Who is the manufacturer of PIVO Pro Needle-free Blood Collection Device?

Becton Dickinson Infusion Therapy Systems, Inc. filed the 510(k) submission for PIVO Pro Needle-free Blood Collection Device (K230865).

What is the FDA product code for PIVO Pro Needle-free Blood Collection Device?

JKA. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for PIVO Pro Needle-free Blood Collection Device?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PIVO Pro Needle-free Blood Collection Device?

PIVO™ Needle-free Blood Collection Device (K193569).

Who can help prepare an FDA 510(k) submission like PIVO Pro Needle-free Blood Collection Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PIVO Pro Needle-free Blood Collection Device

K230865 · Becton Dickinson Infusion Therapy Systems, Inc. · JKA · Sep 28, 2023 · Clinical Chemistry

Device Facts

Record ID	K230865
Device Name	PIVO Pro Needle-free Blood Collection Device
Applicant	Becton Dickinson Infusion Therapy Systems, Inc.
Product Code	JKA · Clinical Chemistry
Decision Date	Sep 28, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2
Attributes	Pediatric

Intended Use

The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.

Device Story

The PIVO™ Pro is a sterile, single-use, needle-free blood collection device designed to attach to peripheral IV catheters and extension sets (including NearPort™ IV Access). It consists of an inner flow tube with a slider, a proximal flexible tube with a female Luer, an outer housing, and a distal winged clip. The clinician attaches the winged clip to the IV system and the female Luer to an evacuated tube holder or syringe. The inner flow tube is advanced through the IV catheter into the vein to collect blood, then retracted and removed. Used in clinical settings, it facilitates blood draws in patients with difficult venous access, potentially reducing the need for additional venipunctures and improving patient comfort.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including biocompatibility (ISO 10993-1), packaging (ASTM D4169, ISO 11607-1), sterilization validation (ISO 11137-1), and internal BD studies (catheter compatibility, flow rate, hemolysis, leak testing, and usability testing).

Technological Characteristics

Materials: Polycarbonate (housing, winged clip), Polyimide (inner flow tube), Vestamid (proximal tubing), Nylon (Luer, slider, clamp). Sensing/Actuation: Mechanical advancement of flow tube. Energy: None (manual). Connectivity: None. Sterilization: Gamma. Form factor: 20GA, 22GA, 24GA compatible.

Indications for Use

Indicated for adult and pediatric patients, including those with difficult intravenous access (DIVA) having small, fragile, or non-palpable veins, to obtain venous blood specimens via 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

PIVO™ Needle-free Blood Collection Device (K193569)

