BD Trek Powered Bone Biopsy System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font than the rest of the text. The overall design is clean and professional, reflecting the FDA's role in regulating food and drugs in the United States. March 30, 2022 Bard Peripheral Vascular, Inc. Mrs. Kristen DeJeu, BSN, RN Sr. Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281 Re: K213896 Trade/Device Name: BD Trek™ Bone Marrow Biopsy System BD Trek™ Bone Lesion Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 24, 2022 Received: February 28, 2022 Dear Ms. DeJeu: 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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-device-advice-comprehensive-regulatoryassistance/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, Long Chen, Ph.D. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213896 #### Device Name BD Trek™ Bone Marrow Biopsy System BD Trek™ Bone Lesion Biopsy System #### Indications for Use (Describe) The BD Trek™ Bone Marrow Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Marrow Biopsy Kit) is intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older. The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Bone Lesion Biopsy Kit) is intended for bone biopsy of the vertebral body and bone lesions. The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver. BD Trek™ Bone Lesion Bionsy Kit) is intended for bone marrow aspiration and biopsy. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | |-----------------------------------------------------------------------------------------------| | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows two company logos. The first logo is for BD, which includes an orange sun-like symbol and the letters "BD" in blue. The second logo is for BARD, with the name in green and the tagline "has joined BD" in gray underneath. The logos suggest a connection or acquisition between the two companies. ## 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 as follows: ### 1. Submitter Information: | Applicant: | Bard Peripheral Vascular, Inc.<br>1625 West 3rd Street<br>Tempe, AZ 85281 | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone:<br>Fax: | (602) 894-9515<br>(312) 949-0436 | | Manufacturer/510(k)<br>Applicant: | Bard Peripheral Vascular, Inc.<br>1625 West 3rd Street<br>Tempe, AZ 85281<br>Contact: Mrs. Kristen DeJeu, BSN, RN<br>Title: Sr. Regulatory Affairs Specialist<br>Email: Kristen.DeJeu@bd.com<br>Phone: (602) 830-5333 | | Date: | 25 March 2022 | | 2. Subject Device Name: | | | Device Trade Name: | BD Trek™ Bone Marrow Biopsy System<br>BD Trek™ Bone Lesion Biopsy System | | Common or Usual Name: | Bone Marrow Biopsy Needle<br>Bone Biopsy and Biopsy Needle | | Classification: | Class II<br>KNW (Gastroenterology-urology biopsy instrument) | | Review Panel: | Gastroenterology / Urology | Regulation Number: 21 CFR 876.1075 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logos of BD and BARD. The BD logo is on the left and consists of an orange circle with a white design inside, followed by the letters "BD" in blue. The BARD logo is on the right and consists of the word "BARD" in green, with the words "has joined BD" in a smaller, lighter font below it. #### 3. Predicate Device: | Device Trade Name: | OnControl™ Bone Marrow Biopsy System by Vidacare™<br>OnControl™ Bone Access and Bone Biopsy System by Vidacare™ | |-----------------------|-----------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K142377, K113872 | | Common or Usual Name: | Bone Marrow Biopsy Needle, Cement Dispenser Conduit for Vertebroplasty and Bone Biopsy Needle | | Classification: | Class II KNW (Gastroenterology-urology biopsy instrument) | | Regulation Number: | 21 CFR 876.1075 | #### 4. Subject Indications for Use: The BD Trek™ Bone Marrow Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Marrow Biopsy Kit) is intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older. The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Lesion Biopsy Kit) is intended for bone biopsy of the vertebral body and bone lesions. The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Lesion Biopsy Kit) is intended for bone marrow aspiration and biopsy. #### 5. Subject Device Description: The BD Trek™ Bone Marrow Biopsy System and Bone Lesion Biopsy System consists of a variable speed Power Driver and compatible BD Trek™ Biopsy Kits. The BD Trek™ Power Driver is a handheld, battery-powered, reusable bone drill. The Power Driver has a variable speed function which is controlled by the amount of pressure applied to the trigger. Applying light pressure on the trigger activates the drill at a low speed