Who is the manufacturer of Velano Vascular Q2 Extension Set?

Velano Vascular filed the 510(k) submission for Velano Vascular Q2 Extension Set (K182897).

What is the FDA product code for Velano Vascular Q2 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 Vascular Q2 Extension Set?

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

What are the predicate devices for Velano Vascular Q2 Extension Set?

Q2® Low Pressure Power Injection Set (K162804).

Who can help prepare an FDA 510(k) submission like Velano Vascular Q2 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 Vascular Q2 Extension Set

K182897 · Velano Vascular · FPA · Mar 26, 2019 · General Hospital

Device Facts

Record ID	K182897
Device Name	Velano Vascular Q2 Extension Set
Applicant	Velano Vascular
Product Code	FPA · General Hospital
Decision Date	Mar 26, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5440
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent 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® 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.

Device Story

Sterile, single-use intravenous administration extension set; 5.75-inch tubing with male luer, T-connector, and clamp. T-connector includes female luer and swabable needle-free port. Used in clinical settings for fluid delivery or aspiration; compatible with PIVO devices. Operated by healthcare professionals. Device facilitates connection between vascular access points and infusion/injection equipment. Benefits include needle-free access and power injection capability, reducing need for multiple access points.

Clinical Evidence

Bench testing only. No clinical data. Testing included visual inspection, simulated shipping, priming volume, backpressure leak, flow rate, simulated use, tubing bond strength, engagement testing, activation force, kink resistance, and PIVO compatibility.

Technological Characteristics

Materials: PVC (non-DEHP) tubing, co-polyester luer, polycarbonate/silicone needleless valve. Dimensions: 5.75 inch length. Sterilization: Ethylene oxide (ISO 11135:2014). Connectivity: Mechanical luer connection. Energy: User-operated. No software or electronics.

Indications for Use

Indicated for patients requiring intravenous fluid administration, direct injection, intermittent/continuous infusion, or aspiration via needleless components. Compatible with power injectors up to 325 psi at 10ml/sec. Single-use only.

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

Q2® Low Pressure Power Injection Set (K162804)

