25G Huber Needle

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 18, 2026 Martech Medical Products Ashley Rolfe Corporate Manager of Regulatory Affairs 1500 Delp Dr. Harleysville, Pennsylvania 19438 Re: K254095 Trade/Device Name: 25G Huber Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: August 17, 2026 Received: August 18, 2026 Dear Ashley Rolfe: 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. FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254095 - Ashley Rolfe Page 2 required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively. 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. {2} K254095 - Ashley Rolfe Page 3 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-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, GANG PENG -S Gang Peng for David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology 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) K254095 Device Name 25G Huber Needle Indications for Use (Describe) The 25G Huber Needle is indicated for short-term use for insertion into the septum of a subcutaneous implanted intravascular port for intravenous administration of fluids or medications and blood sampling. 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} [LOGO] MARTECH MEDICAL PRODUCTS # K254095: 510(k) Summary # 1. Submitter Information: 510(k) Submitted By: Martech Medical Products 1500 Delp Drive Harleysville, PA 19438 United States of America Primary Correspondent: Ashley Rolfe, Corporate Manager of Regulatory Affairs arolfe@martechmedical.com +1 (763) 439-1474 Date Prepared: September 18, 2026 # 2. Subject Device Information: Trade Name: 25G Huber Needle Common Name: Non-Coring (Huber) Needle Classification Regulation: 21 CFR 880.5570, Hypodermic single lumen needle Device Class: Class II Classification Panel: General Hospital FDA Product Code: PTI # 3. Predicate Device Information: Trade Name (predicate): Huber Needle Infusion Set Common Name (predicate): Non-Coring (Huber) Needle Classification Regulation: 21 CFR 880.5570, Hypodermic single lumen needle Device Class: Class II Classification Panel: General Hospital FDA Product Code: PTI Predicate 510(k) Number: K200463, cleared on 04/07/2021 Predicate 510(k) Owner: Jiangsu Caina Medical Co., Ltd - Proprietary and Confidential - Page 1 of 8 {5} MARTECH MEDICAL PRODUCTS # 4. Device Description: The 25G Huber Needle is a hypodermic non-coring right angle needle protected by an LDPE tube to avoid the risk of needlestick during its handling. The 25G Huber Needle is attached to a female luer-lock through an extension. The extension has an in-line clamp for fluid control and an ID tag that indicates the needle's gauge size. The 25G Huber Needle hub has flexible external wings with an irregular surface to facilitate its manipulation during use. # 5. Intended Use The 25G Huber Needle is intended for use in pediatric or adult patients with a subcutaneous implanted intravascular port where it is deemed necessary based on the direction of a qualified, licensed physician to access the central venous system through the subcutaneous implanted intravascular port. This device is for Single Use Only. # 6. Indications for Use The 25G Huber Needle is indicated for short-term use for insertion into the septum of a subcutaneous implanted intravascular port for intravenous administration of fluids or medications and blood sampling. # 7. Summary of Technological Characteristics The Substantial Equivalence Comparison Table below provides evidence of the similarities and differences between the 25G Huber Needle (AC9100KT) to the predicate device the Huber Needle Infusion Set to facilitate the substantial equivalence determination. Any difference between the subject device and the predicate device have been evaluated and do not raise new or different questions of safety and effectiveness. | Table 1 – Substantial Equivalence | | | | | --- | --- | --- | --- | | Device Characteristic | Subject Device (25G Huber Needle) | Predicate Device (Huber Needle Infusion Set) | Same/Different Assessment | | Device Trade Name | 25G Huber Needle | Huber Needle Infusion Set | N/A | | 510(k) submitter/holder | Martech Medical Products | Jiangsu Caina Medical Co., Ltd | N/A | | 510(k) Number | K254095 | K200463, cleared on 04/07/2021 | N/A | | Primary Product Code | PTI Non-Coring Huber Needle | PTI Non-Coring Huber Needle | Same | | Primary Product Code Regulation Description | 21 CFR 880.5570 Hypodermic Single Lumen Needle | 21 CFR 880.5570 Hypodermic Single Lumen Needle | Same | | Class | II | II | Same | - Proprietary and Confidential - Page 2 of 8 {6} **MARTECH**^{}[] MEDICAL PRODUCTS | Intended Use | The 25G Huber Needle is intended for use in pediatric or adult patients with a subcutaneous implanted intravascular port where it is deemed necessary based on the direction of a qualified, licensed physician to access the central venous system through the subcutaneous implanted intravascular port. This device is for Single Use Only. | The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G. | Different – The subject device identifies pediatric patients in addition to adults as the intended patient population, whereas the predicate labeling does not specifically identify pediatrics as a target population. Clinical literature and professional standards of practice support the appropriateness of the 25G, 0.625-inch needle for pediatric port access, including guidance from BC Children's Hospital establishing that 22G needles up to 19 mm are routinely used in pediatric port access, with needle selection based on patient weight and subcutaneous tissue thickness. The subject device's 25G gauge (smaller diameter) and 16 mm length (shorter than the commonly used 19 mm) fall within the clinically accepted range for pediatric use. A simulated clinical use study was conducted to support use in both adult and pediatric environments. EO residuals were evaluated and confirmed to fall within pediatric limits per ISO 10993-7. Non-clinical testing was also performed to mitigate risks of needle dislodgement, connector separation, and detachment events applicable to the intended use environment. These differences do not affect the intended use or fundamental technology of the device and do not raise new questions of safety or effectiveness. | | --- | --- | --- | --- | - Proprietary and Confidential - Page 3 of 8 {7} **MARTECH**^{}[] MEDICAL PRODUCTS | Device Characteristic | Subject Device (25G Huber Needle) | Predicate Device (Huber Needle Infusion Set) | Same/Different Assessment | | --- | --- | --- | --- | | Indications for Use | The 25G Huber Needle is indicated for shortterm use for insertion into the septum of a subcutaneous implanted intravascular port for intravenous administration of fluids or medications and blood sampling. | The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G. | Different – Both the subject and predicate devices are non-coring right-angle Huber needles indicated for insertion into the septum of a subcutaneously implanted port for infusion of fluids or medications and blood sampling. The subject device is limited to a single 25G configuration and is not indicated for power injection. The predicate includes additional power-injectable configurations (19G–22G); however, the 25G configuration of the predicate is also not power injectable, consistent with the subject device. The subject device therefore represents a subset of the predicate's cleared indications. This difference does not raise new questions of safety or effectiveness | | Prescription/Over-the-Counter Use | Prescription | Prescription | Same | | Sterilization Method | EO Sterilization | EO Sterilization | Same | | **Technical Specifications** | | | | | Configuration | Non-Coring Needle Needle Protector Tubing Extension Clamps Female Luer fitting Flexible double wings Hub Needleless Connector ID ring | Non-Coring Needle Needle Cap PVC Tubing extension Clamps Female Luer fitting Male Luer Cap Hub/Casing Needleless Connector Y Needleless Adapters Y-Needle Adapters | Different – The subject device shares the core configuration of the predicate (non-coring needle, needle protector, extension tubing, clamp, female luer fitting). The subject device includes flexible