MAMMOTOME MR BIOPSY SYSTEM

K042753 · Ethicon Endo-Surgery, Inc. · KNW · Nov 8, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042753
• Device Name: MAMMOTOME MR BIOPSY SYSTEM
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended 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 examination with partial or complete removal of the imaged abnormality. The Mammotome Biopsy System is intended to provide breast tissue for 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, 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. 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.

Device Story

The Mammotome MR Biopsy System is a vacuum-assisted biopsy device designed for use in magnetic resonance (MR) environments. It consists of a disposable biopsy probe, a bladed needle-like introducer, a reusable holster with keypad, and a reusable control module. The system uses vacuum and radial cutting functions to extract breast tissue samples for histologic examination. A microprocessor-controlled motor system powers a mechanical cable to drive the cutter, providing closed-loop control of rotation and translation speed to minimize variability. The device is operated by clinicians to facilitate diagnostic tissue removal under MR imaging guidance. The output is a tissue sample for pathology. The system is modified from the Mammotome EX Hand Held System to ensure safety in 3.0 Tesla MR environments.

Clinical Evidence

Bench testing only. MR safety testing demonstrated satisfactory material performance in a 3.0 Tesla magnet environment.

Technological Characteristics

System includes disposable biopsy probe, bladed introducer, reusable holster, and control module. Employs vacuum-assisted radial cutting. Microprocessor-based closed-loop control for cutter rotation and translation. Designed for compatibility with 3.0 Tesla MR environments.

Indications for Use

Indicated for patients with breast abnormalities requiring diagnostic tissue sampling; includes partial or complete removal of imaged abnormalities and partial removal of palpable abnormalities (e.g., fibroadenoma, fibrocystic lesions).

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 EX Hand Held System

Submission Summary (Full Text)

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NOV - 8 2004

K042753 1/2

# Mammotome® MR Biopsy 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:

October 1, 2004

#### Name of Device

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

#### Predicate Device:

Mammotome EX Hand Held System

#### Device Description

The Mammotome MR Biopsy System consists of four major components: a disposable biopsy probe; a disposable, bladed, needle-like introducer; a reusable holster with detachable keypad, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, and control module cart.

#### Indications for Use

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

- 트 The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- 포 The Mammotome Biopsy System is intended to provide breast tissue for 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, e.g., malignancy. When the sampled abnormality is not histologically

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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.

### Technological Characteristics

The Mammotome MR Biopsy System is a modification of the currently marketed Mammotome EX Hand Held System. It represents a refinement in design to assure safety in a magnetic resonance (MR) environment, however, the basic configuration, technology, and principles of operation of the proposed and marketed devices are equivalent.

The MR biopsy device, used with imaging modalities, facilitates the diagnostic removal of tissue with fluid management through a combination of vacuum and radial crting 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 utilized to power a mechanical cable. 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

MR safety testing was performed to ensure the device can be used safely in the MR environment. Testing demonstrated satisfactory material performance in a 3.0 Tesla magnet environment.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

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

Re: K042753

Trade/Device Name: Mammotome MR Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 1, 2004 Received: October 4, 2004

Dear Ms. Sprinkle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(tr) premainer is substantially equivalent (for the indications felerenced above und nave acterimes ally marketed predicate devices marketed in interstate for use stated in the cholosure) to regars actual date of the Medical Device American Comments, or to commence provision to May 26, 1976, the enaonance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM alle Costliete Act (71ct) that do not request of the general controls provisions of the Act. The You may, therefore, market the dovrees, becales for annual registration, listing of general controls provisions of the Fict lierate soquents misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs of Pounts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3 issumter of a budevice complies with other requirements of the Act that I DA has made a dolorimation administered by other Federal agencies. You must or ally recetal statutes and regulations ancluding, but not limited to: registration and listing (21 comply with an the Ace 31equirements, and manufacturing practice requirements as set CITN Fart 807), adoning (21 CFR Part 820); and if applicable, the electronic forum in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Ms. Carol J. Sprinkle, RN, BSN

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin harketing your as rece as valence of your device to a legally premarket notification. The PDA midning of bassification 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 advice for your act [phone]. Also, please note the regulation entitled, provinces and "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Missuranting Uy reference to premail.orginibilities under the Act from the Division of Small other general Information on your responsibility of the mumber [phone] or
Manufacturers, International and Consumer Assistance at its toll-free humber (800) the local [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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

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### Indications for Use

510(k) Number (if known):

Device Name: MAMMOTOME MR Biopsy System

Indications For Use:

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

Ko42753

- The Mammotome Biopsy System is intended to provide breast tissue for histologic 에 examination with partial or complete removal of the imaged abnormality.
- The Mammotome Biopsy System is intended to provide breast tissue for I 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, 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.

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Mriam C. Provost (Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K042753