Surflo Winged Infusion Set

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font and is placed above the rest of the text. The text is aligned to the right of the symbol. June 23, 2023 Terumo Medical Products (Hangzhou) Co., Ltd. % Brian Byrd Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, New Jersey 08873 Re: K221411 Trade/Device Name: Surflo Winged Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: June 19, 2023 Received: June 20, 2023 Dear Brian Byrd: 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/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. 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 {1}------------------------------------------------ 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 (OS) 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 Advice (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, David Walloschek 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221411 Device Name Surflo Winged Infusion Set Indications for Use (Describe) The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size. Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> <span>Research Use Only (21 CFR 801.4; Subpart B)</span> </div> | |---------------------------------------------------------------------------------------------------------------| | <div> <input type="checkbox"/> <span>For In-Vitro Use Only (21 CFR 801.4; Subpart I)</span> </div> | > 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a sense of motion or direction. # K221411 510(K) SUMMARY #### A. SUBMITTER INFORMATION (807.92(a)(1)) Prepared by: Brian Byrd Regulatory Affairs Specialist Terumo Medical Corporation Tel. (908) 208-5226 Fax (410) 398-6079 #### Prepared for: Owner/Operator Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang CN 310018 Owner/Operator Number: 10033965 Manufacturer and Sterilization Facility (Applicant) Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang CN 310018 Registration Number: 3004102031 Contact Person: Brian Byrd Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (908) 208-5226 Fax (410) 398-6079 E-mail: brian.byrd@terumomedical.com June 20, 2023 Date prepared: {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the company name, which is written in green, sans-serif font. The arc is positioned above and to the left of the word "TERUMO." #### B. DEVICE NAME (807.92(a)(2)) | Proprietary Name: | Surflo Winged Infusion Set | |-----------------------|----------------------------------| | Common Name: | Intravascular Administration Set | | Classification Name: | Intravascular Administration Set | | Classification Panel: | General Hospital | | Regulation: | 21 CFR 880.5440 | | Product Code: | FPA | | Classification: | Class II | #### C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is: Primarv Predicate: - . K 771204 - Surflo Winged Infusion Set, manufactured by Kofu Factory of Terumo Corporation. #### D. REASON FOR 510(k) SUBMISSION This Traditional 510(k) is being submitted for the Surflo Winged Infusion Set, an intravascular administration set manufactured by Terumo Medical Products (Hangzhou) Co., Ltd., for the purposes of establishing substantial equivalence to a legally marketed predicate device. The device design remains the same excluding the material of the Connector Cap, available needle lengths, and solvent for the tubing/connector. The remaining components including the needle are the same. #### E. INDICATIONS FOR USE (807.92(a)(5)) The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size. #### F. DEVICE DESCRIPTION (807.92(a)(4)) The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the company name, which is written in green, block letters. The arc is positioned above and to the left of the word "TERUMO." (the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel. The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility. The Surflo Winged Infusion Set is available in different gauge sizes and tubing lengths. Table 5.1 shows the available product codes and their specifications. | Product<br>code | Needle<br>gauge<br>(mm)* | Wall<br>thickness** | Needle<br>length<br>(inch) | Tubing<br>length<br>(mm) | Tubing<br>Inner / Outer<br>Diameter<br>(mm) | Priming<br>volume<br>(ml) | Wing<br>type*** | |-----------------|--------------------------|---------------------|----------------------------|--------------------------|---------------------------------------------|---------------------------|-----------------| | SV*18BLK | 18G (1.20) | TW | 3/4 | 300 | 1.2/2.2 | 0.45±0.10 | C | | SV*19BLK | 19G (1.10) | TW | 3/4 | 300 | 1.2/2.2 | 0.45±0.10 | C | | SV*21BLK | 21G (0.80) | UTW | 3/4 | 300 | 1.1/2.1 | 0.41±0.08 | C | | SV*22BLK | 22G (0.70) | UTW | 3/4 | 300 | 1.1/2.1 | 0.41±0.08 | C | | SV*23BLK | 23G (0.65) | UTW | 3/4 | 300 | 1.1/2.1 | 0.40±0.08 | C | | SV*25BLK | 25G (0.50) | TW | 3/4 | 300 | 1.1/2.1 | 0.40±0.08 | C | | SV*19BLS | 19G (1.10) | TW | 3/4 | 90 | 1.2/2.2 | 0.21±0.08 | C | | SV*21BLS | 21G (0.80) | UTW | 3/4 | 90 | 1.1/2.1 | 0.20±0.08 | C | | SV*23BLS | 23G (0.65) | UTW | 3/4 | 90 | 1.1/2.1 | 0.20±0.08 | C | | SV*25BLS | 25G (0.50) | TW | 3/4 | 90 | 1.1/2.1 | 0.19±0.08 | C | | SV*25EL | 25G (0.50) | TW | 1/2 | 200 | 1.1/2.1 | 0.30±0.05 | D | | SV*27EL | 27G (0.40) | RW | 1/2 | 200 | 1.1/2.1 | 0.30±0.05 | D | Table 5.1 Surflo Winged Infusion Set specifications *Referred to as Needle I/OD in Performance Testing **TW = Thin Wall, UTW = Ultra-Thin Wall, RW = Regular Wall ***Wing Type: See Figure 11.1 in Section 11 - Device Description for differences in dimensions The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas. ## Mechanical Specifications applicable to the Surflo Winged Infusion Set: | | Tensile stress strength when<br>100% elongated | Tensile fracture strength | |------------------------|------------------------------------------------|---------------------------| | PVC (TR-630T) [tubing] | 5.84±1.96 MPa | 17.3±4.9 MPa | Table 5.2 Strength of material (body-contacting material) {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word. | PVC (R-500T) 【wing】 | $10.3\pm2.9$ MPa | $22.2\pm5.9$ MPa | |----------------------|------------------|------------------| | Izod impact strength | | | | PMMA 【connector】 | >68.6J/m | | Tubing elongation: 410~490% #### G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) The Surflo Winged Infusion Set, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the Surflo Winged Infusion Set (K771204), manufactured by Kofu Factory of Terumo Corporation, Japan. A comparison of the technological characteristics is summarized in the table below: | Device<br>Characteristic | Subject Device: Surflo<br>Winged Infusion Set | Predicate: Surflo<br>Winged Infusion Set,<br>K771204 | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Terumo Medical Products<br>(Hangzhou) Co., Ltd. | Terumo Corporation | | Intended Use | The Surflo Winged<br>Infusion Set is a device<br>used to administer fluids<br>from a container to a<br>patient's vascular system<br>through a needle<br>inserted in a vein. | Same | | Indications for<br>Use | The Surflo Winged Infusion<br>Set is indicated for<br>venipuncture and<br>intravenous administration of<br>fluids for up to 24 hours<br>using compatible/appropriate<br>disposable infusion devices<br>for medical purposes. It may<br>be used for any patient<br>population with<br>consideration given to<br>patient size. | The Surflo Winged<br>Infusion Set is a device<br>used to administer fluids<br>from a container to a<br>patient's vascular system<br>through a needle<br>inserted in a vein. The<br>product consists of a<br>needle with attached<br>tubing and connectors. | | Operation<br>Principle | Manual | Same | Table 5.3: Summary of Comparative Information {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Terumo, a medical device company. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and positioned above and to the left of the word "TERUMO." | Device<br>Characteristic | Subject Device: Surflo<br>Winged Infusion Set | Predicate: Surflo<br>Winged Infusion Set,<br>K771204 | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design /<br>Construction | • Needle, needle protector,<br>winged type hub, tubing,<br>connector, connector cap | Same | | Materials | • Needle: stainless steel<br>• Needle protector:<br>Polyethylene<br>• Wing: PVC<br>• Tubing: PVC<br>• Connector: PMMA<br>• Connector cap:<br>Polypropylene | • Needle: Same<br>• Needle protector:<br>Same<br>• Wing: Same<br>• Tubing: Same<br>• Connector: Same<br>• Connector cap:<br>Polyethylene or<br>Polypropylene | | Package | • Primary pack<br>• Shelf box<br>• Shipping carton | Same | | Specifications | Needle Gauge:<br>18G, 19G, 21G, 22G, 23G,<br>25G, 27G<br>Needle Length (inch):<br>3/4", 1/2"<br>Tubing Length (mm):<br>300, 90, 200 | Needle Gauge:<br>18G, 19G, 21G, 22G,<br>23G, 25G, 27G<br>Needle Length (inch):<br>3/4", 1/4", 1/2", 1", 1 1/4"<br>Tubing Length (mm):<br>300, 90, 200 | | Sterilization | Ethylene oxide (validated<br>in accordance with ISO<br>11135 to achieve SAL 10-6) | Same | | Shelf Life | 3 years | Same | Note: - . The subject device needle lengths fall within the range of the predicate device's cleared needle lengths. Therefore, the product is substantially equivalent because no new needle lengths were introduced. - . The indications for use of the K771204 cleared product is essentially the same as the subject device except for the inclusion of the patient population statement and {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word. duration for use. The patient population statement was added because the predicate does not identify the intended patient population. This statement aims to direct the user to be mindful of the patient size so the patient can be administered intravenous therapy safely. While the predicate did not specify duration for use, the duration for use was added to clarify the period where the product can be safely used. Although there are wording differences within the statements, the intended use