The Velano Vascular Blood Collection Adapter is indicated for use as a blood collection system that manually diverts the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

Device Description

The Blood Collection Adapter is a sterile, single-use device that removes the initial portion of the blood specimen (potentially contaminated) into a waste or discard tube prior to collecting a subsequent blood sample. The Blood Collection Adapter is comprised of a transfer device, a waste tube, a skirt that holds the waste tube in place, and an adapter inside the transfer device that is used for narrow neck culture tubes and additional blood collection tubes. The device is designed to be attached to a newly placed IV-line, vascular access device, or venipuncture needle set and is not intended for blood specimen collection from preexisting lines or IV site. Place a new peripheral IV catheter prior to drawing blood sample. The device collects approximately 3mL of the initial blood sample into the waste tube. The subsequent blood sample is collected directly into a culture bottle (not provided by Velano Vascular) or into an evacuated tube for additional processing.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Velano Vascular Blood Collection Adapter

The provided FDA 510(k) summary for the Velano Vascular Blood Collection Adapter (K201237) outlines the device's indications for use and the testing performed to demonstrate its substantial equivalence to a predicate device. The core function of the device is to reduce blood culture contamination by diverting the initial potentially contaminated blood specimen.

While the document does not explicitly present a formal "acceptance criteria table" with numerical metrics for clinical efficacy (e.g., specific contamination rate reduction targets), the contamination study serves as the primary evidence for meeting the performance requirement related to its intended use: reducing blood culture contamination.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device and the provided documentation, the acceptance criteria are implicitly derived from the successful outcome of the contamination study, demonstrating the device's ability to prevent the passage of contaminants under simulated conditions.

Acceptance Criteria Category	Specific Acceptance Criteria (Implicit)	Reported Device Performance
Functional Performance	Device mechanically functions as intended, including proper diversion of waste blood and collection of subsequent samples. No leaks or malfunctions during simulated use.	- Visual inspection: Passed - Simulated shipping: Passed - Dimensional measurements: Passed - Activation force: Passed - Inlet compatibility: Passed - Outlet compatibility: Passed - Simulated use: Passed - Discard volume: Achieved 3mL discard - Multiple engagements: Passed
Sterilization	Device achieves and maintains sterility.	- Ethylene Oxide Sterilization: Performed to ISO 11135 and AAMI TIR28, achieving a minimum SAL of 1 x 10-6.
Biocompatibility	Device materials are biocompatible and do not cause adverse biological reactions.	- In vitro cytotoxicity: Passed (ISO 10993-5) - Skin sensitization: Passed (ISO 10993-10) - Irritation: Passed (ISO 10993-23)
Efficacy (Contamination Reduction)	Device effectively prevents the passage of various bacterial contaminants from the initial diverted sample to the subsequent collected sample under simulated use conditions.	- Contamination Study: Test samples using the Blood Collection Adapter demonstrated no growth of
Staphylococcus aureus, Bacillus Cereus, Escherichia coli, Pseudomonas aeruginosa from the collected sample.

2. Sample Size Used for the Test Set and Data Provenance

Contamination Study (Test Set):
- Sample Size: The document states "Test samples" and "all positive control test samples" but does not explicitly provide the numerical sample size (number of devices or tests performed) for this study.
- Data Provenance: The study was a "simulated use" study, implying it was conducted in a laboratory setting, not on human subjects. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical clinical study sense.
Functional and Safety Testing (Excluding Contamination Study):
- Sample Size: The document does not specify the sample size for tests like visual inspection, simulated shipping, dimensional measurements, etc.
- Data Provenance: These are laboratory-based engineering and quality assurance tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The provided document does not indicate that expert review was used to establish ground truth for the contamination study or other functional/safety tests. The ground truth for the contamination study was established through laboratory culture results (presence or absence of bacterial growth).

4. Adjudication Method for the Test Set

Not applicable. The contamination study's outcome (bacterial growth or no growth) is an objective laboratory result, not subject to subjective interpretation requiring an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Velano Vascular Blood Collection Adapter is a mechanical blood collection device, not an imaging or diagnostic algorithm.

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

Yes, the contamination study effectively represents a standalone performance evaluation of the device's ability to prevent contamination. The device's efficacy in diverting contaminants was assessed independently in a simulated environment, without direct human influence on the contamination-prevention mechanism during the "collection" phase of the study setup. While human manipulation is required to use the device, the study isolates the device's functional performance regarding contamination prevention.

7. The Type of Ground Truth Used

Contamination Study: The ground truth was laboratory culture results (positive for growth in controls, negative for growth in test samples). This is a definitive biological outcome.
Functional and Safety Testing: The ground truth was based on engineering specifications and established test methodologies (e.g., measurements falling within specified ranges, successful activation, absence of visible defects).

8. The Sample Size for the Training Set

Not applicable. The Velano Vascular Blood Collection Adapter is a mechanical device, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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October 3, 2022

Velano Vascular Tiffini Wittwer Regulatory Affairs Consultant 221 Pine Street #200 San Francisco, California 94104

Re: K201237

Trade/Device Name: Velano Vascular Blood Collection Adapter Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: September 26, 2022 Received: October 3, 2022

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 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

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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,

Paval Patel 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) K201237

Device Name Velano Vascular Blood Collection Adapter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart G)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K201237 – September 26, 2022

