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510(k) Data Aggregation
(385 days)
VANISHPOINT BLOOD COLLECTION SET
The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients.
The VanishPoint® Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.
The VanishPoint® Blood Collection Set is safety device that is sterile and non-pyrogenic and is designed for collection of blood specimens or intravenous administration of fluid. The device will initially be available with either 7" or 12" tubing, ¼" length needles and gauge sizes of 19, 21, 23 and 25.
The provided text describes a 510(k) premarket notification for the "VanishPoint® Blood Collection Set". The submission focuses on adding an additional indication for intermittent or short-term intravenous administration of fluid, as the device was previously cleared for blood collection only.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device for the new indication. The performance is described qualitatively.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitability for additional indication (intermittent/short-term IV fluid administration) | A simulated use study utilizing healthcare professionals was performed. The subject device was found suitable for the intended uses and is as safe and effective and performs at least as safely and effectively as the legally marketed predicate device. |
| No new issues of safety and effectiveness with the new indication | "The operation, similar design and materials between the predicate devices and the subject device do not raise new issues of safety and effectiveness when used as labeled." |
| Functional testing (unchanged by new indication) | Previously presented functional testing (needle pullout force, trigger force, tubing connection strength, tubing strength, air, liquid leakage, and complete needle retraction) remained unaffected by the addition of the new indication. (Implies these met prior acceptance criteria). |
| Biocompatibility | Biocompatibility testing was performed and had acceptable results (under the previously cleared 510(k)). |
| Sterilization Validation | Sterilization Validation was completed (SAL 10^-6) according to applicable standards. |
| Extractables | An extractable study was performed with acceptable results to support the additional indication. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "simulated use study utilizing healthcare professionals" but does not specify the sample size for this study.
- Data Provenance: The study was a simulated use study, implying a controlled environment rather than real-world patient data. The country of origin is not explicitly stated, but the submission is to the FDA in the USA, suggesting the study was likely conducted in the USA or in a manner compliant with US regulatory guidelines. The study appears to be prospective in nature, designed specifically to evaluate the new indication.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "a simulated use study utilizing healthcare professionals".
- Number of experts: Not specified.
- Qualifications of experts: The general term "healthcare professionals" is used, but specific qualifications (e.g., nurses, phlebotomists, years of experience) are not detailed. Their role in establishing "ground truth" would likely be as evaluators of the device's performance in a simulated setting, providing feedback on usability, safety, and effectiveness.
4. Adjudication method for the test set:
- The document does not specify an adjudication method. For a simulated use study, "adjudication" in the sense of resolving discrepancies in expert interpretations of images or clinical findings is less applicable. The evaluation would likely involve collecting structured feedback or success/failure rates from the healthcare professionals.
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:
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (blood collection set), not an AI-powered diagnostic or assistive tool involving human readers interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an algorithm or software. Its performance inherently involves human interaction (healthcare professionals using it).
7. The type of ground truth used:
- For the simulated use study, the "ground truth" would be established by the observation and assessment of the device's performance by the healthcare professionals according to predefined criteria for safe and effective use during the simulated procedures. This would likely involve direct observation of usability, deployment of the safety mechanism, fluid administration rates if applicable, and absence of malfunctions. It is not based on pathology, expert consensus on a diagnostic finding, or long-term outcomes data in the usual sense.
8. The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not an AI model or algorithm that requires a "training set" in the computational learning sense.
9. How the ground truth for the training set was established:
- Not applicable. As stated in point 8, there is no "training set" for this type of medical device.
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(51 days)
VANISHPOINT BLOOD COLLECTION SET
The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.
The VanishPoint® Blood Collection Set is designed to collect blood specimens from patients. The VanishPoint® Blood Collection Set aids in the prevention of needlestick injuries through its retraction mechanism. The device will initially be available with either 7" or 12" tubing, ¾" length needles and gauge sizes of 19, 21, 23 and 25.
The provided text describes a 510(k) submission for the VanishPoint® Blood Collection Set, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria based on studies involving AI or complex statistical analysis typical for diagnostic algorithms.
Therefore, many of the requested fields are not applicable to this document. The "acceptance criteria" here are that the device performs as expected and is substantially equivalent to a predicate device in terms of safety and effectiveness.
Here's the information based on the provided text, with explanations for non-applicable sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria/Requirement | Reported Device Performance/Result |
|---|---|---|
| Engineering Testing | Device must perform acceptably in various applicable performance tests. | "The subject device performed as expected in all areas of testing." (e.g., needle pullout force, trigger force, tubing connection strength, tubing strength, air/liquid leakage, complete needle retraction). |
| Biocompatibility | All materials in the subject device must be biocompatible. | "Biocompatibility testing was performed on all materials in the subject device with acceptable results." |
| Simulated Use Study | The device must be found suitable for its intended use by healthcare professionals in a simulated use environment. | "A simulated use study utilizing healthcare professionals was performed using the VanishPoint® Blood Collection set in a variety of uses. The subject device was found suitable for the intended use." |
| Substantial Equivalence to Predicate Device (K030573) | The device must be similar in design, technological characteristics, and materials to the predicate device, and not raise new issues of safety and effectiveness despite differences in indications. The predicate device is the BD Vacutainer Push Button Blood Collection Set (K030573). The subject device's indication for use is "to provide safe and reliable access to the vascular system to obtain blood specimens from patients," and "aids in the prevention of needlestick injuries." The predicate device is indicated for both blood collection and intravenous administration of fluids. | "The subject VanishPoint® Blood Collection Set and the predicate device are similar in design, technological characteristics and materials." "The operation, similar design and materials between the predicate devices and the subject device do not raise new issues of safety and effectiveness. The difference in indications does not affect the safety and effectiveness of the subject device when used as labeled. It is our opinion that the devices are substantially equivalent." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the engineering tests or biocompatibility. For the simulated use study, the sample size of healthcare professionals is not specified, nor is the number of "uses" performed.
- Data Provenance: Not specified. Given the nature of a 510(k) submission, the studies are typically conducted by or for the applicant (Retractable Technologies, Inc.), likely in the USA where the company is based. The studies would be considered prospective for the purpose of this submission.
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)
- Number of Experts: For the simulated use study, it states "healthcare professionals" were utilized. The specific number is not provided, and no "ground truth" in the diagnostic sense was established by experts. Their role was to determine suitability for use.
- Qualifications of Experts: Not specified beyond "healthcare professionals."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This document describes performance and safety testing for a physical device, not a diagnostic algorithm requiring adjudicated ground truth.
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
- MRMC Study: No. This is not applicable. The device is a blood collection set, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical medical device, not an algorithm. Its performance is inherent in its design and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For engineering tests, the "ground truth" is adherence to predefined engineering specifications and functional requirements (e.g., specific force values, absence of leakage). For biocompatibility, it's compliance with established biocompatibility standards. For the simulated use study, the "ground truth" was a subjective assessment by healthcare professionals that the device was "suitable for the intended use."
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is not a machine learning or AI device.
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