Who is the manufacturer of Velano ExT Extension Set?

Velano Vascular filed the 510(k) submission for Velano ExT Extension Set (K200439).

What is the FDA product code for Velano ExT Extension Set?

FPA. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Velano ExT Extension Set?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Velano ExT Extension Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Velano ExT Extension Set

K200439 · Velano Vascular · FPA · Feb 23, 2021 · General Hospital

Device Facts

Record ID	K200439
Device Name	Velano ExT Extension Set
Applicant	Velano Vascular
Product Code	FPA · General Hospital
Decision Date	Feb 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5440
Device Class	Class 2
Attributes	Therapeutic

Intended Use

For administration of intravenous fluids to a patient's vascular system utilizing needle-free components and provide term intravascular or subcutaneous access using a variety of infusates (i.e. anesthesia drugs, chemotherapeutics, drugs, antibiotics, blood products, commonly used prep solutions). The device may also be used with low pressure power injectors rated for a maximum setting of 325 psi. The ExT™ Extension Set is compatible with Velano Vascular PIVOTM devices.

Device Story

Sterile, single-use, non-pyrogenic intravenous administration extension set; 5-inch PVC tubing with T-connection port, needle-free connector, and female luer. Includes integrated stabilizer for anchoring to patient. Used in clinical settings for fluid administration, infusion, or aspiration; compatible with power injectors (max 325 psi, 10 ml/s). Operated by healthcare professionals. Output is fluid delivery to patient vascular system. Benefits include secure, needle-free access for various infusates and power injection capability.

Clinical Evidence

Bench testing only. No clinical data. Testing included visual inspection, simulated shipping, priming volume, microbial ingress, particulate matter, backpressure leak, flow rate, spin collar geometry, simulated use, tubing bond strength, multiple/continuous engagement, activation force, and kink resistance.

Technological Characteristics

PVC tubing; polycarbonate luer; polycarbonate/silicone needle-free connector. 5-inch length. Ethylene oxide sterilization (ISO 11135:2014). Biocompatibility per ISO 10993-1:2018. Particulate testing per USP <788>. Packaging per ASTM F1980:2016. Shipping per ASTM D4169:2016. Manual operation; no software or energy source.

Indications for Use

Indicated for single use in patients requiring intravenous fluid administration, intermittent or continuous infusion, direct injection, or aspiration. Compatible with power injector procedures up to 325 psi at 10 ml/sec flow rate.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

Velano Vascular Q2® Low Power Injector Extension Set (K182897)

