SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

K042136 · Sanarus Medical, Inc. · KNW · Sep 8, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042136
• Device Name: SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
• Applicant: Sanarus Medical, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination 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 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.

Device Story

The Sanarus Cassi Rotational Core Biopsy System is a biopsy instrument consisting of a sticking needle, cutting cannula, control unit, and specimen container. The system uses cold temperatures at the needle tip to engage target tissue. A coaxially mounted cutting cannula cores the tissue specimen. The device is operated by a clinician to obtain histologic samples from soft tissues or breast abnormalities. The output is a tissue core for histologic examination. The device facilitates diagnostic sampling and partial or complete removal of imaged breast abnormalities. It is intended for prescription use.

Clinical Evidence

Bench testing only. Performance testing confirmed that the quality of samples obtained with the Sanarus Cassi Rotational Core Biopsy System is equivalent to the predicate device.

Technological Characteristics

System includes a sticking needle, cutting cannula, control unit, and specimen container. Features include cryo-assisted tissue engagement at the needle tip and coaxial cutting cannula available in various gauges and lengths. Sterilization and packaging are equivalent to the predicate.

Indications for Use

Indicated for obtaining soft tissue biopsies (liver, kidney, prostate, spleen, lymph nodes, tumors) and diagnostic breast tissue sampling in patients with breast abnormalities. Contraindicated for use in bone.

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

• Sanarus Centrica™ II Rotational Core Biopsy System (K032506)

Submission Summary (Full Text)

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

Premarket Submission: Special 510k

Sanarus Cassi Rotational Core E

# Appendix A: 510k Summary of Safety and Effectiveness

### CONTACT INFORMATION

Trena Depel Director, Regulatory and Clinical Affairs Telephone: [phone], x-6715 FAX: [phone] e-mail: [e-mail]

#### COMPANY INFORMATION

Sanarus Medical, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588 Telephone: [phone] FAX: [phone]

#### DEVICE NAME

Sanarus Cassi™ Rotational Core Biopsy System

#### DEVICE DESCRIPTION

The Sanarus Cassi Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

#### INDICATIONS FOR USE

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination 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 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.

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

K042i36

Premarket Submission: Special 510k

Sanarus Cassi Rotational Core Biopsy

Page 2 of 2

## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

Sanarus Centrica™ II Rotational Core Biopsy System

### SUBSTANTIAL EQUIVALENCE

The Sanarus Cassi Rotational Core Biopsy System is substantially equivalent to the Centrica Rotational Core Biopsy System that was determined to be substantially equivalent on Oct 9, 2003 (reference K032506).

The Sanarus Cassi Rotational Core Biopsy System has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials for obtaining core biopsy samples in both the new and predicate device are the same. The packaqing materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent.

Based on the indications for use, technological characteristics and performance testing results, the Sanarus Cassi Rotational Core Biopsy System does not raise significant new questions of safety and effectiveness.

#### PERFORMANCE TESTING SUMMARY

Performance testing confirms that the quality of samples obtained with the Sanarus Cassi Rotational Core Biopsy System is equivalent to the predicate device.

{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, topped by a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Ms. Trena Depel Director, Regulatory and Clinical Affairs Medical, Inc. Sanarus 5880 W. Las Positas Blvd. Suite 52 PLEASANTON CA 94588

Re: K042136

Ro42130
Trade/Device Name: Sanarus Cassi™ Rotational Core Biopsy System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: 78 KNW Dated: August 6, 2004 Received: August 9, 2004

Dear Ms. Depel:

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 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 (21 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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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

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 mating of substantial equivalence of your device to a legally prematication. The Pice and 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 If you desire specific advise to your are of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on any prosse note the regulation entitled, "Misbranding Other of Onliphallos at (301) 21 11:53 Part 807.97) you may obtain. Other general by reletence to premarked nonmoution (er the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Section: http://www.fda.gov/cdch/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

l'age 2

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

Sanarus Cassi Rotational Core Biopsy System

# APPENDIX B: INDICATIONS FOR USE

510(k) Number: _ K042136

Device Name: Sanarus Cassi™ Rotational Core Biopsy System

Indications for Use: The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination 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 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.

Concurrence of CDRH, Office of Device Evaluation (ODE):

David A. Legum

(Division Sign-Off) Division of Reproductive Ahrinminal and Radiological Devices 510(k) Number ___

Prescription Use: × (Per 21 CFR 801.109)