FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)

K103359 · C.R. Bard, Inc. · KNW · Dec 27, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K103359
• Device Name: FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
• Applicant: C.R. Bard, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The modified FINESSE™ Ultra Breast Biopsy System Driver is intended to obtain soft tissue samples for diagnostic and histological analysis of breast abnormalities.

Device Story

Handheld, reusable, electro-mechanical vacuum-assisted breast biopsy driver; powered by rechargeable lithium-ion battery. Operates with FINESSE™ Ultra Breast Biopsy System probe to collect soft tissue samples for diagnostic/histologic analysis. Used by clinicians in breast biopsy procedures. Software manages driver-probe alignment; updates allow recovery from non-clinically relevant errors and facilitate software updates via IR port. Output is tissue sample for pathology. Benefits include diagnostic tissue acquisition for breast abnormality assessment.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Electro-mechanical vacuum-assisted biopsy driver; rechargeable lithium-ion battery; handheld form factor. Software-controlled alignment and error recovery. IR port for software updates. Non-sterile.

Indications for Use

Indicated for obtaining tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities and histologic examination, including partial or complete removal of imaged abnormalities. Not intended to predict the extent of removal of histologic malignancy based on mammographic appearance. Requires surgical examination of margins if samples are not histologically benign.

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

• FINESSE™ Ultra Breast Biopsy System (K093068)

Submission Summary (Full Text)

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## Modified FINESSE™ Ultra Breast Biopsy System Driver

510(k) Summary of Safety and Effectiveness 21 CFR 807.92

DEC 2 7 2010

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:

#### Submitter Information:

| Applicant: | Bard Peripheral Vascular, Inc<br>1415 West 3rd Street<br>P.O. Box 1740<br>Tempe, Arizona 85281 |
|------------|------------------------------------------------------------------------------------------------|
| Phone: | 480-379-2836 |
| Fax: | 480-449-2546 |
| Contact: | Cindy Moss, Project Manager, Regulatory Affairs |
| Date | November 15, 2010 |

## Subject Device Name:

| Device Trade Name: | Modified FINESSE™ Ultra Breast Biopsy<br>System Driver |
|-----------------------|----------------------------------------------------------|
| Common or Usual Name: | Biopsy Instrument (21 CFR 876.1075, Product<br>Code KNW) |
| Classification: | Class II |
| Classification Panel: | Gastroenterology/Urology |

#### Predicate Device:

:

- · FINESSE™ Ultra Breast Biopsy System (K093068, cleared November 10, 2009), manufactured by Bard Peripheral Vascular, Inc.
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#### Device Description:

The subject device, the modified FINESSE™ Ultra Breast Biopsy System Driver, is a non-sterile, self-contained, handheld, reuseable, electro-mechanical vacuum-assisted breast biopsy device that utilizes a rechargeable lithium-ion battery. The driver is designed to operate safely when used with the FINESSE™ Ultra Breast Biopsy System probe for diagnostic sampling of tissue during a breast biopsy procedure.

#### Intended Use of Device:

The modified FINESSE™ Ultra Breast Biopsy System Driver is intended to obtain soft tissue samples for diagnostic and histological analysis of breast abnormalities.

#### Indications for Use of Device:

The FINESSE™ Ultra Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended 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

#### Technological Comparison to Predicate Devices:

The modified FINESSE™ Ultra Breast Biopsy System Driver is identical to the predicate devices in the following ways:

- . Intended Use
- . Indications for Use
- Target Population .
- Fundamental Scientific Technology .
- . Operating Principle
- Driver Mechanical Design .
- Performance Characteristics .

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The subject device and the predicate device are different in the following way:

- . Software
- o Modifications to address errors resulting from out of alignment issues between driver and probe components. The software updates will allow the device to recover from non-clinically relevant errors and make the device easier to use.
- o Modification to allow use of the current IR port to update software

## Performance Data:

The Modified FINESSE™ Ultra Breast Biopsy System Driver was evaluated via data collected from bench testing, and the data demonstrate that the Modified FINESSE™ Ultra Breast Biopsy System Driver is substantially equivalent to the predicate device. The testing performed was that which was identified during the Risk Assessment and Design Failure Modes and Effects Analysis.

## Conclusions:

The Modified FINESSE™ Ultra Breast Biopsy System Driver met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The modified FINESSE™ Ultra Breast Biopsy System Driver is substantially equivalent to the legally marketed predicate device, the driver of the FINESSE™ Ultra Breast Biopsy System.

Image /page/2/Picture/12 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are evenly spaced and of uniform size, creating a balanced and legible wordmark.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

C. R. Bard. Inc. Bard Peripheral Vascular, Inc. % Ms. Cindy Moss Regulatory Affairs Project Manager 1415 West Third Street Tempe, Arizona 85281

# DEC 2 7 20:0

Re: K103359

Trade/Device Name: FINESSE™ Ultra Breast Biopsy System Driver Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: December 15, 2010 Received: December 16, 2010

Dear Ms. Moss:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Ms. Cindy Moss

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Chaloff

fs

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

DEC 2 7 2010

510(k) Number (if known): 16 10 3359

Device Name: FINESSE™ Ultra Breast Biopsy System Driver

Indications for Use: The FINESSE™ Ultra Breast Biopsy System Driver is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended 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 (Part21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 11.2 1.0. 892 far Mxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103359

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