(87 days)
The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.
The Vial Adapter consists of luer connector, housing and piercing spike, all of which are made of polycarbonate (PC). The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of Vial Adapter. The connector on opposite side of the Vial Adapter is for the connection of a standard Luer needle free syringe for the reconstitution and removal of the contents of the drug vial.
The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter configurations to accommodate respective size of drug vials. The device is intended for use in healthcare facilities or in the home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
This document is a 510(k) summary for a medical device (Vial Adapter) and describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. It does not describe a study involving an AI/Machine Learning (ML) algorithm or human readers.
Therefore, many of the requested details, such as those pertaining to AI/ML acceptance criteria, ground truth establishment for AI/ML, human reader studies (MRMC), number of experts for ground truth, and training/test set sample sizes for AI/ML models, are not applicable to this document.
However, I can extract information related to the performance testing of the device itself and its acceptance criteria, as well as the overall study design of the non-clinical testing.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance tests conducted. The acceptance criteria are implicitly "Pass" for each item, indicating that the device met the required standards for each test.
| Items | Testing Standard | Acceptance Criteria (Implicit) | Reported Performance |
|---|---|---|---|
| Appearance | Internal performance standards | Pass | Pass |
| Particulate | Internal performance standards | Pass | Pass |
| Tensile strength | Internal performance standards | Pass | Pass |
| Leakage | Internal performance standards | Pass | Pass |
| Unobstructed | Internal performance standards | Pass | Pass |
| Piercing Spike | Internal performance standards | Pass | Pass |
| Puncture force | Internal performance standards | Pass | Pass |
| Chips after puncture | Internal performance standards | Pass | Pass |
| Housing | Internal performance standards | Pass | Pass |
| Luer Connector | ISO 80369-7 | Pass | Pass |
| Chemical Properties | Internal performance standards | Pass | Pass |
| (Reducing substances) | |||
| (Metal ions) | |||
| (pH) | |||
| (Evaporation residues) | |||
| (UV absorbance) | |||
| Sterile | Internal performance standards | Pass | Pass |
| Bacterial endotoxin | Internal performance standards | Pass | Pass |
Biocompatibility Testing:
The following tests were performed with acceptance criteria implicitly being "conforming" to the respective ISO standards.
| Test Name | Standard | Implied Acceptance (Conformity) | Performance |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5: 2009 | Conforms to standard | Performed |
| Skin sensitization | ISO 10993-10: 2010 | Conforms to standard | Performed |
| Hemolysis | ISO 10993-4: 2017 | Conforms to standard | Performed |
| Intracutaneous reactivity | ISO 10993-10: 2010 | Conforms to standard | Performed |
| Acute systemic toxicity | ISO 10993-11: 2017 | Conforms to standard | Performed |
| Pyrogenicity | ISO 10993-11: 2017 | Conforms to standard | Performed |
Sterilization and Shelf Life Testing:
The acceptance criterion for sterilization is a minimum SAL 10-6. The shelf life testing acceptance is that the device performs as intended over its 3-year proposed shelf life.
| Test Name | Standard | Acceptance Criteria (Implicit) | Performance |
|---|---|---|---|
| Sterilization Validation | ISO 11137-1, -2 | Minimum SAL 10-6 | Validated |
| Shelf Life (Stability Study) | ISO 11607-1, -2; ASTM F1980-16 | Device performs over 3 years | Tested |
Simulated Transportation Testing:
| Test Name | Standard | Acceptance Criteria (Implicit) | Performance |
|---|---|---|---|
| Transportation Package Integrity | ASTM D4169-DC13 | Package integrity maintained | Tested |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size (the number of units tested) for each of the performance tests. It states that "The following data were provided in support of the substantial equivalence determination," indicating tests were conducted. Standard practice for such tests involves using a statistically relevant sample size, but the specific number is not disclosed in this document.
- Data Provenance: The tests were performed by the manufacturer, Shanghai Ling Fu Technology Co., Ltd. The document is silent on the specific country of origin for the data collection (beyond the manufacturer's location in China) or whether the data was retrospective or prospective. Given the nature of performance validation, it would be prospective testing of newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the device performance testing (e.g., sterilization, leakage, material properties) of a physical medical device (Vial Adapter), not a diagnostic or AI/ML-based device that requires expert interpretation for ground truth. The "ground truth" here is the physical measurement or outcome of the prescribed test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is physical device performance testing, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The "adjudication" is inherently built into the testing protocol and measurement against a standard.
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 is not an AI/ML device. Therefore, no MRMC study with human readers was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's testing is based on objective measurements and adherence to established engineering and medical device standards (e.g., ISO, ASTM, internal performance standards). For example, a "Pass" for Luer Connector leakage means it met the leakage requirements specified in ISO 80369-7. For biocompatibility, the ground truth is conformance to the biological response defined by ISO 10993 series.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device. There is no "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device. There is no "training set."
§ 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.