(57 days)
The Single Dose Dispensing Pin is a stand-alone, single use, disposable access device which permits syringe access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies.
The Single Dose Dispensing Pin is indicated for use with standard medication vials and needleless syringes for withdrawal and/or injection of fluid.
The Single Dose Dispensing Pin (Dispensing Pin) is a stand-alone, single use, disposable syringe access device which permits access to a medication vial without the use of a needle. The Dispensing Pin is connected to a needleless syringe and is inserted into the rubber stopper of a medication vial. The healthcare provider uses the Dispensing Pin to inject or withdraw fluid from a vial.
The provided text describes a medical device, the "Single Dose Dispensing Pin," and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving that the device meets specific performance criteria.
The document is a 510(k) summary for premarket notification to the FDA. In this type of submission, the focus is on demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices, rather than conducting new performance studies against pre-defined acceptance criteria for a novel device.
Here's how the information provided aligns with your request, with critical missing details highlighted:
Description of Acceptance Criteria and Study to Prove Device Meets Them
Missing Information: The provided text explicitly states: "The performance data supplied in this submission indicate that the Single Dose Dispensing Pin meets all specified requirements, and is substantially equivalent to the predicate devices." However, it does not explicitly list the "specified requirements" (acceptance criteria) or describe the actual "performance data" or studies conducted.
Without the actual study report or a more detailed summary of its findings, it's impossible to fill out most of the requested table and answer the specific study-related questions.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, this table cannot be completed. The document only generally states that the device "meets all specified requirements" without detailing those requirements or the specific performance metrics achieved.
| Acceptance Criteria (e.g., specific thresholds for flow rate, leak integrity, compatibility) | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text |
2. Sample size used for the test set and the data provenance
Missing Information: The document does not describe a "test set" in the context of performance testing, nor does it provide any sample size or data provenance details. The 510(k) is about demonstrating substantial equivalence, not a new performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This question is not applicable to the information provided. There is no mention of "ground truth" or expert review in the context of a performance study for this device in the given text.
4. Adjudication method for the test set
Missing Information: Not applicable. No test set or adjudication method 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
Missing Information: This question is not applicable. The device is a "Single Dose Dispensing Pin," which is a physical medical device, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing Information: Not applicable. No "ground truth" is discussed in relation to a performance study for this device.
8. The sample size for the training set
Missing Information: This question is not applicable. The device is a physical medical device and does not involve AI or machine learning models that would require a "training set."
9. How the ground truth for the training set was established
Missing Information: This question is not applicable. As above, there's no training set for this type of device.
In summary: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing predicate devices. It states that performance data was supplied and that the device meets requirements, but it does not provide the details of those performance requirements (acceptance criteria), the actual performance data, or the methodology of any studies conducted. Therefore, most of the specific questions about acceptance criteria and study details cannot be answered from the given text.
§ 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.