SURFLO Hybria Closed System Safety IV Catheter

{0} FDA U.S. FOOD & DRUG ADMINISTRATION December 17, 2025 Terumo Medical Products (Hangzhou) Co., Ltd. Tien Trinh Regulatory Affairs Specialist II Terumo Medical Corporation 265 Davidson Avenue Suite 320 Somerset, New Jersey 08873 Re: K252398 Trade/Device Name: SURFLO Hybria Closed System Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: November 19, 2025 Received: November 19, 2025 Dear Tien Trinh: 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} K252398 - Tien Trinh 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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} K252398 - Tien Trinh 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, # Colleen J. Lawrimore -S Colleen Lawrimore, Ph.D. *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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | 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) K252398 | | | Device Name SURFLO Hybria Closed System Safety IV Catheter | | | Indications for Use (Describe) SURFLO Hybria Closed System Safety IV Catheter is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. The device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. When the device is used with a power injector, the needle-free connector should be removed, and the maximum pressure limit is 325 psi (2.24MPa). | | | 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." | | {4} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary # 510(K) SUMMARY – K252398 ## A. SUBMITTER INFORMATION (807.92(a)(1)) **Prepared by:** Tien Trinh Regulatory Affairs Specialist II Terumo Medical Corporation Tel. (640)-204-6333 Fax (410) 398-6079 **Prepared for:** Owner/Operator Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone, Hangzhou, Zhejiang China 310018 Registration Number: 3004102031 **Manufacturer and Sterilization Facility (Applicant)** Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone, Hangzhou, Zhejiang China 310018 Registration Number: 3004102031 **Contact Person:** Tien Trinh Regulatory Affairs Specialist II Terumo Medical Corporation 265 Davidson Ave, Suite 320 Somerset, NJ 08873 Tel. (640)-204-6333 Terumo Medical Corporation, USA {5} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary Fax (410) 398-6079 E-mail: tien.trinh@terumomedical.com Date prepared: December 17, 2025 ## B. DEVICE NAME (807.92(a)(2)) Trade Name: SURFLO Hybria Closed System Safety IV Catheter Common Name: Catheter, intravascular, therapeutic, short-term less than 30 days Classification Name: Intravascular Catheter Classification Panel: General Hospital Regulation Number: 21 CFR 880.5200 Product Code: FOZ Device Class: Class II ## C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is: - Predicate Device: K102520- BD Nexiva™ Closed IV Catheter System ## D. REASON FOR 510(k) SUBMISSION This Traditional 510(k) for the SURFLO Hybria Closed System Safety IV Catheter, manufactured by Terumo Medical Products (Hangzhou) Co., Ltd is being submitted to establish substantial equivalence to a legally marketed predicate device. Terumo Medical Corporation, USA {6} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary ## E. DEVICE DESCRIPTION (807.92(a)(4)) SURFLO Hybria Closed System Safety IV Catheter is an over-the-needle intravascular catheter. It primarily includes a catheter, a 3D-Shin™ needle with a safety shield, double wings, an extension tube, a luer adapter, vent fitting(s), and a pre-attached SURPLUG™ AD needle-free connector (for some configurations). The double wings of the SURFLO Hybria Closed System Safety IV Catheter can be folded and pinched together for puncture and catheter advancement. The distance from the grip position to the needle tip is short, which facilitates vascular puncture. The 3D-Shin™ needle features an engineered three-dimensional geometry of the needle tip. The needle tip is completely covered by the safety shield when it is withdrawn after visualization of blood return, which minimizes the risk of accidental needlestick injury. The closed design can prevent blood leakage throughout the entire puncture process. ## Design/Construction The subject device and the predicate device- BD Nexiva™ Closed IV Catheter System (K102520) have the same construction. Terumo Medical Corporation, USA {7} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary # Materials The Materials for the subject device are provided in Table 1. Table 1: List of Material | No. | Name of Component | Raw Material | | --- | --- | --- | | 