ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE

K012023 · Senorx, Inc. · KNW · Sep 12, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012023
• Device Name: ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE
• Applicant: Senorx, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anchor Guide™ Localization Device is indicated for localization of breast lesions.

Device Story

The Anchor Guide™ Localization Device is a single-use electrosurgical instrument designed to localize and fixate target breast lesions. It functions as an electrosurgical cutting and coagulation device. The device is intended for use by clinicians in a clinical setting to assist in the surgical localization process. By fixating the lesion, the device aids the surgeon in identifying and removing the target tissue, potentially improving surgical precision and patient outcomes.

Clinical Evidence

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

Technological Characteristics

Single-use electrosurgical device for cutting and coagulation. Operates via electrosurgical energy. Form factor is a localization needle/electrode assembly. No software or complex electronic components described.

Indications for Use

Indicated for localization of breast lesions in patients requiring surgical intervention.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Kopans Breast Lesion Localization Needle (Cook)
• Milex (K900903)
• Biopsy Assistant (Surgimedics)
• PrecisionGuide Breast Lesion Localization Needle (Becton-Dickinson K881687/C)
• Bovie Hand Control (Sybron K790187)
• Sure Core Biopsy Electrode (Interventional Concepts, Inc. K963813)

Submission Summary (Full Text)

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

012023 1/2

SenoRx Inc. Premarket Notification Anchor Guide™ Localization Device

June 27, 2001

SEP 1 2 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

#### 1. SUBMITTER INFORMATION

| 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 27, 2001

#### DEVICE IDENTIFICATION 2.

Anchor Guide™ Localization Device a. Trade/Proprietary Name:

- Electrosugical cutting and coagulation b. Classification Name: device and accessories, 21 CFR 878.4400
### IDENTIFICATION OF PREDICATE DEVICES 3.

| Kopans Breast Lesion<br>Localization Needle | Cook (K# unknown)<br>Milex (K900903) |
|-----------------------------------------------------|--------------------------------------------|
| Biopsy Assistant | Surgimedics (K# unknown) |
| PrecisionGuide Breast<br>Lesion Localization Needle | Becton-Dickinson (K881687/C) |
| Bovie Hand Control | Sybron (K790187) |
| Sure Core Biopsy<br>Electrode | Interventional Concepts, Inc.<br>(K963813) |

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

K012023 2/2

SenoRx Inc. Premarket Notification Anchor Guide™ Localization Device

June 27, 2001

#### DESCRIPTION OF THE DEVICE 4.

The SenoRx Anchor Guide™ Localization Device is a single use electrosurgical localization device which is used to localize and fixate a target lesion in the breast. Accessories are available separately.

#### STATEMENT OF INTENDED USE ડ.

The Anchor Guide™ Localization Device is indicated for localization of breast lesions.

#### 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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

SEP 1 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012023

Trade/Device Name: Anchor Guide™ Localization Device Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: June 27, 2001 Received: June 28, 2001

Dear Ms. Boucly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Amy Boucly

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow your of substantial equivalence of your device to a legally marketed nouticate 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 activer diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This craguestions on the promotion and advertising of your device, [phone]. Nathlendry, sopiance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number [phone] or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Susan Walker, MD

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly a lowercase 'f' or a similar character with a loop at the top and a curved line extending to the right. The character is drawn with a thin line and has a slightly irregular shape.

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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### FDA Indications for Use Page 2

510(k) number (if known): k012023

Device Name:

# Anchor Guide™ Localization Device

Indications for Use: The Anchor Guide™ Localization Device is indicated for localization of breast lesions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> |
|------------------------------------------|---------------------------------------------------|
|------------------------------------------|---------------------------------------------------|

| | OR |
|--|----|
|--|----|

| Over-The-Counter Use | <span style="text-decoration: overline;"></span> |
|----------------------|--------------------------------------------------|
|----------------------|--------------------------------------------------|

| | <span style="text-decoration: overline;">Susan Walke</span> |
|--|--------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative<br>and Neurological Devices |

| 510(k) Number | <span style="text-decoration: overline;">K012023</span> |
|---------------|---------------------------------------------------------|
|---------------|---------------------------------------------------------|