and increasing trigger pressure activates higher speeds. Full depression of the trigger will activate the maximum speed. Full release of the trigger will stop the motor function. The BD Trek™ Bone Biopsy Kits are single-use bone biopsy kits designed exclusively for use with the BD Trek™ Power Driver. The BD Trek™ Power Driver is reusable and is supplied non-sterile. The BD Trek™ Bone Biopsy Kits are supplied sterile, non-pyrogenic, and are available in different needle gauge sizes and lengths. {5}------------------------------------------------ Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281 Image /page/5/Picture/2 description: The image shows the logos of two companies, BD and Bard. The BD logo is on the left and consists of an orange sun-like symbol and the letters "BD" in blue. The Bard logo is on the right and consists of the word "BAIRD" in green, with the text "has joined BD" in a smaller font below it. The image suggests that Bard has been acquired or merged with BD. ### 6. Technological Comparison to Predicate Device: The table below provides a technological comparison between the subject devices and the predicate devices. The information following the table provides a discussion between the similarities and differences of these devices. | | Characteristic | Predicate<br>OnControl™ Powered Bone Access<br>System<br>OnControl™ Bone Marrow Biopsy System -<br>K142377<br>OnControl™ Bone Access and Bone Biopsy<br>System - K113872 | Subject<br>BD Trek™ Powered Bone Biopsy<br>System<br>BD Trek™ Bone Marrow Biopsy System<br>BD Trek™ Bone Lesion Biopsy System | |-----------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 | | | Class | II | II | | | Primary FDA Product Code | KNW - Instrument, Biopsy | KNW - Instrument, Biopsy | | Indications<br>for Use | Bone Marrow | The OnControl™ Bone Marrow Biopsy<br>System is intended for bone marrow<br>aspiration and biopsy in adult and<br>pediatric patients age 2 and older. | The BD Trek™ Bone Marrow Biopsy<br>System is intended for bone marrow<br>aspiration and biopsy in adult and<br>pediatric patients age 2 and older. | | | Bone Lesion | The OnControl™ Bone Access and Bone<br>Biopsy System is intended for use with<br>a standard cement delivery system for<br>the fixation of fractures of the vertebral<br>body using vertebroplasty and/or for<br>bone biopsy of the vertebral body and<br>bone lesions. | The BD Trek™ Bone Lesion Biopsy<br>System is intended for bone biopsy of<br>the vertebral body and bone lesions.<br>The BD Trek™ Bone Lesion Biopsy<br>System is intended for bone marrow<br>aspiration and biopsy. | | Target<br>Population | Bone Marrow | Adult and pediatric patients needing<br>bone marrow aspiration or bone<br>marrow biopsy. | Adult and pediatric patients needing<br>bone marrow aspiration or bone<br>marrow biopsy. | | | Bone Lesion | Patients requiring fixation of fractures<br>of the vertebral body or bone biopsy. | Patients requiring bone biopsy.<br>Patients needing bone marrow<br>aspiration or bone marrow biopsy. | | | Fundamental Scientific<br>Technology | Power Driver with Needle Attachments | Power Driver with Needle<br>Attachments | | | Power Driver Design | Cordless, lithium battery-powered;<br>reusable with disposable sterile sleeve | Cordless, lithium battery-powered;<br>reusable with disposable sterile<br>sleeve | | | Power Driver Energy<br>Delivered | Non-Accessible, Internal, 18 V Lithium<br>Battery | Non-Accessible, Internal, 18 V Lithium<br>Battery | | | Power Driver<br>Cybersecurity/Interfaces | Does not contain any external wired<br>and/or wired communication<br>interfaces | Does not contain any external wired<br>and/or wired communication<br>interfaces | | | Characteristic | Predicate<br>OnControl™ Powered Bone Access<br>System<br>OnControl™ Bone Marrow Biopsy System -<br>K142377<br>OnControl™ Bone Access and Bone Biopsy<br>System - K113872 | Subject<br>BD Trek™ Powered Bone Biopsy<br>System<br>BD Trek™ Bone Marrow Biopsy System<br>BD Trek™ Bone Lesion Biopsy System | | | Needle Design | Sterile, single-use, disposable | Sterile, single-use, disposable | | | Operating Principle | Needle set attaches to battery-<br>powered driver | Needle set attaches to battery-<br>powered driver | | | Mode of Action | Single puncture, bone access, and<br>sample | Single puncture, bone access, and<br>sample | | | Energy Used / Delivered | Lithium battery provides rotational<br>kinetic energy to aid the physician in<br>inserting and advancing the needle<br>through cortical and/or cancellous<br>bone | Lithium battery provides rotational<br>kinetic energy to aid the physician in<br>inserting and advancing the needle<br>through