PIVO(TM)

K193569 · Velano Vascular · JKA · Jan 21, 2020 · Clinical Chemistry

Device Facts

• Record ID: K193569
• Device Name: PIVO(TM)
• Applicant: Velano Vascular
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jan 21, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The PIVO™ device is attached to a peripheral IV catheter 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; attaches to peripheral IV (PIV) catheter systems via clip-to-connect mechanism. Device consists of inner tube with pusher/slider, proximal flexible tube with female luer, outer housing, and distal clip. Operation: clinician attaches device to PIV; advances slider to move inner tube into PIV system; blood is drawn through tube into vacuum tube or syringe; inner tube is retracted; device is removed. Used in clinical settings to facilitate blood draws via existing PIV access. Benefits patient by potentially reducing need for additional venipunctures. Available in 20, 22, and 24 gauge sizes.

Clinical Evidence

Bench testing only. Performance testing included leak testing, dimensional testing, joint strength testing, and flow rate testing. Packaging validation performed per ASTM D4169-16, ASTM F1980-16, and ISO 11607-1:2019. Biocompatibility evaluation conducted per ISO 10993-1.

Technological Characteristics

Sterile, single-use, needle-free blood collection device. Components include inner tube, pusher/slider, flexible tube with female luer, and outer housing. Available in 20G, 22G, and 24G sizes. Attaches to PIV via clip-to-connect. Packaging materials include Tyvek/PET or Nylon/Nylon. Sterilization via Gamma radiation. Complies with ISO 11607-1:2019 for packaging and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for use as a direct blood draw device into a vacuum tube or syringe when attached 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™ Device (K190604)

Submission Summary (Full Text)

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January 21, 2020

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

Re: K193569

Trade/Device Name: PIVO™ Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: December 17, 2019 Received: December 23, 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 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.

for Geeta Pamidimukkala Acting 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) K193569

Device Name PIVOTM

Indications for Use (Describe)

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

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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## Submitter: Velano Vascular 221 Pine St #200 San Francisco CA 94104 January 6, 2020 Date prepared: Contact Person: Tiffini Wittwer, MPH Consulting Director Regulatory Affairs Phone: [phone] E-mail: [e-mail] PIVOTM Trade Name: 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: • K190604 – PIVO™ Device Description: The PIVOTM device is a sterile, single use device. It is a needlefree blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-toconnect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge. 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. Reason For Submission: An alternate colorant material is being added to the pink components of the 20G device. Additional changes since last 510(k) clearance include the addition of a second contract manufacturer and alternate packaging material for all products. Technological Characteristics: The PIVO™ device attaches to a PIV system via a clip-to-connect attachment. Once attached, a slider is moved forward and advances the inner tube into the PIV system. The differences between the predicate and the subject devices, are the alternate red colorant for the 20G components and the addition of a nylon/ nylon pouch for packaging and terminally sterilizing the devices.

# 510(k) Summary (K193569):

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| | PIVO Devices<br>(Subject Device) | PIVO Devices<br>(Predicate Device) | Analysis of Differences |
|--------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number<br>Decision Date | K193569 | K190604 | |
| Manufacturer | Same | Velano Vascular, Inc. | |
| Classification | Same | Class II | |
| Product Code | Same | JKA | |
| Regulation | Same | 21 CFR 862.1675 | |
| Indications for Use | Same | The PIVO™ device is attached<br>to a peripheral IV catheter for<br>use as a direct blood draw<br>device into a vacuum tube or a<br>syringe. | |
| Intended Use | Same | Venous blood drawing | |
| Patient Interface | Same | Separately placed commercially<br>available peripheral IV catheter | |
| PIV Attachment | Same | Clip-to-Connect | |
| Blood Collection<br>Attachment | Same | Female Luer to Blood Transfer<br>Device or Syringe | |
| Blood Control<br>Mechanism | Same | Cap on female luer and clamp<br>on flexible tubing | |
| Tubing | Same | Transparent<br>Flexible | |
| Compatible PIV<br>Sizes | Same | 14G - 24G | |
| Color | 20G Pink DEV-MCC 0436<br>OR DEV-MCC 0155<br>Same<br>Same | 20G Pink DEV-MCC 0155<br>22G Blue DEV-MMC 0154<br>24 G Yellow DEV-MCC 0267 | Biocompatibility<br>assessment and testing<br>demonstrate that this<br>alternate material does<br>alter the safety of the<br>device |
| Inner Tubing<br>Length | Same | 141.2mm | |
| Outer Diameter<br>(OD) of Distal Inner<br>Tubing | Same | 20 gauge = 0.709mm max<br>22 gauge = 0.543mm max<br>24 gauge = 0.400mm max | |
| Wall Thickness of<br>Distal Inner Tubing | Same | 20 G wall = 0.0750mm +/-<br>0.01mm<br>22 G wall = 0.0635mm +/-<br>0.01mm<br>24 G wall = 0.0575mm +/-<br>0.01mm | |
| Sample collection | Same | Device attaches to female luer<br>of PIV system, tube inserted<br>into PIV, blood is drawn<br>through tube into a blood<br>transfer device | |
| Packaging Material | Tyvek/PET<br>OR<br>Nylon/Nylon | Tyvek/PET | Transit, Aging, and<br>Packaging validation<br>testing demonstrates that<br>the difference does not<br>alter the safety of the<br>devices |
| Complete<br>Retraction | Same | Yes | |
| Sterilization Method | Same | Gamma | |
| Single Use Only | Same | Yes | |

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Risk Analysis:

| Risk Analysis: | A risk analysis was performed for the modifications done to the subject device, in accordance to ISO 14971, Medical Devices – Applications of Risk Management to Medical Devices and Velano Vascular Risk Management SOP. Possible risks were identified which resulted from the alternate materials and new contract manufacturer. Based on risk identification, verification and validation activities were carried out to ensure the risk acceptability criteria have been met and the risks have been mitigated. All testing was performed on sterilized product. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | Based on the risks identified, the following tests were performed on the PIVO devices:<br>● Leak testing<br>● Dimensional testing<br>● Joint strength testing<br>● Flow rate testing |

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| | Packaging testing per ASTM D4169-16 Standard Practice<br>For Performance Testing Of Shipping Containers And<br>Systems, ASTM F1980-16 Standard Guide For Accelerated<br>Aging Of Sterile Barrier Systems For Medical Devices, and<br>ISO 11607-1:2019 Packaging For Terminally Sterilized<br>Medical Devices - Part 1: Requirements For Materials,<br>Sterile Barrier Systems And Packaging Systems Biocompatibility testing per ISO 10993-1 Biological<br>evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process and |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Substantial<br>Equivalence: | The changes made to the previously cleared PIVOT™ devices does<br>not raise different questions regarding the safety and effectiveness<br>of the device. Current PIVOT™ is substantially equivalent to the<br>predicate PIVOT™ devices. This conclusion is based upon the<br>devices' identical intended use, indications for use, principles of<br>operation, fundamental scientific technology, patient contacting<br>materials, and performance specifications. The changes made<br>were tested using the same acceptance criteria as the predicate<br>device and demonstrated that there are no new risks and the<br>device is substantially equivalent. |