(41 days)
Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.
The Churchill Medical Systems Mini Transfer Device is a standard vented access device. It contains a universal piercing spike with female luer lock and .22 micron hydrophobic filter. The purpose of the filter within the spike body is to provide air-venting.
The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Access Device" (also referred to as "Mini Transfer Device"). The document outlines the device's description, intended use, and a performance summary. However, it does not detail specific acceptance criteria or a comprehensive study report with quantitative results in the way a modern clinical trial or AI/software validation study would.
Instead, the performance summary focuses on compliance with established standards and comparison to a predicate device for the purpose of demonstrating "substantial equivalence" to obtain market clearance.
Here's an attempt to structure the information based on your request, highlighting what is available and what is not:
Acceptance Criteria and Study for the Churchill Medical Systems Mini Transfer Device (K013950)
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a typical clinical trial format (e.g., specific sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and demonstration of substantial equivalence to a predicate device. The study described is a series of tests to ensure this compliance and equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Physical Performance | Conformance to applicable requirements set forth in documented internal requirements for physical testing. (Specific thresholds not detailed) | Device is "manufactured and tested in accordance with physical... specification." Implied successful performance as concluded to be safe and effective. |
| Chemical Performance | Conformance to applicable requirements set forth in documented internal requirements for chemical testing. (Specific thresholds not detailed) | Device is "manufactured and tested in accordance with... chemical... specification." Implied successful performance as concluded to be safe and effective. |
| Biological Performance | Conformance to ISO 10993-1 (Biological evaluation of medical devices). | Device is "manufactured and tested in accordance with... biological specification conforming to the applicable requirements set forth in ISO 10993-1..." Implied bio-compatibility and safety. |
| Conformance to USP 24 (United States Pharmacopeia standards, likely for pyrogenicity and other sterility/endotoxin tests). | Device is "manufactured and tested in accordance with... biological specification conforming to the applicable requirements set forth in... USP 24..." | |
| Conformance to USP Pyrogenicity test requirements. | "USP Pyrogenicity test requirements" were met. | |
| Sterilization/Packaging | Conformance to ISO 11607-1 (Packaging for terminally sterilized medical devices) and ISO 11135 (Sterilization of health care products — Ethylene oxide). | Device is "manufactured and tested in accordance with... specification conforming to the applicable requirements set forth in... ISO 11607-1, ISO 11135..." This indicates proper packaging integrity and effective sterilization. |
| Functional Equivalence | Performance similar to the predicate device: Baxter Healthcare Chemo-Aide Dispensing Pin (K003730). | "This device performs similarly to the predicate device... Testing summary results confirm this device to be safe and effective and substantially equivalent to the predicate device." This is the core finding for 510(k) clearance, implying functional equivalence for transferring/dispensing medications from multi-dose vials. Specific quantitative functional metrics are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample sizes used for the various tests (physical, chemical, biological, or functional comparison). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The implication is that standard manufacturing and testing batches were used as per the mentioned ISO and USP standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and therefore not provided in the 510(k) summary. For a device like a vial access device, "ground truth" is typically established by objective measurement against engineering specifications and validated test methods, rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be quality engineers, microbiologists, and other technical professionals conducting the tests, ensuring compliance with standards.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective measurements against established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI-driven systems where human interpretation is a key component and the goal is to show improvement with AI assistance. The Mini Transfer Device is a mechanical access device.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this medical device. The device is a physical product, not a software algorithm that operates without human interaction.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Compliance with international and national standards (e.g., ISO 10993-1, USP 24, ISO 11607-1, ISO 11135).
- Adherence to internal company specifications for physical and chemical properties.
- Performance comparison to a legally marketed predicate device (Baxter Healthcare Chemo-Aide Dispensing Pin), demonstrating "similar technical characteristics" and performance.
These are objective, measurable criteria related to the device's physical properties, biocompatibility, sterility, and functional operation (transferring/dispensing fluids) as designed.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or an "algorithm" in the sense that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
Summary Takeaway:
The K013950 510(k) summary demonstrates compliance and substantial equivalence through a series of tests against established industry standards and comparison to a predicate device. It does not provide detailed quantitative performance metrics or studies akin to those for AI/software devices or complex diagnostic tools. The focus is on ensuring the device meets safety and effectiveness requirements through adherence to manufacturing and testing protocols relevant to its classification as an IV administration set accessory.
§ 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.