(29 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
No
The device is described as a "direct blood draw device" that "attaches to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe." This indicates its purpose is for diagnostic sample collection, not for treating or curing a disease or condition.
No
The device is described as a "direct blood draw device" for collecting blood samples into a vacuum tube or a syringe. It is a tool for blood collection, not for analyzing or interpreting the blood sample to make a diagnosis.
No
The device description clearly outlines a physical, sterile, single-use device comprised of various hardware components (inner tube, pusher/slider, flexible tube, outer housing, clip-to-connect distal end). The performance studies listed are also focused on physical properties and packaging, not software validation.
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 facilitate the collection of blood from a peripheral IV catheter. It does not perform any testing or analysis on the blood sample itself.
- Device Description: The description focuses on the mechanical function of the device for drawing blood. There is no mention of reagents, assays, or any components that would be used to analyze the blood.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Specific analytes being measured.
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.).
- Calibration or quality control procedures for testing.
- Interpretation of results.
The PIVO™ device is a medical device used for the collection of a biological sample (blood), which can then be used for in vitro diagnostic testing, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
JKA
Device Description
The PIVOTM device is a sterile, single use device. It is a needlefree 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the risks identified, the following tests were performed on the PIVO devices:
● Leak testing
● Dimensional testing
● Joint strength testing
● Flow rate testing
Packaging testing per ASTM D4169-16 Standard Practice For Performance Testing Of Shipping Containers And Systems, ASTM F1980-16 Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices, and ISO 11607-1:2019 Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems Biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
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.
January 21, 2020
Velano Vascular Tiffini Wittwer Consulting Director Regulatory Affairs 221 Pine St #200 San Francisco, California 94104
Re: K193569
Trade/Device Name: PIVO™ Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: December 17, 2019 Received: December 23, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/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 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 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).
Sincerely.
for Geeta Pamidimukkala Acting 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
2
Indications for Use
510(k) Number (if known) K193569
Device Name PIVOTM
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Submitter: Velano Vascular 221 Pine St #200 San Francisco CA 94104 January 6, 2020 Date prepared: Contact Person: Tiffini Wittwer, MPH Consulting Director Regulatory Affairs Phone: 707.799.6732 E-mail: twittwer@mededge.io PIVOTM Trade Name: 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: • K190604 – PIVO™ Device Description: The PIVOTM device is a sterile, single use device. It is a needlefree 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-toconnect 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. 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. Reason For Submission: An alternate colorant material is being added to the pink components of the 20G device. Additional changes since last 510(k) clearance include the addition of a second contract manufacturer and alternate packaging material for all products. Technological Characteristics: The PIVO™ 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 devices, are the alternate red colorant for the 20G components and the addition of a nylon/ nylon pouch for packaging and terminally sterilizing the devices.
510(k) Summary (K193569):
4
| | PIVO Devices
(Subject Device) | PIVO Devices
(Predicate Device) | Analysis of Differences |
|--------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number
Decision Date | K193569 | K190604 | |
| Manufacturer | Same | Velano Vascular, Inc. | |
| Classification | Same | Class II | |
| Product Code | Same | JKA | |
| Regulation | Same | 21 CFR 862.1675 | |
| Indications for Use | Same | 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. | |
| 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 | Same | Transparent
Flexible | |
| Compatible PIV
Sizes | Same | 14G - 24G | |
| Color | 20G Pink DEV-MCC 0436
OR DEV-MCC 0155
Same
Same | 20G Pink DEV-MCC 0155
22G Blue DEV-MMC 0154
24 G Yellow DEV-MCC 0267 | Biocompatibility
assessment and testing
demonstrate that this
alternate material does
alter the safety of the
device |
| Inner Tubing
Length | Same | 141.2mm | |
| Outer Diameter
(OD) of Distal Inner
Tubing | Same | 20 gauge = 0.709mm max
22 gauge = 0.543mm max
24 gauge = 0.400mm max | |
| Wall Thickness of
Distal Inner Tubing | Same | 20 G wall = 0.0750mm +/-
0.01mm
22 G wall = 0.0635mm +/-
0.01mm
24 G wall = 0.0575mm +/-
0.01mm | |
| 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 | |
| Packaging Material | Tyvek/PET
OR
Nylon/Nylon | Tyvek/PET | Transit, Aging, and
Packaging validation
testing demonstrates that
the difference does not
alter the safety of the
devices |
| Complete
Retraction | Same | Yes | |
| Sterilization Method | Same | Gamma | |
| Single Use Only | Same | Yes | |
5
Risk Analysis:
| Risk Analysis: | A risk analysis was performed for the modifications done to the subject device, in accordance to ISO 14971, Medical Devices – Applications of Risk Management to Medical Devices and Velano Vascular Risk Management SOP. Possible risks were identified which resulted from the alternate materials and new contract manufacturer. 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 PIVO devices: |
| ● Leak testing | |
| ● Dimensional testing | |
| ● Joint strength testing | |
| ● Flow rate testing |
6
| | Packaging testing per ASTM D4169-16 Standard Practice
For Performance Testing Of Shipping Containers And
Systems, ASTM F1980-16 Standard Guide For Accelerated
Aging Of Sterile Barrier Systems For Medical Devices, and
ISO 11607-1:2019 Packaging For Terminally Sterilized
Medical Devices - Part 1: Requirements For Materials,
Sterile Barrier Systems And Packaging Systems Biocompatibility testing per ISO 10993-1 Biological
evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process and |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Substantial
Equivalence: | The changes made to the previously cleared PIVOT™ devices does
not raise different questions regarding the safety and effectiveness
of the device. Current PIVOT™ is substantially equivalent to the
predicate PIVOT™ devices. This conclusion is based upon the
devices' identical intended use, 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. |