for the subject and the predicate devices are the same. The Surflo Winged Infusion Set, manufactured by Terumo Medical Products (Hangzhou) Co., Ltd., is substantially equivalent to K771204 Surflo Winged Infusion Set, manufactured by Kofu Factory of Terumo Corporation. ## H. NON-CLINICAL TESTS (807.92(b)(1)) #### Performance Performance testing was conducted to ensure the Surflo Winged Infusion Set met the predetermined specifications throughout the shelf life, verify conformity to the applicable parts of ISO and non-ISO standards, and demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed. The following performance tests were performed on the Surflo Winged Infusion Set: Table 5.4: Performance Tests {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red curved line above the word "TERUMO" in green. The red curved line is positioned above and to the left of the word "TERUMO", creating a sense of motion or direction. | Test | Standard | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Flow rate | GB 18671-2009 Intravenous<br>needles for single use | | Leak test | JIS T 3222:2011 Sterile<br>winged intravenous devices | | Wing to tubing connection strength (static<br>pull force) | ISO 8536-4:2019 Infusion<br>equipment for medical use –<br>Part 4: Infusion sets for<br>single use, gravity feed | | Tubing to connector connection strength<br>(static pull force) | ISO 8536-4:2019 Infusion<br>equipment for medical use –<br>Part 4: Infusion sets for<br>single use, gravity feed | | Needle to wing connection strength (static<br>pull force) | ISO 8536-4:2019 Infusion<br>equipment for medical use –<br>Part 4: Infusion sets for<br>single use, gravity feed | | Needle curvature | JIS T 3222:2011 Sterile<br>winged intravenous devices | No deviations from recognized consensus ISO or non-ISO standards were identified in the testing to standards. Additionally, performance testing other than to the above ISO and non-ISO Standards was performed on the device. The device complies with the acceptance criteria established based on the predicate device: | Performance Test | Results | |-----------------------------------------------------------------|---------------------------| | Wing to tubing connection strength (dynamic<br>pull force) | Meets acceptance criteria | | Tubing to connector connection strength<br>(dynamic pull force) | Meets acceptance criteria | | Needle to wing connection strength (dynamic<br>pull force) | Meets acceptance criteria | | Wing-needle protector fit | Meets acceptance criteria | | Needle penetration resistance | Meets acceptance criteria | | Blockage test | Meets acceptance criteria | Table 5.5: Additional Performance Tests {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a dynamic and modern look. | Performance Test | Results | |------------------|---------------------------| | Priming volume | Meets acceptance criteria | Performance testing demonstrates that the Surflo Winged Infusion Set conforms to the recognized consensus ISO and non-ISO standards, is substantially equivalent to the predicate device, and is acceptable for clinical use throughout the shelf life. #### Biocompatibility In accordance with ISO 10993-1, the Surflo Winged Infusion Set is classified as: Externally Communicating Device, Blood Path, Indirect, Prolonged Contact (>24 hours to 30 days). This classification was chosen as "worst case scenario," and is the same as the Surflo Winged Infusion Set, K771204. The finished device's patient contacting parts were tested in accordance with the tests recommended in FDA Guidance for Industry and Food and Drug Administration Staff – Use of International Standard ISO-10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. " The tests were performed on non-aged (time=0) and accelerated-aged devices to show that biocompatibility is maintained throughout the shelf life of the product. Table 5.6 provides a list of biocompatibility tests conducted on the Surflo Winged Infusion Set. | Non-Aged, Sterile, Whole Device | |---------------------------------------------------| | Cytotoxicity | | Sensitization | | Intracutaneous Reactivity | | Acute System Toxicity | | Pyrogenicity | | Hemolysis | | Subacute/Subchronic Toxicity | | Accelerated-Aged (3 Years), Sterile, Whole Device | | Cytotoxicity | | Sensitization | | Intracutaneous Reactivity | | Acute System Toxicity | | Pyrogenicity | | Hemolysis | | Subacute/Subchronic Toxicity | Table 5.6: Summary of ISO 10993 Biocompatibility Testing {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The logo is simple and modern, and the colors are eye-catching. Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product. ## 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 Winged Infusion Set 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 Winged Infusion Set, subject of this 510(k), is Substantially Equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device K771204 – Surflo Winged Infusion Set manufactured by Kofu Factory of Terumo Corporation.