1** | Catheter | Polyurethane | | 2 | Catheter (Radiopaque layer) | Polyurethane+Barium Sulfate | | 3* | Catheter hub | Polycarbonate | | 4* | Needle | Stainless steel | | 5* | Rivet pin | Stainless steel | | 6* | Seal gum | Isoprene rubber | | 7 | Safety shield | Stainless steel | | 8 | Needle hub | Polycarbonate | | 9 | Wing | Polyurethane | | 10* | Extension tube | Polyurethane | | 11* | Y Luer connector | Copolyester | | 12* | I Luer connector | Copolyester | | 13 * | Needle-free connector | Polypropylene and silicone rubber | | 14 | Vent fitting | Polystyrene | | 15 | Clamp | POM | | 16 | Protective caps | Polypropylene | | 17 | Silicone Oil | NCT 911, ELEMENT14*PDMS 30K-J | | 18 | UV Adhesive | LOCTITE 3301 | * Blood Path, Indirect, **Circulating Blood Terumo Medical Corporation, USA {8} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary # Specifications The specifications for the subject device are provided in Table 2. Table 2: SURFLO Hybria Closed System Safety IV Catheter Specifications | Catheter gauge | Needle gauge | Product code | Catheter OD× length | Infusion connector type | ID of extension tube | | --- | --- | --- | --- | --- | --- | | 18G | 20G | SH18322332AF | 18G×1¼" ( 1.3mm×32mm ) | Dual Port, 1 vent fitting, 2 needle-free connectors | | | | | SH18252332AF | 18G×1" ( 1.3mm×25mm ) | | | | | | SH18192332AF | 18G×3/4" ( 1.3mm×19mm ) | | | | 20G | 22G | SH20322332AF | 20G×1¼" ( 1.1mm×32mm ) | | | | | | SH20252332AF | 20G×1" ( 1.1mm×25mm ) | | | | | | SH20192332AF | 20G×3/4" ( 1.1mm×19mm ) | | | | 22G | 24G | SH22252332AF | 22G×1" ( 0.9mm×25mm ) | | | | | | SH22192332AF | 22G×3/4" ( 0.9mm×19mm ) | | | | 24G | 27G | SH24192332AF | 24G×3/4" ( 0.7mm×19mm ) | | | | | | SH24132332AF | 24G×1/2" ( 0.7mm×13mm ) | | | | 18G | 20G | SH18322331AF | 18G×1¼" ( 1.3mm×32mm ) | | | | | | SH18252331AF | 18G×1" ( 1.3mm×25mm ) | | | | | | SH18192331AF | 18G×3/4" ( 1.3mm×19mm ) | | | | 20G | 22G | SH20322331AF | 20G×1¼" ( 1.1mm×32mm ) | | | | | | SH20252331AF | 20G×1" ( 1.1mm×25mm ) | | | | | | SH20192331AF | 20G×3/4" ( 1.1mm×19mm ) | | | | 22G | 24G | SH22252331AF | 22G×1" ( 0.9mm×25mm ) | | | | | | SH22192331AF | 22G×3/4" ( 0.9mm×19mm ) | | | | 24G | 27G | SH24192331AF | 24G×3/4" ( 0.7mm×19mm ) | | | | | | SH24132331AF | 24G×1/2" ( 0.7mm×13mm ) | | | | 18G | 20G | SH18322333AF | 18G×1¼" ( 1.3mm×32mm ) | Dual port, 2 vent fittings | | | | | SH18252333AF | 18G×1" ( 1.3mm×25mm ) | | | | | | SH18192333AF | 18G×3/4" ( 1.3mm×19mm ) | | | | 20G | 22G | SH20322333AF | 20G×1¼" ( 1.1mm×32mm ) | | | | | | SH20252333AF | 20G×1" ( 1.1mm×25mm ) | | | Terumo Medical Corporation, USA {9} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary | Catheter gauge | Needle gauge | Product code | Catheter OD× length | Infusion connector type | ID of extension tube | | --- | --- | --- | --- | --- | --- | | | | SH20192333AF | 20G×3/4" ( 1.1mm×19mm ) | | | | 22G | 24G | SH22252333AF | 22G×1" ( 0.9mm×25mm ) | | | | | | SH22192333AF | 22G×3/4" ( 0.9mm×19mm ) | | | | 24G | 27G | SH24192333AF | 24G×3/4" ( 0.7mm×19mm ) | | | | | | SH24132333AF | 24G×1/2" ( 0.7mm×13mm ) | | | | 18G | 20G | SH18322320AF | 18G×11/4" ( 1.3mm×32mm ) | Single port, 1 vent fitting | | | | | SH18252320AF | 18G×1" ( 1.3mm×25mm ) | | | | | | SH18192320AF | 18G×3/4" ( 1.3mm×19mm ) | | | | 20G | 22G | SH20322320AF | 20G×11/4" ( 1.1mm×32mm ) | | | | | | SH20252320AF | 20G×1" ( 1.1mm×25mm ) | | | | | | SH20192320AF | 20G×3/4" ( 1.1mm×19mm ) | | | | 22G | 24G | SH22252320AF | 22G×1" ( 0.9mm×25mm ) | | | | | | SH22192320AF | 22G×3/4" ( 0.9mm×19mm ) | | | | 24G | 27G | SH24192320AF | 24G×3/4" ( 0.7mm×19mm ) | | | | | | SH24132320AF | 24G×1/2" ( 0.7mm×13mm ) | | | | 18G | 20G | SH18322321AF | 18G×11/4" ( 1.3mm×32mm ) | Single port, 1 vent fitting, 1 needle-free connector | | | | | SH18252321AF | 18G×1" ( 1.3mm×25mm ) | | | | | | SH18192321AF | 18G×3/4" ( 1.3mm×19mm ) | | | | 20G | 22G | SH20322321AF | 20G×11/4" ( 1.1mm×32mm ) | | | | | | SH20252321AF | 20G×1" ( 1.1mm×25mm ) | | | | | | SH20192321AF | 20G×3/4" ( 1.1mm×19mm ) | | | | 22G | 24G | SH22252321AF | 22G×1" ( 0.9mm×25mm ) | | | | | | SH22192321AF | 22G×3/4" ( 0.9mm×19mm ) | | | | 24G | 27G | SH24192321AF | 24G×3/4" ( 0.7mm×19mm ) | | | | | | SH24132321AF | 24G×1/2" ( 0.7mm×13mm ) | | | Terumo Medical Corporation, USA {10} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary ## F. INDICATIONS FOR USE (807.92(a)(5)) SURFLO Hybria Closed System Safety IV Catheter is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. The