(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.
§ 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.