(94 days)
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 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.
The provided document is a 510(k) summary for the TIVA™ blood specimen collection device (K152924). It compares the subject device to a predicate device (K142946). The document does not include information about AI/ML models or clinical studies involving human readers or comparative effectiveness studies of AI vs. human readers. Therefore, I can only address aspects related to the device's functional and safety testing as described.
Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document details performance testing for both the predicate and subject devices. The "acceptance criteria" are implied by successful completion of these tests, demonstrating the device meets its functional and safety requirements.
| Acceptance Criteria (Implied by Test) | Reported Device Performance |
|---|---|
| Clamp functionality | Successful completion of "Clamp functional testing." The subject device's added clamp is an "additional blood control mechanism" and "performs as intended." |
| Leak integrity | Successful completion of "Leak testing." For the predicate, this was part of "Performance testing." For the subject device, it was specifically re-evaluated due to modifications ("Additional bench testing (leak testing) demonstrates the modified TIVA device performs as intended"). |
| Joint strength | Successful completion of "Joint strength testing" (performed on the predicate device and unchanged for the subject device). Implies the joints maintain structural integrity during use. |
| Flow rate functionality | Successful completion of "Flow rate testing" (performed on the predicate device and unchanged for the subject device). Implies the device facilitates appropriate blood draw speed. |
| Biocompatibility (Hemolysis, Intracutaneous, Cytotoxicity, Sensitization, Material Mediated Pyrogen, Systemic Toxicity) | Successful completion of "Biocompatibility testing per ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11" (performed on the predicate device and unchanged for the subject device). Implies the device is bio-compatible and does not cause adverse biological reactions. |
| Sterilization effectiveness | Successful completion of "Sterilization validation testing per ISO-11137-1" (performed on the predicate device and unchanged for the subject device). Implies the device is terminally sterilized and maintains sterility until use. |
| Performance as intended (general) | "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." |
| Substantial Equivalence | "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." This is the ultimate acceptance criterion for 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the functional and safety tests. It generally refers to "representative samples of the device." The data provenance is internal testing conducted by Velano Vascular, Inc. (the manufacturer). The testing is retrospective in the sense that it's performed on manufactured devices as part of product verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. The ground truth for functional and safety testing is typically established by engineering specifications, recognized industry standards (like ISO standards), and internal quality control protocols. The "experts" would be the engineers and technicians performing and validating these tests, ensuring they follow established procedures and standards.
4. Adjudication Method for the Test Set
Not applicable in the context of functional and safety testing of a medical device. The tests have predefined pass/fail criteria based on engineering specifications and industry standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The TIVATM device is a mechanical blood collection device, not an AI/ML-driven diagnostic or interpretative tool. Therefore, no MRMC study or AI-related comparative effectiveness study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a mechanical blood collection tool and does not involve any algorithm or AI.
7. The Type of Ground Truth Used
For the functional and safety testing described, the ground truth is based on:
- Engineering Specifications: Defined parameters for device performance (e.g., specific thresholds for leak testing, joint strength).
- Recognized Standards: International standards like ISO 10993 (biocompatibility) and ISO 11137-1 (sterilization).
- User Feedback: The document explicitly states the addition of the clamp was based on "user feedback that a clamp is preferred when using blood control devices with a syringe." This indirectly influences the "ground truth" for a desirable functional feature.
8. The Sample Size for the Training Set
Not applicable, as the device is a mechanical one and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for AI/ML was used.
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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 StPhiladelphia PA 19102 | ||
|---|---|---|---|
| Contact Person: | Tiffini DiageConsulting Director Regulatory AffairsPhone: 707.799.6732E-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 | ||
| PredicateDevice(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 CollectionDevice(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 aperipheral IV catheter for use as adirect blood draw device into avacuum tube or a syringe. | The TIVA™ device is attached to aperipheral IV catheter at the time ofIV catheter placement 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 | Same | Male Luer Connection | |
| Blood CollectionAttachment | Same | Female Luer to Blood Transfer Deviceor Syringe | |
| Blood ControlMechanism | Cap on female luer and clamp onflexible tubing | Cap on female luer | |
| Materials | |||
| Tubing | Same | TransparentFlexible | |
| Performance Specifications | |||
| Compatible PIV Sizes | Same | 14G - 22G | |
| Tubing Length | Same | 6" and 12" | |
| Inner Diameter (ID) ofTubing | Same | 20G = 0.022"22G = 0.018" | |
| Sample collection | Same | Male luer connection to PIV, tubeinserted into PIV, blood is drawnthrough tube into an blood transferdevice | |
| Complete Retraction | Same | Yes | |
| Sterilization Method | Same | Gamma | |
| Single Use Only | Same | Yes | |
| Discussion ofDifferences | The subject device has a clamp on the flexible tubing where thepredicate device did not. This clamp has been added to serve asan additional blood control mechanism. This modification isbeing made based on user feedback that a clamp is preferredwhen 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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| blood collection device, is identical and unchanged from that ofthe originally cleared TIVA. | |
|---|---|
| No changes were made to the intended use, materials, existingdesign specifications or performance specifications.Performance testing provides objective evidence that the subjectTIVA device does not introduce any new questions of safety oreffectiveness compared to the predicate device and performs asintended. | |
| Functional andSafety Testing: | To verify that the device design meets its functional andperformance requirements, representative samples of the deviceunderwent the following mechanical testing: |
| Clamp functional testing Leak testing No changes were made to patient contacting materials,sterilization method, and existing design specifications. Thefollowing testing was performed on the predicate device and areunchanged for the subject device: | |
| Joint strength testing Performance testing Leak testing Flow rate testing Biocompatibility testing per ISO 10993-1 Biologicalevaluation of medical devices – Part 1: Evaluation andtesting 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 perISO 10993-11 Sterilization validation testing per ISO-11137-1 Sterilizationof Health Care Products. GAMMA SterilizationRequirements for Development, Validation and RoutineControl of a Sterilization Process for Medical Devices(Overkill method) | |
| Conclusion: | The TIVA device is substantially equivalent to the predicatedevice listed above. This conclusion is based upon the identicalintended use, design specifications, patient contacting materials,manufacturing and sterilization processes. Additional benchtesting (leak testing) demonstrates the modified TIVA deviceperforms as intended and is substantially equivalent to thepredicate TIVA. |
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§ 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.