device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. When the device is used with a power injector, the needle-free connector should be removed, and the maximum pressure limit is 325 psi (2.24MPa). ## G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) The SURFLO Hybria Closed System Safety IV Catheter, subject of this Traditional 510(k), is substantially equivalent¹ in its intended use/indications for use, technology/principal of operation, materials, and performance to BD Nexiva™ Closed IV Catheter System (K102520), manufactured by Becton Dickinson Infusion Therapy Systems, Inc. A comparison of the technological characteristics is summarized in Table 3 ¹ A statement of substantial equivalence to another product is required by 21CFR807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, “...a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits” 42 Fed. Reg. 42,520, et seq. (1977) Terumo Medical Corporation, USA {11} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary Table 3: Comparison of Technological Characteristics | Device Characteristic | Subject Device: SURFLO Hybria Closed System Safety IV Catheter | Predicate Device: BD Nexiva™ Closed IV Catheter System (K102520) | Same/Different Assessment | | --- | --- | --- | --- | | Indications for Use | SURFLO Hybria Closed System Safety IV Catheter is intended to be inserted into a patient’s peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids. The device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. When the device is used with a power injector, the needle-free connector should be removed, and the maximum pressure limit is 325 psi (2.24MPa). | BD Nexiva™ Closed IV Catheter Systems are intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | Although the wording differs here, both devices may be used with power injectors and require the removal of connectors/access ports prior to use with a power injector. However, the maximum pressure limit for the subject device is 325 psi, while the predicate’s is 300 psi. The 325 psi value for the subject device was selected to align with clinically used power injectors, which commonly have a pressure limit of 325 psi. This difference does not raise any new questions of safety and effectiveness of the device based on the performance test results. | Terumo Medical Corporation, USA {12} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary | Operation Principle | Manual | Same | Same | | --- | --- | --- | --- | | Design / Construction | • Catheter assembly (catheter, catheter hub, needle, needle hub), extension tube, safety shield • In accordance with ISO 10555-1 | • Catheter assembly (catheter, catheter hub, needle, needle hub), extension tube, safety shield • In accordance with ISO 10555-1 | Same | | Materials | • Catheter – Polyurethane • Catheter Hub – Polycarbonate • Needle – Stainless Steel • Needle hub – Polycarbonate • Extension tube – Polyurethane • Safety shield – Stainless Steel | • Catheter – Polyurethane • Catheter Hub – Copolyester • Needle – Stainless Steel • Needle hub – Polycarbonate • Extension tube – Polyurethane • Safety shield – Polycarbonate + stainless steel | Although the material differs, Terumo has conducted chemical characterization and biocompatibility tests, and the results confirm that the material poses no chemical or biological safety concerns. This difference does not raise any new questions of safety and effectiveness. | | Package | • Blister • Shelf box • Shipping carton | • Blister • Shelf box • Shipping carton | Same | | Catheter Gauge | 18G, 20G, 22G, 24G | Same | Same | Terumo Medical Corporation, USA {13} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary | Sterilization | EO (validated in accordance with ISO 11135 to achieve SAL 10^{-6}) | Same | Same | | --- | --- | --- | --- | | Shelf life | 3 Years | Same | Same | | MRI Safety | MR Conditional | Same | Same | Terumo Medical Corporation, USA {14} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary ## H. NON-CLINICAL TESTS (807.92(b)(1)) ## Performance Performance testing was conducted to ensure that the SURFLO Hybria Closed System Safety IV Catheter is as substantially equivalent to the predicate device throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate that the device is MR Conditional. The following performance tests were performed on both non-aged and/or accelerated-aged samples. Table 4 provides a list of the performance tests that were performed on the SURFLO Hybria Closed System