SENORX BIOPSY DEVICE II

K040842 · Senorx, Inc. · KNW · Apr 30, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040842
• Device Name: SENORX BIOPSY DEVICE II
• Applicant: Senorx, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The SenoRx Biopsy Device II is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue sampling with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged 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.

Device Story

SenoRx Biopsy Device II is a breast biopsy instrument used to obtain tissue samples from imaged breast abnormalities. Device allows for partial or complete removal of the target lesion. Operated by clinicians in a clinical setting. Output consists of retrieved breast tissue samples for histologic examination. Device assists in diagnostic assessment of breast lesions; however, it does not definitively determine the extent of histologic abnormality based on mammographic appearance alone. If malignancy is identified, standard surgical procedures are required to ensure complete margin removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gastroenterology-urology biopsy instrument (21 CFR 876.1075); Product Code KNW. Mechanical biopsy device designed for tissue sampling.

Indications for Use

Indicated for patients with imaged breast abnormalities requiring diagnostic tissue sampling or partial/complete removal of the abnormality.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 3 0 2004

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

Re: K040842

Trade/Device Name: SenoRx Biopsy Device II Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 31, 2004 Received: April 1, 2004

Dear Ms. Boucly:

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 cnactment 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 cither 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 Codc 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 (21 CFR Part 807); labcling (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. Amy Boucly

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,

Mark A. Milkerem

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):

K040842

Device Name:

SenoRx Biopsy Device II

Indications for Use:

The SenoRx Biopsy Device II is indicated to provide breast tissue samples for The Sellorx Diopsy Devrest abnormalities. It is intended to provide breast tissue thaghostic sampling of ere with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its The extent of insterears ase. Therefore the extent of removal of the imaged mailmographic upportuitor. The extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not ablormanty, org, maily it is essential that the tissue margins be examined for mstologically 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)

Mark A. Milkerson

I. Restorative, and Neurological Devices

K040842

510(k) Number.