(66 days)
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 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.
The provided text describes a 510(k) premarket notification for the PIVO™ device, a blood specimen collection device. The submission is for a line extension to include a 24G compatible size device, along with some dimensional and material changes to existing 20G and 22G devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly provide a table of acceptance criteria with corresponding performance metrics. However, it lists several performance tests conducted and states that "All testing was performed on sterilized product." The overarching acceptance criterion for the subject device (PIVO™ 24G and modified 20G/22G) is that it "demonstrated that there are no new risks and the device is substantially equivalent" to the predicate devices. It also states that testing used "the same acceptance criteria as the predicate device."
Here's an inferred table based on the provided information:
| Performance Test | Implied Acceptance Criteria (based on "no new risks" and "same acceptance criteria as predicate") | Reported Device Performance |
|---|---|---|
| Leak testing | No leaks | Demonstrated no new risks, substantially equivalent to predicate. |
| Dimensional testing | Meets specified dimensions for compatibility | Differences do not create additional risk to safety and effectiveness. |
| Joint strength testing | Meets specified joint strength requirements | Demonstrated no new risks, substantially equivalent to predicate. |
| PIV compatibility testing | Compatible with PIV gauges (24G for subject device) | Compatible with smaller (24G) PIV systems; no additional risk. |
| Flow rate testing | Meets specified flow rate requirements (comparable to predicate) | Demonstrated no new risks, substantially equivalent to predicate. |
| Hemolysis testing | No significant hemolysis | Demonstrated no new risks, substantially equivalent to predicate. |
| Shelf life testing | Maintains performance over shelf life | Demonstrated no new risks, substantially equivalent to predicate. |
| Biocompatibility testing | Meets ISO 10993-1 requirements | Demonstrated no new risks, substantially equivalent to predicate. |
| Proximal Tube Material | (for material change) Performance (leak testing, joint strength, hemolysis) is not affected. | Material change does not affect the effectiveness of the subject device. |
| Inner Tubing Wall Thickness | (for wall thickness changes) Performance (hemolysis, flow rate, kink resistance) is not affected. | No additional risks to safety and effectiveness. |
The subsequent information is either not applicable (N/A), not explicitly stated (NSE), or can be inferred as follows:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: NSE. The document states that testing was performed, but does not specify the number of devices or samples used for each test.
- Data Provenance: NSE regarding country of origin or whether it was retrospective/prospective. The testing was conducted by the manufacturer, Velano Vascular (based in San Francisco, California, though this doesn't specify test location).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This device is a blood collection device, not an AI/diagnostic imaging device requiring expert interpretation of results for ground truth. Performance testing would rely on objective physical and chemical measurements rather than expert consensus on a 'ground truth' image or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for the performance testing described for this physical device.
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
- N/A. This device is not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Physiological standards and engineering specifications. For a blood collection device, "ground truth" would be established by predefined engineering specifications (e.g., specific dimensions, flow rates), established biochemical limits (e.g., for hemolysis), and relevant international standards (e.g., ISO 10993-1 for biocompatibility). The claim of "no new risks" and "substantially equivalent" implies meeting these objective standards relevant to the device's function.
8. The sample size for the training set
- N/A. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set for a physical device, this question is not applicable.
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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
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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 Vascular221 Pine St #200San Francisco CA 94104 |
|---|---|
| Date Prepared | April 3, 2019 |
| Contact Person: | Tiffini Wittwer, MPHConsulting Director of Regulatory AffairsPhone: 707.799.6732E-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 aneedle- free blood collection device that attaches to aperipheral IV (PIV) catheter system. The device is comprisedof an inner tube with a pusher/slider, proximal flexible tubewith female luer, outer housing and clip-to-connect distalend. The clip-to-connect attaches to the PIV system. Thefemale 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 isremoved 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 systemfor use as a direct blood draw device into a vacuum tube or asyringe. |
| Reason For Submission: | Line extension to include a 24G compatible size device.Additional changes since last 510(k) clearance includedimensional change to 20G device and material change to non-patient contacting component in 20G and 22G device. |
| TechnologicalCharacteristics: | The PIVOTM device attaches to a PIV system via a clip-to-connect attachment. Once attached, a slider is moved forwardand advances the inner tube into the PIV system. Thedifferences between the predicate and the subject device, are thedifferent colored features to visually separate the different sizes |
510(k) Summary (K190604):
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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 ofdifferences | |
|---|---|---|---|
| 510(k) NumberDecision 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™ deviceattaches to a peripheral IVcatheter system for use asa direct blood draw deviceinto a vacuum tube or asyringe. | The PIVO™ device isattached to a peripheral IVcatheter for use as a directblood draw device into avacuum tube or a syringe. | Wording change wasmade for clarity anddoes not change theintended use. |
| Intended Use | Same | Venous blood drawing | |
| Patient Interface | Same | Separately placedcommercially availableperipheral IV catheter | |
| PIV Attachment | Same | Clip-to-Connect | |
| Blood CollectionAttachment | Same | Female Luer to BloodTransfer Device or Syringe | |
| Blood ControlMechanism | Same | Cap on female luer andclamp on flexible tubing | |
| Tubing(distal) | Same | TransparentFlexible | |
| Proximal TubeMaterial(no patient contact) | Pebax Vestimide | Pebax | Performance testing(leak testing, jointstrength, hemolysis)demonstrated thatthis material changedoes not affect the |
| effectiveness of thesubject device | |||
| Compatible PIVSizes | 24G | 14G-22G | PIV compatibilitydemonstrates that thesubject device iscompatible withsmaller (24G) PIVsystems and there isno additional risk tosafety andeffectiveness. Thereis no change tocompatibility withlarger G devices. |
| Color | Yellow | 20G Pink22G Blue | |
| Inner TubingLength | 141.2mm | Same | |
| Outer Diameter(OD) of Distal InnerTubing | 24 gauge = 0.400mm max | 20 gauge = 0.709mm max22 gauge = 0.543mm max | PIV compatibilitytesting anddimensional testingdemonstrate that thedifference does notcreate additional riskto safety andeffectiveness of thesubject device |
| Wall Thickness ofDistal Inner Tubing | 24 G wall = 0.0575mm +/- 0.01mm20 G wall = 0.070mm +/- 0.01mm22 G Same | 20 G wall = 0.089mm +/- 0.01mm22 G wall = 0.0635mm +/- 0.01mm | Performance testing(hemolysis, flowrate, kink resistance)demonstrate thatthere are noadditional risks tosafety andeffectiveness of thesubject device. |
| Sample collection | Same | Device attaches to femaleluer of PIV system, tubeinserted into PIV, blood isdrawn through tube into ablood transfer device | |
| CompleteRetraction | 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 forthe subject device, in accordance to ISO 14971:2012 MedicalDevices - Applications of Risk Management to MedicalDevices and Velano Vascular Risk Management SOP.Possible risks were identified which resulted from the gaugesize. Based on risk identification, verification and validationactivities were carried out to ensure the risk acceptabilitycriteria have been met and the risks have been mitigated. Alltesting was performed on sterilized product. |
|---|---|
| Performance Testing: | Based on the risks identified, the following tests wereperformed 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 Biologicalevaluation of medical devices – Part 1: Evaluation andtesting within a risk management process |
| Summary of SubstantialEquivalence: | The changes made to the previously cleared PIVOTM devicesdoes not raise different questions regarding the safety andeffectiveness of the device. 24G PIVOTM is substantiallyequivalent to the predicate 20G and 22G devices. Thisconclusion 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 testedusing the same acceptance criteria as the predicate device anddemonstrated that there are no new risks and the device issubstantially equivalent. |
§ 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.