(51 days)
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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.