510(k) Summary

Submitter:	Velano Vascular221 Pine Street #200San Francisco CA 94104		Subject Device:Velano Vascular BloodCollection Adapter	Predicate Device:Magnolia Steripath®Gen2 Blood CollectionSystem	Comment:
Contact Person:	Tiffini WittwerRegulatory Affairs ConsultantPhone: (707) 799-6732Email: twittwer@mededge.io	510(k)	K201237	K192247
Trade Name:	Velano Vascular Blood Collection Adapter	Manufacturer	Velano Vascular	Magnolia
Common Name:	Blood Collection Serum Separators, Systems, Vials, Tubes	Classification	II	II	Same
Classification:	Class II	Product Code	JKA	JKA	Same
Product Code:	JKA	SubsequentProduct Code	None	FPA	Predicate design allowsfor infusion, subjectdevice does not. No effecton safety or efficacy forblood collection indication
Regulation:	CFR 862.1675 – Blood specimen collection device	Regulation	862.1675	862.1675	Same
Predicate Device(s):	The subject device is equivalent to the following device:• Magnolia Steripath Gen2 Blood Collection System - K192247	CommonName	Blood Specimen CollectionSet	Blood SpecimenCollection Set	Same
Device Description:	The Blood Collection Adapter is a sterile, single-use device thatremoves the initial portion of the blood specimen (potentiallycontaminated) into a waste or discard tube prior to collecting asubsequent blood sample. The Blood Collection Adapter iscomprised of a transfer device, a waste tube, a skirt that holds thewaste tube in place, and an adapter inside the transfer device that isused for narrow neck culture tubes and additional blood collectiontubes.The device is designed to be attached to a newly placed IV-line,vascular access device, or venipuncture needle set and is not intendedfor blood specimen collection from preexisting lines or IV site. Placea new peripheral IV catheter prior to drawing blood sample. Thedevice collects approximately 3mL of the initial blood sample intothe waste tube. The subsequent blood sample is collected directlyinto a culture bottle (not provided by Velano Vascular) or into anevacuated tube for additional processing.	DeviceClassification	Tubes, Vials, Systems, SerumSeparators	Tubes, Vials, Systems,Serum Separators
Indication for Use:	The Velano Vascular Blood Collection Adapter is indicated for useas a blood collection system that manually diverts the initialspecimen prior to collection of a subsequent test sample to reduce thefrequency of blood culture contamination when contaminants arepresent in the initial blood sample compared to blood cultures drawnwith standard procedure without manual diversion.	Indications forUse	The Velano Vascular BloodCollection Adapter isindicated for use as a bloodcollection system thatmanually diverts the initialspecimen prior to collection ofa subsequent test sample toreduce the frequency of bloodculture contamination whencontaminants are present inthe initial blood samplecompared to blood culturesdrawn with standardprocedure without manualdiversion.	The Steripath® Gen2Blood Collection Systemis indicated for use as ablood collection systemthat diverts and sequestersthe initial specimen priorto collection of asubsequent test sample toreduce the frequency ofblood culturecontamination whencontaminants are presentin the initial blood samplecompared to bloodcultures drawn withstandard procedurewithout manualdiversion.Additionally, componentsof the system may be usedfor infusion followingsample collection afterdisconnection of the InitialSpecimen DiversionDevice® (ISDD®).Venipuncture needles areindicated for short terminfusion (less than 2hours).	Same indication for usefor blood collection;subject device does nothave an infusionindication.
Intended Use	The Velano Vascular BloodCollection Device is intended	The Steripath® Gen2Blood Collection Systemis a system to draw blood	Same

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	Subject Device:	Predicate Device:	Comment:
	Velano Vascular BloodCollection Adapter	Magnolia Steripath®Gen2 Blood CollectionSystem
	to draw blood for in vitrodiagnostic testing.	for in vitro diagnostictesting.
Method ofOperation	Used with newly placed IVlines or blood collectiondevices, diverts initial bloodvolume into separate locationprior to attaching culturebottle	Used with newly placedIV lines or bloodcollection devices, ,diverts initial bloodvolume into separatelocation prior to attachingculture bottle	Same
Patient Contact	Yes	Yes	Same
Blood VolumeDiscarded	2 - 3mL	1.5 - 2mL	Subject device divertsmore blood than predicate.Simulated use andcontamination studydemonstrate thisdifference does not alterthe safety or efficacy ofthe device.
Bloodcollectiondevice inlet	Male Luer	Male Luer	Same
Off the shelfcollectiondevice	Yes	Yes	Same
InfusionCapabilities	No	Yes	Subject device has noinfusion indication wherepredicate device does. Nochange to the safety orefficacy of the device forblood collection
Can be usedfor additionalblood tubedraws (afterblood culturecollection)	No	No	Same
Disposable orReusable	Single-use, disposable	Yes	Same
SterilizationMethod	Ethylene Oxide	Yes	Same
Minimum SAL	1 x 10-6	Yes	Same

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Functional and Safety Testing:

To verify that the device design meets its functional and performance requirements, devices underwent physical and 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 ●
Dimensional measurements
Activation force
Inlet compatibility ●
Outlet compatibility ●
Simulated use
. Discard volume
Multiple engagements ●

Testing was performed in accordance with the following:

ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

ISO 11135, Sterilization of health-care products -Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices

AAMI TIR28, Product Adoption and Process Equivalence for Ethylene Oxide Sterilization

ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for skin sensitization

ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation

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	ASTM D4169, Standard practice for performance testing of shippingcontainers and systems
	ASTM F1980, Standard guide for accelerated aging of sterilemedical device packages.
	In addition, a contamination study was performed to validate thedevice performs as intended. Under simulated use conditions, testsamples were contaminated with various organisms ( Staphylococcusaureus, Bacillus Cereus, Escherichia coli, Pseudomonasaeruginosa ). Test samples using the Blood Collection Adapterdemonstrated no growth and all positive control test samplesdemonstrated growth of each organisms evaluated.
Conclusion:	The Blood Collection Adapter device is substantially equivalent tothe predicate device listed above. This conclusion is based upon theidentical intended use, similar indication for use, principles ofoperation, and sterilization processes and results of functionalperformance testing and contamination study.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.