Related Devices

K163508 — PIVO · Velano Vascular · Feb 9, 2017
K190604 — PIVO · Velano Vascular · May 13, 2019
K193569 — PIVO(TM) · Velano Vascular · Jan 21, 2020
K241586 — PIVO Pro Needle-free Blood Collection Device · Becton Dickinson Infusion Therapy Systems, Inc. · Feb 27, 2025
K152924 — TIVA¿ · Velano Vascular · Jan 7, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 28, 2023 Becton Dickinson Infusion Therapy Systems, Inc. Amy Moore Senior Regulatory Affairs Specialist 9450 S State St Sandy, Utah 84070 Re: K230865 Trade/Device Name: PIVOTM Pro Needle-free Blood Collection Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: August 25, 2023 Received: August 28, 2023 Dear Amy Moore: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230865 Device Name PIVO™ Pro Needle-free Blood Collection Device #### Indications for Use (Describe) The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the BD logo. The logo consists of an orange circle with a white starburst inside on the left. To the right of the circle are the letters "BD" in blue. # K230865 510(k) Summary (21 CFR §807.92) PIVO™ Pro Needle-free Blood Collection Device | Submitter Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | | Submitter Address: | 9450 South State Street, Sandy, Utah 84070 | | | Contact Person: | Amy Moore, Sr. Regulatory Affairs Specialist | | | Email Address: | amy.moore@bd.com | | | Phone Number: | (801) 522-5000 | | | Date of Preparation: | September 28, 2023 | | Subject Device | Trade Name: | PIVO™ Pro Needle-free Blood Collection Device | | | Common Name: | Blood Collection Device | | | 510(k) Reference: | K230865 | | | Regulation Number: | 21 CFR §862.1675 | | | Regulation Name: | Blood Specimen Collection Device | | | Regulatory Class: | II | | | Product Code: | JKA | | | Classification Panel: | General Hospital | | Predicate Device | Trade Name: | PIVO™ Needle-free Blood Collection Device | | | Common Name: | Blood Collection Device | | | 510(k) Reference: | K193569 | | | Regulation Number: | 21 CFR 862.1675 | | | Regulation Name: | Blood Specimen Collection Device | | | Regulatory Class: | II | | | Product Code: | JKA | | | Classification Panel: | General Hospital | | Reason for Submission | The purpose of this submission is to notify the FDA of the introduction of PIVO™ Pro Needle-free Blood Collection Device, allowing for compatibility with a peripheral IV catheter with NearPort™ IV Access and addition of a patient population statement to the Indications for Use. | | | Device Description | The PIVO™ Pro Needle-free Blood Collection Device is a sterile, single use needle- free collection device that attaches to a peripheral intravascular catheter (IV) system. The device is comprised of an inner flow tube with a slider, proximal flexible tube | | | with female Luer, outer housing, and winged clip on the distal end. The winged clip attaches to the IV system. The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is available in three sizes: 20GA, 22GA, and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPort™ IV Access. | | | | Indications for Use (21 CFR § 807.92(a)(5)) | The PIVOTM Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. | | | Technological Characteristics | Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject PIVOTM Pro Needle-free Blood Collection Device achieves its intended use based on the same technology and principles of operation as the predicate device. | | {5}------------------------------------------------ A comparison of the subject and predicate device technological characteristics is provided in the table below. | Attribute | SUBJECT (K230865) PIVO™ Pro Needle-free Blood Collection Device | PREDICATE (K193569) PIVO™ Needle-free Blood Collection Device | Comparison & Discussion | |-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | 21 CFR 862.1675 Class II JKA – Blood Specimen Collection Device | 21 CFR 862.1675 Class II JKA – Blood Specimen Collection Device | Same | | Indications for Use | The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. | 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. | Minor grammatical wording changes with no change to meaning. Addition of a patient population statement, with specific reference to pediatric patients and patients with DIVA (difficult intravenous access) which are subsets of 'General Use' and do not introduce new risks not normally associated with the general use of the subject device. Therefore, modifications, do not raise | | Attribute | SUBJECT (K230865) PIVOTM Pro Needle-free Blood Collection Device | PREDICATE (K193569) PIVOTM Needle-free Blood | Comparison & Discussion | | | | Collection Device | new or different questions of safety or effectiveness. | | Intended Use | Venous blood draw | Venous blood draw | Same | | Patient Interface | Separately placed commercially available peripheral IV catheter | Separately placed commercially available peripheral IV catheter | Same | | PIV Attachment | Clip-to-Connect | Clip-to-Connect | Same | | Blood Collection Attachment | Female Luer to Blood Transfer Device or Syringe | Female Luer to Blood Transfer Device or Syringe | Same | | Blood Control Mechanism | Cap on female luer and clamp on flexible tubing | Cap on female luer and clamp on flexible tubing | Same | | Tubing | Transparent Flexible | Transparent Flexible | Same | | | Primary Components Material Composition | | | | ISO 10993-1 Biocompatibility Contact Type and Duration | Body Contact: Externally communicating device Contact: Circulating blood Contact Duration: Limited (A) (<24 hrs) | Body Contact: Externally communicating device Contact: Circulating blood Contact Duration: Limited (A) (<24 hrs) | Same | | Housing | Polycarbonate | Polycarbonate | Same | | Inner Flow Tube | Polyimide | Polyimide | Same | | Proximal Tubing | Vestamid | Vestamid | Same | | Luer | Nylon | Nylon | Same | | Slider (Pusher) | Nylon | Nylon | Same | | Winged Clip | Polycarbonate | Polycarbonate | Same | | Clamp | Nylon | HDPE | Same | | Color | Pink Blue Yellow | Pink Blue Yellow | Same | | Compatible PIV Sizes | The device is available in three sizes: 20 GA, 22 GA, and 24 GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. | 14 GA - 24 GA | Clarification only. Both the predicate and subject devices are available in three sizes: 20GA, 22GA and 24 GA IV compatible, as indicated on the product label. The subject and predicate devices are compatible with the corresponding IV gauge and larger IV catheters. | | Attribute | SUBJECT (K230865) PIVO™ Pro Needle-free Blood Collection Device | PREDICATE (K193569) PIVO™ Needle-free Blood Collection Device | Comparison & Discussion | | | | | corresponding IV gauge and larger IV catheters. For example, a 20GA IV compatible subject or predicate device can be used with a 20GA or larger IV catheter (e.g., 18GA). | | | | | The clarification does not change the use of the device or device specifications and, therefore, does not raise new or different questions of safety or effectiveness. | | Proximal Tubing | Transparent Flexible | Transparent Flexible | Same | | Inner Flow Tube (Distal Tubing) Length | 20 GA = 155.28 mm 22 GA = 155.28 mm 24 GA = 132.68 mm | 20 GA = 141.2 mm 22 GA = 141.2 mm 24 GA = 141.2 mm | The results of design validation and verification testing demonstrate that the modifications to the subject device perform as intended and do not raise new or different questions of safety or effectiveness. | | Outer Diameter (OD) of Inner Flow Tube (Distal Tubing) | 20 GA = 0.709 mm max 22 GA = 0.543 mm max 24 GA = 0.400 mm max | 20 GA = 0.709 mm max 22 GA = 0.543 mm max 24 GA = 0.400 mm max | Same | | Wall Thickness of Inner Flow Tube (Distal Tubing) | 20 GA = 0.709 mm 22 GA = 0.0635 mm 24 GA = 0.0575 mm | 20 GA = 0.709 mm 22 GA = 0.0635 mm 24 GA = 0.0575 mm | Same | | Sample collection | Device attaches to female luer of PIV system, tube inserted into PIV, blood is drawn through tube into a blood transfer device | Device attaches to female luer of PIV system, tube inserted into PIV, blood is drawn through tube into a blood transfer device | Same | | Packaging Material | Tyvek/PET OR Nylon/Nylon | Tyvek/PET OR Nylon/Nylon | Same | | Complete Retraction | Yes | Yes | Same | | Attribute | SUBJECT (K230865) PIVOTM Pro Needle-free Blood Collection Device | PREDICATE (K193569) PIVOTM Needle-free Blood Collection Device | Comparison & Discussion | | Sterilization Method | Gamma | Gamma | Same | | Single Use Only | Yes | Yes | Same | {6}------------------------------------------------ Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA ### bd.com {7}------------------------------------------------ Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA ### bd.com {8}------------------------------------------------ Performance tests completed on the subject devices were limited to those tests required Summary of Performance to support a determination of substantial equivalence to the predicate device. A risk Tests analysis was conducted to assess the impact of the proposed modifications to the predicate device. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets predetermined design requirements: - 1) Compliance Testing - Biocompatibility (ISO 10993-1) ● - Body contact: Externally communicating device - - Contact: Circulating blood - - -Contact duration: Limited (A) (<24 hrs) - Packaging Testing (ASTM D4169) ● - Sterilization Validation (ISO 11137-1) ● ### 2) BD Internal Studies - Catheter Gauge Compatibility ● - Extension Length - Catheter Perforation ● - Insertion ● - Alignment - Atraumatic Tip ● - Flow Rate - Hemolysis ● - Pusher Pull Force - Blood Leak ● - Pressure Leak ● - . Vacuum Leak 3) Packaging verification testing per ISO 11607-1 Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems {9}------------------------------------------------ | | 4) Usability testing per Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued February 2016 | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices. | | | Clinical studies are not required to demonstrate substantial equivalence to the predicate device. | | Summary of Substantial Equivalence | Based on the indications for use, technological characteristics, and results of performance testing, the subject PIVOT™ Pro Needle-free Blood Collection Device has been demonstrated to be substantially equivalent to the predicate PIVOT™ Needle-free Blood Collection Device. |

PIVO Pro Needle-free Blood Collection Device

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Submission Summary (Full Text)

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PIVO Pro Needle-free Blood Collection Device