(197 days)
The OnGuard®2 Chemfort™ Closed Administration is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
OnGuard®2 Chemfort™ Closed Administration prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.
The OnGuard®2 Chemfort™ Closed Administration (CADM) devices allow drug transfer to the IV bag and drug administration to the patient. The use of elastomeric seals in CADM prevents hazardous drugs contamination of healthcare professionals, the patient and the environment.
The OnGuard®2 Chemfort™ Closed Administration contains four devices that connect between infusion containers and primary sets:
- Bag Adaptor Chemfort™ Port (BACP)
- Closed Y Inline Set (Y-Set)
- Closed IV Secondary Set (Secondary)
- Closed Adaptor Spike Port (CASP)
CADM devices are an addition to the cleared Chemfort™ system (K192866). CADM provides closed system protection during the following procedures:
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- Drug transfer to a container (e.g. IV bag) through the Chemfort™ Syringe Adaptor (K192866) and CADM Bag Adaptor Chemfort™ Port (BACP).
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- Drug administration, with one of the CADM sets after it is attached to the BACP and creates a closed system.
The provided text describes the OnGuard®2 Chemfort™ Closed Administration (CADM) device, a single-use, sterile Closed System Transfer Device (CSTD). It focuses on demonstrating its substantial equivalence to a predicate device (K192866) by comparing indications for use, technological characteristics, and performance data.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" versus "reported device performance." Instead, it lists the performance tests conducted and states that the device "comply with the following standards and that they function as intended" or "met the USP acceptance criteria," or "All tests passed according to the predetermined acceptance criteria." It implies compliance rather than detailing specific numerical criteria and results for each test.
However, based on the Performance Data and Biocompatibility sections, we can infer the tested areas and the general outcome:
| Category | Test Performed | Reported Device Performance/Acceptance |
|---|---|---|
| General Device Performance | Air & Fluid Tightness | Conducted to evaluate differences in Chemfort™ port location. Implied successful compliance. |
| Bidirectional flow | Conducted to evaluate differences in Chemfort™ port location. Implied successful compliance. | |
| Leakage (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Tensile Strength (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Closure Piercing Device (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Flow Rate (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Tubing, Drip Chamber & Drip Tube, Flow Regulator & Protective Cap (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Positive Pressure Liquid Leakage (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Sub-atmospheric Pressure Air Leakage (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Stress Cracking (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Resistance to Separation from Axial Load (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Resistance to Separation from Unscrewing & Resistance to Overriding (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Particulate Matter | Particulate Matter in Injections (USP ) | Met the USP acceptance criteria. |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Subacute/subchronic toxicity, Hemolysis (ISO 10993-1) | All parts in contact with patient comply with ISO 10993-1 requirements. Specific tests were conducted. |
| Sterility | Sterility Assurance Level (SAL) | Achieved a SAL of at least 10^-6 through Ethylene Oxide (EtO) gas sterilization, validated by 'overkill' (half cycle) approach. |
| Residuals of Ethylene Oxide (EtO) and Ethylene Chlorhydrine (ECH) | Complied with requirements of ISO 10993-7:2008 for prolonged exposure devices (Category B). | |
| Bacterial Endotoxins Test (LAL) | Less than 20 EU per device for 10 samples (in pool). | |
| Shelf-Life & Packaging | Accelerated Aging (ASTM F1980-16) | Functional and packaging integrity tests passed according to predetermined acceptance criteria after accelerated aging equivalent to 3 years. |
| Package Integrity (ISTA 3A, ASTM F88/F88-15, ASTM F1929-15) | Deemed acceptable for protection of product and sterility maintenance after environmental conditioning and simulated transportation. Passed seal strength and dye penetration tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly mentions a sample size only for the Bacterial Endotoxins Test, where "10 samples (in pool)" were used. For other performance tests and biocompatibility, specific sample sizes are not provided in the summary.
- Data Provenance: The document does not specify the country of origin of the data. It's a regulatory submission from Simplivia Healthcare LTD. located in Israel. The studies appear to be device performance and laboratory tests rather than clinical studies on human subjects, so the "retrospective or prospective" designation is not directly applicable in the typical sense of clinical data. These are prospective engineering and biological tests conducted for regulatory compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of studies described. The "ground truth" for these tests (e.g., whether a device leaks, its tensile strength, or if it is cytotoxic) is established by adherence to recognized international standards (ISO, USP, ASTM) and validated laboratory methods, not by expert consensus in interpreting complex data like medical images.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are objective performance and laboratory tests against predefined standards, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes laboratory and engineering performance tests of a medical device, not a comparative effectiveness study involving human readers or AI algorithms.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a physical medical device (Closed System Transfer Device), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used
The ground truth used for these studies is defined by:
- International Standards: e.g., ISO 8536-4, ISO 80369-7, ISO 10993-1, ISO 10993-7, ISO 14971.
- Pharmacopeial Standards: e.g., USP .
- Industry Standards: e.g., ASTM F1980-16, ASTM F88/F88-15, ASTM F1929-15, ISTA 3A.
- Predetermined Acceptance Criteria: The document frequently refers to tests passing "according to the predetermined acceptance criteria," implying established limits or thresholds for each test based on these standards.
8. Sample Size for the Training Set
Not applicable. This document is about a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI algorithm training set mentioned.
§ 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.