TIVA¿

K152924 · Velano Vascular · JKA · Jan 7, 2016 · Clinical Chemistry

Device Facts

• Record ID: K152924
• Device Name: TIVA¿
• Applicant: Velano Vascular
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jan 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

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.

Device Story

TIVA is a sterile, single-use, needle-free blood collection device; attaches to peripheral IV (PIV) systems. Comprised of inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. Operation: male luer connects to PIV; female luer connects to blood transfer device or syringe; device advanced to collect blood sample; retracted and removed post-collection. Used in clinical settings by healthcare providers. Provides a method for blood sampling via existing PIV access, potentially reducing need for additional venipuncture. Includes a clamp on flexible tubing as a blood control mechanism.

Clinical Evidence

Bench testing only. Mechanical testing included clamp functional testing and leak testing. Predicate device testing (unchanged for subject device) included joint strength, flow rate, biocompatibility (ISO 10993-4, -5, -10, -11), and gamma sterilization validation (ISO 11137-1).

Technological Characteristics

Sterile, single-use, needle-free blood collection device. Materials: transparent flexible tubing. Dimensions: compatible with 20G and 22G PIVs; tubing lengths 6" and 12". Connectivity: mechanical luer-lock interface. Sterilization: Gamma (overkill method). No software or electronic components.

Indications for Use

Indicated for use as a direct blood draw device into a vacuum tube or syringe when attached to a peripheral IV catheter.

Regulatory Classification

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.

Predicate Devices

• TIVA™ (K142946)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 7, 2016

Velano Vascular Ms. Tiffini Diage Consulting Director of Regulatory Affairs 1500 Locust Street, Suite 4311 Philadelphia, PA 19102

Re: K152924

Trade/Device Name: TIVA™M Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: October 8, 2015 Received: October 9, 2015

Dear Ms. 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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Page 2 – Ms. Tiffini Diage

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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) K152924

Device Name TIVA™M

Indications for Use (Describe) 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.

| Type of Use (Select one or both, as applicable) | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|---|--|
| 1 / = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = | | | . | |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# K152924--510(k) Summary

## Table 1: 510(k) Summary

| Submitter: | Velano Vascular, Inc.<br>4040 Locust St<br>Philadelphia PA 19102 | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Tiffini Diage<br>Consulting Director Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] | | |
| Date Prepared: | 10/2/15 | | |
| Trade Name: | TIVA™ | | |
| Common Name: | Blood specimen collection device | | |
| Classification: | Class II | | |
| Product Code: | 21 CFR 862.1675 | | |
| Predicate<br>Device(s): | The subject device is equivalent to the following devices:<br>• K142946 – TIVA™ | | |
| Device Description: | The TIVA™ 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 plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer 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 gauge PIV's, respectively. | | |
| Indication for Use: | 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. | | |
| | TIVA<br>(Subject Device) | TIVA Blood Specimen Collection<br>Device<br>(Predicate Device) | |
| 510(k) Number | To be determined | K142946 | |
| Decision Date | | | |
| 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 TIVA™ device is attached to a<br>peripheral IV catheter for use as a<br>direct blood draw device into a<br>vacuum tube or a syringe. | The TIVA™ device is attached to a<br>peripheral IV catheter at the time of<br>IV catheter placement for use as a<br>direct blood draw device into a<br>vacuum tube or a syringe. | |
| Intended Use | Same | Venous blood drawing | |
| Patient Interface | Same | Separately placed commercially<br>available peripheral IV catheter | |
| PIV Attachment | Same | Male Luer Connection | |
| Blood Collection<br>Attachment | Same | Female Luer to Blood Transfer Device<br>or Syringe | |
| Blood Control<br>Mechanism | Cap on female luer and clamp on<br>flexible tubing | Cap on female luer | |
| Materials | | | |
| Tubing | Same | Transparent<br>Flexible | |
| Performance Specifications | | | |
| Compatible PIV Sizes | Same | 14G - 22G | |
| Tubing Length | Same | 6" and 12" | |
| Inner Diameter (ID) of<br>Tubing | Same | 20G = 0.022"<br>22G = 0.018" | |
| Sample collection | Same | Male luer connection to PIV, tube<br>inserted into PIV, blood is drawn<br>through tube into an blood transfer<br>device | |
| Complete Retraction | Same | Yes | |
| Sterilization Method | Same | Gamma | |
| Single Use Only | Same | Yes | |
| Discussion of<br>Differences | The subject device has a clamp on the flexible tubing where the<br>predicate device did not. This clamp has been added to serve as<br>an additional blood control mechanism. This modification is<br>being made based on user feedback that a clamp is preferred<br>when using blood control devices with a syringe.<br>Minor modifications have been made to the indication for use. | | |

Velano Vascular, Inc.

Premarket Notification for the TIVA Blood Collection Device

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| | blood collection device, is identical and unchanged from that of<br>the originally cleared TIVA. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No changes were made to the intended use, materials, existing<br>design specifications or performance specifications.<br>Performance testing provides objective evidence that the subject<br>TIVA device does not introduce any new questions of safety or<br>effectiveness compared to the predicate device and performs as<br>intended. |
| Functional and<br>Safety Testing: | To verify that the device design meets its functional and<br>performance requirements, representative samples of the device<br>underwent the following mechanical testing: |
| | Clamp functional testing Leak testing No changes were made to patient contacting materials,<br>sterilization method, and existing design specifications. The<br>following testing was performed on the predicate device and are<br>unchanged for the subject device: |
| | Joint strength testing Performance testing Leak testing Flow rate testing Biocompatibility testing per ISO 10993-1 Biological<br>evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process, specifically: Hemolysis and Intracutaneous Activity per ISO 10993-4 Cytotoxicity per ISO 10993-5 Sensitization per ISO 10993-10 Material Mediated Pyrogen and Systemic Toxicity per<br>ISO 10993-11 Sterilization validation testing per ISO-11137-1 Sterilization<br>of Health Care Products. GAMMA Sterilization<br>Requirements for Development, Validation and Routine<br>Control of a Sterilization Process for Medical Devices<br>(Overkill method) |
| Conclusion: | The TIVA device is substantially equivalent to the predicate<br>device listed above. This conclusion is based upon the identical<br>intended use, design specifications, patient contacting materials,<br>manufacturing and sterilization processes. Additional bench<br>testing (leak testing) demonstrates the modified TIVA device<br>performs as intended and is substantially equivalent to the<br>predicate TIVA. |

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