(94 days)
Not Found
No
The summary describes a purely mechanical blood collection device with no mention of AI or ML capabilities. The performance studies focus on mechanical and biological testing.
No
Explanation: The device is intended for blood collection (diagnostic) and does not provide therapy or treatment to the patient.
No
Justification: The device is used to collect blood samples, which are then used for diagnostic purposes, but the device itself does not perform any diagnostic function.
No
The device description clearly states it is a physical, sterile, single-use device comprised of an inner tube, plunger, flexible tube, and outer barrel, designed to attach to a peripheral IV catheter for blood drawing. It undergoes mechanical and biological testing, indicating it is a hardware device.
Based on the provided information, the TIVA™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is described as a "direct blood draw device into a vacuum tube or a syringe." This is a device used for the collection of a biological sample (blood).
- Device Description: The description details a mechanical device for attaching to an IV catheter and facilitating blood collection. It does not describe any components or functions related to analyzing or testing the collected blood sample.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analytical procedures, or any other elements typically associated with devices used for in vitro examination of specimens.
- Performance Studies: The performance studies focus on the mechanical and biological safety aspects of the device itself (leak testing, joint strength, biocompatibility, sterilization), not on the accuracy or performance of any diagnostic test.
An IVD is a device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility of transfused blood. The TIVA™ device's function is solely to collect the specimen, not to perform any diagnostic analysis on it.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
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.
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)
To verify that the device design meets its functional and performance requirements, representative samples of the device underwent the following mechanical testing:
Clamp functional testing
Leak testing
The following testing was performed on the predicate device and are unchanged for the subject device:
Joint strength testing
Performance testing
Leak testing
Flow rate testing
Biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and 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 ISO 10993-11 Sterilization validation testing per ISO-11137-1 Sterilization of Health Care Products. GAMMA Sterilization Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Overkill method)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.
4040 Locust St
Philadelphia PA 19102 | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Tiffini Diage
Consulting Director Regulatory Affairs
Phone: 707.799.6732
E-mail: tdiage@raechelon.com | | |
| Date Prepared: | 10/2/15 | | |
| Trade Name: | TIVA™ | | |
| Common Name: | Blood specimen collection device | | |
| Classification: | Class II | | |
| Product Code: | 21 CFR 862.1675 | | |
| Predicate
Device(s): | The subject device is equivalent to the following devices:
• 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
(Subject Device) | TIVA Blood Specimen Collection
Device
(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
peripheral IV catheter for use as a
direct blood draw device into a
vacuum tube or a syringe. | The TIVA™ device is attached to a
peripheral IV catheter at the time of
IV catheter placement 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 | Male Luer Connection | |
| Blood Collection
Attachment | Same | Female Luer to Blood Transfer Device
or Syringe | |
| Blood Control
Mechanism | Cap on female luer and clamp on
flexible tubing | Cap on female luer | |
| Materials | | | |
| Tubing | Same | Transparent
Flexible | |
| Performance Specifications | | | |
| Compatible PIV Sizes | Same | 14G - 22G | |
| Tubing Length | Same | 6" and 12" | |
| Inner Diameter (ID) of
Tubing | Same | 20G = 0.022"
22G = 0.018" | |
| Sample collection | Same | Male luer connection to PIV, tube
inserted into PIV, blood is drawn
through tube into an blood transfer
device | |
| Complete Retraction | Same | Yes | |
| Sterilization Method | Same | Gamma | |
| Single Use Only | Same | Yes | |
| Discussion of
Differences | The subject device has a clamp on the flexible tubing where the
predicate device did not. This clamp has been added to serve as
an additional blood control mechanism. This modification is
being made based on user feedback that a clamp is preferred
when using blood control devices with a syringe.
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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5
| | blood collection device, is identical and unchanged from that of
the originally cleared TIVA. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No changes were made to the intended use, materials, existing
design specifications or performance specifications.
Performance testing provides objective evidence that the subject
TIVA device does not introduce any new questions of safety or
effectiveness compared to the predicate device and performs as
intended. |
| Functional and
Safety Testing: | To verify that the device design meets its functional and
performance requirements, representative samples of the device
underwent the following mechanical testing: |
| | Clamp functional testing Leak testing No changes were made to patient contacting materials,
sterilization method, and existing design specifications. The
following testing was performed on the predicate device and are
unchanged for the subject device: |
| | Joint strength testing Performance testing Leak testing Flow rate testing Biocompatibility testing per ISO 10993-1 Biological
evaluation of medical devices – Part 1: Evaluation and
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
ISO 10993-11 Sterilization validation testing per ISO-11137-1 Sterilization
of Health Care Products. GAMMA Sterilization
Requirements for Development, Validation and Routine
Control of a Sterilization Process for Medical Devices
(Overkill method) |
| Conclusion: | The TIVA device is substantially equivalent to the predicate
device listed above. This conclusion is based upon the identical
intended use, design specifications, patient contacting materials,
manufacturing and sterilization processes. Additional bench
testing (leak testing) demonstrates the modified TIVA device
performs as intended and is substantially equivalent to the
predicate TIVA. |
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