double wings and an ID ring not present in the predicate, and does not include a male luer cap, needleless connector, or Y-site components. The predicate is also available in configurations without Y-site components. Living hinge fatigue testing and a simulated clinical use study were performed to evaluate the wings. Biocompatibility testing of the finished sterilized device was performed and found acceptable per ISO 10993-1:2020 for all components. These differences do not raise new questions of safety or effectiveness. | - Proprietary and Confidential - Page 4 of 8 {8} MARTECH MEDICAL PRODUCTS | Table 1 – Substantial Equivalence | | | | | --- | --- | --- | --- | | Device Characteristic | Subject Device (25G Huber Needle) | Predicate Device (Huber Needle Infusion Set) | Same/Different Assessment | | Needle Gauge | 25G | 19G, 20G, 22G, 24G, 25G | Different- The subject device is limited to a single 25G configuration. The predicate includes gauge sizes 19G–25G. The 25G gauge is within the range cleared for the predicate. Needle performance testing per applicable standards demonstrated compliance. This difference does not raise new questions of safety or effectiveness. | | Needle Length | 0.625in (16mm) | 0.5", 0.75", 1", 1.25", 1.5" | Different – The subject device needle length of 0.625 inches (16 mm) falls within the range of lengths cleared for the predicate (0.5"–1.5"). Non-clinical testing including needle insertion/extraction force characterization, septum coring evaluation, and gravity flow testing demonstrated that the device performs safely and effectively at this length. This difference does not raise new questions of safety or effectiveness. | | Needle Bevel Design | Non-Coring Needle | Non-Coring Needle | Same | | Priming Volume | 0.37cc ± 0.2cc | S-1s: 0.4mL S-2s: 0.5mL Y-1s: 0.7mL Y-2s: 0.7mL D-2: Not applicable | Different – The priming volume of the subject device (average 0.37 cc) differs from the predicate due to differences in device configuration and tubing dimensions. The priming volume is documented in the Instructions for Use for user reference. Performance testing confirmed the device performs as intended. This difference does not raise new questions of safety or effectiveness. | | Power Injection Capability | Not intended for Power Injection | 19G, 20G, and 22G configurations are suitable for power injection of contrast media. 24G and 25G configurations are not intended for Power Injection | Different – The subject device is not intended for power injection. The 25G configuration of the predicate is also not intended for power injection. This characteristic is the same between the subject and predicate devices at the 25G gauge level. No new questions of safety or effectiveness were raised. | - Proprietary and Confidential - Page 5 of 8 {9} MARTECH MEDICAL PRODUCTS | Table 1 – Substantial Equivalence | | | | | --- | --- | --- | --- | | Device Characteristic | Subject Device (25G Huber Needle) | Predicate Device (Huber Needle Infusion Set) | Same/Different Assessment | | Safety Mechanism | N/A | N/A | Same | | MR Safety | MR Conditional up to 3-Tesla | MR Compatible | Different – Non-Clinical testing was performed to support the MR Conditional claim of the subject device. This difference does not raise new questions of safety or effectiveness. | | Materials | | | | | Needle Cannula | 304 Stainless steel | 304 Stainless steel | Same | | Needle Protector/Cap | LDPE | PVC/PP | Different – Several component materials of the subject device differ from the predicate due to design and supplier differences. All patient-contacting and non-patient-contacting materials were evaluated through biocompatibility testing of the finished sterilized device in accordance with ISO 10993-1:2020. The device was classified as externally communicating, indirect blood path with prolonged contact (>24 hours – 30 days). All biocompatibility endpoints, including subacute systemic toxicity per ISO 10993-11:2017, were evaluated and found acceptable. These material differences do not raise new questions of safety or effectiveness. | | Tubing Extension | Pellethane 2363-90AE