Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

K250032 · Bard Peripheral Vascular, Inc. · KNW · Jul 10, 2025 · Gastroenterology, Urology

Device Facts

Record IDK250032
Device NameMarquee™ Disposable Core Biopsy Instrument and Instrument Kit
ApplicantBard Peripheral Vascular, Inc.
Product CodeKNW · Gastroenterology, Urology
Decision DateJul 10, 2025
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 876.1075
Device ClassClass 2

Intended Use

The Marquee™ Disposable Core Biopsy Instrument and Kit are intended for use in obtaining biopsies from soft tissues such as breast, 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 instrument and kit; available in various needle gauges and lengths. Used by clinicians to obtain soft tissue samples from breast, liver, kidney, prostate, spleen, lymph nodes, and tumors. Device features color-coded coaxial cannula release for gauge identification. Operates via manual mechanical action to extract tissue cores. Provides diagnostic tissue samples for pathology analysis. Benefits patients by enabling minimally invasive tissue acquisition for disease diagnosis. Used in clinical settings.

Clinical Evidence

No clinical trials performed. Evidence includes bench testing (tensile strength, safety, reliability, sterile barrier integrity, shelf life, shipping/storage performance) and ex-vivo testing on porcine tissue to verify sample quality across 12G, 14G, and 20G models. Systematic literature review conducted to support breast biopsy indication.

Technological Characteristics

Single-use core biopsy instrument. Materials evaluated per ISO 10993-1:2018 (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity). Mechanical actuation. Color-coded coaxial cannula (yellow, pink, purple, green, light blue). Sterilized device.

Indications for Use

Indicated for obtaining biopsies from soft tissues including breast, 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

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 10, 2025 Bard Peripheral Vascular, Inc. Rachel Lapoint Regulatory Affairs Associate 1625 West 3rd Street Tempe, Arizona 85281 Re: K250032 Trade/Device Name: Marquee™ Disposable Core Biopsy Instruments and Kits (MQ1210, MQ1213, MQ1410, MQ1413, MQ1416, MQ1610, MQ1616, MQ1620, MQ1810, MQ1816, MQ1820, MQ1825, MQ2010, MQ2016, MQ2020, MQK1210, MQK1213, MQK1410, MQK1413, MQK1416, MQK1610, MQK1616, MQK1620, MQK1810, MQK1816, MQK1820, MQK1825, MQK2010, MQK2016, MQK2020) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: June 13, 2025 Received: June 13, 2025 Dear Rachel Lapoint: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250032 - Rachel Lapoint Page 2 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K250032 - Rachel Lapoint Page 3 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Carr -S Jessica Carr, PhD Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250032 Device Name Marquee™ Disposable Core Biopsy Instruments and Kits (MQ1210, MQ1213, MQ1410, MQ1413, MQ1416, MQ1610, MQ1616, MQ1620, MQ1810, MQ1816, MQ1820, MQ1825, MQ2010, MQ2016, MQ2020, MQK1210, MQK1213, MQK1410, MQK1413, MQK1416, MQK1610, MQK1616, MQK1620, MQK1810, MQK1816, MQK1820, MQK1825, MQK2010, MQK2016, MQK2020) Indications for Use (Describe) The Marquee™ Disposable Core Biopsy Instrument and Kit are intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. Type of Use (Select one or both, as applicable) ☑ 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 PRAStaff@fda.hhs.gov > "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." {4} K250032 Special 510(k): Device Modification Marquee™ Disposable Core Biopsy Instrument and Instrument Kit Page 1 of 3 # Marquee™ Disposable Core Biopsy Instrument and Instrument Kit 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 substantial equivalence determination is as follows: ## Submitter Information: Applicant: Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, Arizona 85281 Phone: (602) 830-5273 Contact Person: Rachel LaPoint, Regulatory Affairs Specialist Date of Submission: July 10, 2025 ## Subject Device Name: Device Trade Name: Marquee™ Disposable Core Biopsy Instrument and Instrument Kit Common or Usual Name: Instrument, Biopsy (Product Code: KNW) Classification: Class II Classification Name: Gastroenterology-Urology Biopsy Instrument Review Panel: Gastroenterology / Urology Regulation Number: 21 CFR 876.1075 ## Predicate Devices: Bard® Monopty® Disposable Core Biopsy Instrument (K133948, cleared February 21, 2014) Bard® Mission® Disposable Core Biopsy Instrument and Instrument Kit (K171953, cleared September 14, 2017) ## Device Description: The Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The coaxial cannula release is color coded according to the various gauge sizes, e.g., yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, green = 14 gauge, and light blue = 12 gauge. Bard Peripheral Vascular, Inc. BD {5} K250032 Special 510(k): Device Modification Marquee™ Disposable Core Biopsy Instrument and Instrument Kit Page 2 of 3 The Marquee™ Disposable Core Biopsy Instrument is available as a biopsy instrument only and as a kit, which includes the Marquee™ Disposable Core Biopsy Instrument and compatible Disposable Coaxial Biopsy Needle. ## Indications for Use: The Marquee™ Disposable Core Biopsy Instrument and Kit are intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. ## Technological Comparison to the Predicate Device: The technological characteristics of the subject device Marquee™ Disposable Core Biopsy Instrument and Instrument Kit are the same or similar as those of the predicate devices, Bard® Monopty® Disposable Core Biopsy Instrument and Bard® Mission® Disposable Core Biopsy Instrument and Instrument Kit: - Same intended use - Similar Indications for Use - Same patient population - Same principle of operation - Same duration of use - Similar device dimensions and materials - Same sterility assurance level and method of sterilization - Similar packaging configuration The subject device and predicate devices are different in the following manner: - New labeling with the same intended use and modifications to the Indications for Use Statement - Change in design (including patient/use interface, needle length, sample notch length, penetration depth) - Material changes including addition of colorants - Additional performance specifications - Addition of Convenience Kit ## Biocompatibility: Per ISO 10993-1:2018, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The following biocompatibility tests were successfully Bard Peripheral Vascular, Inc. BD {6} K250032 Special 510(k): Device Modification Marquee™ Disposable Core Biopsy Instrument and Instrument Kit Page 3 of 3 performed: - Cytotoxicity - Sensitization - Intracutaneous Reactivity - Acute System Toxicity - Material Mediated Pyrogenicity The results of biocompatibility testing demonstrate that the subject device Marquee™ is considered biocompatible for its intended use. ## Performance Data: To demonstrate that the subject device Marquee™ is as safe and as effective as the predicate device, its technological characteristics and performance criteria were evaluated. The following in vitro tests were performed on the subject device: - Number of Samples - Penetration Depths - Stylet / Cannula to Handle Tensile Strength - Coaxial Stylet to Hub Tensile Strength - Corresponding Working Needle Length and Cutting Cannula/Coaxial Cannula OD - Safety - Reliability - Integrity of the Sterile Barrier - Performance After Ship Testing - Needle Protection After Shipping and Storage - Shelf Life Additionally, ex-vivo testing was conducted on porcine tissue to determine sample quality using 12G, 14G, and 20G models of the Marquee™. A systematic literature review was conducted to support the addition of the breast biopsy indication with peer-reviewed published literature. ## Conclusion: Comparison of technological specifications and performance test data demonstrated that the subject device, the Marquee™ Disposable Core Biopsy Instrument and Instrument Kit, is substantially equivalent to the legally marketed predicate devices for the requested indications for use. Bard Peripheral Vascular, Inc. BD
Innolitics
510(k) Summary
Decision Summary
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