BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT

K133948 · Bard Peripheral Vascular, Inc. · KNW · Feb 21, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133948
• Device Name: BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The core needle biopsy device is intended 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.

Device Story

Single-use core biopsy instruments (Monopty and Max-Core) designed for soft tissue sampling. Devices feature color-coded actuator buttons corresponding to needle gauge sizes (12G to 20G). Operated manually by clinicians to obtain tissue samples from liver, kidney, prostate, spleen, lymph nodes, or tumors. Mechanical action facilitates core tissue extraction. Used in clinical settings for diagnostic biopsy procedures. Benefits include standardized, disposable access to soft tissue samples for pathological evaluation.

Clinical Evidence

Bench testing only. Testing included dimensional analysis, sample quality, durability, needle-to-device tensile strength, and echogenicity. No clinical data provided.

Technological Characteristics

Single-use, manual core biopsy instruments. Available in multiple needle gauges (12G-20G) and lengths. Color-coded actuators for gauge identification. Mechanical spring-loaded or manual actuation. Sterile, disposable. No software or electronic components.

Indications for Use

Indicated for obtaining biopsies from soft tissues including liver, kidney, prostate, spleen, lymph nodes, and soft tissue tumors. 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

• Bard® Monopty® Disposable Core Biopsy Instrument (K922939)

Submission Summary (Full Text)

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FEB 2 1 2014 Page 29 of 106

# 510(k) Summary 21 CFR 807.92

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

## 1. Submitter Information:

| Applicant: | Bard Peripheral Vascular, Inc.<br>1625 West 3rd Street<br>Tempe, Arizona 85281 |
|------------|--------------------------------------------------------------------------------|
| Phone: | 480-638-2954 |
| Fax: | 480-449-2546 |
| Contact: | Sarah McCartney, Regulatory Affairs Specialist |
| Date: | January 23, 2014 |

# 2. Subject Device:

| Device Trade Name: | Bard® Monopty® Disposable Core Biopsy Instrument<br>Bard® Max-Core® Disposable Core Biopsy Instrument |
|-----------------------|-------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Core Biopsy Instrument |
| Classification: | Class II |
| Classification Name: | Instrument, Biopsy (Product Code KNW) |
| Review Panel: | Gastroenterology / Urology |
| Regulation Number: | 21 CFR 876.1075 (Gastroenterology-urology biopsy instrument) |

# 3. Predicate Device:

The predicate device is the Bard® Monopty® Disposable Core Biopsy Instrument, K922939, cleared February 16, 1993.

# 4. Summary of Change:

This Special 510(k) provides an updated file to FDA including several changes that have occurred to the subject device since the predicate submission. These changes include updates to the labeling and the addition of a needle gauge size, addition of needle lengths, and addition of performance specifications.

TRADE SECRET/CONFIDENTIAL INFORMATION Notify C. R. Bard Before Releasing this Document.

Image /page/0/Figure/15 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and blocky, with a thick black outline. The letters are closely spaced, creating a compact and unified appearance.

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## 5. Subject Device Description:

### Bard® Monopty® Disposable Core Biopsy Instrument

The Bard® Monopty® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow = 20 gauge, Pink = 18 gauge, Purple = 16 gauge and Green = 14 gauge, and Light Blue = 12 gauge.

## Bard® Max-Core® Disposable Core Biopsy Instrument

The Bard® Max-Core® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes, e.g., Yellow = 20 gauge, Pink = 18 gauge, Purple = 16 gauge and Green = 14 gauge.

#### 6. Indications for Use of Device:

The core needle biopsy device is intended 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.

#### 7. Technological Comparison to Predicate Devices:

The technological characteristics of the subject devices are substantially equivalent to those of the predicate device, in terms of following:

- Same intended use .
- Same indications for use .
- Similar penetration depth .
- Similar sample notch .
- Same number of samples .
- Same mechanics of action .
- Same mode of action .
- Same energy used / delivered .
- Same patient-contacting materials .
- Same fundamental scientific technology .

TRADE SECRET/CONFIDENTIAL INFORMATION Notify C. R. Bard Before Releasing this Document.

Image /page/1/Figure/24 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. The image is simple and clear, with a focus on the word itself.

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- . Same patient population
- Same sterility .
- Similar packaging configuration �

When reviewing the changes from the predicate submission, the subject devices and the predicate device are different in the following manner:

- Updated labeling .
- . Addition of needle gauge size
- . Addition of needle lengths
- Addition of performance specifications .

#### 8. Performance Testing Summary:

To verify that the device design met its functional and performance requirements, representative samples of the device underwent bench testing (dimensional, sample quality, durability, needle to device tensile strength, and echogenicity). Results of this testing demonstrate that the design outputs continue to meet the design inputs and user need requirements.

#### 9. Conclusion:

Bard Peripheral Vascular, Inc. considers the subject devices to be substantially equivalent to the predicate device.

TRADE SECRET/CONFIDENTIAL INFORMATION Notify C. R. Bard Before Releasing this Document

BARD

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Image /page/3/Picture/0 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 an abstract symbol that resembles a stylized human figure with outstretched arms.

Public Health Service

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

February 21, 2014

Bard Peripheral Vascular, Inc. Sarah McCartney Regulatory Affairs Specialist 1625 West 3rd Street Tempe, AZ 85281

Re: K133948

> Trade/Device Name: Bard® Monopty® Disposable Core Biopsy Instrument Bard® Max-Core® Disposable Core Biopsy Instrument Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: January 27, 2014 Received: January 28, 2014

Dear Sarah McCartney,

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. 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.

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.

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Page 2 - Sarah McCartney

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 (OS) 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.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black, and the background is white. The letters "P.L" are surrounded by a decorative, circular pattern.

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K133948 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Bard® Monopty® Disposable Core Biopsy Instrument<br>Bard® Max-Core® Disposable Core Biopsy Instrument |
| Indications for Use: | The core needle biopsy device is intended for use in<br>obtaining biopsies from soft tissues such as liver, kidney.<br>prostate, spleen, lymph nodes and various soft tissue<br>tumors. It is not intended for use in bone. |

X Prescription Use (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)

Herbert Prefer 2014.02.21 -05'00'