(14 days)
The indication for use is reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.
The single lumen docking station of the Protector is fitted to the drug vial for the parenteral drug. The Injector is connected to the Protector and liquid transfer takes place through tightly fitting elastomeric double membranes to minimize leakage during reconstitution, administration and disposal processes. The Protector equilibrates the pressure difference which occurs when fluid or air is added to, or removed from the drug vial.
The provided text describes a 510(k) summary for a medical device called "PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs" and its components (Protector P14, P21, P28, and P50). However, the document does not contain acceptance criteria, a specific study proving the device meets those criteria, or the detailed information requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details).
Instead, the document details a substantial equivalence comparison to predicate devices for regulatory clearance. The core of the submission is to demonstrate that the new devices (Modified P14, P21, P28, P50) are functionally equivalent to previously cleared devices (Predicate P14, P21, P50 from K001368).
The relevant sections are "5. Technological characteristics, comparison to predicate device" and "6. Discussion of performance testing."
Here's a breakdown of what can be extracted and what information is missing based on your prompt:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or a direct measurement of "device performance" in terms of specific metrics like leakage rates or contamination levels. Instead, it relies on demonstrating equivalence to predicate devices, which are presumed to meet established safety and effectiveness standards.
The closest we can get to "performance" is the comparison table which shows direct equivalence in intended use, material, spike type (with one exception for P28), drug vial size, expansion chamber, and sterilization method.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Drug Vial Adapter for closed reconstitution of parenteral drugs. | Met: Identical |
| Material: Polypropylene | Met: Identical |
| Spike: Stainless steel | Met for P14, P21, P50: Identical |
| Spike: Stainless steel | Not met for P28 (Plastic): Different, but presumably deemed acceptable through "performance testing" referenced generally. |
| Drug vial size: Ø 13 mm (P14), Ø 20 mm (P21, P50), Ø 28 mm (P28) | Met: Identical |
| Expansion chamber: 20 ml (P14, P21), 50 ml (P28, P50) | Met: Identical |
| Sterilization method: EtO | Met: Identical |
| Overall Safety and Effectiveness: No new concerns compared to predicate. | "The Protectors have been tested and found in compliance with applicable requirements and standards specifications." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document states "The Protectors have been tested and found in compliance with applicable requirements and standards specifications," but does not detail what tests, how many samples, or where the data originated from.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is entirely absent. The submission is based on demonstrating substantial equivalence through material and design comparisons and general performance testing (details not provided), not an expert-driven ground truth assessment.
4. Adjudication method for the test set
- Not applicable/Not specified. There's no mention of a formal adjudication process for test results in this 510(k) summary.
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
- This is not an AI/software device. No MRMC comparative effectiveness study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of expert-derived ground truth. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new devices are deemed "substantially equivalent" if they meet the same functional and material characteristics and do not raise new safety or effectiveness concerns.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See answer for #8).
Study that proves the device meets the acceptance criteria:
The document refers to a general "Discussion of performance testing" stating: "The Protectors have been tested and found in compliance with applicable requirements and standards specifications."
This is a high-level statement indicating that the device has undergone testing, but the 510(k) summary does not provide details of a specific study or its results to quantitatively demonstrate compliance with acceptance criteria. The core approval mechanism here is demonstration of substantial equivalence to predicate devices, not a novel performance study against specific acceptance metrics. The FDA's letter confirms this, stating, "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."
§ 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.