Marrow Marxman

{0}  Medimetrix, LLC % Christine Scifert Partner MRC Global 9160 Hwy. 64, Suite 12 P.O. Box 330 Lakeland, Tennessee 38002 August 4, 2026 Re: K260572 Trade/Device Name: Marrow Marxman Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: July 6, 2026 Received: July 6, 2026 Dear Christine Scifert: 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260572 - Christine Scifert Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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 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- {2} K260572 - Christine Scifert Page 3 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, Colin K. Chen -S Digitally signed by Colin K. Chen -S Date: 2026.08.04 16:04:24 -04'00' Colin Kejing Chen, Ph.D. Acting 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. 510(k) Number (if known) K260572 Device Name Marrow Marxman Indications for Use (Describe) The Marrow Marxman is intended for aspiration of bone marrow or autologous blood using a standard piston syringe. 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."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K260572 Page 1 of 3 ### 510(k) Summary Marrow Marxman 31 July 2026 Company: Medimetrix LLC 3012 Centre Oak Way Suite 102 Germantown, TN 38138 Primary Contact: Christine Scifert – Partner MRC Global 9160 Hwy 64, Ste 12 PO Box 330 Lakeland, TN 38002 Phone: (901) 831-8053 Email: christine.scifert@AskMRCGlobal.com Company/Secondary Brian Austin Contact: Medimetrix, LLC Managing Member Phone: 901-748-2581 brian@austinmedco.com Trade Name: Marrow Marxman Common Name: Instrument, Biopsy Classification: Class II Regulation: 21 CFR 876.1075 – Gastroenterology-urology biopsy instrument Panel: Gastroenterology & Urology Product Code: KNW Primary Predicate: Ranfac Lateral Access Bone Marrow Aspiration Needle – K223612 ### Device Description: The Marrow Marxman is a manual, sterile disposable flexible cannula intended for the purposes of aspirating bone marrow or autologous blood. The device consists of a flexible shaft with trocar installed, pusher rod for removing clogs, and a 4.75mm drill with depth stop. The Marrow Marxman flexible cannula with sharp tip and trocar installed penetrates bone and bone marrow with the aspirate obtained through the flexible cannula after the trocar is removed. {5} K260572 Page 2 of 3 Once the flexible cannula is properly positioned and the trocar removed, the aspiration cannula has a flexible shaft which will redirect if the tip encounters the wall of the marrow cavity. A 4.75mm drill with depth stop is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed. **Indications for Use:** The Marrow Marxman is intended for aspiration of bone marrow or autologous blood using a standard piston syringe. **Substantial Equivalence:** The subject Marrow Marxman substantial equivalence was evaluated to the following predicate devices: Primary Predicate: - Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (Ranfac Corporation) – K223612 Additional Predicate Devices: - Marrow Cellution Bone Marrow Aspiration Needle (Ranfac Corporation) – K150563 - Ran-Flex B Bone Marrow Aspiration Needle (Ranfac Corporation) – K202287 - Ranfac Bone Marrow Aspiration Needle (Ranfac Corporation) – K131157 There are insignificant differences between the subject Marrow Marxman and the predicate devices. The Indications for Use are identical to that of the predicate and additional predicate devices, as all are indicated for “aspiration of bone marrow or autologous blood using a standard piston syringe.” The patient contacting portions of the subject and predicate devices are all manufactured from stainless steel. The subject device has a slightly larger diameter (5.0mm) than that of the predicate devices (2.11mm – 4.6mm), but simulated use has shown similar performance when compared to the predicates. The insertable length (12.5cm) of the subject device falls within the range of the predicate devices (3 – 25cm). The design of the subject device has many similar features when compared to the predicate devices. Similarly, the function of the subject device is equivalent to the Ran-Flex B device in its ability to flex and “redirect if the tip encounters the wall of the marrow cavity.” Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness. {6} K260572 Page 3 of 3 # **Performance Testing:** Biocompatibility testing including cytotoxicity per ISO 10993-5, sensitization per ISO 10993-10, irritation per ISO 10993-10, systemic toxicity per ISO 10993-11, and material mediated pyrogenicity per ISO 10993-11 has been performed and determined that the subject device is non-cytotoxic, non-sensitizing, non-irritant, non-systemically toxic following acute exposure, and non-pyrogenic. Torque and bending tests have been conducted on the subject device, in addition to simulated use comparison to the predicate. Testing and simulated use have confirmed that the proposed design changes do not raise new issues of safety and effectiveness. # **Conclusion:** Based on the specifications and performance comparison to the predicate device, the subject device is determined to be substantially equivalent in terms of safety and effectiveness to the predicate device for the requested indications for use.