(269 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is used to obtain blood specimens, which is a diagnostic purpose, not a therapeutic one.
No
The device is designed to collect blood specimens and does not perform any analysis or interpretation of the collected blood to diagnose a medical condition.
No
The device description clearly outlines physical components (inner flow tube, slider, flexible tube, housing, winged clip) and mentions physical tests (Insertion Test, Blood Leak Test, Pressure Leak Test, Vacuum Leak Test, Seal Strength), indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain venous blood specimens. It does not describe any testing or analysis of the blood specimen itself.
- Device Description: The description focuses on the mechanism for collecting blood, not on any components or processes for analyzing the blood.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostic devices that perform tests on biological samples.
The device is a tool for collecting a sample that could be used for in vitro diagnostic testing, but the device itself does not perform the diagnostic test.
N/A
Intended Use / 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.
Product codes
JKA
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 (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 PIVO™ Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
February 27, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name reads "U.S. Food & Drug Administration".
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"
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.
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).
2
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
3
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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4
BD
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, 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 | ||
| Predicate | |||
| Device | 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 for | |||
| Submission | The purpose of this submission is to notify the FDA of the addition of blood culture | ||
| collection in addition to the predicate device's general blood collection indications for | |||
| use and an extension of the device shelf life to 3-years. | |||
| Device | |||
| Description | 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. | |||
| 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, 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. | |||
| 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. | |||
| A comparison of the subject and predicate device technological characteristics is | |||
| provided in the table below. | |||
| Attribute | SUBJECT | ||
| PIVOTM Pro Needle-free | |||
| Blood Collection Device | PREDICATE (K230865) | ||
| PIVOTM Pro 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 | ||
| Attribute | SUBJECT | ||
| PIVO™ Pro Needle-free | |||
| Blood Collection Device | PREDICATE (K230865) | ||
| PIVO™ Pro Needle-free | |||
| Blood Collection Device | Comparison & Discussion | ||
| 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. | 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 addition of a new specific | ||
| indication for use (i.e. blood | |||
| culture collection) is included | |||
| within the current general | |||
| intended use (i.e. general blood | |||
| draw). | |||
| This addition does not raise 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) | |||
| ( |