(177 days)
The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures.
The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.
The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to an MR procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of Gadavist® (gadobutrol) injection contrast media only. Each imaging bulk transfer set consists of a spike and a swabbable valve. The transfer spike is provided sterile, individually packaged, and is not intended to be resterilized.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MEDRAD® Imaging Bulk Package Transfer Spike:
The document is a 510(k) Premarket Notification from the FDA for the MEDRAD® Imaging Bulk Package Transfer Spike. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "studies" are primarily bench and verification tests to show compliance with standards and functional specifications.
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a dedicated "acceptance criteria" table with specific quantitative thresholds. Instead, it lists various performance tests and states that "All testing passed" or "Verification results indicate that the Transfer Spike complies with the standards" or "Verification results indicate that the Transfer Spike complies with its predetermined specifications."
Here's a table summarizing the tests performed and the reported outcomes, essentially inferring the acceptance criteria as "compliance with the standard" or "meeting predetermined specifications":
| Performance Aspect | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ISO 11137-1, 11137-2, 11137-3 | All testing passed; complies with standards. |
| Shelf-Life | Performance not affected by accelerated aging up to three years; meet all established acceptance criteria. | All testing passed; demonstrated product performance met all prior established acceptance criteria. |
| Packaging | Validated in accordance with ISO 11607-1 and ISO 11607-2. | All testing passed; complies with standards. |
| Biocompatibility | Compliant with ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility). | Verification results indicated materials comply with the standard. |
| Bench Performance (General) | Compliant with ISO 80369-7 and ISO 8536-4:2010. | Verification results indicate compliance with standards. |
| Microbial Ingress | Maintain integrity at specified time points (0, 7, 11, 15, 20, 24 hr, and bottle depletion) for various components. | Complies with predetermined specifications. |
| Injectable Particulate | Conformance to USP . | Complies with predetermined specifications. |
| Chemical Compatibility | Conformance to approved release specifications of Gadavist (gadobutrol). | Demonstrated that differences do not raise new questions of safety and effectiveness. (Implies compliance during testing) |
| Pyrogenicity | Non-pyrogenic. | Non-pyrogenic. |
| Latex Content | Not made with natural rubber latex. | Not made with natural rubber latex. |
| Fill (Load) Rate | 10 mL/sec for manual fill, 4 mL/sec for autoload. | Same as predicate (implied compliance). See Predicate Comparison. |
| Use Environment | Ambient conditions (MR Suite). | Same as predicate (Ambient environment of radiology suite). See Predicate Comparison. |
| Use Time | 24 hours (aligned with Gadavist contrast media). | Testing demonstrated the differences do not raise new questions of safety and effectiveness. See Predicate Comparison. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify general "sample sizes" for the test sets in a clinical study sense, as the testing described is primarily bench validation. For validation tests like sterilization, shelf-life, packaging, and biocompatibility, sample sizes would be determined by the relevant ISO standards and internal validation protocols, but these specifics are not provided in the summary.
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the cited ISO standards and internal protocols.
- Data Provenance: The studies are prospective bench and laboratory testing conducted by or for Bayer Medical Care Inc. The location of the test facilities is not explicitly stated beyond Bayer's address in Indianola, Pennsylvania, USA.
3. 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 information is not applicable to this submission. The device is a medical accessory (transfer spike) and the studies are technical engineering verifications (sterilization, shelf-life, biocompatibility, etc.), not diagnostic or treatment efficacy studies that would require expert consensus for ground truth. The "ground truth" is established by adherence to recognized national and international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers interpret medical images or data to establish a consensus ground truth. The tests performed for this device are objective measurements and validations against predefined technical standards, not subjective interpretations.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI algorithm or an imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the various tests performed is the compliance with established national and international standards and predetermined specifications for medical devices and their components. Examples include:
- ISO 11137-1, 11137-2, 11137-3 for sterilization.
- ISO 11607-1 and ISO 11607-2 for packaging.
- ISO 10993-1:2018 for biocompatibility.
- ISO 80369-7 and ISO 8536-4:2010 for bench performance.
- **USP ** for injectable particulate matter.
- Approved release specifications for chemical compatibility with Gadavist.
These standards and specifications are the "ground truth" against which the device's technical performance is measured.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this device is not an AI algorithm.
9. How the ground truth for the training set was established
This information 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.