Bard Mission Disposable Core Biopsy Instrument

K171953 · Bard Peripheral Vascular, Inc. · KNW · Sep 14, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171953
• Device Name: Bard Mission Disposable Core Biopsy Instrument
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Bard® Mission® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.

Device Story

Single-use, semi-automatic core biopsy instrument; used by clinicians to obtain soft tissue samples. Device features color-coded plungers for needle gauge identification (14G-20G), centimeter markings, and echogenic enhancement for ultrasound guidance. Operation involves manual insertion and spring-loaded firing mechanism to capture tissue in a specimen notch. Used in clinical settings for diagnostic biopsy procedures. Output is a tissue core sample for pathological analysis. Benefits include standardized, minimally invasive tissue acquisition for disease diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included penetration depth, tensile strength, sterile barrier integrity, and performance after shipping/storage. Biocompatibility testing performed per ISO 10993-1:2009, including cytotoxicity, sensitization, intracutaneous reactivity, and material-mediated pyrogenicity.

Technological Characteristics

Semi-automatic spring-loaded core biopsy instrument. Materials evaluated per ISO 10993-1:2009. Features include centimeter markings, echogenic enhancement, and color-coded plungers. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for obtaining biopsy samples from soft tissues including lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and soft tissue tumors in patients requiring tissue sampling.

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

• M-Biopsy™ Semi-Automatic Biopsy Instrument (K161409)
• BARD® MONOPTY® and BARD® MAX-CORE® Disposable Core Biopsy Instruments (K133948/S001)

Reference Devices

• POWERGLIDE® Midline Catheter (K121073)
• ULTRACLIP® DUAL TRIGGER Breast Tissue Marker (K042341)
• ENCOR® Breast Biopsy System (K051158)
• SIDEKICK® and USHER® Support Catheters (K131493)

Submission Summary (Full Text)

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

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

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

September 14, 2017

Bard Peripheral Vascular, Inc. % Mark Job Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K171953

Trade/Device Name: Bard® Mission® Disposable Core Biopsy Instrument Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: September 5, 2017 Received: September 6, 2017

Dear Mark Job:

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.

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

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Joyce M. Whang -S

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

{2}------------------------------------------------

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K171953

Device Name

Bard® Mission® Disposable Core Biopsy Instrument

Indications for Use (Describe)

The Bard® Mission® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

### BARD® MISSION® Disposable Core Biopsy Instrument 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 510(k) summary upon which substantial equivalence determination is based is as follows:

## Submitter Information:

| Applicant: | Bard Peripheral Vascular, Inc |
|------------|-------------------------------|
| | 1625 West 3rd Street |
| | Tempe, Arizona 85281 |

| Phone: | 480-350-6067 |
|----------|-----------------------------------------------|
| Fax: | 480-449-2570 |
| Contact: | Susan Sheffield, Regulatory Affairs Associate |
| Date: | 15 May 2017 |

### Subject Device Name:

| Device Trade Name: | Bard® Mission® Disposable Core Biopsy Instrument |
|-----------------------|--------------------------------------------------|
| Common or Usual Name: | Core Biopsy Instrument |
| Classification: | Instrument, Biopsy (Product Code KNW); Class II |
| Review Panel: | Gastroenterology / Urology |
| Regulation Number: | 21 CFR 876.1075 |

#### Predicate Devices:

- M-Biopsy™ Semi-Automatic Biopsy Instrument by Mermaid ● Medical (K161409; cleared 2 August 2016)
- . BARD® MONOPTY® and BARD® MAX-CORE® Disposable Core Biopsy Instruments (K133948/S001; cleared 21 February 2014)

#### Reference Devices:

- POWERGLIDE® Midline Catheter (K121073; cleared 1 June 2012) .
- ULTRACLIP® DUAL TRIGGER Breast Tissue Marker (K042341; 20 September . 2004)
- ENCOR® Breast Biopsy System (K051158; 16 May 2005)
- . SIDEKICK® and USHER® Support Catheters (K131493; cleared 2 August 2013)

The purpose of the secondary predicate device BARD® MAX-CORE®/MONOPTY® is to highlight similarities to the branding for BARD® disposable core biopsy devices. The reference

Image /page/3/Picture/17 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are a solid green color. The "A" in "BARD" is unique, as it is formed by two triangles that meet at the top, creating a sharp, angular shape. The letters are bold and evenly spaced, giving the word a strong and balanced appearance.

