(69 days)
"Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.
The device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The infusion set has a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end, connected by 42" of 2mm medical grade tubing. The luer lock connects to the infusion pump device. The device is for single use.
The provided text describes a 510(k) premarket notification for a medical device called "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set. This document evaluates the device's substantial equivalence to a legally marketed predicate device, the Minimed MMT-106 (and related models).
However, the provided text does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study that proves the device meets specific acceptance criteria in the manner requested.
The document from Ko20530 is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics against acceptance criteria. It states that "Testing was performed according to internal company standards to verify device performance. Testing verifies that the actual device performance satisfies the design intent." but it does not provide the specifics of these tests or their results in a quantitative manner.
Therefore, many of the requested fields cannot be directly extracted or inferred from the provided text. I will fill in what can be gathered and explicitly state when information is not available.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (as inferred or stated in document) |
|---|---|---|
| Safety | e.g., Biocompatibility, Sterility, Freedom from manufacturing defects, Secure attachment to skin, Material integrity over time | "Testing was performed according to internal company standards to verify device performance... actual device performance satisfies the design intent." |
| Effectiveness | e.g., Reliable medication delivery, Flow rate consistency, Luer lock integrity, Needle insertion characteristics, Tubing integrity | "substantially equivalent to several similar devices" in materials, packaging, and indications for use. "actual device performance satisfies the design intent." |
| Material Responsibility | e.g., Lack of adverse material reactions, Durability | "In all material respects" substantially equivalent to predicate. |
| Sterility | e.g., Maintenance of sterility until use | "Packed sterile for single patient use" (same as predicate) |
| Packaging | e.g., Integrity of sterile barrier, clear labeling | "Packed sterile for single patient use" (same as predicate) |
Study Information
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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. The document states "Testing was performed according to internal company standards," but does not detail the sample size for any specific tests.
- Data Provenance: Not specified. It's likely internal company data given the statement, but no country of origin or retrospective/prospective nature is mentioned.
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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 provided in the document. The filing is a 510(k) premarket notification relying on substantial equivalence, and as such, it does not typically detail expert panel reviews or ground truth establishment in this manner for its "internal company standards" testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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. An MRMC comparative effectiveness study was not conducted according to the document. This device is a physical medical device (infusion set), not an AI/software device, so such a study would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm, so this concept is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth for "design intent" and "device performance" was established through engineering specifications and internal company standards. It does not refer to clinical outcomes, pathology, or expert consensus in the context of a validation study as might be seen for diagnostic devices. The primary "ground truth" for marketing authorization in this document is the predicate device, against which substantial equivalence is claimed.
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The sample size for the training set:
- This concept is not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- This concept is not applicable as there is no training set for this type of 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.