SUREcore Plus Biopsy Instrument

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. December 2, 2022 Uro-1, Inc. Thomas Lawson Regulatory Consultant 3701-A Alliance Drive Greensboro, North Carolina 27407 Re: K220611 Trade/Device Name: SUREcore Plus Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 28, 2022 Received: March 3, 2022 Dear Thomas Lawson: 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). 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Sincerely, Image /page/1/Picture/5 description: The image shows the name "Jessica Carr -S" in a large, bold font. The name is written in black and is centered in the image. The background of the image is a light blue color. The text is clear and easy to read. for Long Chen 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) K220611 #### Device Name SUREcore Plus Biopsy Instrument #### Indications for Use (Describe) The SUREcore Plus Biopsy Instrument is intended for use in obt tissue such as liver, kidney, and prostate. It is not intended for use in bone. | 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 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."* Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # SECTION 5. # 510(k) SUMMARY # General Information | Submitter | Uro-1, Inc. | |-----------------------|---------------------------------------------------------| | Address | 3703-A Alliance Drive<br>Greensboro, NC 27404 | | Correspondence Person | Thomas Lawson, PhD<br>Regulatory Affairs<br>Uro-1, Inc. | | Contact Information | Email: drthomlawson@gmail.com<br>Phone: 510-206-1794 | | Date Prepared | 1 December 2022 | ## Proposed Device | Trade Name | SUREcore Plus Biopsy Instrument | |----------------------------------------------|---------------------------------------------------------------| | Common Name | SUREcore Plus | | Regulation Number and<br>Classification Name | 21 CFR§876.1075 Gastroenterology-urology biopsy<br>instrument | | Product Code | KNW | | Regulatory Class | II | ## Predicate Device | Trade Name | Max-Core Biopsy Instrument | |--------------------------------------------------------------------------|-------------------------------------------------| | Common Name | Max-Core | | Premarket Notification | K133948 | | Regulation Number and | 21 CFR§876.1075 Gastroenterology-urology biopsy | | Classification Name | instrument | | Product Code | KNW | | Regulatory Class | II | | Note: This predicate device has been subject to a design-related recall. | | {4}------------------------------------------------ ### Device Description The SUREcore Plus biopsy instrument facilitates collection of tissue for analysis by pathology in order to assist with a diagnosis of a disease condition in a patient. The SUREcore Plus device consists of two elements: (1) a handle and (2) a needle set. The handle contains springs that energize the biopsy needles and when used will cause rapid advance of the needles into target tissue. This action causes tissue to be held within a component of the needle (the core collector) intact from the body. The tissue samples are removed from the needle set and prepared for transfer to a pathologist or lab. The user can re-energize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue. When the user has determined that sufficient amount of tissue has been obtained, the SUREcore Plus device is disposed in accordance with local and facility policies and procedures. The device is single-use only and is not to be resterilized by the user. #### Indications for Use The indication for use for the SUREcore Plus biopsy instrument is: The SUREcore Plus biopsy instrument is intended for use in obtaining biopsies from soft tissue such as liver, kidney, and prostate. It is not intended for use in bone. ### Comparison to the Predicate Device Uro-1, Inc. has identified the Max-Core Biopsy Instrument (Bard Medical) as the predicate device. The SUREcore Plus Biopsy Instrument is substantially equivalent to the predicate device based upon the following similarities: - 1. The intended use of both the predicate device and the SUREcore Plus device are equivalent for the two devices, which is to obtain biopsies from soft tissues such as liver, kidney, and prostate. Neither are not intended for use in bone. - Both devices introduce a biopsy needle into the body under imaging control (e.g., 2. ultrasound, X-Ray, CT, etc.) - 3. Both devices are designed to collect multiple samples. - Both devices are made from biocompatible materials. 