(57 days)
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.
The PIVO™ 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.
The provided document is a 510(k) premarket notification for a medical device called PIVO™, a blood specimen collection device. It details the device's characteristics, indications for use, and a comparison to its predicate device, TIVA™.
However, the document does not contain information related to a study proving the device meets acceptance criteria for an AI-powered medical device, or any acceptance criteria related to AI/algorithm performance. The acceptance criteria mentioned are for a physical medical device, PIVO™, comparing its performance characteristics to a predicate device (TIVA™) after material and component changes.
Therefore, I cannot extract the information required by your prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm.
The document discusses:
- Device Performance Testing:
- Clamp functional testing
- Leak testing
- Dimensional testing
- Joint strength testing
- Performance testing
- Flow rate testing
- Biocompatibility testing (per ISO 10993-1, -4, -5, -10, -11)
- Summary of Substantial Equivalence: It states that the changes made to PIVO™ (formerly TIVA™) do not raise new questions regarding safety and efficacy, and that PIVO™ is equivalent to the predicate device based on identical indications for use, principles of operation, fundamental scientific technology, and performance specifications. It explicitly states: "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."
Based on the provided text, the device is a physical blood collection device, not an AI or algorithm-driven device. Thus, your request for an AI acceptance criteria table or details about an AI study (sample size, experts, adjudication, MRMC, standalone, ground truth, training set) cannot be fulfilled from this document.
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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 Vascular1756 Fillmore StSan Francisco CA 94115 | |
|---|---|---|
| Contact Person: | Tiffini DiageConsulting Director 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:• K152924 – TIVA | |
| Device Description: | The PIVOTM device is a sterile, single use device. It is aneedle- free blood collection device that attaches to aperipheral IV system (PIV). The device is comprised of aninner tube with a pusher/slider, proximal flexible tube withfemale luer, outer housing and clip-to-connect distal end. Theclip-to-connect attaches to the PIV system. The female luerattaches to a blood transfer device or syringe. The device isthen advanced to collect a blood sample. Once complete, thedevice is retracted and removed from the PIV.The device comes in two sizes compatible with 20 and 22 gagePIV's, respectively. | |
| Indication for Use: | The PIVOTM device is attached to a peripheral IV catheter for useas a direct blood draw device into a vacuum tube or a syringe. | |
| Reason For Submission: | Component and material changes were made. The table belowidentifies the specific changes made. | |
| TechnologicalCharacteristics: | The PIVO device attaches to a PIV system via a clip-to-connectattachment. This was previously a twist on attachment. Onceattached a pusher / slider (previously was a plunger style) ismoved forward and advances the inner tube into the PIV system.The inner tube in the predicate design was PEEK or nylon and hasbeen changed to polyimide for both sizes. | |
| PIVO(Subject Device) | TIVA(Predicate Device) | |
| 510(k) NumberDecision 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 aperipheral IV catheter for use as adirect blood draw device into avacuum tube or a syringe. | |||
| Intended Use | Same | Venous blood drawing | |||
| Patient Interface | Same | Separately placed commerciallyavailable peripheral IV catheter | |||
| PIV Attachment | Clip-to-Connect | Male Luer Connection | |||
| Blood CollectionAttachment | Same | Female Luer to Blood TransferDevice or Syringe | |||
| Blood ControlMechanism | Same | Cap on female luer and clamp onflexible tubing | |||
| Materials | |||||
| Tubing Proximal | Same | PebaxTransparentFlexible | |||
| 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) ofTubing | 20G = 0.0275"22G = 0.0210" | 20G = 0.0275"22G = 0.0215" | |||
| Inner Diameter (ID) ofTubing | 20G = 0.0205"22G = 0.0156" | 20G = 0.0220"22G = 0.0180" | |||
| Sample collection | Same | Device attaches to female luer of PIVsystem, tube inserted into PIV, bloodis drawn through tube into a bloodtransfer 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. |
§ 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.