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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device (Velano Vascular Q2 Extension Set), which focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria through a rigorous study. Therefore, the information typically required to answer your prompt about AI acceptance criteria and study details (such as sample size for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) for an AI/ML device is not present in this document.

This document describes a traditional medical device (an intravascular administration set) and performs mechanical and functional testing to demonstrate its safety and effectiveness relative to a legally marketed predicate device.

However, I can extract the relevant information regarding the device's functional and safety testing, despite it not being an AI-driven device.

Here's a breakdown of the acceptance criteria and study information provided in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a table of "acceptance criteria" against "reported performance" in a quantitative manner for each test. Instead, it lists the types of functional and safety tests performed and states that these tests ensured the device design meets its functional and performance requirements. The conclusion explicitly states that "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." This implies that the device met the implicit acceptance criteria for each test to achieve substantial equivalence.

Implicit Acceptance Criteria and Demonstrated Performance (Inferred from the document):

Test Performed	Implicit Acceptance Criterion	Reported Device Performance (Implied)
Visual inspection	Device must be free from visible defects.	Met requirements (ensured device design meets functional and performance requirements).
Simulated shipping	Device must withstand shipping stresses without damage or compromise to function.	Met requirements.
Priming volume	Priming volume must be consistent with specifications and safe for intended use.	< 1 mL (consistent with predicate and acceptable).
Backpressure leak (normal use & power injection)	No leakage under normal operating pressures and specified power injection pressures (max 325 psi).	Met requirements (demonstrates the addition of the T-connector and female luer does not alter the safety or effectiveness of the device compared to the predicate, which also withstands 325 psi).
Flow rate (normal use & power injection)	Flow rate must meet specified values for normal and power injection (10ml/sec at 325 psi).	Met requirements (demonstrates the addition of the T-connector and female luer does not alter the safety or effectiveness of the device, and the shorter length of the new device still results in acceptable flow rate and kink resistance).
Simulated use	Device must perform as intended during simulated clinical use.	Met requirements.
Tubing bond strength	Bonds must withstand specified forces without separation.	Met requirements.
Multiple Engagement	Needleless connector must function accurately after multiple engagements.	Met requirements.
Continuous Engagement	Needleless connector must maintain integrity during continuous engagement.	Met requirements.
Activation Force	Force required to activate the device must be within acceptable limits.	Met requirements (demonstrates the addition of the T-connector and female luer does not alter the safety or effectiveness of the device).
Tubing kink resistance	Tubing must resist kinking under normal manipulation.	Met requirements (demonstrates the change in length does not risk safety or effectiveness).
Multiple clamping	Clamp must function effectively after multiple closures.	Met requirements.
Prolonged clamping	Clamp must maintain occlusion over prolonged periods.	Met requirements.
PIVO compatibility testing	Device must be compatible with PIVO™ devices as claimed.	Met requirements (demonstrates compatibility with PIVO™ devices does not affect safety or effectiveness).
Sterilization (ISO 11135:2014)	Sterilization process (EtO) achieves a sterility assurance level (SAL) of 1 x 10^-6.	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 ISO 11135:2014, achieving 1 x 10^-6 SAL.

2. Sample sized used for the test set and the data provenance:

Sample Size: The document repeatedly refers to "representative samples" being used for mechanical testing (Page 7). However, it does not specify the exact number of samples (sample size) used for each test.
Data Provenance: Not applicable in the context of "data" for an AI/ML device. For a physical device, the data provenance is the location where the manufacturing and testing occurred. This information is not detailed beyond the manufacturer's address (San Francisco, CA). The tests are presumably performed in a controlled laboratory environment. The testing is prospective in the sense that it's performed as part of the submission process for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as this is not an AI/ML device requiring human expert ground truth for classification or interpretation. The performance is assessed through objective physical and functional tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable as this is not an AI/ML device requiring human expert adjudication. The test results are based on objective measurements and established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable as this is not an AI/ML device. The device's "standalone" performance is its physical and functional performance during the mechanical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For physical/mechanical devices, "ground truth" is established by engineering specifications, industry standards (e.g., ISO), and physical measurements against known values and benchmarks (like the predicate device's performance). For example, a leak test's "ground truth" is "no leak detected under specified pressure." This is not based on expert consensus in the diagnostic sense, but rather adherence to predefined engineering limits and physical laws.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:

This is not applicable as this is not an AI/ML device.

