11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT

K992813 · Ethicon Endo-Surgery, Inc. · KNW · Nov 18, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992813
• Device Name: 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Mammotome® Biopsy System is intended for diagnostic sampling of breast tissue during a biopsy procedure.

Device Story

Mammotome Biopsy System is a biopsy needle device used for diagnostic sampling of breast tissue. It operates under imaging guidance (ultrasound, X-ray, or CT) to excise suspicious breast tissue. The system allows for multiple samples to be collected without removing the needle. Operators may label or code tissue samples to correspond with imaging displays. Fluids can be delivered through the probe for procedure requirements. Used in clinical settings by healthcare professionals. The device provides tissue samples for histologic examination to assist in diagnosis. It is not intended for therapeutic removal of abnormalities.

Clinical Evidence

Clinical data from published literature provided to support the clarification in the indication for use.

Technological Characteristics

Biopsy needle system; utilizes imaging guidance (ultrasound, X-ray, CT); includes powered suction pump, tubing, and accessory clamps; allows fluid delivery through the probe.

Indications for Use

Indicated for diagnostic sampling of breast abnormalities to provide tissue for histologic examination, including partial or complete removal of imaged abnormalities. Contraindicated for therapeutic use.

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

• Mammotome® Biopsy System Powered Suction Pump (K992813)
• Tubing Clamp and Tubing Accessory Arm Clamp (K992813)

Submission Summary (Full Text)

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

NOV 1 8 1999

# Mammotome® Biopsy System

# 510(k) Summary of Safety and Effectiveness

k992813

### Company

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

# Contact

Tamima Itani, Ph.D., RAC Director, Regulatory Affairs

# Date Prepared:

November 18, 1999

#### Name of Device

Trade Name: Mammotome® Biopsy System Classification Name: Biopsy Needle

#### Predicate Devices:

Mammotome® Biopsy System Powered Suction Pump Tubing Clamp and Tubing Accessory Arm Clamp

#### Intended Use

The Mammotome® Biopsy System is intended for diagnostic sampling of breast tissue during a biopsy procedure.

# Indication for Use

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

The extent of a 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.

#### Contraindication:

The Mammotome® Biopsy System is for diagnostic use only and is not indicated for therapeutic use.

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

# Device Description

The Mammotome Biopsy System may use imaging guidance such as ultrasound, X-ray, and Computed Tomography (CT) to excise a diagnostic sample for diagnosis. The Mammotome® Biopsy System allows the operator to sample breast tissue that has been identified as suspicious. Multiples samples, if necessary, can be taken without removing the needle. When imaging guidance is used, the operator may label or code the tissue as it is collected to correspond with the imaging display. Fluids can be delivered through the Mammotome® probe for the management of selected patient/procedure requirements.

#### Technological Characteristics

The technological characteristics are identical to those of the predicate device.

#### Performance Data

Clinical data from published literature is provided that supports the clarification in the indication for use.

{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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Tamima Itani, Ph.D., RAC Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

K992813 Re:

> Trade Name: Mammotome® Biopsy System Regulatory Class: II Product Code: KNW Dated: August 19, 1999 Received: August 20, 1999

Dear Dr. Itani:

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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

#### Page 2 - Tamima Itani, Ph.D., RAC

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### Indications for Use Statement

510(k) Number: K992813

Device Name: Mammotome® Biopsy System

Indications for Use:

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

The extent of a bistologic 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 benigo, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Acelbs

General Restorative De

**Prescription Use**
**(Per 21 CFR 801.109)**