Search Results
Found 1 results
510(k) Data Aggregation
(195 days)
MP VIAL ADAPTER 13MM
Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.
The device is a needless transfer device which enables reconstitution of one diluent vial and up to five vials of the fertility drugs Bravelle®, or Menopur® manufactured by Ferring using one MP Vial Adapter 13 mm.
The device is a single use sterile device which will be included into Ferring Pharmaceutical's Bravelle® and/or Menopur® drug kits to assist in the reconstitution of these lyophilized drugs for injection using one reconstitution diluent vial.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided text is a Traditional 510(k) Summary for a medical device called the "MP Vial Adapter 13mm." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive standalone clinical trials with predefined acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.
Therefore, the document does not contain a table of acceptance criteria for device performance with corresponding reported values in the typical sense of diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to predicate devices and successful completion of "bench testing."
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics | The MP Vial Adapter 13mm's material of construction and design is identical to the vial adapter subcomponent of the previously cleared Medimop Mixject with spray head (K122023). |
| Performance (Functional Equivalence) | The proposed device's performance, packaging, and sterilization are the same as that of a previously cleared Medimop 13mm Dispensing Pin (K963583). |
| Indication for Use Equivalence | The device's updated indication for use with Ferring Pharmaceutical's fertility drugs Bravelle® and/or Menopur® is equivalent to that of the previously cleared Q-Cap (K043304). |
| Bench Testing | "Bench testing was performed to demonstrate the ability of the proposed MP Vial Adapter 13mm to effectively reconstitute and transfer Bravelle® and/or Menopur® fertility drugs." (The specific results or metrics of this bench testing are not provided in this summary.) |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the 510(k) summary. Given it's a bench testing study for a physical device, the "test set" would refer to the number of devices or vials tested. The provenance of "data" (e.g., country of origin, retrospective/prospective) is typically associated with clinical studies involving human or patient data, which is not the case here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/provided. The "ground truth" for this type of device (a vial adapter) would be its physical functionality and ability to perform the intended actions (reconstitution, transfer). This is assessed through engineering and bench testing, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in interpreting clinical data, which is not relevant for the bench testing of this device.
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
There was no MRMC comparative effectiveness study and this question is not applicable. This device is a manual medical device, not an AI-driven system that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not an algorithm seeking standalone performance evaluation. Its "standalone" performance refers to its ability to function as designed when used by a human user, which was assessed via bench testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was functional performance established through bench testing, likely against engineering specifications and industry standards for fluid transfer and reconstitution. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided. As explained, there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1