Summary

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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

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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/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)

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 #200San Francisco CA 94133
Contact Person:	Tiffini WittwerConsulting Director Regulatory AffairsPhone: 707.799.6732E-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 administrationextension set comprised of 5.75 inch tubing bonded to a maleluer on one end and a T-connector on the other end with aclamp in between. The T-connector has a female luer on oneside and a swabable, needle-free port on the other side. Thisdevice is not made with the plasticizer Diethylhexylphthalate(DEHP). The Velano Vascular Q2® Extension Set iscompatible 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 PowerInjector Extension Set	Velano Vascular Q2 ExtensionSet
Manufacturer	Quest Medical, Inc.	SAME
FDARegulationNumber	21CFR 880.5440Intravascular AdministrationSet	SAME
FDA Class	II	SAME
FDA ProductCode	FPA	SAME
DeviceDescription	The device is an intravascularextension set available in oneconfiguration that includes aneedleless connector. Thedevice is not made with theplasticizerDiethylhexylphthalate (DEHP).	Sterile, single use non-pyrogenicintravenous administrationextension set comprised of 5.75inch tubing bonded to a male lueron one end and a T-connector onthe other end with a clamp inbetween. The T-connector has afemale luer on one side and aswabable, needle-free port on theother side. This device is not madewith the plasticizerDiethylhexylphthalate (DEHP). TheVelano Vascular Q2® ExtensionSet is compatible with PIVO™devices.	Additional testing foractivation force, leak,and flow ratedemonstrate that theaddition of the T-connector and femaleluer dos not alter thesafety oreffectiveness of thedevice.
IntendedUse	For administration ofintravenous fluids to a patient'svascular system utilizingneedlefree components. Thedevice may be used with lowpressure power injectors ratedfor a maximum setting of325psi.	For administration of intravenousfluids to a patient's vascular systemutilizing needlefree components.The device may be used with lowpressure power injectors rated for amaximum setting of 325psi. TheQ2® is compatible with PIVOTMdevices.	Additional testing foractivation force, leak,and flow ratedemonstrateindication for usewith PIVOTM devicesdoes not affect safetyor effectiveness ofextension set device.Note: PIVOTM is aproduct tradenameand not an acronym.
Indication forUse	Pressure Rated: The Q2®Extension Set with needlelessconnector is for single use only.The extension set may be usedfor direct injection, intermittentinfusion, continuous infusion oraspiration. This set may be usedwith power injector proceduresto a maximum pressure of 325psi at a flow rate of 10ml persecond.Non Pressure Rated: The Q2®Low Pressure Power InjectorExtension Set with needlelessconnector is for single use only.The extension set may be usedfor direct injection, intermittentinfusion, continuous infusion oraspiration.	Pressure Rated: The Q2®Extension Set with needlelessconnector is for single use only. Theextension set may be used for directinjection, intermittent infusion,continuous infusion or aspiration.This set may be used with powerinjector procedures to a maximumpressure of 325 psi at a flow rate of10ml per second.Non Pressure Rated: The Q2®Extension Set with needlelessconnector is for single use only.The extension set may be used fordirect injection, intermittentinfusion, continuous infusion oraspiration.	Same
Components	Tubing, Luer, Needle-lessConnector, Male spin lockconnectorNon-fluid contacting:Pinch clamp, ventedfemale luer lock cap	SAME
Dimensions	Length: 7 inch (18cm)	Length: 5.75 inch (14.6cm)	Flow rate and kinkresistance testingdemonstrates no riskto safety oreffectiveness
Material Comparison
Tubing	PVC - clear, non-DEHP AlphaGary 2235L-78, standard bore	SAME
Luer	Co-polyester	SAME
Needleless	SwabSite Valve –Polycarbonate/silicone	SAME
Connector
Colorant	None	SAME
Use	Use with low pressure powerinjectors up to 325 psi andmaximum flow rate of 10mL/second	SAME
Primingvolume	< 1 mL	SAME
Energy Source	User Operated	SAME
Principle ofOperation	Luer activation; directinjection, intermittent infusion,continuous infusion, aspiration	SAME
Method	EtO	SAME
Minimum SAL	1 x 10-6	SAME
Packaging	Tyvek pouch	SAME
Disposable orReusable	Disposable	SAME

Velano Vascular, Inc.

Premarket Notification for the Velano Vascular Q2® Extension Set

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Velano Vascular, Inc.

Page 3 of 5

Premarket Notification for the Velano Vascular Q2® Extension Set

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Page 4 of 5

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Functional and SafetyTesting:	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 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 designspecifications are identical and unchanged from the predicatedevice. Additional sterilization assessments and testing wereperformed in accordance with the following:ISO 11135:2014, Sterilization of health-care products -Ethyleneoxide - Requirements for the development, validation and routinecontrol of a sterilization process for medical devices
Conclusion:	Velano Vascular considers the Velano Vascular Q2® Extension Setdevice 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.

Functional and SafetyTesting:

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 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 designspecifications are identical and unchanged from the predicatedevice. Additional sterilization assessments and testing wereperformed in accordance with the following:ISO 11135:2014, Sterilization of health-care products -Ethyleneoxide - Requirements for the development, validation and routinecontrol of a sterilization process for medical devices

Conclusion:

Velano Vascular considers the Velano Vascular Q2® Extension Setdevice 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

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.