SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012

K080171 · Sanarus Medical, Inc. · KNW · Mar 6, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080171
• Device Name: SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
• Applicant: Sanarus Medical, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Mar 6, 2008
• Decision: SESE
• Submission Type: Traditional
• 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

Sanarus InCore Rotational Core Biopsy System; consists of integrated control unit, sticking needle, cutting cannula, sample collection tray. Sticking needle uses cold temperatures at tip to engage tissue; coaxially mounted cutting cannula cores tissue specimen. Available in various gauge sizes/lengths. Used by clinicians for soft tissue and breast biopsies. Provides tissue samples for histologic examination; allows partial or complete removal of imaged abnormalities. Output is physical tissue specimen for pathology. Benefits patient by enabling diagnostic sampling of abnormalities.

Clinical Evidence

Bench testing only. Performance testing confirms quality of samples obtained is equivalent to predicate device.

Technological Characteristics

System includes control unit, sticking needle, cutting cannula, and sample collection tray. Coaxial design. Cold-tip tissue engagement. Available in multiple gauge sizes and lengths. Sterilization method equivalent to predicate.

Indications for Use

Indicated for obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, soft tissue tumors) and diagnostic sampling of breast abnormalities. Not 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

• Cassi II Rotational Core Biopsy System (K051581)

Submission Summary (Full Text)

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# SECTION 5: 510(K) SUMMARY

#### Contact Information

Lisa Henry Manager, Regulatory & Clinical Affairs Telephone: [phone] FAX: [phone] E-mail: [e-mail]

MAR - 6 2008

#### Company Information

Sanarus Medical, Inc. 4696 Willow Road Pleasanton, CA 94588 Telephone: [phone] FAX: [phone]

### Device Name

Sanarus InCore Rotational Core Biopsy System

#### Device Description

The Sanarus InCore Rotational Core Biopsy System consists of a fully integrated control unit, sticking needle, cutting cannula and sample collection tray. 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.

#### Name of Predicate or Legally Marketed Device

Sanarus InCore Rotational Core Biopsy System

Sanarus Medical CONFIDENTIAL

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SC 171

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## Substantial Equivalence

The Sanarus InCore Rotational Core Biopsy System is substantially equivalent to the Cassi II Rotational Core Biopsy System that was determined to be substantially equivalent on July 27, 2005 (reference K051581).

The Sanarus InCore 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 packaging 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 InCore 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 InCore Rotational Core Biopsy System is equivalent to that of the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Lisa Henry Manager, Clinical and Regulatory Affairs Sanarus Medical, Incorporated 4696 Willow Road PLEASANTON CA 94588

Re: K080171

Trade/Device Name: Sanarus InCore™ Rotational Core Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: January 23, 2008 Received: January 24, 2008

Dear Ms. Henry:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The central element is the acronym "FDA" in a stylized font, with the words "Centennial" written below it in a cursive font. Above the "FDA" acronym, the years "1906-2006" are displayed. The entire design is surrounded by a circular border with text along the top and bottom, and stars are placed at the bottom of the central design.

*Protecting and Promoting Public Health*

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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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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

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## SECTION 4: INDICATIONS FOR USE STATEMENT

Ko80171 510(k) Number:

Device Name: Sanarus InCore 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.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices Section 4 Page 1 510(k) Number_

Sanarus Medical CONFIDENTIAL