SENORX ES-300

K030473 · Senorx, Inc. · GEI · Feb 26, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030473
• Device Name: SENORX ES-300
• Applicant: Senorx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.

Device Story

The ES 300 Generator is an electrosurgical unit designed for use in general surgical procedures. It utilizes radio frequency (RF) energy to perform cutting and coagulation of soft tissues. The device operates by delivering RF energy through compatible handpieces to the target tissue. It is intended for use by clinicians in surgical settings. The output of the device allows the surgeon to achieve precise tissue management, facilitating surgical intervention and potentially reducing intraoperative bleeding.

Technological Characteristics

Electrosurgical generator utilizing radio frequency (RF) energy for cutting and coagulation of soft tissues. Operates via RF handpieces. Class II device (Regulation 878.4400, Product Code GEI).

Indications for Use

Indicated for general surgical procedures requiring electrosurgical cutting or coagulation of soft tissues. Prescription use only.

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

• Force FX (Valleylab, Incorporated, K944602)
• Surgitron IEC II (Ellman International, Inc., K001253, K001407)

Submission Summary (Full Text)

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K030473 1/2

# FEB 2 6 2003

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92

### SUBMITTER INFORMATION 1.

| a. Company Name: | SenoRx Inc. |
|-----------------------------|---------------------------------------------------------------------|
| b. Company Address: | 11 Columbia, Suite A |
| c. Telephone:<br>Facsimile: | [phone]<br>[phone] |
| d. Contact Person: | Amy Boucly<br>Director, Regulatory Affairs<br>and Quality Assurance |

e. Date Summary Prepared: January 30, 2003

#### 2. DEVICE IDENTIFICATION

| a. Trade/Proprietary<br>Name: | ES 300 Generator |
|-------------------------------|-------------------------------------------------------------------------------|
| b. Classification Name: | Electrosurgical Cutting and<br>Coagulation Device and Accessories<br>878.4400 |

#### IDENTIFICATION OF PREDICATE DEVICES 3.

Force FX Surgitron IEC II

Valleylab, Incorporated, K944602 Ellman International, Inc., K001253, K001407

#### DESCRIPTION OF THE DEVICE 4.

The ES 300 Electrosurgical Generator is designed to cut and coagulate soft tissue. The ES 300 uses radio frequency (RF) energy to perform both cutting and coagulation, using RF handpieces.

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K030473 2/2

# STATEMENT OF INTENDED USE 5.

The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.

# 6. COMPARISON WITH PREDICATE DEVICES

The intended use, design, construction, material and nominal specifications are comparable to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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.

Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intertek Testing Services Donald J. Sherratt Medical Stream Director 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K030473

Trade/Device Name: SENORX ES 300 Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 7, 2003 Received: February 12, 2003

Dear Mr. Sherratt:

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. Iisting 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

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Page 2 – Mr. Donald J. Sherratt

(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. 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). 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,

Muriam C. Provost

for 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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SenoRx Inc. Premarket Notification ES 300 Generator

## 2 . Indications for Use Page

1 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ES 300 Generator

Indications for Use:

The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <span>✓</span> </div> |
|---------------------------------------|-----------------------------|
|---------------------------------------|-----------------------------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

Miriam C. Provost

(Division Sign-Off) (Division Sign of General, Restorative and Neurological Devices

510(k) Number K030473

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