(90 days)
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.
The TIVATM 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 20 and 22 gauge.
The provided text is a 510(k) summary for the TIVA™ blood specimen collection device. It describes the device, its intended use, and its substantial equivalence to a predicate device based on functional and performance requirements and a comparison of design specifications.
However, the document does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or information regarding sample sizes for training/test sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
The section titled "Functional and Safety Testing" briefly mentions that "representative samples of the device underwent biocompatibility, sterilization, and mechanical testing in accordance with the following industry standards," but it does not provide the results of these tests or specific acceptance criteria for them.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on the study specifics as the input document does not contain this level of detail.
In summary, the document states that functional and safety testing was performed according to industry standards, but it does not report the acceptance criteria or the specific performance results for the TIVA™ device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8,2015
Velano Vascular Ms. Tiffini Diage Consulting Director of Regulatory Affairs 1500 Locust Street, Suite 4311 Philadelphia, PA 19102
Re: K142946
Trade/Device Name: TIVA™ Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: October 8, 2014 Received: October 10, 2014
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. 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,
Susan Runno, DDS, MA
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
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1.0 Indications for Use Statement
Device Name: TIVA™M
Indications for Use:
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.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
Table 1: 510(k) Summary
| Submitter: | Velano Vascular, Inc.1500 Locust St Suite 4311Philadelphia PA 19102 |
|---|---|
| Contact Person: | Tiffini DiageConsulting Director Regulatory AffairsPhone: 707.799.6732E-mail: tdiage@raechelon.com |
| Date Prepared: | 10/10/14 |
| Trade Name: | TIVATM |
| 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:• K081229 - Saf-T Closed Blood Collection System |
| Device Description: | The TIVATM 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 20 and 22 gauge. |
| Indication for Use: | 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. |
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| Functional and | To verify that the device design meets its functional andperformance requirements, representative samples of the deviceunderwent biocompatibility, sterilization, and mechanical testingin accordance with the following industry standards. |
|---|---|
| Safety Testing: | ISO 10993-1 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process |
| ISO-11137-1 Sterilization of Health Care Products. GAMMASterilization Requirements for Development, Validation andRoutine Control of a Sterilization Process for Medical Devices |
Table 2: Comparison to Predicate Device
| TIVA(Subject Device) | Saf-T Closed Blood CollectionSystem(Predicate Device) | |
|---|---|---|
| Manufacturer | Velano Vascular, Inc. | Smiths Medical ASD, Inc. |
| Intended Use | Same | Venous blood sampling |
| Patient Interface | Same | Separately placed commerciallyavailable peripheral IV catheter |
| PIV Attachment | Same | Male Luer Connection |
| Blood CollectionAttachment | Same | Female Luer to Blood Transfer Deviceor Syringe |
| Materials and Chemical Composition | ||
| Tubing | Same | TransparentFlexible |
| Latex | Same | No |
| Pyrogen | Same | Non-pyrogenic |
| Performance / Design Specifications | ||
| Compatible PIV Sizes | 14G - 22G | 14G - 24G |
| Tubing Length | 11" | 6" and 12" |
| Sample collection | Male luer connection to PIV, tubeinserted into PIV, blood is drawnthrough tube into an blood transferdevice | Male luer connection to PIV, blood isdrawn through tubing and into bloodtransfer device |
| Complete Retraction | Yes | Not Applicable |
| Sterilization Method | Gamma | Ethylene Oxide |
| Single Use Only | Same | Yes |
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| Conclusion: | Velano Vascular considers the TIVA device to be equivalent tothe predicate device listed above. This conclusion is based uponthe device's similarities in indications for use, principles ofoperation, materials, and intended use. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.