(99 days)
The indication for use is admixing of drug into an IV container and administration/transfer of drug from the container to an external IV line, while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the admixing, administration and disposal process.
The Injector is a sterile device for single-use within the PhaSeal® closed transfer device system for preparation and administration of parenteral drugs.
Here's a breakdown of the acceptance criteria and study information for the Infusion Adapter C100, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| General Performance | Verify integrity of the device and compatibility with other PhaSeal components | Passed |
| Pulling force test (in connection to other PhaSeal components) | Passed | |
| Torque test (in connection to other PhaSeal components) | Passed | |
| Liquid flow test | Passed | |
| Air tightness test | Passed | |
| Handling tests | Passed | |
| Material Testing | Functional and mechanical properties on product after 24h of chemical exposure with Etopside, Taxo, and Busulfan | Passed |
| Functional and mechanical properties on product after 72h of chemical exposure with Etopside, Taxo, and Busulfan | Passed | |
| Biocompatibility | Systemic Injection test | Passed |
| Cytotoxicity test | Passed | |
| Hemolysis test | Passed | |
| Dermal sensitization test | Passed | |
| Intracutaneous test | Passed | |
| Physicochemical tests - plastic | Passed |
Study Details
Based on the provided text, the device in question, the Infusion Adapter C100, is being submitted for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with human subjects in the same way a novel drug or high-risk device might. The information provided heavily focuses on performance and material testing for safety and functionality.
Here's a breakdown of the requested information based on the document:
1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size for each test. It states "Performance testing refer to verify integrity of the device and compatibility with the relevant other PhaSeal components." and lists various tests. For the material testing, it refers to "product after 24h and 72h of chemical exposure." Typical 510(k) submissions for devices like this involve a sufficient number of units to demonstrate statistical reliability for the specific tests (e.g., n=3 or n=10 per test) but these numbers are not explicitly stated.
- Data Provenance: Not explicitly stated, but the submitter Carmel Pharma AB is located in Mölndal, Sweden. It is highly likely the testing was conducted either internally at their facilities or by contract testing laboratories, which could be in Sweden or other countries. The document does not specify if the data is retrospective or prospective, but as these are laboratory performance and material tests, they would be conducted prospectively for the submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable in the context of this device and submission type. The "ground truth" for these types of tests (e.g., pulling force, liquid flow, biocompatibility) is established by predefined engineering specifications, industry standards, and regulatory requirements, not by expert consensus on interpreting data like imaging. The "experts" involved would be engineers, material scientists, and toxicologists conducting and interpreting the tests against established criteria. Their qualifications are implicitly assumed to be appropriate for performing these specific tests within standard laboratory practices.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with clinical studies where multiple human readers or evaluators independently assess patient data and their disagreements are resolved. For the performance and material testing described here, adjudication is not applicable. The results are objective measurements against predefined pass/fail criteria.
4. 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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices, particularly those involving human interpretation of images or other subjective data, often in the context of AI assistance. The Infusion Adapter C100 is a drug delivery accessory, and its evaluation focuses on physical performance, material compatibility, and biocompatibility, not on human interpretation or AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. This device is a physical medical device, not a software algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance tests outlined here consists of predefined engineering specifications, industry standards, and regulatory requirements. For example, a successful "pulling force" test means the device withstood a certain force without separating or failing, as specified in its design requirements. For biocompatibility, the ground truth is adherence to internationally recognized standards for biological evaluation of medical devices (e.g., ISO 10993 series), where specific test results (e.g., absence of cytotoxicity) are considered "passing."
7. The sample size for the training set
- This question is not applicable. This device is a physical product and does not involve AI or machine learning models that require a "training set" of data.
8. How the ground truth for the training set was established
- This question is not applicable, as there is no training set for this device.
§ 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.