(141 days)
Latex Free Bionector is a multi-purpose catheter accessory; a closed needieless system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latex Free Bionector is a Male/Female Luer device that displaces a positive bolus during disconnection of the Male Luer devices connected to it.
The Latex Free Bionector is a multi-purpose, closed, needle-free IV connection accessory for sampling, injection or continuous infusion of fluids or drugs.
The Vygon Latex Free Bionector is a multi-purpose, closed, needle-free IV connection accessory. The submission K052881 seeks to demonstrate its substantial equivalence to the predicate device, Vygon Bionector (K941678).
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria as a quantitative threshold in the typical sense for a diagnostic device. Instead, it focuses on demonstrating that the new Latex Free Bionector performs equivalently to the predicate device and meets safety standards despite a material change. The "acceptance criteria" here are implied through the successful completion of testing confirming functionality and safety.
| Acceptance Criteria (Implied) | Reported (Demonstrated) Device Performance |
|---|---|
| Non-irritant (Biocompatibility) | Biocompatibility testing of the Latex Free Bionector demonstrates that it is non-irritant. |
| Non-toxic (Biocompatibility) | Biocompatibility testing of the Latex Free Bionector demonstrates that it is non-toxic. |
| Device functionality unaffected by material change | Performance testing demonstrates that the change in material (removal of latex) does not affect device functionality. |
| Compliance with ISO 14971 (Risk Management) | Risk Assessment was conducted in compliance with ISO 14971. |
| Disinfectable membrane | The Bionector has a disinfectable membrane. (This is a characteristic, not a performance criterion, but listed as a key technology characteristic that would need to be maintained post-material change). |
| Automatic closure upon disconnection | The Bionector's membrane closes automatically when the infusion line or syringe is disconnected. (Again, a characteristic that must be maintained). |
| Resistance to lipid emulsions, cytotoxic drugs, and antiseptics | The Bionector is resistant to lipid emulsions, most cytotoxic drugs, and antiseptics. (Characteristic that must be maintained). |
| Substantial equivalence to predicate device (K941668) in intended use | The Latex Free Bionector's intended use and technological characteristics (excluding latex content) are described as substantially equivalent to the predicate device (K941678). Both are multi-purpose catheter accessories for sampling, injection, or continuous infusion with Luer systems. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the performance and biocompatibility testing. The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective, performed specifically for this 510(k) submission to evaluate the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For biocompatibility and performance testing of a medical device, the "ground truth" is typically established by recognized standards, validated testing methodologies, and expert interpretation of results by qualified laboratory personnel, rather than a consensus of clinical experts for a diagnostic output.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (biocompatibility, performance testing against specifications), a consensus-based adjudication method for a "test set" is not typically applicable in the same way it would be for a diagnostic image review. The results would be interpreted against established acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. This device is a medical accessory, not a diagnostic imaging device that requires human interpretation.
6. Standalone Performance Study
Yes, standalone performance studies were conducted. The "Performance testing" mentioned in the "Summary of Design Control Activities" section appears to be a standalone evaluation of the device's functionality. This testing directly addressed whether the change in material affected device performance. Biocompatibility testing was also a standalone evaluation.
7. Type of Ground Truth Used
The ground truth for the performance and biocompatibility testing was established through:
- Established Biocompatibility Standards: "Biocompatibility testing... demonstrate that it is non-irritant and non-toxic," implying testing against recognized standards for biocompatibility (e.g., ISO 10993 series).
- Device Functionality Specifications: "Performance testing demonstrates that the change in material does not affect device functionality," indicating that critical functional parameters were tested against predefined specifications derived from those of the predicate device.
- Risk Management Standards: "Risk Assessment was conducted in compliance with ISO 14971."
8. Sample Size for the Training Set
No training set is applicable or mentioned. This is a physical medical device, not an AI/ML algorithm that requires 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.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).