(117 days)
Churchill Medical Systems Vial Access Spike with Needleless Connector is used in I.V. therapy to pierce glass and plastic stopper top vials for the transfer of medical fluids. This device climinates the use of metal hypodermic needles to reduce the chance of inadvertent needle sticks.
The Churchill Medical Systems vial access device is a sterile, single use, one piece shrouded plastic cannula designed to penetrate septums covering plastic or glass medication vials. The device is intended to be marketed with and without needleless connector port permanently attached.
The provided text describes a 510(k) summary for a medical device called the "Universal Vial Access Spike with Needleless Connector" by Churchill Medical Systems, Inc. However, the document does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and performance studies.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device is manufactured and tested in accordance with certain physical, chemical, and biological specifications. It references standards but does not provide specific quantitative acceptance criteria or detailed results.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Specifications | Conforms to internal requirements |
| Chemical Specifications | Conforms to applicable requirements set forth in USPXX111 |
| Biological Specifications | Conforms to applicable requirements set forth in ISO 10993, USP Pyrogenicity test requirements |
| Sterilization | Conforms to applicable requirements set forth in ISO 11135 |
| Packaging | Conforms to applicable requirements set forth in ISO 11607-1 |
| Prevention of Accidental Needle Sticks | Confirmed to be safe and effective (by sharing similar technical characteristics to predicate device) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified, but generally, such studies for 510(k) submissions are conducted internally by the manufacturer or their contracted labs. Given the device type, it's likely physical and chemical lab testing, not patient data. Retrospective or Prospective: N/A (not applicable as it's not a clinical study with patient data).
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):
- This information is not provided in the document. The nature of the device (a vial access spike) suggests that "ground truth" would be established through laboratory testing against predefined specifications rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given it's a device for fluid transfer and needle stick prevention, not diagnostic imaging, adjudication methods like 2+1 or 3+1 are not typically relevant.
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. This type of study (MRMC for AI assistance) is not applicable to this device. The device is a physical medical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI algorithm. Its performance is evaluated based on its physical and material properties and its ability to prevent needle sticks, which is a standalone function of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device would be the specific, quantifiable parameters defined by the referenced industry standards (ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements) and internal physical testing requirements. For example, burst pressure for the spike, material compatibility, sterility assurance level, and ability to prevent needle sticks in simulated use.
8. The sample size for the training set:
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- N/A. This device does not involve a "training set" or "ground truth" for training in the machine learning sense. The "ground truth" for its physical performance characteristics is established by adherence to recognized standards and validated internal test methods.
§ 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.