PIVO

K163508 · Velano Vascular · JKA · Feb 9, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163508
• Device Name: PIVO
• Applicant: Velano Vascular
• Product Code: JKA · Clinical Chemistry
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for 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. It attaches to an existing peripheral IV (PIV) catheter via a clip-to-connect mechanism. The device consists of an inner tube, a pusher/slider, a proximal flexible tube with a female luer, and an outer housing. To operate, the clinician connects the device to the PIV, advances the inner tube through the PIV using the pusher/slider to collect blood into a vacuum tube or syringe, then retracts and removes the device. It is designed for use with 20G and 22G PIVs. By enabling blood draws through an existing IV line, the device aims to reduce the need for additional venipunctures, potentially improving patient comfort and reducing procedure-related trauma.

Clinical Evidence

Bench testing only. Verification and validation activities included clamp functional testing, leak testing, dimensional testing, joint strength testing, flow rate testing, and biocompatibility testing per ISO 10993-1, 10993-4, 10993-5, 10993-10, and 10993-11. No clinical data was provided.

Technological Characteristics

Sterile, single-use, needle-free blood collection device. Materials: Polyimide inner tubing, Pebax proximal tubing. Attachment: Clip-to-connect to PIV system. Sterilization: Gamma. Compatible with 20G and 22G PIV catheters. Mechanical operation via manual pusher/slider mechanism.

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.

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

• TIVA (K152924)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2017

Velano Vascular Tiffini Diage, MPH Consulting Director of Regulatory Affairs 1756 Fillmore Street San Francisco, California 94115

Re: K163508 Trade/Device Name: PIVO™M Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: January 11, 2017 Received: January 12, 2017

Dear Ms. Tiffini Diage:

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. 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.

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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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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) K163508

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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## 510(k) Summary: K163508

| Submitter: | Velano Vascular<br>1756 Fillmore St<br>San Francisco CA 94115 | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Contact Person: | Tiffini Diage<br>Consulting Director 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>• K152924 – TIVA | |
| 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 system (PIV). The device is comprised of an<br>inner tube with a pusher/slider, proximal flexible tube with<br>female luer, outer housing and clip-to-connect distal end. The<br>clip-to-connect attaches to the PIV system. The female luer<br>attaches to a blood transfer device or syringe. The device is<br>then advanced to collect a blood sample. Once complete, the<br>device is retracted and removed from the PIV.<br>The device comes in two sizes compatible with 20 and 22 gage<br>PIV's, respectively. | |
| Indication for Use: | The PIVOTM device is attached to a peripheral IV catheter for use<br>as a direct blood draw device into a vacuum tube or a syringe. | |
| Reason For Submission: | Component and material changes were made. The table below<br>identifies the specific changes made. | |
| Technological<br>Characteristics: | The PIVO device attaches to a PIV system via a clip-to-connect<br>attachment. This was previously a twist on attachment. Once<br>attached a pusher / slider (previously was a plunger style) is<br>moved forward and advances the inner tube into the PIV system.<br>The inner tube in the predicate design was PEEK or nylon and has<br>been changed to polyimide for both sizes. | |
| | PIVO<br>(Subject Device) | TIVA<br>(Predicate Device) |
| 510(k) Number<br>Decision Date | To be determined | K152924 |

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| 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 | Same | The TIVA™ device is attached to a<br>peripheral IV catheter for use as a<br>direct blood draw device into a<br>vacuum tube or a syringe. | | | |
| Intended Use | Same | Venous blood drawing | | | |
| Patient Interface | Same | Separately placed commercially<br>available peripheral IV catheter | | | |
| PIV Attachment | Clip-to-Connect | Male Luer Connection | | | |
| 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 on<br>flexible tubing | | | |
| Materials | | | | | |
| Tubing Proximal | Same | Pebax<br>Transparent<br>Flexible | | | |
| Tubing Distal | Polyimide (20G & 22G) | PEEK (22G)<br>Nylon (20G) | | | |
| Performance Specifications | | | | | |
| Compatible PIV Sizes | Same | 14G - 22G | | | |
| Inner Tubing Length | 5.85" | 4.99" | | | |
| Outer Diameter (OD) of<br>Tubing | 20G = 0.0275"<br>22G = 0.0210" | 20G = 0.0275"<br>22G = 0.0215" | | | |
| Inner Diameter (ID) of<br>Tubing | 20G = 0.0205"<br>22G = 0.0156" | 20G = 0.0220"<br>22G = 0.0180" | | | |
| Sample collection | Same | Device attaches to female luer of PIV<br>system, tube inserted into PIV, blood<br>is drawn through tube into a blood<br>transfer device | | | |
| Complete Retraction | Same | Yes | | | |
| Sterilization Method | Same | Gamma | | | |
| Single Use Only | Same | Yes | | | |

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| Performance Testing: | Based on the identified risks additional testing was performed. 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: | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Clamp functional testing Leak testing Dimensional testing Joint strength testing Performance testing Flow rate testing Biocompatibility testing per ISO 10993-1 ISO 10993-4 ISO 10993-5 ISO 10993-10 ISO 10993-11 | |
| Summary of Substantial Equivalence: | The changes made to the previously cleared TIVA (now called PIVO™) device does not raise new questions regarding safety and efficacy of the device. PIVO is equivalent to the predicate device. This conclusion is based upon the devices' identical indications for use, principles of operation, fundamental scientific technology, and performance specifications. The changes made were tested using the same acceptance criteria as the predicate device and provide objective evidence that there are no new risks and the device is substantially equivalent. | |