Safety IV Catheter. Table 4: Summary of Performance Tests | Test Item | | --- | | Safety mechanism activation | | Needle tip exposure in safe mode | | Force to push needle back through safety mechanism | | Safety mechanism unintentional activation | | Penetration resistance | | Protective caps | | Clamps | | Engagement and disengagement of clamp | | Needle/needle hub bonding strength (static and dynamic) | | Needle-free connector-leakage | | Needle-free connector- access times | | Tensile strength of extension tube (static and dynamic) | | Catheter collapse | | Tip flexural fatigue | | Simulated Clinical Use | | MRI Compatibility Test | | Radiopacity Test | | Particle Contamination | Terumo Medical Corporation, USA {15} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary | Microbial Ingress | | --- | | Luer Connector | # MRI Compatibility Testing MRI Compatibility testing was performed on the SURFLO Hybria Closed System Safety IV Catheter finished device without the needle. Testing was performed in accordance with the tests recommended in the FDA Guidance for Industry and Food and Drug Administration Staff, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" to obtain MR Conditional safety information. Table 5 below lists MRI tests conducted on the SURFLO Hybria Closed System Safety IV Catheter. Table 5: Summary of MRI Tests Performed | Test Items | Applicable Standards | | --- | --- | | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment | ASTM F2052-21 | | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment | ASTM F 2213-2017 | | Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants | ASTM F2119-07(2013) | Performance testing for $t=0$ and $t=36AA$ (3-year accelerated age) and the MRI Compatibility Testing demonstrated that the predetermined acceptance criteria were met, that the SURFLO Hybria Closed System Safety IV Catheter is acceptable for clinical use throughout its shelf life, and that the device is MR Conditional. # Biocompatibility Classification In accordance with ISO 10993-1, the SURFLO Hybria Closed System Safety IV Terumo Medical Corporation, USA {16} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary Catheter is classified as Externally Communicating Device, Circulating Blood, Prolonged Exposure (24 hours to 30 days). ## Biocompatibility Testing The finished device’s blood/body contacting parts were tested in accordance with the tests recommended in the FDA Guidance: Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a risk management process”. Screening tests were performed on non-aged and accelerated-aged devices to show that biocompatibility is maintained throughout the shelf life of the product. Table 6 provides a list of biocompatibility testing conducted on the SURFLO Hybria Closed System Safety IV Catheter. Table 6: Biocompatibility Tests | Non-aged, Sterile, Whole Device | Applicable Standard | | --- | --- | | Genotoxicity | ISO 10993-3:2014 | | Implantation | ISO 10993-6:2016 | | Hemocompatibility | ISO 10993-4:2017 | | Cytotoxicity | ISO 10993-5:2009 | | Subacute Toxicity | ISO 10993-11:2017 | | Sensitization | ISO 10993-10:2021 | | Irritation or Intracutaneous Reactivity | ISO 10993-23:2021 | | Acute System Toxicity | ISO 10993-11:2017 | | Complement Activation | ISO 10993-4:2017 | | Pyrogenicity | ISO 10993-11:2017 | | Accelerated age (36-months (3 years)), Sterile, Whole Device | Applicable Standard | | Cytotoxicity | ISO 10993-5:2009 | | Irritation or Intracutaneous Reactivity | ISO 10993-23:2021 | | Acute System Toxicity | ISO 10993-11:2017 | The testing results demonstrate that the device is biocompatible throughout the Terumo Medical Corporation, USA {17} TERUMO TERUMO MEDICAL Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang, 310018 China TELEPHONE: (86) 571-8731-8100 FAX: (86) 571-8691-0293 SURFLO Hybria Closed System Safety IV Catheter 510(k) Summary product's shelf life. ## Sterilization The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices. The SURFLO Hybria Closed System Safety IV Catheter is sterilized to provide a Sterility Assurance Level (SAL) of $10^{-6}$. ## I. CLINICAL TESTS (807.92(b)(2)) This 510(k) does not include data from clinical tests. ## J. CONCLUSION (807.92(b)(3)) In summary, the SURFLO Hybria Closed System Safety IV Catheter, subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device BD Nexiva™ Closed IV Catheter System (K102520), manufactured by Becton Dickinson Infusion Therapy Systems, Inc. Terumo Medical Corporation, USA