(57 days)
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No
The device description and performance studies focus on mechanical and functional aspects of a blood collection device, with no mention of AI or ML technologies.
No
The device is described as a "direct blood draw device" used for collecting blood samples, which is a diagnostic purpose, not a therapeutic one.
No
The device is described as a "direct blood draw device" that attaches to a peripheral IV catheter for collecting blood samples. Its purpose is to facilitate blood collection, not to diagnose.
No
The device description clearly outlines physical components (inner tube, pusher/slider, flexible tube, outer housing, clip-to-connect distal end) and describes a mechanical action (advanced to collect a blood sample, retracted and removed). The performance studies also focus on physical characteristics and functionality (clamp functional testing, leak testing, dimensional testing, etc.), indicating it is a hardware device.
No, the PIVO™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the collection of blood samples from a peripheral IV catheter. It is a tool for obtaining the sample, not for performing a diagnostic test on the sample itself.
- Device Description: The description details a mechanical device for blood collection, not a reagent, instrument, or system designed to examine specimens from the human body to provide information for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device analyzing the blood sample, interacting with reagents, or providing any diagnostic information. Its function is purely to facilitate the physical act of drawing blood.
IVD devices are used on the sample to perform a test and provide diagnostic information. The PIVO™ device is used to obtain the sample that would then be used in an IVD 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 (comma separated list FDA assigned to the subject device)
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 system (PIV). 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 device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV.
The device comes in two sizes compatible with 20 and 22 gage PIV's, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the identified risks additional testing was performed. As a result of verification and validation activities and risk assessment, testing ensured the device design meets its functional and performance requirements. The following tests were performed:
Clamp functional testing
Leak testing
Dimensional testing
Joint strength testing
Performance testing
Flow rate testing
Biocompatibility testing per ISO 10993-1
ISO 10993-4
ISO 10993-5
ISO 10993-10
ISO 10993-11
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Velano Vascular Tiffini Diage, MPH Consulting Director of Regulatory Affairs 1756 Fillmore Street San Francisco, California 94115
Re: K163508 Trade/Device Name: PIVO™M Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: January 11, 2017 Received: January 12, 2017
Dear Ms. Tiffini Diage:
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. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163508
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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510(k) Summary: K163508
| Submitter: | Velano Vascular
1756 Fillmore St
San Francisco CA 94115 | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Contact Person: | Tiffini Diage
Consulting Director 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:
• K152924 – TIVA | |
| 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 system (PIV). 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 device is
then advanced to collect a blood sample. Once complete, the
device is retracted and removed from the PIV.
The device comes in two sizes compatible with 20 and 22 gage
PIV's, respectively. | |
| Indication for Use: | The PIVOTM device is attached to a peripheral IV catheter for use
as a direct blood draw device into a vacuum tube or a syringe. | |
| Reason For Submission: | Component and material changes were made. The table below
identifies the specific changes made. | |
| Technological
Characteristics: | The PIVO device attaches to a PIV system via a clip-to-connect
attachment. This was previously a twist on attachment. Once
attached a pusher / slider (previously was a plunger style) is
moved forward and advances the inner tube into the PIV system.
The inner tube in the predicate design was PEEK or nylon and has
been changed to polyimide for both sizes. | |
| | PIVO
(Subject Device) | TIVA
(Predicate Device) |
| 510(k) Number
Decision Date | To be determined | K152924 |
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| 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 | Same | The TIVA™ 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 | Clip-to-Connect | Male Luer Connection | |||
| 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 | |||||
| Materials | |||||
| Tubing Proximal | Same | Pebax | |||
| Transparent | |||||
| Flexible | |||||
| Tubing Distal | Polyimide (20G & 22G) | PEEK (22G) | |||
| Nylon (20G) | |||||
| Performance Specifications | |||||
| Compatible PIV Sizes | Same | 14G - 22G | |||
| Inner Tubing Length | 5.85" | 4.99" | |||
| Outer Diameter (OD) of | |||||
| Tubing | 20G = 0.0275" | ||||
| 22G = 0.0210" | 20G = 0.0275" | ||||
| 22G = 0.0215" | |||||
| Inner Diameter (ID) of | |||||
| Tubing | 20G = 0.0205" | ||||
| 22G = 0.0156" | 20G = 0.0220" | ||||
| 22G = 0.0180" | |||||
| 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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| Performance Testing: | Based on the identified risks additional testing was performed. As a result of verification and validation activities and risk assessment, testing ensured the device design meets its functional and performance requirements. The following tests were performed: | |
|---|---|---|
| Clamp functional testing Leak testing Dimensional testing Joint strength testing Performance testing Flow rate testing Biocompatibility testing per ISO 10993-1 ISO 10993-4 ISO 10993-5 ISO 10993-10 ISO 10993-11 | ||
| Summary of Substantial Equivalence: | The changes made to the previously cleared TIVA (now called PIVO™) device does not raise new questions regarding safety and efficacy of the device. PIVO is equivalent to the predicate device. This conclusion is based upon the devices' identical indications for use, principles of operation, fundamental scientific technology, and performance specifications. The changes made were tested using the same acceptance criteria as the predicate device and provide objective evidence that there are no new risks and the device is substantially equivalent. |