(66 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 collect blood samples, which is a diagnostic procedure, not a therapeutic intervention.
No
The device description indicates it is a "blood collection device." Its intended use is to "attach[] to a peripheral IV catheter system for use as a direct blood draw device." Collecting blood samples for diagnostic purposes does not make the collection device itself a diagnostic device. The diagnostics would be performed on the collected blood sample using other means.
No
The device description clearly outlines a physical, sterile, single-use hardware device with mechanical components for blood collection. There is no mention of software as part of the device itself.
Based on the provided information, the PIVO™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "attach to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe." This describes a device used for collecting a biological sample (blood), not for performing a diagnostic test on that sample.
- Device Description: The description details the physical components and how the device facilitates blood collection. It does not mention any components or functions related to analyzing the blood sample for diagnostic purposes.
- Lack of Diagnostic Function: The device's function is purely mechanical – to provide a needle-free way to access blood from a PIV. It does not perform any analysis, measurement, or interpretation of the blood itself.
- Performance Studies: The performance studies listed focus on the physical and functional aspects of the device for blood collection (leak testing, joint strength, flow rate, hemolysis, etc.). There are no studies related to diagnostic accuracy or performance.
An IVD device is specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The PIVO™ device is used in vivo (on the body) to collect the sample, which is then typically used in vitro with other devices or tests.
N/A
Intended Use / Indications for Use
The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.
Product codes
JKA
Device Description
The PIVOTM device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.
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
Not Found
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
Performance Testing: Based on the risks identified, the following tests were performed on the 24G: • Leak testing • Dimensional testing • Joint strength testing • PIV compatibility testing • Flow rate testing • Hemolysis testing • Shelf life testing • Biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
Key Metrics
Not Found
Predicate Device(s)
K163508 – PIVOTM
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2019
Velano Vascular Tiffini Wittwer Consulting Director of Regulatory Affairs 221 Pine St #200 San Francisco, California 94104
Re: K190604
Trade/Device Name: PIVO™M Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: April 12, 2019 Received: April 15, 2019
Dear Tiffini Wittwer:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tina Kiang, Ph.D 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) K190604
Device Name PIVOTM
Indications for Use (Describe)
The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.
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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| Submitter: | Velano Vascular
221 Pine St #200
San Francisco CA 94104 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 3, 2019 |
| Contact Person: | Tiffini Wittwer, MPH
Consulting Director of Regulatory Affairs
Phone: 707.799.6732
E-mail: tdiage@raechelon.com |
| Trade Name: | PIVOTM |
| Common Name: | Blood specimen collection device |
| Classification: | Class II |
| Product Code: | JKA per 21CFR 862.1675 |
| Predicate Device(s): | The subject device is equivalent to the following devices:
• K163508 – PIVOTM |
| Device Description: | The PIVOTM device is a sterile, single use device. It is a
needle- free blood collection device that attaches to a
peripheral IV (PIV) catheter system. The device is comprised
of an inner tube with a pusher/slider, proximal flexible tube
with female luer, outer housing and clip-to-connect distal
end. The clip-to-connect attaches to the PIV system. The
female luer attaches to a blood transfer device or syringe.
The inner tube is then advanced to collect a blood sample.
Once complete, the inner tube is retracted, and the device is
removed from the PIV.
The device is available in three sizes, 20, 22, and 24 gauge. |
| Indication for Use: | The PIVOTM device attaches to a peripheral IV catheter system
for use as a direct blood draw device into a vacuum tube or a
syringe. |
| Reason For Submission: | Line extension to include a 24G compatible size device.
