(269 days)
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, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.
The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. 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 catheter 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 also suitable for use for blood culture collection at initial placement of peripheral IV catheters. 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 NearPortTM IV Access.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "PIVO™ Pro Needle-free Blood Collection Device." This document details the device's indications for use, technological characteristics, and comparison to a predicate device, along with a summary of performance tests. However, it does not describe an AI/ML powered device or a study involving human experts for ground truth establishment, MRMC studies, or training/test set sample sizes in the context of AI/ML.
The document primarily focuses on establishing substantial equivalence for the device itself (a needle-free blood collection device), specifically for the addition of blood culture collection and an extended shelf life. The performance tests mentioned (e.g., Insertion Test, Blood Leak Test, Package Integrity) are related to the physical and functional aspects of the hardware device, not the performance of an AI/ML algorithm.
Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML powered device, the study proving its performance (in terms of AI metrics), sample sizes for AI test/training sets, expert involvement in ground truth, or MRMC studies, as this information is not present in the provided text.
The text does state:
- "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."
- "Summary of Performance tests completed on the subject devices were limited to those tests required Performance to support a determination of substantial equivalence to the predicate device."
- "Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance test, demonstrating substantial equivalence to the predicate device."
This indicates that internal performance tests were conducted against pre-determined acceptance criteria, but these are for the physical device's functionality and safety, not for an AI/ML algorithm's diagnostic or predictive performance.
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February 27, 2025
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Becton Dickinson Infusion Therapy Systems, Inc. Amy Moore Staff Regulatory Affairs Specialist 9450 S State St Sandy, Utah 84070
Re: K241586
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: January 27, 2025 Received: January 28, 2025
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"
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(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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
David Walloschek
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
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Indications for Use
510(k) Number (if known) K241586
Device Name
PIVO™ Pro Needle-free Blood Collection Device
Indications for Use (Describe)
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, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.
| 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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BD
510(k) Summary (21 CFR §807.92) PIVO™ Pro Needle-free Blood Collection Device
| SubmitterInformation | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | |
|---|---|---|---|
| Submitter Address: | 9450 South State Street, Sandy, Utah 84070 | ||
| Contact Person: | Amy Moore, Staff Regulatory Affairs Specialist | ||
| Email Address: | amy.moore@bd.com | ||
| Phone Number: | (801) 522-5200 | ||
| Date of Preparation: | February 27, 2025 | ||
| Subject Device | Trade Name: | PIVOTM Pro Needle-free Blood Collection Device | |
| Common Name: | Blood Collection Device | ||
| Regulation Number: | 21 CFR §862.1675 | ||
| Regulation Name: | Blood Specimen Collection Device | ||
| Regulatory Class: | II | ||
| Product Code: | JKA | ||
| Classification Panel: | General Hospital | ||
| PredicateDevice | Trade Name: | PIVOTM 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 | ||
| Reason forSubmission | The purpose of this submission is to notify the FDA of the addition of blood culturecollection in addition to the predicate device's general blood collection indications foruse and an extension of the device shelf life to 3-years. | ||
| DeviceDescription | The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter systemfor use to obtain venous blood specimens. The device is comprised of an inner flowtube with a slider, proximal flexible tube with female Luer, outer housing and wingedclip on the distal end. The winged clip attaches to the catheter system The female | ||
| Luer attaches to an evacuated tube holder or syringe. The inner flow tube is thenadvanced to collect a blood sample. Once complete, the inner flow tube is retracted,and the device is removed from the IV. | |||
| The device is also suitable for use for blood culture collection at initial placement ofperipheral IV catheters. | |||
| The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. Thedevice is compatible with the corresponding IV gauge and larger IV catheters. | |||
| The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheralIV catheters and extension sets with NearPortTM IV Access. | |||
| Indications forUse(21 CFR §807.92(a)(5)) | The PIVOTM Pro Needle-free Blood Collection Device attaches to a peripheral IVcatheter system for use to obtain venous blood specimens into a vacuum tube, bloodculture bottle, or syringe from adult and pediatric patients, including those withdifficult intravenous access who may have small, fragile, and/or non-palpable veins.For blood culture, the device can be used at initial placement of the peripheral IVcatheter. | ||
