(365 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.
No
The device is an extension set used for administering fluids, but it does not directly treat or diagnose a medical condition; it is an accessory to therapeutic procedures.
No
The device description indicates it is an "intravenous administration extension set" used for injection, infusion, or aspiration, and testing focuses on mechanical function and performance rather than diagnostic capabilities. There is no mention of analysis, measurement, or diagnosis of a medical condition.
No
The device description clearly details physical components like tubing, ports, luers, and a clamp, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "intravenous administration extension set" for direct injection, intermittent infusion, continuous infusion, aspiration, and power injector procedures. These are all procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description details the physical components of the extension set, such as tubing, ports, and a clamp. It focuses on how the device facilitates the delivery or removal of substances to or from the patient's vascular system.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies described are focused on the mechanical and functional aspects of the device (flow rate, pressure resistance, bond strength, etc.), not on its ability to accurately detect or measure substances in a sample.
In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate the administration or removal of substances directly to or from the patient's bloodstream, which is a therapeutic or procedural function, not a diagnostic one.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
• 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | 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. |