Velano Vascular Blood Collection Adapter

K201237 · Velano Vascular · JKA · Oct 3, 2022 · Clinical Chemistry

Device Facts

• Record ID: K201237
• Device Name: Velano Vascular Blood Collection Adapter
• Applicant: Velano Vascular
• Product Code: JKA · Clinical Chemistry
• Decision Date: Oct 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Velano Vascular Blood Collection Device is intended to draw blood for in vitro diagnostic testing.

Device Story

Sterile, single-use blood collection adapter; attaches to newly placed IV-line, vascular access device, or venipuncture needle set. Device diverts ~3mL of initial blood sample into integrated waste tube; subsequent sample collected into culture bottle or evacuated tube. Used in clinical settings by healthcare providers. Manual diversion reduces blood culture contamination by sequestering initial specimen potentially containing contaminants. Benefits patient by improving accuracy of blood culture results.

Clinical Evidence

Bench testing only. Contamination study performed under simulated use conditions using Staphylococcus aureus, Bacillus Cereus, Escherichia coli, and Pseudomonas aeruginosa. Test samples using the adapter demonstrated no growth, while all positive controls demonstrated growth.

Technological Characteristics

Sterile, single-use, disposable adapter. Components: transfer device, waste tube, skirt, and adapter for narrow neck culture tubes. Inlet: Male Luer. Sterilization: Ethylene Oxide (ISO 11135, AAMI TIR28). Biocompatibility: ISO 10993-5, -10, -23. Mechanical testing: ISO 80369-7, ASTM D4169, ASTM F1980.

Indications for Use

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.

Regulatory Classification

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.

Predicate Devices

• Magnolia Steripath® Gen2 Blood Collection System (K192247)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> </span>Prescription Use (Part 21 CFR 201 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span>Over-The-Counter Use (21 CFR 201 Subpart G) </div> |

> 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 Vascular<br>221 Pine Street #200<br>San Francisco CA 94104 | | Subject Device:<br>Velano Vascular Blood<br>Collection Adapter | Predicate Device:<br>Magnolia Steripath®<br>Gen2 Blood Collection<br>System | Comment: |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Wittwer<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Email: [e-mail] | 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 | Subsequent<br>Product Code | None | FPA | Predicate design allows<br>for infusion, subject<br>device does not. No effect<br>on safety or efficacy for<br>blood 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:<br>• Magnolia Steripath Gen2 Blood Collection System - K192247 | Common<br>Name | Blood Specimen Collection<br>Set | Blood Specimen<br>Collection Set | Same |
| Device Description: | The Blood Collection Adapter is a sterile, single-use device that<br>removes the initial portion of the blood specimen (potentially<br>contaminated) into a waste or discard tube prior to collecting a<br>subsequent blood sample. The Blood Collection Adapter is<br>comprised of a transfer device, a waste tube, a skirt that holds the<br>waste tube in place, and an adapter inside the transfer device that is<br>used for narrow neck culture tubes and additional blood collection<br>tubes.<br>The device is designed to be attached to a newly placed IV-line,<br>vascular access device, or venipuncture needle set and is not intended<br>for blood specimen collection from preexisting lines or IV site. Place<br>a new peripheral IV catheter prior to drawing blood sample. The<br>device collects approximately 3mL of the initial blood sample into<br>the waste tube. The subsequent blood sample is collected directly<br>into a culture bottle (not provided by Velano Vascular) or into an<br>evacuated tube for additional processing. | Device<br>Classification | Tubes, Vials, Systems, Serum<br>Separators | Tubes, Vials, Systems,<br>Serum Separators | |
| Indication for Use: | The Velano Vascular Blood Collection Adapter is indicated for use<br>as a blood collection system that manually diverts the initial<br>specimen prior to collection of a subsequent test sample to reduce the<br>frequency of blood culture contamination when contaminants are<br>present in the initial blood sample compared to blood cultures drawn<br>with standard procedure without manual diversion. | Indications for<br>Use | The Velano Vascular Blood<br>Collection Adapter is<br>indicated for use as a blood<br>collection system that<br>manually diverts the initial<br>specimen prior to collection of<br>a subsequent test sample to<br>reduce the frequency of blood<br>culture contamination when<br>contaminants are present in<br>the initial blood sample<br>compared to blood cultures<br>drawn with standard<br>procedure without manual<br>diversion. | The Steripath® Gen2<br>Blood Collection System<br>is indicated for use as a<br>blood collection system<br>that diverts and sequesters<br>the initial specimen prior<br>to collection of a<br>subsequent test sample to<br>reduce the frequency of<br>blood culture<br>contamination when<br>contaminants are present<br>in the initial blood sample<br>compared to blood<br>cultures drawn with<br>standard procedure<br>without manual<br>diversion.<br>Additionally, components<br>of the system may be used<br>for infusion following<br>sample collection after<br>disconnection of the Initial<br>Specimen Diversion<br>Device® (ISDD®).<br>Venipuncture needles are<br>indicated for short term<br>infusion (less than 2<br>hours). | Same indication for use<br>for blood collection;<br>subject device does not<br>have an infusion<br>indication. |
| Intended Use | The Velano Vascular Blood<br>Collection Device is intended | The Steripath® Gen2<br>Blood Collection System<br>is a system to draw blood | Same | | |

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| | Subject Device: | Predicate Device: | Comment: |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Velano Vascular Blood<br>Collection Adapter | Magnolia Steripath®<br>Gen2 Blood Collection<br>System | |
| | to draw blood for in vitro<br>diagnostic testing. | for in vitro diagnostic<br>testing. | |
| Method of<br>Operation | Used with newly placed IV<br>lines or blood collection<br>devices, diverts initial blood<br>volume into separate location<br>prior to attaching culture<br>bottle | Used with newly placed<br>IV lines or blood<br>collection devices, ,<br>diverts initial blood<br>volume into separate<br>location prior to attaching<br>culture bottle | Same |
| Patient Contact | Yes | Yes | Same |
| Blood Volume<br>Discarded | 2 - 3mL | 1.5 - 2mL | Subject device diverts<br>more blood than predicate.<br>Simulated use and<br>contamination study<br>demonstrate this<br>difference does not alter<br>the safety or efficacy of<br>the device. |
| Blood<br>collection<br>device inlet | Male Luer | Male Luer | Same |
| Off the shelf<br>collection<br>device | Yes | Yes | Same |
| Infusion<br>Capabilities | No | Yes | Subject device has no<br>infusion indication where<br>predicate device does. No<br>change to the safety or<br>efficacy of the device for<br>blood collection |
| Can be used<br>for additional<br>blood tube<br>draws (after<br>blood culture<br>collection) | No | No | Same |
| Disposable or<br>Reusable | Single-use, disposable | Yes | Same |
| Sterilization<br>Method | 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 shipping<br>containers and systems |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ASTM F1980, Standard guide for accelerated aging of sterile<br>medical device packages. |
| | In addition, a contamination study was performed to validate the<br>device performs as intended. Under simulated use conditions, test<br>samples were contaminated with various organisms ( <i>Staphylococcus</i><br><i>aureus, Bacillus Cereus, Escherichia coli, Pseudomonas<br/>aeruginosa</i> ). Test samples using the Blood Collection Adapter<br>demonstrated no growth and all positive control test samples<br>demonstrated growth of each organisms evaluated. |
| Conclusion: | The Blood Collection Adapter device is substantially equivalent to<br>the predicate device listed above. This conclusion is based upon the<br>identical intended use, similar indication for use, principles of<br>operation, and sterilization processes and results of functional<br>performance testing and contamination study. |