4. {5}------------------------------------------------ Table 1 shows the comparison of the SUREcore Plus Biopsy Instrument (the subject of this submission) to the predicate device, Max-Core Biopsy Instrument (K133948). The similarities between the two devices satisfy the criteria for a 510(k) notice. | | Subject device | Predicate device | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | | SUREcore Plus<br>Biopsy Instrument<br>URO-1, Inc.<br><br>(this submission) | Max-Core Biopsy<br>Instrument<br>Bard Medical<br>(K133948) | | Indication for use | For use in obtaining<br>biopsies from soft<br>tissues | Same | | Intended use | The introduction of<br>the needle into the<br>body should be<br>carried out under<br>imaging control<br>(ultrasound, X-Ray,<br>CT, etc.). It is<br>provided sterile for<br>single use. | Same | | Route of<br>advancement | Percutaneous | Same | | Target populations | Male & Female | Same | | Location of biopsy | Liver, kidney,<br>and prostate. | Liver, kidney, prostate,<br>spleen, lymph nodes and<br>various soft tissue<br>tumors. | | Site of use | Hospitals, clinics,<br>and physician<br>offices | Same | | Device Features | | | | Components | (1) Handle<br>(2) Needle set consisting<br>of a core collector<br>and an outer cannula | Same | | Dimension of the handle | 5.5 in X 1.5 in X 1 in | 6 in X 1.4 in (cylinder diameter) | | Mechanics of energizing the needle | 2-stroke cocking action (using a lever on the handle) | Same | | Mechanics of releasing the needle to puncture tissue | Pressing on an activator button on the handle | Same | | Size of needle | 18 gauge | 14 to 20 ga | | Length of needle tissue collection trough (sample notch) | 19 mm | Same | | Length of needle assembly | 10-25 cm | Same | | <b>Performance</b> | | | | Depth of penetration | 22 mm | Same | | Sterilization | Gamma Radiation | ETO | | Frequency of use | Single patient use | Same | | Tissue contact materials | Compliant with ISO 10993 | Same | Table 1. Comparison of the SUREcore Plus Biopsy Instrument to the predicate device, the Bard Max-Core Biopsy Instrument. {6}------------------------------------------------ ## Comparison of Technological Characteristics with the Predicate Device The technological characteristics of the subject device are substantially equivalent to those of the predicate device in terms of the following: - . Equivalent intended use; - Equivalen indications for use; ● - Similar penetration depth; - Similar sample notch; . - Same mechanics of action; ● - Same mode of action; - Same energy used/delivered; - . Similar patient-contacting materials; - . Same fundamental scientific technology; - . Same patient population; - Single-use device; . {7}------------------------------------------------ - Supplied sterile; and ● - Similar packaging. #### Performance Data The performance testing conducted establishes that SUREcore Plus Biopsy Instrument does not raise new questions of the safety and effectiveness for a biopsy system. #### Biocompatibility testing The handle of the SUREcore Plus Biopsy Instrument does not come into contact with the patient, but it has been assessed for cytotoxicity and found to pass such testing. The VMCore needle set does contact patient tissue and passed all tests, as noted in K201650: - Cytotoxicity, O - O Sensitization, - Irritation, and O - Systemic toxicity. o In this respect, the VMCore needle set is a reference device for the biocompatibility information for this submission related to the needle set. ### Electrical safety and electromagnetic compatibility (EMC) The subject and predicate devices do not have electronic components, so such testing was not required. ### Software Verification and Validation Testing Neither the subject nor predicate devices contain software. ### Mechanical Testing The mechanical testing of the subject device included: - . Capacity to collect tissue in ex vivo models of liver, kidney & prostate tissue, and - Force necessary to deform the needle set. {8}------------------------------------------------ #### Preclinical (Animal) Studies Bench testing was sufficient to demonstrate performance of the device. No preclinical testing of the subject device was necessary. #### Clinical Studies Bench testing was sufficient to demonstrate performance of the device. No clinical testing of the subject device was necessary. #### Conclusion The information submitted in this premarket notification confirms that the SUREcore Plus Biopsy Instrument raises no new questions of safety and effectiveness and that the SUREcore Plus Biopsy Instrument is substantially equivalent to the predicate device.