(183 days)
Not Found
No
The summary describes a mechanical device for blood collection and does not mention any AI/ML components or capabilities.
No.
The device is used to collect blood specimens and does not provide any therapy or treatment to the patient.
No
The device is used to collect blood specimens, not to analyze them for diagnostic purposes. It is a collection device, accessory to a diagnostic process, but not diagnostic in itself.
No
The device description clearly outlines physical components (inner flow tube, slider, proximal flexible tube, outer housing, winged clip) and the performance studies focus on physical characteristics and interactions (biocompatibility, flow rate, pressure leak, etc.), indicating it is a hardware device.
Based on the provided information, the PIVO™ Pro Needle-free Blood Collection 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 sample itself.
- Device Description: The device is a tool for collecting blood, not for performing diagnostic tests on the blood.
- No Mention of Diagnostic Testing: The document focuses on the physical collection of blood and the device's compatibility with IV systems. There is no mention of any diagnostic function or analysis of the collected blood.
- Performance Studies: The performance studies listed are related to the device's physical properties, safety, and functionality in collecting blood (e.g., flow rate, hemolysis, leak testing), not its ability to perform a diagnostic test.
IVD devices are used to examine specimens (like blood) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is solely to facilitate the collection of the specimen.
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 or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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)
Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate device. A risk 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) (
§ 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.
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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) |
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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)
(