(81 days)
The Subcutaneous Infusion Sets with Indwelling Catheters are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.
The general description, operation, construction and use of the Maersk Medical Pureline™ Subcutaneous Infusion Sets With Indwelling Catheters has not changed as a result of the modifications. They remain sterile, non-pyrogenic, single use subcutaneous infusion sets designed to be used with commercially available infusion devices. There are two basic components provided for each device. The first is a stand-alone subcutaneous indwelling catheter. This catheter is provided as an integral assembly with a Teflon cannula, adhesive backed fixation tape, an iniection port and the female portion of a proprietary plastic "click-lock" connector. The catheter assembly comes with a stainless steel insertion cannula. The insertion cannula is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion cannula is come to the user inserted through the injection port and the inner lumen of the Teflon catheter with the needle end protruding past the tip of the catheter. The male connector is locked to the female connector on the indwelling catheter. A needle protector is assembled over the Teflon catheter and the insertion cannula. A separate male portion of the proprietary connector without the insertion cannula is provided in the package. This component is used to attach to the female connector of the catheter after the indwelling Teflon cannula has been inserted and the steel insertion cannula has been withdrawn. The connector protects the indwelling catheter when the infusion set is not attached. The second component of the Maersk Medical Subcutaneous infusion Set with Indwelling Catheter is the infusion set. The infusion set is comprised of a co-extruded tube with a female luer lock connector at the pump end and a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. In order to maintain the sterility of the infusion path, a male luer cap covers the female luer lock connector and the male "click-lock" connector comes attached to a mating female connector. The sets come packaged in blister packs sealed with paper lid stock.
The provided text is a 510(k) summary for the "Maersk Medical Pureline™ Subcutaneous Infusion Set." It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding a device performance study, sample sizes, expert involvement, and ground truth cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, with clear indications where information is not available:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Showed substantial equivalence to the unmodified device. |
| Component Security | Showed substantial equivalence to the unmodified device. |
| Design Equivalence | Achieved; described as "design equivalency." |
| Functional Testing | Achieved; part of "functional and safety testing" demonstrating substantial equivalence. |
| Safety Testing | Achieved; part of "functional and safety testing" demonstrating substantial equivalence. |
| Intended Use | No change from the predicate device; continues to be "for the infusion and/or injection of fluids into the body below the surface of the skin." |
| Technological Characteristics | No change from the predicate device; "not been affected by these modifications." |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified. The study is described as "biocompatibility testing and component security testing," but no details on data origin or study design (retrospective/prospective) are provided.
-
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):
- Not applicable/Not specified. The document refers to "testing" (biocompatibility and component security) rather than a study requiring expert-established ground truth in a clinical assessment sense.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. There is no mention of adjudication, as the tests are for biocompatibility and component security, not a diagnostic or clinical assessment requiring human expert consensus.
-
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. This is a medical device (infusion set) and not an AI/imaging device. Therefore, an MRMC study is not relevant and was not performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical device (infusion set) and not an AI/algorithm-based device. Therefore, standalone algorithm performance is not relevant and was not assessed.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" equivalent here would be the established safety and performance standards for biocompatibility and component security for such devices. The document states "The results of the biocompatibility testing and component security testing showed the device is substantially equivalent to the unmodified device," implying comparison to established benchmarks or the predicate device's performance. Specific types of ground truth like pathology or outcomes data are not mentioned in this context.
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, 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.