(118 days)
The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials
The vial adapter is a one piece molded polycarbonate device that is used to aide in the reconstitution and transfer of drugs contained in vials. The sterile device pierces the elastomeric septum of a drug vial with its integrated spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the "legs" of the vial adapter. The opposing side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the drug vial. After drug removal, the syringe is removed and the vial adapter is properly discarded with the drug vial.
The proposed device, Vial Adapter 15mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
The proposed device, Vial Adapter 15mm is a 15mm version of the currently available 13mm Vial Adapter or 20mm Vial Adapter. The device consists of a piercing spike and integrated Vial Adapter (15mm) for access to the drug/solution vial.
The device does not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.
The device does not contain any medicinal substances, and can be used with standard drug vials.
The provided document focuses on the 510(k) summary for the Medimop Vial Adapter 15mm, asserting its substantial equivalence to a predicate device. While it lists various performance tests, it does not provide a detailed study or specific acceptance criteria with reported device performance values in a format requested.
The document mentions that "All testing met the required acceptance criteria," but it does not elaborate on what those criteria were or the actual quantitative results achieved for each test.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Total Penetration Force | Tested to internal performance standards (Specific criteria not provided) | "All testing met the required acceptance criteria." (Specific results not given) |
| Removal From Blister | Tested to internal performance standards (Specific criteria not provided) | "All testing met the required acceptance criteria." (Specific results not given) |
| Vial Adapter Detachment Force | Tested to internal performance standards (Specific criteria not provided) | "All testing met the required acceptance criteria." (Specific results not given) |
| Spike Tip Ductility Test | Tested to internal performance standards (Specific criteria not provided) | "All testing met the required acceptance criteria." (Specific results not given) |
| Fluid Leakage Test | Tested to internal performance standards (Specific criteria not provided) | "All testing met the required acceptance criteria." (Specific results not given) |
| Packaging (Visual Peel, Seal, Methylene Blue Bubble Leak) | Tested per ISO 11607-1 (Specific criteria not provided) | "All testing met the required acceptance criteria." (Specific results not given) |
| Sterilization | SAL 10-6 (Validated according to ISO 11137-1, ISO 11137-2, AAMI TIR 33) | SAL 10-6 (Achieved) |
| Biocompatibility (various tests) | Per ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, USP (Specific criteria not provided for each test) | "successfully completed" (Specific results not given) |
| Bacterial Endotoxin | 0.5 EU/ml or 20 EU/device | (Implicitly met, but no specific values provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the performance tests. It mentions "Representative samples from every lot of product are tested for bacterial endotoxin," but no numerical sample size is given for this or any other test.
The data provenance is internal testing performed by Medimop Medical Project Ltd., as indicated by "Tested to internal performance standards." No country of origin for the data (other than the company's location in Israel) or whether it was retrospective or prospective is stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable to this type of device and testing. The "ground truth" for a medical device like a vial adapter is typically based on established engineering and materials science standards, not expert consensus in a diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. The testing described is objective performance testing against engineering standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging or AI-driven decision support systems where human reader performance is a key metric. The Vial Adapter is a mechanical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve algorithms or AI. The performance tests are standalone in the sense that they evaluate the device's physical properties and functionality.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on:
- Established engineering standards: e.g., "Tested per ISO 11607-1" for packaging, "ISO 11137-1, ISO 11137-2 and AAMI TIR 33" for sterilization, and "ISO 10993-1" series for biocompatibility.
- Internal performance standards: for tests like Total Penetration Force, Detachment Force, etc. These internal standards are derived from engineering requirements and risk assessments.
- Pharmacopoeial standards: e.g., USP for pyrogenicity.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as 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.