Additional changes since last 510(k) clearance include
dimensional change to 20G device and material change to non-
patient contacting component in 20G and 22G device. |
| Technological
Characteristics: | The PIVOTM device attaches to a PIV system via a clip-to-
connect attachment. Once attached, a slider is moved forward
and advances the inner tube into the PIV system. The
differences between the predicate and the subject device, are the
different colored features to visually separate the different sizes |
510(k) Summary (K190604):
4
and the diameter of the inner tube for compatibility to various PIV gauges, dimensional change to the 20G inner tube to reduce stiffness and the change in material in the proximal tube. The 20G has pink features and the largest inner tube, the 22G has blue features, and the 24G has yellow features and the smallest inner tube.
| | PIVOTM 24G
(Subject Device) | PIVOTM 20G and22G
(Predicate Device) | Analysis of
differences |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number
Decision Date | K190604 | K163508 | |
| Manufacturer | Same | Velano Vascular, Inc. | |
| Classification | Class II | Class II | |
| Product Code | JKA | JKA | |
| Regulation | 21 CFR 862.1675 | 21 CFR 862.1675 | |
| Indications for Use | The PIVO™ device
attaches to a peripheral IV
catheter system for use as
a direct blood draw device
into a vacuum tube or a
syringe. | 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. | Wording change was
made for clarity and
does not change the
intended use. |
| Intended Use | Same | Venous blood drawing | |
| Patient Interface | Same | Separately placed
commercially available
peripheral IV catheter | |
| PIV Attachment | Same | Clip-to-Connect | |
| Blood Collection
Attachment | Same | Female Luer to Blood
Transfer Device or Syringe | |
| Blood Control
Mechanism | Same | Cap on female luer and
clamp on flexible tubing | |
| Tubing
(distal) | Same | Transparent
Flexible | |
| Proximal Tube
Material
(no patient contact) | Pebax Vestimide | Pebax | Performance testing
(leak testing, joint
strength, hemolysis)
demonstrated that
this material change
does not affect the |
| | | | effectiveness of the
subject device |
| | | | |
| Compatible PIV
Sizes | 24G | 14G-22G | PIV compatibility
demonstrates that the
subject device is
compatible with
smaller (24G) PIV
systems and there is
no additional risk to
safety and
effectiveness. There
is no change to
compatibility with
larger G devices. |
| Color | Yellow | 20G Pink
22G Blue | |
| Inner Tubing
Length | 141.2mm | Same | |
| Outer Diameter
(OD) of Distal Inner
Tubing | 24 gauge = 0.400mm max | 20 gauge = 0.709mm max
22 gauge = 0.543mm max | PIV compatibility
testing and
dimensional testing
demonstrate that the
difference does not
create additional risk
to safety and
effectiveness of the
subject device |
| Wall Thickness of
Distal Inner Tubing | 24 G wall = 0.0575mm +/- 0.01mm
20 G wall = 0.070mm +/- 0.01mm
22 G Same | 20 G wall = 0.089mm +/- 0.01mm
22 G wall = 0.0635mm +/- 0.01mm | Performance testing
(hemolysis, flow
rate, kink resistance)
demonstrate that
there are no
additional risks to
safety and
effectiveness of the
subject device. |
| Sample collection | Same | Device attaches to female
luer of PIV system, tube
inserted into PIV, blood is
drawn through tube into a
blood transfer device | |
| Complete
Retraction | Same | Yes | |
| Sterilization Method | Same | Gamma | |
| Single Use Only | Same | Yes | |
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| Risk Analysis: | A risk analysis was performed for the modifications done for
the subject device, in accordance to ISO 14971:2012 Medical
Devices - Applications of Risk Management to Medical
Devices and Velano Vascular Risk Management SOP.
Possible risks were identified which resulted from the gauge
size. Based on risk identification, verification and validation
activities were carried out to ensure the risk acceptability
criteria have been met and the risks have been mitigated. All
testing was performed on sterilized product. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | Based on the risks identified, the following tests were
performed on the 24G:
• Leak testing
• Dimensional testing
• Joint strength testing
• PIV compatibility testing
• Flow rate testing
• Hemolysis testing
• Shelf life testing
• Biocompatibility testing per ISO 10993-1 Biological
evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process |
| Summary of Substantial
Equivalence: | The changes made to the previously cleared PIVOTM devices
does not raise different questions regarding the safety and
effectiveness of the device. 24G PIVOTM is substantially
equivalent to the predicate 20G and 22G devices. This
conclusion is based upon the devices' identical intended use,
similar indications for use, principles of operation,
fundamental scientific technology, patient contacting materials,
and performance specifications. The changes made were tested
using the same acceptance criteria as the predicate device and
demonstrated that there are no new risks and the device is
substantially equivalent. |