cortical and/or cancellous<br>bone | | | Imaging Compatibility | X-Ray / CT and Ultrasound<br>Compatibility | X-Ray / CT and Ultrasound<br>Compatibility | | | Speed | Single-Speed | Variable | | | Power Driver Motor Braking | No Braking Feature | Braking Feature upon Trigger Release | | | Bone Marrow | OnControl™ Bone Marrow Biopsy Tray<br>1. Alignment Guide<br>2. Biopsy Needle<br>3. Depth Stop<br>4. Ejector Rod<br>5. Connector Hub with Sterile<br>Sleeve<br>6. Fenestrated Drape | BD Trek™ Bone Marrow Biopsy Kit<br>1. Ejector Guide<br>2. Biopsy Cannula and Stylet<br>(Needle Assembly)<br>3. Needle Grip<br>4. Ejector Rod<br>5. Manual Driver<br>6. Sterile Sleeve with Quick<br>Connect Hub<br>7. Fenestrated Drape | | Kit<br>Components | Bone Lesion | OnControl™ Bone Lesion Biopsy Tray<br>1. Transfer Rod<br>2. Bone Access Ejector Rod<br>3. Bone Access Needle Set<br>4. Bone Lesion Biopsy Needle<br>5. Bone Lesion Biopsy Ejector Rod<br>6. Depth Stop<br>7. Manual Handle<br>8. Connector Hub with Sterile Sleeve<br>9. Fenestrated Drape<br>10. Ejector Assist | BD Trek™ Bone Lesion Biopsy Kit<br>1. Transfer Rod<br>2. Introducer Ejector Rod<br>3. Introducer Cannula and<br>Stylet<br>4. Biopsy Cannula<br>5. Biopsy Ejector Rod<br>6. Needle Grip<br>7. Manual Driver<br>8. Sterile Sleeve with Quick<br>Connect Hub<br>9. Fenestrated Drape | | Gauge Sizes | Bone Marrow | Biopsy Cannula:<br>11G | Biopsy Cannula:<br>11G | | | Characteristic | Predicate<br>OnControl™ Powered Bone Access<br>System<br>OnControl™ Bone Marrow Biopsy System -<br>K142377<br>OnControl™ Bone Access and Bone Biopsy<br>System - K113872 | Subject<br>BD Trek™ Powered Bone Biopsy<br>System<br>BD Trek™ Bone Marrow Biopsy System<br>BD Trek™ Bone Lesion Biopsy System | | | Bone Lesion | Access Cannula:<br>10G and 11G<br>Biopsy Cannula:<br>12G and 13G | Introducer Cannula:<br>10G and 11G<br>Biopsy Cannula:<br>12G and 13G | | | Bone Marrow | Biopsy Needle Assembly:<br>102 and 152 mm | Biopsy Needle Assembly:<br>100 and 150 mm | | Overall<br>Needle<br>Assembly<br>Length | Bone Lesion | Bone Access Needle Assembly:<br>62, 102 and 152 mm | Introducer Needle Assembly:<br>60, 100 and 150 mm | | | | Biopsy Needle Assembly:<br>108, 148, and 198 mm | Biopsy Needle Assembly:<br>108, 148, 198 mm | | | Biopsy Kits - Sterility | Single Use, Ethylene Oxide | Single Use, Ethylene Oxide | | | Power Driver - Sterility | Reusable, non-sterile.<br>Used with Single Use Disposable Sterile<br>Sleeve with Connector Hub | Reusable, non-sterile.<br>Used with Single Use Disposable<br>Sterile Sleeve with Quick Connect Hub | | | Power Driver - Disinfection | Disinfected utilizing an antimicrobial<br>solution | Disinfected utilizing an antimicrobial<br>solution | {6}------------------------------------------------ ## K213896 ### Becton, Dickinson and Company Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281 Image /page/6/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized sunburst in orange on the left and the letters "BD" in blue on the right. The sunburst is made up of several triangular shapes radiating outward from a central point. The letters "BD" are in a bold, sans-serif font. Image /page/6/Picture/4 description: The image shows the BARD logo in green, with the text "has joined BD" in a smaller, gray font below it. The BARD logo is a stylized, bold typeface. The text "has joined BD" indicates a merger or acquisition of BARD by BD. {7}------------------------------------------------ #### K213896 #### Becton, Dickinson and Company Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281 Image /page/7/Picture/3 description: The image shows the logos of two companies. The first logo consists of an orange sun-like symbol next to the letters "BD" in blue. The second logo is a green letter "L". Image /page/7/Picture/4 description: The image shows the BARD logo in green, with the text "has joined BD" in gray underneath. The BARD logo is a stylized wordmark with a geometric design. The text "has joined BD" is smaller and in a different font than the BARD logo. The overall design is simple and clean. The predicate device is the OnControl™ Powered Bone Biopsy System, which is comprised of the OnControl™ Bone Marrow Biopsy System and the OnControl™ Bone Access and Bone Biopsy System. The OnControl™ Bone Biopsy System is referenced as the predicate device for the BD Trek™ Bone Biopsy System as it is the same or similar to the subject device in the following ways: - 1. Intended Use - 2. Indications for Use - a. The BD Trek™ Bone Marrow Biopsy System shares the same indications for use as the predicate's Bone Marrow Biopsy System. - b. The BD Trek™ Bone Lesion Biopsy System shares the same indications for use as the predicate, OnControl™ Bone Marrow Biopsy System, and also utilizes a subset of the indications from the predicate, the OnControl™ Bone Access and Bone Biopsy System. Indications for vertebroplasty have been omitted. - 3. Performance Characteristics - 4. Target Population - 5. Fundamental Scientific Technology - 6. Operating Principle, Mechanism of Action - Sterility Assurance Level and Method of Sterilization 7. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logos of two companies, BD and BARD. The BD logo is on the left and consists of an orange sun-like symbol and the letters BD in blue. The BARD logo is on the right and consists of the word BARD in green, with the words "has joined BD" in gray underneath. The subject device is different from the predicate device in the following ways: - 1. Combined Marrow/Lesion Indications for the BD Trek™ Bone Lesion Biopsy System - 2. Enhanced Power Driver Technology - a. Variable Speed Functionality: The subject device utilizes a variable speed Power Driver. The variable speed functionality was designed to allow the user to control the speed of the needle rotation depending on their needs and the type of procedure being performed. - Motor Brake Function: The subject device's brake control stops the needle b. rotation upon trigger release through dynamic braking. - ﻥ Reference LED Indicator that displays Relative Speed: The subject device utilizes a Reference LED indicator that displays motor state, battery life, and relative speed. - 3. Biopsy Kit Components - a. Optimized Biopsy and Introducer Cannula Dimensions and Tip Design: The subject device Biopsy and Introducer Cannulas feature enhanced designs for optimal sample acquisitions. - b. T-Handle Manual Driver: The subject device's Manual Driver is a T-Handle and attaches to the needle assembly via interfacing and a locking mechanism. - Quick Connect Release Mechanism: The subject device was designed to release C. the Needle Assembly from the Power Driver by retracting the Quick Connect Hub (in the same manner as the predicate device) or advancing the Release Arm forward. #### 7. Performance Data: To demonstrate that the BD Trek™ Powered Bone Biopsy System is as safe and effective as the predicate, the technological characteristics and performance criteria were evaluated. Using internal risk assessment procedures, tests of the following characteristics and performance criteria were performed on the subject device: - · Membrane Penetration Force - Tissue Sampling - Reliability Testing Sterile Sleeve - Tensile Strength Needle Hub - Dead Space Measurements - Luer Testing - · Creep Testing - Power Driver Battery Life - Power Driver Drive Adapter Reliability Additionally, biocompatibility testing was performed in accordance with ISO 10993-1 to demonstrate that the BD Trek™ Powered Bone Biopsy System is biocompatible for its intended use. Sterilization was performed in accordance with 11135:2014 to confirm the Sterility Assurance Level (SAL) of 10-6 for the BD Trek™ Biopsy Kits. Electromagnetic Compatibility and Electrical Safety Testing was performed on the BD Trek™ Power Driver in accordance with IEC 60601-1-2. The results from this testing demonstrate the BD Trek™ Power Driver meets electrical safety and performance requirements established, and acceptance criteria for all tests were met. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows two company logos. The first logo is for BD, featuring an orange sun-like symbol next to the blue letters "BD". The second logo is for BARD, with the letters "BARD" in green and the text "has joined BD" underneath in a smaller font size. The logos suggest a partnership or acquisition between the two companies. The subject device, BD Trek™ Bone Marrow Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Marrow Biopsy Kit) and BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Lesion Biopsy Kit), met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. ### 8. Conclusion: The subject device and the predicate device share or similar characteristics: intended use, indications for use, target population, conditions for use, and fundamental scientific technology. As such, Bard Peripheral Vascular, Inc. has demonstrated that the subject device BD Trek™ Bone Marrow Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Marrow Biopsy Kit) and BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver, BD Trek Bone Lesion Biopsy Kit) is substantially equivalent to the legally marketed predicate device OnControl™ Bone Marrow Biopsy System and OnControl™ Bone Access and Bone Biopsy System, respectively.