EASY GUIDE ELECTROSURGICAL ACCESS DEVICE

K012004 · Senorx, Inc. · GEI · Sep 25, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012004
• Device Name: EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
• Applicant: Senorx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Easy Guide™ is indicated for use in diagnostic breast biopsy procedures to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

Device Story

Monopolar electrosurgical trocar and cannula system; used to penetrate breast tissue under ultrasound guidance; provides access channel for biopsy instruments. Operated by clinicians in clinical settings. Device facilitates minimally invasive access to breast lesions for diagnostic sampling; benefits patient by enabling targeted biopsy procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar electrosurgical trocar and cannula. Electrosurgical cutting and coagulation principle. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for patients requiring diagnostic breast biopsy; used to penetrate breast tissue under ultrasound guidance to create a passageway for biopsy instrumentation.

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

• Sure Core Biopsy Electrode (K963813)
• Accucise Electrosurgical Trocar (K925984)
• Bovie Hand Control (K790187)

Submission Summary (Full Text)

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June 26, 2001

2.

# SEP 2 5 2001

## 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: | June 26, 2001 |
| DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | Easy Guide™ Electrosurgical Access<br>Device |
| b. Classification Name: | Electrosurgical cutting and coagulation<br>device and accessories, 21 CFR |

878.4400

#### IDENTIFICATION OF PREDICATE DEVICES 3.

Sure Core Biopsy Electrode

Interventional Concepts, Inc. K963813

Accucise Electrosurgical Trocar

Applied Medical Resources K925984

Bovie Hand Control

Sybron Corporation K790187

ਟ I

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#### DESCRIPTION OF THE DEVICE 4.

The SenoRx Easy Guide™ Electrosurgical Access Device consists of a monopolar electrosurgical trocar used to penetrate the breast, and a cannula to provide a passageway through which a breast biopsy instrument may be placed.

#### STATEMENT OF INTENDED USE ડ.

The Easy Guide™ is indicated for use in diagnostic breast biopsy procedures to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

#### COMPARISON WITH PREDICATE DEVICES 6.

The intended use, design, construction, materials and technology 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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2001

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

Re: K012004

Trade/Device Name: SenoRx EasyGuide™ Electrosurgical Access Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 26, 2001 Received: July 27, 2001

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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### Page 2 -- Ms. Amy Boucly,

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Mark N. Mikkelson

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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#### 2 FDA Indications for Use Page

510(k) number (if known)

510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Easy Guide™ Electrosurgical Access Device

**Indications for Us**

Indications for Use: The Easy Guide™ Electrosurgical Access Device is indicated for use to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

for Mark N. Mellkuan

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

510(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________