Related Devices

K200439 — Velano ExT Extension Set · Velano Vascular · Feb 23, 2021
K162804 — Q2 Low Pressure Power Injection Extension Set · Quest Medical, Inc. · Mar 8, 2017
K222766 — Disposable Extension Set · Shandong Ande Healthcare Apparatus Co., Ltd. · Apr 12, 2024
K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) · Cair Lgl · Aug 15, 2017
K230528 — Extension Set · Medcaptain Life Science Co., Ltd. · Dec 1, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION". March 26, 2019 Velano Vascular Tiffini Wittwer Consulting Director of Regulatory Affairs 221 Pine St. #200 San Francisco, California 94104 Re: K182897 Trade/Device Name: Velano Vascular Q2® Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 19, 2019 Received: February 21, 2019 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Sapana Patel -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182897 Device Name Velano Vascular Q2® Extension Set #### Indications for Use (Describe) Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent 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® 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. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | X 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}------------------------------------------------ #### 510(k) Summary K182897 # Table 1: 510(k) Summary | Submitter: | Velano Vascular, Inc. 221 Pine St #200 San Francisco CA 94133 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Tiffini Wittwer Consulting Director Regulatory Affairs Phone: 707.799.6732 E-mail: tdiage@raechelon.com | | Trade Name: | Velano Vascular Q2® Extension Set | | Common Name: | Intravascular Administration Set | | Classification: | Class II | | Product Code: | FPA | | Regulation | 21 CFR 880.5440 | | Predicate Device(s): | The subject device is equivalent to the following devices: • K162804 – Q2® Low Pressure Power Injection Set | | Device Description: | Sterile, single use non-pyrogenic intravenous administration extension set comprised of 5.75 inch tubing bonded to a male luer on one end and a T-connector on the other end with a clamp in between. The T-connector has a female luer on one side and a swabable, needle-free port on the other side. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano Vascular Q2® Extension Set is compatible with PIVO™ devices. | {4}------------------------------------------------ | Indication for Use: | Pressure Rated: The Q2® 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® 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. | | | Predicate Device | Subject Device | Differences | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | Rationale | | 510(k) | K162804 | K182897 | | | Model # | 95714 | 201-0001 | | | Brand Name | Q2 Low Pressure Power Injector Extension Set | Velano Vascular Q2 Extension Set | | | Manufacturer | Quest Medical, Inc. | SAME | | | FDA Regulation Number | 21CFR 880.5440 Intravascular Administration Set | SAME | | | FDA Class | II | SAME | | | FDA Product Code | FPA | SAME | | | Device Description | The device is an intravascular extension set available in one configuration that includes a needleless connector. The device is not made with the plasticizer Diethylhexylphthalate (DEHP). | Sterile, single use non-pyrogenic intravenous administration extension set comprised of 5.75 inch tubing bonded to a male luer on one end and a T-connector on the other end with a clamp in between. The T-connector has a female luer on one side and a swabable, needle-free port on the other side. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano Vascular Q2® Extension Set is compatible with PIVO™ devices. | Additional testing for activation force, leak, and flow rate demonstrate that the addition of the T- connector and female luer dos not alter the safety or effectiveness of the device. | | Intended Use | For administration of intravenous fluids to a patient's vascular system utilizing needlefree components. The device may be used with low pressure power injectors rated for a maximum setting of 325psi. | For administration of intravenous fluids to a patient's vascular system utilizing needlefree components. The device may be used with low pressure power injectors rated for a maximum setting of 325psi. The Q2® is compatible with PIVOTM devices. | Additional testing for activation force, leak, and flow rate demonstrate indication for use with PIVOTM devices does not affect safety or effectiveness of extension set device. Note: PIVOTM is a product tradename and not an acronym. | | Indication for Use | Pressure Rated: The Q2® 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 or aspiration. | Pressure Rated: The Q2® 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® 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. | Same | | Components | Tubing, Luer, Needle-less Connector, Male spin lock connector Non-fluid contacting: Pinch clamp, vented female luer lock cap | SAME | | | Dimensions | Length: 7 inch (18cm) | Length: 5.75 inch (14.6cm) | Flow rate and kink resistance testing demonstrates no risk to safety or effectiveness | | Material Comparison | | | | | Tubing | PVC - clear, non-DEHP Alpha Gary 2235L-78, standard bore | SAME | | | Luer | Co-polyester | SAME | | | Needleless | SwabSite Valve – Polycarbonate/silicone | SAME | | | Connector | | | | | Colorant | None | SAME | | | Use | Use with low pressure power injectors up to 325 psi and maximum flow rate of 10 mL/second | SAME | | | Priming volume | < 1 mL | SAME | | | Energy Source | User Operated | SAME | | | Principle of Operation | Luer activation; direct injection, intermittent infusion, continuous infusion, aspiration | SAME | | | Method | EtO | SAME | | | Minimum SAL | 1 x 10-6 | SAME | | | Packaging | Tyvek pouch | SAME | | | Disposable or Reusable | Disposable | SAME | | Velano Vascular, Inc. Premarket Notification for the Velano Vascular Q2® Extension Set {5}------------------------------------------------ Velano Vascular, Inc. Page 3 of 5 Premarket Notification for the Velano Vascular Q2® Extension Set {6}------------------------------------------------ Page 4 of 5 {7}------------------------------------------------ | Functional and Safety Testing: | To verify that the device design meets its functional and performance requirements, representative samples of the device 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 Backpressure leak under normal use and power injection Flow rate for normal use and power injection Simulated use Tubing bond strength Multiple Engagement Continuous Engagement Activation Force Tubing kink resistance Multiple clamping Prolonged clamping PIVO compatibility testing All patient contacting materials, sterilization, and design specifications are identical and unchanged from the predicate device. Additional sterilization assessments and testing were performed in accordance with the following: 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 | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion: | Velano Vascular considers the Velano Vascular Q2® Extension Set device to be substantially equivalent to the predicate device listed above. This conclusion is based upon the intended use, design specifications, patient contacting materials, manufacturing and sterilization processes. | Premarket Notification for the Velano Vascular Q2® Extension Set