The PIVO™ 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-to-connect 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.

AI/ML Overview

This looks like a 510(k) summary for a medical device called PIVO™. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than a study proving performance against acceptance criteria in the context of AI/ML.

Here's why it's not applicable to the requested information and what information it does contain:

No AI/ML Component: The PIVO™ device is a "blood specimen collection device" (a needle-free blood collection device that attaches to a peripheral IV catheter). There is no mention of any AI or machine learning component in its functionality or development. Therefore, questions related to AI performance, such as sample size for test sets, ground truth establishment, MRMC studies, or standalone algorithm performance, are not relevant.
Substantial Equivalence, Not De Novo Performance: The document's primary purpose is to justify that the modified PIVO™ device is "substantially equivalent" to an already legally marketed predicate device (K190604). This means the focus is on showing that the changes (alternate colorant material, second contract manufacturer, alternate packaging material) do not raise new questions of safety or effectiveness. It's not about proving inherent performance against new, specific acceptance criteria for a novel device.
Performance Testing for Equivalence: The "Performance Testing" section lists tests conducted to demonstrate that the modifications do not negatively impact the device's performance compared to the predicate. These are:
- Leak testing
- Dimensional testing
- Joint strength testing
- Flow rate testing
- Packaging testing (per ASTM D4169-16, ASTM F1980-16, ISO 11607-1:2019)
- Biocompatibility testing (per ISO 10993-1)
The document states: "All testing was performed on sterilized product." And, "The changes made were tested using the same acceptance criteria as the predicate device and demonstrated that there are no new risks and the device is substantially equivalent."

Since it's not an AI/ML device and the submission is for substantial equivalence rather than original performance evaluation, I cannot fill in the requested table and study details related to an AI/ML device. The document does not provide information on:

Acceptance Criteria and Reported Device Performance (as typically defined for AI): It states "same acceptance criteria as the predicate device" for the performance tests listed, but doesn't quantify them.
Sample sizes for test set and data provenance.
Number of experts used to establish ground truth and qualifications.
Adjudication method.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Standalone (algorithm-only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 707.799.6732 E-mail: twittwer@mededge.io 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(Subject Device)	PIVO Devices(Predicate Device)	Analysis of Differences
510(k) NumberDecision 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 attachedto a peripheral IV catheter foruse as a direct blood drawdevice into a vacuum tube or asyringe.
Intended Use	Same	Venous blood drawing
Patient Interface	Same	Separately placed commerciallyavailable peripheral IV catheter
PIV Attachment	Same	Clip-to-Connect
Blood CollectionAttachment	Same	Female Luer to Blood TransferDevice or Syringe
Blood ControlMechanism	Same	Cap on female luer and clampon flexible tubing
Tubing	Same	TransparentFlexible
Compatible PIVSizes	Same	14G - 24G
Color	20G Pink DEV-MCC 0436OR DEV-MCC 0155SameSame	20G Pink DEV-MCC 015522G Blue DEV-MMC 015424 G Yellow DEV-MCC 0267	Biocompatibilityassessment and testingdemonstrate that thisalternate material doesalter the safety of thedevice
Inner TubingLength	Same	141.2mm
Outer Diameter(OD) of Distal InnerTubing	Same	20 gauge = 0.709mm max22 gauge = 0.543mm max24 gauge = 0.400mm max
Wall Thickness ofDistal Inner Tubing	Same	20 G wall = 0.0750mm +/-0.01mm22 G wall = 0.0635mm +/-0.01mm24 G wall = 0.0575mm +/-0.01mm
Sample collection	Same	Device attaches to female luerof PIV system, tube insertedinto PIV, blood is drawnthrough tube into a bloodtransfer device
Packaging Material	Tyvek/PETORNylon/Nylon	Tyvek/PET	Transit, Aging, andPackaging validationtesting demonstrates thatthe difference does notalter the safety of thedevices
CompleteRetraction	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:● Leak testing● Dimensional testing● Joint strength testing● Flow rate testing

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:● Leak testing● Dimensional testing● Joint strength testing● Flow rate testing

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	Packaging testing per ASTM D4169-16 Standard PracticeFor Performance Testing Of Shipping Containers AndSystems, ASTM F1980-16 Standard Guide For AcceleratedAging Of Sterile Barrier Systems For Medical Devices, andISO 11607-1:2019 Packaging For Terminally SterilizedMedical Devices - Part 1: Requirements For Materials,Sterile Barrier Systems And Packaging Systems Biocompatibility testing per ISO 10993-1 Biologicalevaluation of medical devices – Part 1: Evaluation andtesting within a risk management process and
Summary of SubstantialEquivalence:	The changes made to the previously cleared PIVOT™ devices doesnot raise different questions regarding the safety and effectivenessof the device. Current PIVOT™ is substantially equivalent to thepredicate PIVOT™ devices. This conclusion is based upon thedevices' identical intended use, indications for use, principles ofoperation, fundamental scientific technology, patient contactingmaterials, and performance specifications. The changes madewere tested using the same acceptance criteria as the predicatedevice and demonstrated that there are no new risks and thedevice is substantially equivalent.

Packaging testing per ASTM D4169-16 Standard PracticeFor Performance Testing Of Shipping Containers AndSystems, ASTM F1980-16 Standard Guide For AcceleratedAging Of Sterile Barrier Systems For Medical Devices, andISO 11607-1:2019 Packaging For Terminally SterilizedMedical Devices - Part 1: Requirements For Materials,Sterile Barrier Systems And Packaging Systems Biocompatibility testing per ISO 10993-1 Biologicalevaluation of medical devices – Part 1: Evaluation andtesting within a risk management process and

Summary of SubstantialEquivalence:

The changes made to the previously cleared PIVOT™ devices doesnot raise different questions regarding the safety and effectivenessof the device. Current PIVOT™ is substantially equivalent to thepredicate PIVOT™ devices. This conclusion is based upon thedevices' identical intended use, indications for use, principles ofoperation, fundamental scientific technology, patient contactingmaterials, and performance specifications. The changes madewere tested using the same acceptance criteria as the predicatedevice and demonstrated that there are no new risks and thedevice is substantially equivalent.

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.