PIVO

K190604 · Velano Vascular · JKA · May 13, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190604
• Device Name: PIVO
• Applicant: Velano Vascular
• Product Code: JKA · Clinical Chemistry
• Decision Date: May 13, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.

Device Story

PIVO is a sterile, single-use, needle-free blood collection device. It attaches to a peripheral IV (PIV) catheter system via a clip-to-connect mechanism. The device consists of an inner tube with a pusher/slider, a proximal flexible tube with a female luer, and an outer housing. To operate, the clinician attaches the device to the PIV, advances the inner tube through the PIV into the vein using the slider, and collects blood into a vacuum tube or syringe attached to the female luer. After collection, the inner tube is retracted and the device is removed. It is used in clinical settings to facilitate blood draws, potentially reducing the need for additional venipunctures and improving patient comfort. Available in 20, 22, and 24 gauge sizes.

Clinical Evidence

Bench testing only. Performance testing included leak testing, dimensional testing, joint strength, PIV compatibility, flow rate, hemolysis, shelf life, and biocompatibility per ISO 10993-1. No clinical data was required or provided.

Technological Characteristics

Sterile, single-use, needle-free blood collection device. Materials include Pebax/Pebax Vestimide. Features a clip-to-connect attachment for PIV systems, a slider-actuated inner tube, and a female luer for vacuum tube/syringe connection. Available in 20G, 22G, and 24G sizes with color-coded features (pink, blue, yellow). Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use as a direct blood draw device into a vacuum tube or syringe by attaching to a peripheral IV catheter system.

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

• PIVO™ (K163508)

Submission Summary (Full Text)

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May 13, 2019

Velano Vascular Tiffini Wittwer Consulting Director of Regulatory Affairs 221 Pine St #200 San Francisco, California 94104

Re: K190604

Trade/Device Name: PIVO™M Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: April 12, 2019 Received: April 15, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D 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) K190604

Device Name PIVOTM

Indications for Use (Describe)

The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.

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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| Submitter: | Velano Vascular<br>221 Pine St #200<br>San Francisco CA 94104 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 3, 2019 |
| Contact Person: | Tiffini Wittwer, MPH<br>Consulting Director of Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] |
| Trade Name: | PIVOTM |
| Common Name: | Blood specimen collection device |
| Classification: | Class II |
| Product Code: | JKA per 21CFR 862.1675 |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K163508 – PIVOTM |
| Device Description: | The PIVOTM device is a sterile, single use device. It is a<br>needle- free blood collection device that attaches to a<br>peripheral IV (PIV) catheter system. The device is comprised<br>of an inner tube with a pusher/slider, proximal flexible tube<br>with female luer, outer housing and clip-to-connect distal<br>end. The clip-to-connect attaches to the PIV system. The<br>female luer attaches to a blood transfer device or syringe.<br>The inner tube is then advanced to collect a blood sample.<br>Once complete, the inner tube is retracted, and the device is<br>removed from the PIV.<br>The device is available in three sizes, 20, 22, and 24 gauge. |
| Indication for Use: | The PIVOTM device attaches to a peripheral IV catheter system<br>for use as a direct blood draw device into a vacuum tube or a<br>syringe. |
| Reason For Submission: | Line extension to include a 24G compatible size device.<br>Additional changes since last 510(k) clearance include<br>dimensional change to 20G device and material change to non-<br>patient contacting component in 20G and 22G device. |
| Technological<br>Characteristics: | The PIVOTM device attaches to a PIV system via a clip-to-<br>connect attachment. Once attached, a slider is moved forward<br>and advances the inner tube into the PIV system. The<br>differences between the predicate and the subject device, are the<br>different colored features to visually separate the different sizes |

## 510(k) Summary (K190604):

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and the diameter of the inner tube for compatibility to various PIV gauges, dimensional change to the 20G inner tube to reduce stiffness and the change in material in the proximal tube. The 20G has pink features and the largest inner tube, the 22G has blue features, and the 24G has yellow features and the smallest inner tube.

