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LMT-KATH-S and LMT-KATH-I Infusion Sets are indicated for the infusion and/or injection of medication that is dispensed by means of micro-dosage pump into the body below the surface of the skin. These sets are intended to be used with manual injection and infusion and automated infusion with infusion pumps.

The LMT-KATH-S and LMT-KATH-I infusion sets are administration sets intended to deliver medications under the skin. Both connect at the female Luer to a reservoir, which, for example, can be delivered through the use of an external infusion pump or by medical injection. The stainless steel cannula is inserted into the subcutaneous tissue and fixed into place by an attached approximate circular disk bandage with medical grade adhesive. The tubing of both infusion sets is made of polyethylene. The LMT-KATH-S and LMT-KATH-I infusion sets have identical components that allow the set to be disconnected/connected approximately 60 cm / 23.62″ from the insertion site. The disconnect mechanism (Luer connector) on the reservoir side has a protector cap to maintain clean conditions during disconnection and to cover the connector. The tube may have additional bandages with medical adhesive grade.

This is only a 510(k) summary, not a complete study report. It states that the device is substantially equivalent to a predicate device based on similar technological features and intended use. Therefore, it does not include detailed information on acceptance criteria or a study proving device performance as would be found in a full performance study.

Here's a breakdown of what can be gleaned, and what is not present:

Missing Information (Not provided in the 510(k) summary):

• Acceptance Criteria and Reported Device Performance Table: This document is a 510(k) summary for substantial equivalence, not a performance study report. It does not contain pre-defined acceptance criteria for device performance nor detailed performance metrics. The claim is substantial equivalence to a predicate device, meaning it's expected to perform similarly.
• Sample size for the test set: Not applicable to a substantial equivalence submission based on description of features.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done and not mentioned.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information provided in the 510(k) summary, but not directly answering the questions about acceptance criteria and study proving performance:

• Device Name: LMT-KATH-S 28G 10mm x 60cm / 0,394" x 23,62", LMT-KATH-S 28G 8mm x 60cm / 0,315" x 23,62", LMT-KATH-I 25G 12mm x 60cm / 0,472" x 23,62", LMT-KATH-I 25G 8mm x 60cm / 0, 315" x 23,62" (various models of subcutaneous infusion sets).
• Predicate Device: Disetronic Rapid and Rapid D Subcutaneous Infusion Sets (Premarket Notification K003977).
• Basis for "meeting acceptance criteria" (Substantial Equivalence): The document explicitly states: "The infusion sets 'LMT-KATH-S' and 'LMT-KATH-I' are substantially similar to the lawfully marketed predicated device." This "substantial similarity" is the basis for acceptance, rather than a direct performance study meeting specific criteria.
  • