← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K211933 # EleVation Breast Biopsy System (K211933) _Bard Peripheral Vascular · KNW · Jul 15, 2021 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/KNW/K211933 ## Device Facts - **Applicant:** Bard Peripheral Vascular - **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md) - **Decision Date:** Jul 15, 2021 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The 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 essue margins be examined for completeness of removal using standard surgical procedures. ## Device Story Handheld, battery-powered, vacuum-assisted biopsy system; used with ultrasound guidance. Device comprises reusable driver and disposable probe with sample container. Enables single-insertion, multiple-sample collection for histologic examination. Used by clinicians in clinical settings to obtain tissue from breast or axillary lymph nodes. Provides tissue samples for diagnostic analysis; assists in partial or complete removal of imaged abnormalities. Benefits patients by facilitating minimally invasive diagnostic tissue acquisition. ## Clinical Evidence Bench testing only. No clinical data presented. Performance evaluated via software validation, penetration force, tensile testing, prime/pierce testing, reliability testing, and sample mass testing. ## Technological Characteristics Handheld, battery-powered, vacuum-assisted biopsy system. Components: reusable driver, disposable probe, sample container. Modifications include needle tip dimensional changes and venting hole adjustments. Software includes transportation indicator and enhanced logging. Sterilization method and patient-contacting materials remain consistent with predicate. ## Regulatory 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 - ELEVATION™ Breast Biopsy System ([K192948](/device/K192948.md)) ## Related Devices - [K192948](/device/K192948.md) — EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G · Bard Peripheral Vascular, Inc. · Nov 7, 2019 - [K093068](/device/K093068.md) — FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US · C.R. Bard, Inc. · Nov 10, 2009 - [K180233](/device/K180233.md) — Eviva Stereotactic Guided Breast Biopsy System · Hologic, Inc. · Apr 10, 2018 - [K013641](/device/K013641.md) — SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS · Senorx, Inc. · Jan 29, 2002 - [K210654](/device/K210654.md) — EnCor Breast Biopsy Probe with Rinse Tube · Senorx, Inc. · Mar 31, 2021 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 15, 2021 Bard Peripheral Vascular, Inc. Meghan Mckelvev Senior Regulatory Affairs Specialist 1625 W. 3rd Street Tempe, Arizona 85281 Re: K211933 Trade/Device Name: EleVation Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: June 21, 2021 Received: June 22, 2021 Dear Meghan Mckelvey: 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 mediation-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) K211933 Device Name EleVation Breast Biopsy System #### Indications for Use (Describe) The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The 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 essue margins be examined for completeness of removal using standard surgical procedures. 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 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}------------------------------------------------ # 510(k) Summary (K211933) 21 CFR 807.92 As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (()(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: | 602-830-5063 | | Fax: | 312-949-0436 | | Contact: | Meghan McKelvey, Senior Regulatory Affairs Specialist | | Date: | July 14, 2021 | #### 2. Subject Device: | Device Trade Name: | ELEVATIONTM Breast Biopsy System | |----------------------|---------------------------------------| | Classification Name: | Instrument, Biopsy (Product Code KNW) | | Review Panel: | Gastroenterology/Urology | | Regulation Number: | 21 CFR 876.1075 | ## 3. Predicate Device: ELEVATION™ Breast Biopsy System (K192948; cleared November 7, 2019) ## 4. Device Description: The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling during a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container. Image /page/3/Picture/13 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and connected, giving the word a unified appearance. The overall design is simple and modern. {4}------------------------------------------------ ## 5. Indications for Use of Device: The ELEVATION™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for 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. ## 6. Technological Comparison to Predicate Devices: The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following: - Intended Use - . Indications for Use - Performance Characteristics . - . Target Population - . Fundamental Scientific Technology - . Operating Principle (Mechanism of Action) - . Patient Contacting Materials - . Sterility Assurance Level and Method of Sterilization - . Shelf-Life - Packaging Configuration The subject device and the predicate device are different in the following manner: - . Software Modifications (Transportation Indicator and Enhanced Logging Capabilities) - . Needle Tip Modification (Needle Tip Dimensional Improvement and Venting Hole Change) - . Addition of Optional Accessories (Introducer Stylet, Half-Notch Support Cannula, Additional Sample Container) Image /page/4/Picture/22 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and modern appearance. The letters are closely spaced, creating a compact and unified design. {5}------------------------------------------------ ## 7. Performance Testing Summary: To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA Guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessments procedures, the following non-clinical tests were performed: - . Software Validation - . Penetration Force Testing - . Tensile Testing - Prime/Pierce Testing - Reliability Testing - . Sample Mass Testing The results demonstrate that the technological characteristics and performance criteria of the modified ELEVATION™ Breast Biopsy System is comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device. #### 8. Conclusion: The modified ELEVATION™ Breast Biopsy System is substantially equivalent to the legally marketed predicate device, the ELEVATION™ Breast Biopsy System (K192948). Image /page/5/Picture/14 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and geometric, with sharp angles and thick lines. The letters are evenly spaced and aligned horizontally, creating a clear and legible wordmark. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/KNW/K211933](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/KNW/K211933) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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