(365 days)
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.
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.
The provided text is a 510(k) premarket notification for a medical device called the "Velano ExT™ Extension Set". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on a clinical trial or algorithm performance study as you might find for an AI/ML medical device.
Therefore, the document does not contain the information required to answer questions 1 through 9, as it does not describe an acceptance criteria table, a study proving the device meets these criteria, or details regarding algorithm performance, ground truth establishment, or expert reviews.
The document details the following regarding the device and its testing:
- Device Name: Velano ExT™ Extension Set
- Intended Use: Administration of intravenous fluids, and use with low-pressure power injectors up to 325 psi and a maximum flow rate of 10 mL/second.
- Predicate Device: Velano Vascular Q2® Low Power Injector Extension Set (K182897)
- Functional and Safety Testing Performed: This section lists various tests conducted to verify the device's design meets functional and performance requirements. These tests are physical and mechanical in nature, not related to an algorithm's diagnostic performance.
- 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
- Multiple Engagement
- Continuous Engagement
- Activation Force
- Tubing kink resistance
- Standards Applied: The document lists several ISO, USP, ASTM, and AAMI standards related to medical device sterilization, biological evaluation, particulate matter, packaging, and accelerated aging.
In summary, this document is a regulatory submission for a physical medical device (an extension set), not an AI/ML-driven device. Thus, the concepts of acceptance criteria for algorithm performance, test set size, expert adjudication, MRMC studies, standalone algorithm performance, or training set details are not applicable or present in this document.
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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
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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
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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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitter: | Velano Vascular |
|---|---|
| Contact Person: | Tiffini WittwerRegulatory Affairs ConsultantPhone: (707) 799-6732Email: 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: VelanoExT TM Extension Set(K20439) | Velano Vascular Q2®Low Pressure PowerInjector 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 forUse | The Velano ExT™Extension Set with needle-free connector is for singleuse only. Each port of theVelano ExT™ Extension Setmay be used for directinjection, intermittentinfusion, continuous infusionor aspiration. The pressurerated port of the VelanoExT™ Extension Set may beused with power injectorprocedures to a maximumpressure of 325 psi at a flowrate of 10ml per second. | Pressure Rated: The Q2®Low Pressure Power InjectorExtension Set with needlelessconnector is for single useonly. The extension set maybe used for direct injection,intermittent infusion,continuous infusion oraspiration. This set may beused with power injectorprocedures to a maximumpressure of 325 psi at a flowrate of 10ml per second.Non Pressure Rated: TheQ2® Low Pressure PowerInjector Extension Set withneedleless connector is forsingle use only. Theextension set may be used fordirect injection, intermittentinfusion, continuous infusion | Wording changes forclarity and does notchange the indicationfor use. |
| or aspiration. | |||
| Intended Use | For administration ofintravenous fluids to apatient's vascular systemutilizing needle-freecomponents and provideterm intravascular orsubcutaneous access usinga variety of infusates (i.e.anesthesia drugs,chemotherapeutics, drugs,antibiotics, blood products,commonly used prepsolutions). The device mayalso be used with low pressurepower injectors rated for amaximum setting of 325 psi.The ExT™ Extension Set iscompatible with VelanoVascular PIVOTM devices. | For administration ofintravenous fluids to apatient's vascular systemutilizing needle-freecomponents and provideterm intravascular orsubcutaneous access usinga variety of infusates (i.e.anesthesia drugs,chemotherapeutics, drugs,antibiotics, blood products,commonly used prepsolutions). The device mayalso be used with low pressurepower injectors rated for amaximum setting of 325 psi.The Q2® Extension Set iscompatible with VelanoVascular PIVOTM devices. | Same |
| Subject Device: VelanoExTTM Extension Set(K20439) | Velano Vascular Q2®Low Pressure PowerInjector Extension Set(K182897) | Comment | |
| Components | Tubing, Luer, Needle-lessConnector, Male spin lockconnectorNon-fluid contacting:Stabilizer, pinch clamp,vented female luer lock cap | Tubing, Luer, Needle-lessConnector, Male spin lockconnectorNon-fluid contacting: Pinchclamp, vented female luerlock cap | Flow rate, spin collarheight and spin collarangle demonstrate thatthe difference does notalter the safety oreffectiveness of thedevice |
| Dimensions | Overall Length: 5.0 inch(12.7cm) | Overall Length: 5.75 inch(14.6cm) | Flow rate, torque, andkink resistance testingdemonstrate that thedifference does notalter the safety oreffectiveness of thedevice |
| Tubing | PVC | PVC | Same |
| Luer | Polycarbonate | Co-polyester | Biocompatibilitytesting demonstrate thatthe difference does notalter safety oreffectiveness of thedevice |
| Needle-freeConnector | NP MedicalProprietary DesignPolycarbonate / silicone | Quest SwabSite Valve –Proprietary DesignPolycarbonate / silicone | Microbial ingress, flowrate, pressure, andmultipleactivation testingdemonstrate that thedifference does notalter safety oreffectiveness of thedevice |
| Stabilizingcomponent | Yes | No | Flow rate, spin collarheight and spin collarangle demonstrate thatthe difference does notalter the safety oreffectiveness of thedevice |
| Principle ofOperation | Swabable luer activation;direct injection, intermittentinfusion, continuousinfusion, aspiration | Swabable luer activation;direct injection, intermittentinfusion, continuousinfusion, aspiration | Same |
| Subject Device: VelanoExTTM Extension Set(K20439) | Velano Vascular Q2®Low Pressure PowerInjector Extension Set(K182897) | Comment | |
| Use | Use with low pressure powerinjectors up to 325 psi andmaximum flow rate of 10mL/second. | Use with low pressure powerinjectors up to 325 psi andmaximum flow rate of 10mL/second. | Same |
| Primingvolume | < 1 mL | < 1 mL | Same |
| Energy Source | User Operated | User Operated | Same |
| Disposable orReusable | Disposable | Disposable | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
| Minimum SAL | 1 x 10-6 | 1 x 10-6 | Same |
| Packaging | Reinforced paper / nylon | Reinforced paper / nylon | Same |
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| Functional andSafety Testing: | To verify that the device design meets its functional andperformance requirements, representative samples of thedevice underwent mechanical testing. As a result ofverification and validation activities and risk assessment,testing ensured the device design meets its functional andperformance requirements. The following tests wereperformed: |
|---|---|
| • 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 |
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| • | Multiple Engagement |
|---|---|
| • | Continuous Engagement |
| • | Activation Force |
| • | Tubing kink resistance |
| ISO 11135:2014, Sterilization of health-care products -Ethyleneoxide - Requirements for the development, validation and routinecontrol 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 ofshipping containers and systems | |
| ASTM F1980:2016 Standard guide for accelerated aging of sterilemedical device packages. | |
| AAMI TIR28: 2016 Product Adoption and Process Equivalence forEthylene Oxide Sterilization | |
| Conclusion: | Velano Vascular considers the Velano ExT™ Extension Set deviceto be equivalent to the predicate devices, K182897, listed above.This conclusion is based upon the identical intended use, Indicationfor use, principles of operation, patient contacting materials, andsterilization processes. |
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.