (Per 21 CFR 801.109) |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED) | |
| (Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| <div> <i>Miriam C. Provost</i> <br/> <b>(Division Sign-Off)</b> <br/> Division of General, Restorative, <br/> and Neurological Devices </div> | |
| 510(k) Number | K041980 |
| (Optional format 1-2-06) | |