MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM

K030472 · Ethicon Endo-Surgery, Inc. · KNW · Oct 9, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030472
• Device Name: MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 9, 2003
• 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

Mechanical breast biopsy device; utilizes directional vacuum-assisted biopsy technique. System components: disposable trocar-tipped needle-like probe; reusable holster/cable assembly; remote reusable control module. Operation: vacuum suction gathers tissue into probe; high-speed rotating cutter severs sample. Used in clinical settings under imaging guidance (stereotactic or ultrasound) by physicians. Output: harvested breast tissue samples for histologic examination. Enables diagnostic sampling and partial/complete removal of breast abnormalities. Clinical benefit: provides tissue for definitive diagnosis and management of breast lesions.

Clinical Evidence

Multicenter clinical study provided to support the expanded indications for use. No further details on sample size or specific statistical metrics provided in the summary.

Technological Characteristics

Mechanical biopsy instrument; vacuum-assisted; high-speed rotating cutter. Components: disposable trocar-tipped probe, reusable holster/cable, remote control module. No software or electronic algorithms described. Non-powered/mechanical operation.

Indications for Use

Indicated for patients with breast abnormalities requiring diagnostic tissue sampling; includes imaged abnormalities (partial/complete removal) and palpable abnormalities (partial removal), including benign lesions like fibroadenomas or 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 Biopsy System (K992813)
• Mammotome Hand Held System (K991980)

Submission Summary (Full Text)

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030472 1/2

OCT - 9 2003

## Mammotome Biopsy System 510(k) Summary of Safety and Effectiveness Information

| Company | Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, OH 45242 |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Georgia C. Abernathy, MBA, RAC<br>Senior Regulatory Affairs Associate<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | October 3, 2003 |
| Device Name | Trade Name: Mammotome Biopsy System<br>Classification Name: Biopsy Instrument |

Predicate Device Mammotome Biopsy System cleared under K992813 on 11/18/99 and Mammotome Hand Held System cleared under K991980 on 8/17/99.

## Device Description

The Mammotome Biopsy System is a mechanical breast biopsy device used in incisional breast biopsy. The Mammotome Biopsy System may be used with imaging guidance (stereotactic or ultrasound).

The Mammotome Biopsy System consists of three major components: a disposable trocar tipped needle-like probe, a reusable holster/cable assembly into which the probes are loaded, and a remote, reusable control module. The system uses vacuum assistance to gather tissue samples and a high-speed rotating cutter. The procedure is referred to as "directional vacuum-assisted biopsy."

## 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 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 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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K030472 2/2

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.

## Comparison of Technological Characteristics

The proposed and currently marketed devices are identical. No changes were made to design, manufacturing or materials. Only the Indications for Use was changed.

#### Performance Data

Clinical data from a multicenter study are provided that supports the additional Indications for use.

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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 image of an eagle with three lines representing its wings.

OCT - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Georgia C. Abernathy, MBA, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K030472 Trade/Device Name: Mammotome Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 9, 2003 Received: September 10, 2003

Dear Ms. Abernathy:

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 Federal 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 comply with all the Act's requirements, including, but not limited to: registration and listing ( 1 1 CFR 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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# Page 2 - Ms. Georgia C. Abernathy, MBA, RAC

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,

Miriam C. Provost

Colia 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 (if known): K030472

Device Name:

Mammotome@ Biopsy 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 ↓ 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriame C. Provost

(Optional Format 3-10-98)

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

510(k) Number K030472