| TechnologicalCharacteristics | Technological characteristics of the subject device are substantially equivalent to thepredicate device. The subject PIVOTM Pro Needle-free Blood Collection Deviceachieves its intended use based on the same technology and principles of operation asthe predicate device. | ||
| A comparison of the subject and predicate device technological characteristics isprovided in the table below. | |||
| Attribute | SUBJECTPIVOTM Pro Needle-freeBlood Collection Device | PREDICATE (K230865)PIVOTM Pro Needle-freeBlood Collection Device | Comparison & Discussion |
| Classification | 21 CFR 862.1675Class IIJKA – Blood SpecimenCollection Device | 21 CFR 862.1675Class IIJKA - Blood SpecimenCollection Device | Same |
| Attribute | SUBJECTPIVO™ Pro Needle-freeBlood Collection Device | PREDICATE (K230865)PIVO™ Pro Needle-freeBlood Collection Device | Comparison & Discussion |
| Indications forUse | The PIVO™ Pro Needle-freeBlood Collection Device attachesto a peripheral IV catheter systemfor use to obtain venous bloodspecimens into a vacuum tube,blood culture bottle, or syringefrom adult and pediatric patients,including those with difficultintravenous access who may havesmall, fragile, and/or non-palpable veins. For blood culture,the device can be used at initialplacement of the peripheral IVcatheter. | The PIVO™ Pro Needle-freeBlood Collection Device attachesto a peripheral IV catheter systemfor use to obtain venous bloodspecimens into a vacuum tube orsyringe from adult and pediatricpatients, including those withdifficult intravenous access whomay have small, fragile, and/ornon-palpable veins. | The addition of a new specificindication for use (i.e. bloodculture collection) is includedwithin the current generalintended use (i.e. general blooddraw).This addition does not raise newor different questions of safetyor effectiveness. |
| Intended Use | Venous blood draw | Venous blood draw | Same |
| PatientInterface | Separately placedcommercially availableperipheral IV catheter | Separately placedcommercially availableperipheral IV catheter | Same |
| PIV Attachment | Clip-to-Connect | Clip-to-Connect | Same |
| Blood CollectionAttachment | Female Luer to BloodTransfer Device or Syringe | Female Luer to BloodTransfer Device or Syringe | Same |
| Blood ControlMechanism | Cap on female Luer andclamp on flexible tubing | Cap on female Luer and clampon flexible tubing | Same |
| Tubing | TransparentFlexible | TransparentFlexible | Same |
| Primary Components Material Composition | |||
| ISO 10993-1BiocompatibilityContact Typeand Duration | Body Contact: Externallycommunicating deviceContact: Circulating bloodContact Duration: Limited (A)(<24 hrs) | Body Contact: Externallycommunicating deviceContact: Circulating bloodContact Duration: Limited (A)(<24 hrs) | Same |
| Housing | Polycarbonate | Polycarbonate | Same |
| Inner FlowTube | Polyimide | Polyimide | Same |
| Attribute | SUBJECTPIVO™ Pro Needle-freeBlood Collection Device | PREDICATE (K230865)PIVOTM Pro Needle-freeBlood Collection Device | Comparison & Discussion |
| ProximalTubing | Vestamid | Vestamid | Same |
| Luer | Nylon | Nylon | Same |
| Slider (Pusher) | Nylon | Nylon | Same |
| Winged Clip | Polycarbonate | Polycarbonate | Same |
| Clamp | Nylon | HDPE | Same |
| Color | PinkBlueYellow | PinkBlueYellow | Same |
| Compatible PIVSizes | The device is available inthree sizes: 20 GA, 22 GA,and 24 GA IV compatible.The device is compatible withthe corresponding IV gaugeand larger IV catheters. | The device is available inthree sizes: 20 GA, 22 GA,and 24 GA IV compatible.The device is compatible withthe corresponding IV gaugeand larger IV catheters. | Same |
| ProximalTubing | TransparentFlexible | TransparentFlexible | Same |
| Inner FlowTube (DistalTubing) Length | 20 GA = 155.28 mm22 GA = 155.28 mm24 GA = 132.68 mm | 20 GA = 155.28 mm22 GA = 155.28 mm24 GA = 132.68 mm | Same |
| Outer Diameter(OD) of InnerFlow Tube(Distal Tubing) | 20 GA = 0.709 mm max22 GA = 0.543 mm max24 GA = 0.400 mm max | 20 GA = 0.709 mm max22 GA = 0.543 mm max24 GA = 0.400 mm max | Same |
| Wall Thicknessof Inner FlowTube (DistalTubing) | 20 GA = 0.709 mm22 GA = 0.0635 mm24 GA = 0.0575 mm | 20 GA = 0.709 mm22 GA = 0.0635 mm24 GA = 0.0575 mm | Same |
| Samplecollection | Device attaches to femaleLuer of PIV system, tubeinserted into PIV, blood isdrawn through tube into ablood transfer device | Device attaches to femaleLuer of PIV system, tubeinserted into PIV, blood isdrawn through tube into ablood transfer device | Same |
| PackagingMaterial | Tyvek/PETORNylon/Nylon | Tyvek/PETORNylon/Nylon | Same |
| CompleteRetraction | Yes | Yes | Same |
| Attribute | SUBJECTPIVOTM Pro Needle-freeBlood Collection Device | PREDICATE (K230865)PIVOTM Pro Needle-freeBlood Collection Device | Comparison & Discussion |
| SterilizationMethod | Gamma | Gamma | Same |
| Single Use Only | Yes | Yes | Same |
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Summary of Performance tests completed on the subject devices were limited to those tests required 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 was conducted to ensure that the subject device meets predetermined design requirements:
BD Internal Studies
- . Insertion Test at 0-degree angle
- Dry & Wet Alignment Test
- . Blood Leak Test
- Pressure Leak Test
- . Vacuum Leak Test
- . Sterile Barrier Integrity (Package Integrity)
- . Package Peel Force - Pouch Seal Strength ≥ 1.0 lb./in.
- Packaging materials microbial barrier (Impermeability Testing) .
- . Label Legibility Evaluation
- . Seal Strength
Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance test, demonstrating substantial equivalence to the predicate device.
Clinical studies are not required to demonstrate substantial equivalence to the predicate device.
Summary of Based on the indications for use, technological characteristics, and results of performance testing, the subject PIVO™ Pro Needle-free Blood Collection Device has Substantial been demonstrated to be substantially equivalent to the predicate PIVO™ Pro Needle-Equivalence free Blood Collection Device.
§ 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.