(147 days)
IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag)
The Chemo Mini Spike Plus is an IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).
The provided text describes a 510(k) submission for a medical device called "Chemo Mini Spike Plus." It outlines the device's description, materials, and substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes.
The document focuses on regulatory approval based on substantial equivalence to an existing marketed device (I.V. Fluid Transfer Pin cleared under K925401).
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
- Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
*The document mentions "All finished products are tested and must meet all required release specifications before distribution." And "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." However, specific quantitative or qualitative acceptance criteria (e.g., fluid flow rate, leakage rate, material strength thresholds) and the actual performance data against these criteria are not provided in this 510(k) summary.*
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size for Test Set: Not specified.
* Data Provenance: Not specified.
The document indicates "All finished products are tested," implying testing on production units, but details on sample size, origin, or study design (retrospective/prospective) are absent.
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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. This device is a component (IV additive dispensing pin) and a "ground truth" based on expert consensus for diagnostic accuracy is not relevant to its regulatory submission as described here. The evaluation is focused on manufacturing specifications and material compatibility, not diagnostic performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed for this device.
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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. This is not an AI/diagnostic imaging device, and no MRMC study or comparative effectiveness study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "testing required for release" and "physical testing," the ground truth appears to be the product design specifications and established testing procedures and parameters. This is a functional and material conformance "ground truth." Not a clinical or diagnostic ground truth.
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The sample size for the training set
- Not applicable. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a "training set."
Summary of the Study (as described in the document):
The "study" described in this 510(k) summary is not a clinical performance study in the traditional sense. Instead, it refers to:
- Materials Testing: "The Chemo Mini Spike Plus is composed of materials that have been tested in accordance with the EN Standard 30993 and have been determined to be suitable for the intended use of this product." This implies material biocompatibility and suitability testing.
- Product Release Testing: "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."
- Quality Control Testing: "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."
Conclusion:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" based on materials, form, and intended use to a previously cleared predicate device, along with adherence to manufacturing quality control specifications. It does not contain the detailed performance data, acceptance criteria, study sizes, or ground truth establishment methods typically found in submissions for diagnostic or AI-enabled devices. The "study" mentioned refers to internal quality control and material testing rather than a formal clinical or in-vitro diagnostic performance study.
§ 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.