Related Devices

K182897 — Velano Vascular Q2 Extension Set · Velano Vascular · Mar 26, 2019
K090134 — INTRAVENOUS POWER INJECTOR EXTENSION SET · C.R. Bard, Inc. · Apr 21, 2009
K162804 — Q2 Low Pressure Power Injection Extension Set · Quest Medical, Inc. · Mar 8, 2017
K103562 — CENTURION PRESSURE INJECTABLE EXTENSION SET · Centurion Medical Products Corporation · Jun 23, 2011
K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) · Cair Lgl · Aug 15, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Velano Vascular Tiffini Wittwer Consulting Director Regulatory Affairs 221 Pine St #200 San Francisco, California 94104 Re: K200439 Trade/Device Name: Velano ExT™ Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 9, 2021 Received: February 22, 2021 Dear Tiffini Wittwer: 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 {1}------------------------------------------------ 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 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 (QS) 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, For Payal Patel Acting 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200439 Device Name Velano ExTTM Extension Set #### Indications for Use (Describe) The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direction, intermittent infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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}------------------------------------------------ | Submitter: | Velano Vascular | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Tiffini Wittwer Regulatory Affairs Consultant Phone: (707) 799-6732 Email: twittwer@mededge.io | | Trade Name: | Velano ExT™ Extension Set | | Common Name: | Intravascular Administration Set | | Classification: | Class II | | Product Code: | FPA | | Regulation: | 880.5440 | | Predicate Device(s): | The subject device is equivalent to the following devices: • Velano Vascular Q2® Low Power Injector Extension Set (K182897) | | Device Description: | The Velano ExT™ Extension Set is a sterile, single use, non-pyrogenic intravenous administration extension set comprised of an approximate 5" inch tube bonded to a T-connection port on one end and a female luer on the other end with a clamp in between. The T-connection port has a swabable, needle-free port on one side and a locking male luer on the other side. The device contains and integrated stabilizer under the swabable needle-free port. This component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano ExT™ Extension Set is compatible with Velano Vascular PIVOT™ devices. | | Indication for Use: | The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. | # February 23, 2021 | | Subject Device: Velano ExT TM Extension Set (K20439) | Velano Vascular Q2® Low Pressure Power Injector Extension Set (K182897) | Comment | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Velano Vascular | Velano Vascular | | | Product Code | FPA | Same | | | Regulation | 880.5440 | Same | | | Classification | II | Same | | | Subject Device: Velano | Velano Vascular Q2® | Comment | | | ExT™ Extension Set | Low Pressure Power | | | | (K20439) | Injector Extension Set | | | | | (K182897) | | | | Indications for Use | The Velano ExT™ Extension Set with needle- free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. | Pressure Rated: The Q2® Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. Non Pressure Rated: The Q2® Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion | Wording changes for clarity and does not change the indication for use. | | | | or aspiration. | | | Intended Use | For administration of intravenous fluids to a patient's vascular system utilizing needle-free components and provide term intravascular or subcutaneous access using a variety of infusates (i.e. anesthesia drugs, chemotherapeutics, drugs, antibiotics, blood products, commonly used prep solutions). The device may also be used with low pressure power injectors rated for a maximum setting of 325 psi. The ExT™ Extension Set is compatible with Velano Vascular PIVOTM devices. | For administration of intravenous fluids to a patient's vascular system utilizing needle-free components and provide term intravascular or subcutaneous access using a variety of infusates (i.e. anesthesia drugs, chemotherapeutics, drugs, antibiotics, blood products, commonly used prep solutions). The device may also be used with low pressure power injectors rated for a maximum setting of 325 psi. The Q2® Extension Set is compatible with Velano Vascular PIVOTM devices. | Same | | | Subject Device: Velano ExTTM Extension Set (K20439) | Velano Vascular Q2® Low Pressure Power Injector Extension Set (K182897) | Comment | | Components | Tubing, Luer, Needle-less Connector, Male spin lock connector Non-fluid contacting: Stabilizer, pinch clamp, vented female luer lock cap | Tubing, Luer, Needle-less Connector, Male spin lock connector Non-fluid contacting: Pinch clamp, vented female luer lock cap | Flow rate, spin collar height and spin collar angle demonstrate that the difference does not alter the safety or effectiveness of the device | | Dimensions | Overall Length: 5.0 inch (12.7cm) | Overall Length: 5.75 inch (14.6cm) | Flow rate, torque, and kink resistance testing demonstrate that the difference does not alter the safety or effectiveness of the device | | Tubing | PVC | PVC | Same | | Luer | Polycarbonate | Co-polyester | Biocompatibility testing demonstrate that the difference does not alter safety or effectiveness of the device | | Needle-free Connector | NP Medical Proprietary Design Polycarbonate / silicone | Quest SwabSite Valve – Proprietary Design Polycarbonate / silicone | Microbial ingress, flow rate, pressure, and multiple activation testing demonstrate that the difference does not alter safety or effectiveness of the device | | Stabilizing component | Yes | No | Flow rate, spin collar height and spin collar angle demonstrate that the difference does not alter the safety or effectiveness of the device | | Principle of Operation | Swabable luer activation; direct injection, intermittent infusion, continuous infusion, aspiration | Swabable luer activation; direct injection, intermittent infusion, continuous infusion, aspiration | Same | | | Subject Device: Velano ExTTM Extension Set (K20439) | Velano Vascular Q2® Low Pressure Power Injector Extension Set (K182897) | Comment | | Use | Use with low pressure power injectors up to 325 psi and maximum flow rate of 10 mL/second. | Use with low pressure power injectors up to 325 psi and maximum flow rate of 10 mL/second. | Same | | Priming volume | < 1 mL | < 1 mL | Same | | Energy Source | User Operated | User Operated | Same | | Disposable or Reusable | Disposable | Disposable | Same | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same | | Minimum SAL | 1 x 10-6 | 1 x 10-6 | Same | | Packaging | Reinforced paper / nylon | Reinforced paper / nylon | Same | {4}------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ | Functional and Safety Testing: | To verify that the device design meets its functional and performance requirements, representative samples of thedevice underwent mechanical testing. As a result of verification and validation activities and risk assessment, testing ensured the device design meets its functional and performance requirements. The following tests were performed: | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • Visual inspection | | | • Simulated shipping | | | • Priming volume | | | • Microbial ingress | | | • Particulate | | | • Backpressure leak under normal use and power injection | | | • Flow rate for normal use and power injection | | | • Spin collar height and spin collar angle | | | • Simulated use | | | • Tubing bond strength | {7}------------------------------------------------ | • | Multiple Engagement | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • | Continuous Engagement | | • | Activation Force | | • | Tubing kink resistance | | 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 | | | ISO 10993-1, 2018 Biological Evaluation of Medical Devices | | | USP <788> Particulate Matter in Injections | | | ASTM D4169:2016 Standard practice for performance testing of shipping containers and systems | | | ASTM F1980:2016 Standard guide for accelerated aging of sterile medical device packages. | | | AAMI TIR28: 2016 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization | | | Conclusion: | Velano Vascular considers the Velano ExT™ Extension Set device to be equivalent to the predicate devices, K182897, listed above. This conclusion is based upon the identical intended use, Indication for use, principles of operation, patient contacting materials, and sterilization processes. |