Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a simple mechanical extension set for intravenous administration and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

No.
This device is an extension set used for administering substances into a patient's vascular system; it does not itself provide a therapeutic effect but rather facilitates the delivery of therapeutic agents or for diagnostic aspiration.

Diagnostic

No

The device is an extension set for administering fluids (injection, infusion, aspiration) to the vascular system; it does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (tubing, luer, T-connector, clamp, needle-free port) and the performance studies focus on mechanical testing of these physical components. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as being used for direct injection, intermittent infusion, continuous infusion, or aspiration within a patient's vascular system. These are procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
Device Description: The description details an intravenous administration extension set used for connecting to a patient's vascular system. This aligns with therapeutic or procedural use, not diagnostic testing of a sample.
Lack of Diagnostic Purpose: There is no mention of the device being used to analyze a sample (like blood, urine, or tissue) to provide information about a patient's health status, disease, or condition.
No Mention of Assays or Reagents: IVD devices often involve the use of assays or reagents to perform diagnostic tests. These are not mentioned in the description.

In summary, the device is designed for administering substances to or withdrawing substances from a patient's vascular system, which is a therapeutic or procedural function, not an in vitro diagnostic function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 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.

Product codes (comma separated list FDA assigned to the subject device)

FPA

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.

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)

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

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.

K162804

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

Regulation Number and Section

§ 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.

Summary

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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

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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)

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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. |

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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