(88 days)
The indication for use of the PhaSeal system and included components are 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 Injector and Connector is a sterile device for single-use within the PhaSeal® closed system drug transfer device for preparation and administration of parenteral drugs.
The provided document describes the 510(k) summary for the Carmel Pharma ab's Injector N34, N35, N35C and Connector C35, C45, which are components of the PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs. The device relies on demonstrating substantial equivalence to previously cleared predicate devices rather than meeting specific quantitative acceptance criteria through a clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This submission is a 510(k) for substantial equivalence, not a performance study with quantitative acceptance criteria against specific metrics. The "acceptance criteria" here are qualitative, focusing on whether the new devices are "substantially equivalent" to predicate devices. The performance is demonstrated by comparing technological characteristics and intended use.
| Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Device's purpose is the same as the predicate. | Injector N34, N35, N35C: Intended use (injecting/withdrawing fluids from drug vials, then into IV sets/containers) is identical to predicate N30 (K972527) and N31 (K001368). |
| Connector C35, C45: Intended use (connecting PhaSeal Injector to IV administration set parts, minimizing drug spillage) is identical to predicate C40 (K972527). | |
| Technological Characteristics: Key features are similar or present acceptable differences. | Injector N34 vs. Predicate N30: Cannula (pencil point vs. cut), Needle safety lock (ErgoMotion™ vs. latch), Fitting connection (Luer rotation vs. no rotation), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. |
| Injector N35/N35C vs. Predicate N31: Cannula (pencil point vs. cut), Needle safety lock (ErgoMotion™ vs. latch), Fitting connection (Luer Lock rotation vs. no rotation), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. | |
| Connector C35 vs. Predicate C40: Bayonet fitting (reduced notches - no click vs. notches - with a "click"), Length (26 mm vs. 26 mm), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. | |
| Connector C45 vs. Predicate C40: Bayonet fitting (reduced notches - no click vs. notches - with a "click"), Length (34 mm for CLAVE connection vs. 26 mm), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. | |
| Safety and Effectiveness: Do not raise new questions of safety or effectiveness. | The submission concludes that "Based on comparison to the predicate device, we come to the conclusion that the Injectors N34, N35, N35C and Connectors C35, C45 included in the PhaSeal System, are substantially equivalent to previously cleared predicate devices and present no new concerns about safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of a performance study with a sample size of clinical cases or data points. This is a submission for substantial equivalence based on bench testing and comparison of technical specifications to predicate devices. Therefore:
- Sample size for the test set: Not applicable, as there's no clinical "test set" described. The testing mentioned is "performance testing" which likely refers to engineering/bench tests rather than clinical data.
- Data provenance: Not applicable. There is no clinical data (e.g., country of origin, retrospective/prospective) used to prove performance in the context of this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a technical comparison for substantial equivalence, not a study involving expert-established ground truth for a test set of medical conditions.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study, nor does it quantify an effect size of human readers improving with or without AI assistance. The device is a physical medical device (injectors and connectors), not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
No. The document does not describe any standalone algorithm performance study. The device is a physical medical device.
7. Type of Ground Truth Used
Not applicable. Since there is no clinical "test set" and outcome evaluation in the traditional sense, there is no ground truth (e.g., pathology, outcomes data) as would be used in a diagnostic study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which the new devices are compared.
8. Sample Size for the Training Set
Not applicable. This is a submission for a physical medical device, not an 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 an algorithm, the concept of establishing ground truth for it does not apply.
§ 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.