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510(k) Data Aggregation
(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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(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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(62 days)
The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
TivaMed Cooled RF System uses radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool and protect the surface tissue.
The provided text describes the TivaMed Cooled RF System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.
Here's a breakdown of what is and is not present in relation to your request:
1. A table of acceptance criteria and the reported device performance:
- Not present. The document mentions "functional and performance requirements" were met, but it does not specify these requirements as acceptance criteria or provide quantitative performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. The document states "representative samples of the device underwent biocompatibility, electrical, and mechanical testing," but it does not specify the sample size for these tests or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not present. As there's no clinical performance study described, there's no mention of ground truth established by experts. The testing described (biocompatibility, electrical, mechanical) are engineering/bench tests, not clinical evaluations requiring expert interpretation of results in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. No clinical test set requiring adjudication is described.
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/Not present. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI performance improvement are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not present. This is hardware, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not present. For the functional and safety testing, "ground truth" would be established by adherence to the specified engineering standards (e.g., IEC 60601-1, ISO 10993-1). There is no clinical "ground truth" mentioned.
8. The sample size for the training set:
- Not applicable/Not present. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not present. See point 8.
Summary of available information regarding testing:
The device underwent:
- Functional and Safety Testing:
- Biocompatibility testing
- Electrical testing
- Mechanical testing
- Standards Adhered to:
- IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety
- IEC 60601-1-2 (Likely electromagnetic compatibility)
- IEC 60601-1-4: Medical Electrical Equipment - General Requirements for Safety - Programmable Electrical Medical Systems (though the device itself doesn't appear to be "programmable" in a complex sense, this standard covers certain aspects)
- IEC 60601-2-2: Medical Electrical Equipment - Particular Requirements for the Safety of High Frequency Surgical Equipment
- AAMI/ANSI/ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- Federal Register, Volume 43, No. 122, 1978 (likely for regulatory context or specific test methods)
- FDA "ETO, ECH, and EG Proposed Maximum Residue Limits and Maximum Limits of Exposure" (for sterilization by-products)
The conclusion is based on the device's "similarities in principles of operation, technology, materials, and indications for use" to its predicate devices, suggesting that the compliance with these standards and functional tests provides the basis for substantial equivalence, rather than a specific clinical performance study against acceptance criteria.
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