SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS

K013641 · Senorx, Inc. · GEI · Jan 29, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013641
• Device Name: SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS
• Applicant: Senorx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The SenoRx Biopsy Device System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Story

Percutaneous electrosurgical biopsy device; system includes driver, control module, and vacuum system. Used for diagnostic sampling of breast abnormalities under ultrasound guidance. Device removes breast tissue for histologic examination; allows for partial or complete removal of imaged abnormalities. Operated by clinicians in a clinical setting. Output is physical tissue sample for pathology. Benefit is minimally invasive diagnostic tissue acquisition.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to predicate devices.

Technological Characteristics

Percutaneous electrosurgical biopsy system. Components: driver, control module, vacuum system. Energy source: electrosurgical. Form factor: handheld biopsy probe with vacuum-assisted suction. Sterilization: not specified.

Indications for Use

Indicated for patients requiring diagnostic breast tissue sampling of imaged abnormalities. Contraindicated for cases where complete removal of malignancy cannot be confirmed via standard surgical margin examination.

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

• Mammotome® Biopsy System (K991980, K003297)
• Easy Guide™ Electrosurgical Access Device (K012004)

Submission Summary (Full Text)

{0}------------------------------------------------

SenoRx Inc. Premarket Notification SenoRx Biopsy Device System

## JAN 2 9 2002

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

KO13641

1/2

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:

#### DEVICE IDENTIFICATION 2.

SenoRx Biopsy Device a. Trade/Proprietary Name: SenoRx Driver SenoRx Control Module SenoRxVacuum System

Biopsy Device, 876.1075 b. Classification Name:

### IDENTIFICATION OF PREDICATE DEVICES 3.

Mammotome® Biopsy System

Ethicon Endo-Surgery (K991980, K003297)

Easy Guide™ Electrosurgical Access Device

SenoRx Inc. (K012004)

SI

{1}------------------------------------------------

013641 2/2

SenoRx Inc. Premarket Notification SenoRx Biopsy Device System

#### DESCRIPTION OF THE DEVICE 4.

The SenoRx Biopsy Device is a percutaneous electrosurgical biopsy device which is indicated for use in providing breast tissue samples for diagnostic sampling of breast abnormalities under ultrasound guidance.

#### STATEMENT OF INTENDED USE ડ.

The SenoRx Biopsy Device System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

### COMPARISON WITH PREDICATE DEVICES 6.

The intended use, design, construction, materials and technology are comparable to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of flowing lines that suggest movement and dynamism. The bird is positioned to the right of the text, which is arranged in a circular fashion around the left side of the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2002

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

Re: K013641

Trade/Device Name: SenoRx Biopsy Device Regulation Number: 878.4400, 876.1075 Regulation Name: Electrosurgical cutting and coagulation device and accessories Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: GEI, KNW Dated: October 30, 2001 Received: November 5, 2001

Dear Ms. Boucly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined 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 clorosure) to regars and ment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, as centrance with the provisions of the Federal Food, Drug, devices that have been rocussions in asse approval of a premarket approval application (PMA). and Costictle Act (110) that to not required to the general controls provisions of the Act. The r ou may, mercere, maniev of the Act include requirements for annual registration, listing of general voltrold profice, 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 rr your de rice is onabilional 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 r rouse of actived 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 or any I vature utates and see and see and the bet not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 6077, accems (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.

{3}------------------------------------------------

Page 2 - Ms. Amy Boucly

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of your premarket notification. The PDA Inding of subsantial equivalier by .
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 If you desire specific advice for your dovice diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices, please contac additionally 21 CFR Part 809.10 In Vitto unable as on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and adverti Compliance at [phone]. Additionally, 16. question of S94-4639. Also, please note the your device, please colliact the Office of Compiller natification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket not may be obtained from t regulation entitled, "Misoranding of receive to production at may be obtained from the Other general information on your responsional 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,

uriam 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

{4}------------------------------------------------

SenoRx Inc. Premarket Notification SenoRx Biopsy Device System

#### FDA Indications for Use Page 2

510(k) number (if known): K013641

Device Name:

SenoRx Biopsy Device

Indications for Use:

The SenoRx Biopsy Device System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined The extent of insteasing appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

# (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 _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

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

510(k) Number K013641