(183 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 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™ 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.
The provided document is a 510(k) summary for the PIVOTM Pro Needle-free Blood Collection Device, which seeks to demonstrate substantial equivalence to a predicate device (PIVOTM Needle-free Blood Collection Device). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving absolute safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence, primarily through non-clinical performance testing and a comparison of technological characteristics.
Here’s a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists the performance tests conducted and states that the device "met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."
However, we can infer some "acceptance criteria" based on the tests performed:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Safety and Biocompatibility: | |
| Biocompatibility (ISO 10993-1) | Met all requirements |
| Packaging Integrity (ASTM D4169 & ISO 11607-1) | Met all requirements |
| Sterilization Validation (ISO 11137-1) | Met all requirements |
| Hemolysis | Met all requirements |
| Blood Leak | Met all requirements |
| Pressure Leak | Met all requirements |
| Vacuum Leak | Met all requirements |
| Device Functionality: | |
| Catheter Gauge Compatibility | Met all requirements |
| Extension Length | Met all requirements |
| Catheter Perforation | Met all requirements |
| Insertion | Met all requirements |
| Alignment | Met all requirements |
| Atraumatic Tip | Met all requirements |
| Flow Rate | Met all requirements |
| Pusher Pull Force | Met all requirements |
| Complete Retraction | Yes (inherent design feature, verified through testing) |
| Usability: | |
| Usability testing per FDA Guidance | Met all requirements |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes (N values) for each individual performance test (e.g., how many devices were tested for catheter perforation, how many for flow rate). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab tests for device clearance, they are inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in the context of this 510(k) summary. The "ground truth" for this device is based on objective measurements and compliance with recognized standards and internal design requirements, not expert consensus on interpretations like with diagnostic imaging. Usability testing would involve users, but the number and qualifications of those users are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not applicable here as these are performance and engineering tests, not studies requiring human interpretation and adjudication (e.g., clinical trials for diagnostic algorithms).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not conducted. This type of study applies to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices where human readers (e.g., radiologists) use AI assistance to improve their diagnostic performance. The PIVOTM Pro is a physical blood collection device, not an AI software. The submission explicitly states: "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical medical device, not an algorithm or AI system. Its performance is evaluated through physical and functional testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" relates to meeting engineering specifications, material properties, sterility, and functional performance benchmarks derived from industry standards (e.g., ISO, ASTM), internal design requirements, and prior knowledge from the predicate device. It is primarily based on:
- Physical measurements and criteria: e.g., acceptable flow rates, specified dimensions, absence of leaks, specified pull force.
- Compliance with recognized standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-1 for sterilization, ASTM D4169 and ISO 11607-1 for packaging.
- Functional tests: verifying proper insertion, alignment, and absence of catheter perforation.
8. The sample size for the training set
This is not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
{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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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
| SubmitterInformation | 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 | |
| PredicateDevice | 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 forSubmission | The purpose of this submission is to notify the FDA of the introduction of PIVO™ ProNeedle-free Blood Collection Device, allowing for compatibility with a peripheral IVcatheter with NearPort™ IV Access and addition of a patient population statement tothe Indications for Use. | |
| DeviceDescription | 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 clipattaches to the IV system. The female Luer attaches to an evacuated tube holder orsyringe. The inner flow tube is then advanced to collect a blood sample. Oncecomplete, 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. 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 NearPort™ 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 orsyringe from adult and pediatric patients, including those with difficult intravenousaccess who may have small, fragile, and/or non-palpable veins. | |
| 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. |
{5}------------------------------------------------
A comparison of the subject and predicate device technological characteristics is provided in the table below.
| Attribute | SUBJECT (K230865)PIVO™ Pro Needle-freeBlood Collection Device | PREDICATE (K193569)PIVO™ Needle-free BloodCollection Device | Comparison & Discussion |
|---|---|---|---|
| Classification | 21 CFR 862.1675Class IIJKA – Blood SpecimenCollection Device | 21 CFR 862.1675Class IIJKA – Blood SpecimenCollection Device | Same |
| Indications forUse | The PIVO™ Pro Needle-freeBlood Collection Deviceattaches to a peripheral IVcatheter system for use toobtain venous bloodspecimens into a vacuum tubeor syringe from adult andpediatric patients, includingthose with difficultintravenous access who mayhave small, fragile, and/ornon-palpable veins. | The PIVO™ device isattached to a peripheral IVcatheter for use as a directblood draw device into avacuum tube or a syringe. | Minor grammatical wordingchanges with no change tomeaning.Addition of a patientpopulation statement, withspecific reference to pediatricpatients and patients withDIVA (difficult intravenousaccess) which are subsets of'General Use' and do notintroduce new risks notnormally associated with thegeneral use of the subjectdevice. Therefore,modifications, do not raise |
| Attribute | SUBJECT (K230865)PIVOTM Pro Needle-freeBlood Collection Device | PREDICATE (K193569)PIVOTM Needle-free Blood | Comparison & Discussion |
| Collection Device | new or different questions ofsafety or 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 and clampon 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 |
| 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. | 14 GA - 24 GA | Clarification only. Both thepredicate and subject devicesare available in three sizes:20GA, 22GA and 24 GA IVcompatible, as indicated onthe product label. The subjectand predicate devices arecompatible with the corresponding IV gauge and larger IV catheters. |
| Attribute | SUBJECT (K230865)PIVO™ Pro Needle-freeBlood Collection Device | PREDICATE (K193569)PIVO™ Needle-free BloodCollection Device | Comparison & Discussion |
| corresponding IV gauge andlarger IV catheters. Forexample, a 20GA IVcompatible subject orpredicate device can be usedwith a 20GA or larger IVcatheter (e.g., 18GA). | |||
| The clarification does notchange the use of the deviceor device specifications and,therefore, does not raise newor different questions ofsafety or effectiveness. | |||
| ProximalTubing | TransparentFlexible | TransparentFlexible | Same |
| Inner FlowTube (DistalTubing) Length | 20 GA = 155.28 mm22 GA = 155.28 mm24 GA = 132.68 mm | 20 GA = 141.2 mm22 GA = 141.2 mm24 GA = 141.2 mm | The results of designvalidation and verificationtesting demonstrate that themodifications to the subjectdevice perform as intendedand do not raise new ordifferent questions of safetyor effectiveness. |
| 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 female luerof PIV system, tube insertedinto PIV, blood is drawnthrough tube into a bloodtransfer device | Device attaches to female luerof PIV system, tube insertedinto PIV, blood is drawnthrough tube into a bloodtransfer device | Same |
| PackagingMaterial | Tyvek/PETORNylon/Nylon | Tyvek/PETORNylon/Nylon | Same |
| CompleteRetraction | Yes | Yes | Same |
| Attribute | SUBJECT (K230865)PIVOTM Pro Needle-freeBlood Collection Device | PREDICATE (K193569)PIVOTM Needle-free BloodCollection Device | Comparison & Discussion |
| SterilizationMethod | 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:
-
- 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
- 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 toMedical 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 allpredetermined acceptance criteria for the above-listed performance tests, demonstratingsubstantial equivalence to the predicate devices. | |
| Clinical studies are not required to demonstrate substantial equivalence to the predicatedevice. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and results ofperformance testing, the subject PIVOT™ Pro Needle-free Blood Collection Device hasbeen demonstrated to be substantially equivalent to the predicate PIVOT™ Needle-freeBlood 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.