MAMMOTOME EX HAND HELD SYSTEM

K033700 · Ethicon Endo-Surgery, Inc. · KNW · Feb 20, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033700
• Device Name: MAMMOTOME EX HAND HELD SYSTEM
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Mammotome EX Hand Held System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The Mammotome EX Hand Held System is also intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Device Story

Mechanical breast biopsy device; consists of disposable bladed trocar-tipped probe, reusable holster, and reusable control module. Operates via vacuum and radial cutting functions to extract tissue samples. Used by clinicians for diagnostic sampling of breast abnormalities. Features microprocessor-controlled closed-loop system for cutter translation and rotation; motors relocated to holster for improved ergonomics. Provides standard and rapid operation modes for cutter advancement and specimen retrieval. Independent control of axial and lateral vacuum. Output is tissue sample for histologic examination. Benefits include easier handling and reduced dependence on user interaction or tissue variability during biopsy.

Clinical Evidence

Bench testing only. Preclinical testing demonstrated satisfactory performance in breast tissue biopsy.

Technological Characteristics

Mechanical breast biopsy system. Components: disposable bladed trocar-tipped probe, reusable holster, reusable control module. Vacuum-assisted radial cutting. Microprocessor-based closed-loop control for cutter translation and rotation. Powered by motors in holster. Independent axial and lateral vacuum control.

Indications for Use

Indicated for diagnostic sampling of breast abnormalities, including imaged abnormalities (microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal disease, diffuse tissue) and palpable abnormalities. Used for partial or complete removal of imaged abnormalities and partial removal of palpable lesions. Not for determining extent of histologic abnormality; surgical margins must be examined if findings are not benign.

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® Hand Held System
• Mammotome® Hand Held 8 Gauge Probe
• Mammotome® Biopsy System

Submission Summary (Full Text)

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# FEB 2 0 2004

510(k) Premarket Notification for Mammotome® EX Hand Held System

K033700
loF2

# Mammotome® EX Hand Held System

# 510(k) Summary of Safety and Effectiveness

#### Company

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

#### Contact

Carol Sprinkle, BSN, RN Associate, Regulatory Affairs

#### Date Prepared:

November 24, 2003

## Name of Device

Trade Name: Mammotome® EX Hand Held System Classification Name: Biopsy Needle

## Predicate Devices:

Mammotome® Hand Held System Mammotome® Hand Held 8 Gauge Probe Mammotome® Biopsy System

#### Device Description

The Mammotome® EX Hand Held System is a mechanical breast biopsy device used in incisional breast biopsy of microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal discase, and diffused tissue.

The Mammotome EX Hand Held System consists of three major components, a disposable bladed trocar tipped needle-like probe, a reusable holster, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, footswitch, remote keypad, support arm and cart.

#### Intended Use

The Mammotome EX Hand Held System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The Mammotome EX Hand Held System is also intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

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#### Ethicon Endo-Surgery, Inc.

510(k) Premarket Notification for Mammotome® FX Hand Held System

K033700
20F-2

### Technological Characteristics

The Mammotome EX Hand Held System is a modification of the currently marketed Mammotome Hand Held System. It represents a refinement in design, software and crgonomic enhancements for ease of use, however, the basic configuration, technology, materials and principles of operation of the proposed and marketed devices are equivalent.

The EX Hand Held biopsy device, used with or without imaging modalities, facilitates the diagnostic removal of tissue with fluid management through a combination of vacuum and radial cutting functions. The proposed and marketed devices contain the same primary components to achieve these functions: a probe, housing/holster, and a control module. The probe needle and cutter, which interface directly with the patient, are similar in both new and marketed devices.

In the proposed device, the control module motors are bypassed and two mechanical cables are eliminated. Two small motors reside in the holster to power the cutter translation and rotation. These physical changes make the probe/holster easier to handle.

Software modifications allow the Mammotome EX Hand Held System to provide standard and rapid modes of operation for cutter advancement and specimen retrieval. A microprocessor provides closed-loop control to reduce dependence of cutter rotation and translation speed on user interaction or tissue variability.

Axial and lateral vacuum can still be controlled independently.

#### Performance Data

Preclinical testing was performed to ensure the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized symbol resembling three abstract human profiles or a triple-stranded helix, often referred to as the "Human Services Symbol".

Public Health Service

FEB 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Sprinkle, BSN, RN Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K033700

Trade/Device Name: Mammotome® EX Hand Held System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: November 24, 2003 Received: November 25, 2003

Dear Ms. Sprinkle:

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 l'ederal 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 or any I cathar all the Act's requirements, including, but not limited to: registration and listing (21 CHR 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. Carol Sprinkle, BSN, RN

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icher will anow you to cogin maing of substantial equivalence of your device to a legally prematics notification. The 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 If you desire specific acries in 1984 and 1) 594-4659. Also, please note the regulation entitled, Contact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Sincerely yours,

Mark N Milliken

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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## Indications for Use Statement

510(k) Number: K 033700

Device Name: Mammotome® EX Hand Held System

Indications for Use:

The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

- The Mammotome Biopsy System is intended to provide breast tissue for histologic 해 examination with partial or complete removal of the imaged abnormality.
- The Mammotome Biopsy System is intended to provide breast tissue for 보 histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, c.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.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.

for

Mark N Millerss

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

510(k) Number K033700

(Please do not write below this line - continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ________

Over-The-Counter-Usc: ________________________________________________________________________________________________________________________________________________________ OR