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

devices are included to provide sufficient evidence for the safe usage of the materials found in BARD® MISSION®.

## Device Description:

The subject device BARD® MISSION® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g. yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, and green = 14 gauge.

## Indications for Use of Device:

The BARD® MISSION® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as from the lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.

## Technological Comparison to Predicate Device:

The subject device BARD® MISSION® has the following similarities to the primary predicate device M-Biopsy™:

- Same class and regulation number
- Same Intended Use ●
- Similar Indications for Use ●
- 0 Same Target Population/Conditions of Use (anatomical location of use, user interface, how device interacts with other devices, interaction with patient, etc.)
- Same Fundamental Scientific Technology, including Design, Mechanism/Mode of Action, and Energy Used/Delivered)
- . Same catalogue offerings, including Gauge Size, Needle Length, and Penetration Depth
- . Similar design features, such as Centimeter Markings, Grip Design, Color Coding, and Echogenicity
- . Same imaging capabilities

The subject device BARD® MISSION® Disposable Core Biopsy Instrument incorporates the following differences:

- Slight alterations to the language used in the Indications for Use in order to maintain . consistency in branding for the BARD® Disposable Core Biopsy products
- Different dimensions of the Specimen Notch used to collect the biopsy sample o
- Differences in design, such as the Finger Grips and Fire Ready Indicator .
- Unknown differences, such as: ●
- Color Coding o
- Echogenic Enhancement o
- Sterility Assurance o

Image /page/4/Picture/24 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are a solid green color. The letters are bold and have a uniform thickness. The overall impression is clean and modern.

{5}------------------------------------------------

### Performance Data:

To demonstrate that the subject device BARD® MISSION® is as safe and as effective as the predicate device M-Biopsy™, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:

- Number of Samples
- · Penetration Depths
- Stylet / Cannula to Handle Tensile Strength
- Corresponding Working Needle Length and Cutting Cannula OD, and Stylet/Cannula Working Needle Lengths
- Integrity of the Sterile Barrier
- · Performance After Ship Testing
- Needle Protection After Shipping and Storage

The results from bench testing demonstrate that the subject device BARD® MISSION® performed as expected according to the technological characteristics and performance requirements of C.R. Bard; and thus, can be concluded as comparable to other semiautomatic core biopsy devices on the market, demonstrating the subject device BARD® MISSION® to be as safe, as effective, and performs as well as the legally marketed device M-Biopsy™.

## Biocompatibility:

Per ISO 10993-1:2009, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The following biocompatibility tests were successfully performed and/or adopted in accordance with GLP regulations:

- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity ●
- o Material Mediated Pyrogenicity

The results of biocompatibility testing demonstrate that the subject device BARD® MISSION® is considered biocompatible for its intended use.

## Conclusions:

The subject device, BARD® MISSION® Disposable Core Biopsy Instrument, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. Likewise, the subject device BARD® MISSION® and the predicate device M-Biopsy™ share the same or similar characteristics: intended use, indications for use, target population / conditions for use, and fundamental scientific technology. Therefore, Bard concludes that the subject device BARD® MISSION® Disposable Core Biopsy Instrument is substantially equivalent to the legally marketed predicate device M-Biopsy™ Semi-Automatic Biopsy Instrument.

Image /page/5/Picture/20 description: The image shows the word "BARD" in a stylized, sans-serif font. The color of the text is a dark green. The letters are bold and have a slightly geometric appearance. The background is white.