Natural Polyurethane | Polyvinyl chloride (PVC) | | | Joint pipe | None | Polyvinyl chloride (PVC) | | | Clamps | Celcon Natural | Unknown | | | Luer | White Isoplast #2510 | Methyl methacrylate acrylonitrile butadiene styrene plastics (MABS); Polypropylene (PP) White Color | | | Male Luer Cap | N/A | Unavailable/Proprietary | | | ID Ring | Bayer ABS #34812002 White | Unknown | | | Hub | Orange PRO-FAX PF511 Polypropylene | Methyl methacrylate acrylonitrile butadiene styrene plastics (MABS) | | | Sub-Hub | Isoplast #2510, 1575C Orange | N/A | | | Needleless Connector | N/A | Polycarbonate (PC) + Silicone Rubber | | | Y Needleless Adapters | N/A | Polycarbonate (PC) + Silicone Rubber | | | Y Needle Adapters | N/A | Connector: Methyl methacrylate acrylonitrile butadiene styrene plastics (MABS) Injection Site: Silicone rubber | | - Proprietary and Confidential - Page 6 of 8 {10} MARTECH MEDICAL PRODUCTS # 9. Summary of Non-Clinical Testing and Standards # 9.1 Biocompatibility Biocompatibility was performed on the 25G Huber Needle (subject device) in accordance with BS EN ISO 10993-1:2020 “Biological evaluation of medical devices – Evaluation and testing within a risk management process”, after undergoing two (2) EO sterilization cycles, in accordance with BS EN ISO 8536-4:2020 “Infusion equipment for medical use – Infusion sets for single use, gravity feed”. The following tests were conducted: | Table 2 – Biocompatibility | | | --- | --- | | Biocompatibility Test | Standard | | Acute Systemic Toxicity | ISO 10993-11:2017 | | Guinea Pig Maximization Sensitization | ISO 10993-10:2021 | | Rabbit Pyrogen Study, Material Mediated | ISO 10993-11:2017 | | Intracutaneous Irritation Study | ISO 10993-23 | | Hemolysis Study | ISO 10993-4:2017 | | Cytotoxicity Study using the ISO Elution Method | ISO 10993-5:2009 | | Subacute Systemic Toxicity | ISO 10993-11:2017 | # 9.2 Performance Testing The following performance tests were conducted to demonstrate that the 25G Huber Needle meets the design requirements and performs as intended post (EO) sterilization. No clinical testing was performed. Bench Testing Elongation and Tensile Testing (BS EN ISO 10555-1:2023) Septum Coring Evaluation [ASTM F3212 – 16 (2023)] Needle Insertion/Extraction Force Characterization Testing (BS EN ISO 10555-6:2017+A1:2019) Living Hinge Fatigue Test Static Load Pull Test (BS EN ISO 10555-6:2017+A1:2019 and BS EN ISO 10555-1:2023) Chemical Test (BS EN ISO 8536-4:2020) MRI Evaluation (ASTM F2052-21, ASTM F2182-19e2, and ASTM F2503–23) Leak Test (BS EN ISO 8536-8:2015) Liquid Leak Test (BS EN ISO 10555-1:2013+A1:2017) Equipment Interaction Clamp Cycle (BS EN ISO 10555-1:2013+A1:2017 and BS EN ISO 8536-8:2015) Force at Break (Needle hub to extension) (EN ISO 10555-1:2013+A1:2017) Force at Break (Extension to luer) (EN ISO 10555-1:2013+A1:2017) Force at Break (Hub to Cannula) (EN ISO 10555-1:2013+A1:2017) Gravity Flow (BS EN ISO 10555-1: 2023) Priming Volume (BS EN ISO 10555-6:2017+A1:2019) Corrosion Resistance (EN ISO 10555-1:2013+A1:2017) Pouch Dye Penetration Test (ASTM F1929-15) Peel Strength Test (ASTM F88/F88M-23) Pressurization Failure Resistance of Unrestrained Packages – Burst Test (ASTM F1140/F1140M-13(2020)e1) Particulate Count (BS EN ISO 8536-4:2020 and USP <788>) - Proprietary and Confidential - Page 7 of 8 {11} MARTECH MEDICAL PRODUCTS Shipping Test (ASTM D4169-22, ASTM D4332-22) ISO 80369-7 Luer Dimensional Test ISO 80369-7 Luer Performance Compliance Usability Test – Summative Evaluation – Simulation Clinical Use PH and Metals Analysis [Annex A of ISO 7864:2016(E) and ISO 7864:2016(E)] Patency of Lumen of Cleanliness (BS EN ISO 7864:2016, section 4.1 3) Testing in accordance with ISO 9626:2016 Pump Infusion simulation (needle dislodgement, leakage) (BS EN ISO 8536-8: 2015) ## 10. Conclusion In conclusion, based on the non-clinical testing performed, the subject device, the 25G Huber Needle, is substantially equivalent to the predicate device, the Huber Needle Infusion Set (K200463) and does not raise new questions of safety and effectiveness. - Proprietary and Confidential - Page 8 of 8