ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000

K052857 · Senorx, Inc. · GEI · Oct 21, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052857
• Device Name: ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000
• Applicant: Senorx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SenoRx ES 3000 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 3000 Electrosurgical Generator System is a medical device designed for use in general surgical procedures. It functions by delivering electrical energy to perform cutting and coagulation of soft tissues. The system is operated by healthcare professionals in a clinical or surgical setting. By providing controlled electrosurgical output, the device assists surgeons in achieving hemostasis and tissue separation, thereby facilitating surgical interventions and potentially improving patient outcomes during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator system; utilizes electrical energy for tissue cutting and coagulation. Class II device under 21 CFR 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.

Submission Summary (Full Text)

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OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Amy Boucly SenoRx . Inc. Director, Regulatory Affairs and Quality Assurance 11 Columbia, Suite A Aliso Viejo, California 92656

Re: K052857

Trade/Device Name: ES 3000 Electrosurgical Generator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 7, 2005 Received: October 11, 2005

Dear Ms. Boucly:

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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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/industry/support/index.html

Sincerely vours,

Barbara Boucher
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number (if known) | K052857 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ES 3000 Electrosurgical Generator System |
| Indications for Use | The SenoRx ES 3000 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required. |

Prescription Use__X__ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bonellino

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

510(k) Number K052657