| | PIVOTM 24G<br>(Subject Device) | PIVOTM 20G and22G<br>(Predicate Device) | Analysis of<br>differences |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number<br>Decision Date | K190604 | K163508 | |
| Manufacturer | Same | Velano Vascular, Inc. | |
| Classification | Class II | Class II | |
| Product Code | JKA | JKA | |
| Regulation | 21 CFR 862.1675 | 21 CFR 862.1675 | |
| Indications for Use | The PIVO™ device<br>attaches to a peripheral IV<br>catheter system for use as<br>a direct blood draw device<br>into a vacuum tube or a<br>syringe. | The PIVO™ device is<br>attached to a peripheral IV<br>catheter for use as a direct<br>blood draw device into a<br>vacuum tube or a syringe. | Wording change was<br>made for clarity and<br>does not change the<br>intended use. |
| Intended Use | Same | Venous blood drawing | |
| Patient Interface | Same | Separately placed<br>commercially available<br>peripheral IV catheter | |
| PIV Attachment | Same | Clip-to-Connect | |
| Blood Collection<br>Attachment | Same | Female Luer to Blood<br>Transfer Device or Syringe | |
| Blood Control<br>Mechanism | Same | Cap on female luer and<br>clamp on flexible tubing | |
| Tubing<br>(distal) | Same | Transparent<br>Flexible | |
| Proximal Tube<br>Material<br>(no patient contact) | Pebax Vestimide | Pebax | Performance testing<br>(leak testing, joint<br>strength, hemolysis)<br>demonstrated that<br>this material change<br>does not affect the |
| | | | effectiveness of the<br>subject device |
| | | | |
| Compatible PIV<br>Sizes | 24G | 14G-22G | PIV compatibility<br>demonstrates that the<br>subject device is<br>compatible with<br>smaller (24G) PIV<br>systems and there is<br>no additional risk to<br>safety and<br>effectiveness. There<br>is no change to<br>compatibility with<br>larger G devices. |
| Color | Yellow | 20G Pink<br>22G Blue | |
| Inner Tubing<br>Length | 141.2mm | Same | |
| Outer Diameter<br>(OD) of Distal Inner<br>Tubing | 24 gauge = 0.400mm max | 20 gauge = 0.709mm max<br>22 gauge = 0.543mm max | PIV compatibility<br>testing and<br>dimensional testing<br>demonstrate that the<br>difference does not<br>create additional risk<br>to safety and<br>effectiveness of the<br>subject device |
| Wall Thickness of<br>Distal Inner Tubing | 24 G wall = 0.0575mm +/- 0.01mm<br>20 G wall = 0.070mm +/- 0.01mm<br>22 G Same | 20 G wall = 0.089mm +/- 0.01mm<br>22 G wall = 0.0635mm +/- 0.01mm | Performance testing<br>(hemolysis, flow<br>rate, kink resistance)<br>demonstrate that<br>there are no<br>additional risks to<br>safety and<br>effectiveness of the<br>subject device. |
| Sample collection | Same | Device attaches to female<br>luer of PIV system, tube<br>inserted into PIV, blood is<br>drawn through tube into a<br>blood transfer device | |
| Complete<br>Retraction | Same | Yes | |
| Sterilization Method | Same | Gamma | |
| Single Use Only | Same | Yes | |

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| Risk Analysis: | A risk analysis was performed for the modifications done for<br>the subject device, in accordance to ISO 14971:2012 Medical<br>Devices - Applications of Risk Management to Medical<br>Devices and Velano Vascular Risk Management SOP.<br>Possible risks were identified which resulted from the gauge<br>size. Based on risk identification, verification and validation<br>activities were carried out to ensure the risk acceptability<br>criteria have been met and the risks have been mitigated. All<br>testing was performed on sterilized product. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | Based on the risks identified, the following tests were<br>performed on the 24G:<br>• Leak testing<br>• Dimensional testing<br>• Joint strength testing<br>• PIV compatibility testing<br>• Flow rate testing<br>• Hemolysis testing<br>• Shelf life testing<br>• Biocompatibility testing per ISO 10993-1 Biological<br>evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process |
| Summary of Substantial<br>Equivalence: | The changes made to the previously cleared PIVOTM devices<br>does not raise different questions regarding the safety and<br>effectiveness of the device. 24G PIVOTM is substantially<br>equivalent to the predicate 20G and 22G devices. This<br>conclusion is based upon the devices' identical intended use,<br>similar indications for use, principles of operation,<br>fundamental scientific technology, patient contacting materials,<br>and performance specifications. The changes made were tested<br>using the same acceptance criteria as the predicate device and<br>demonstrated that there are no new risks and the device is<br>substantially equivalent. |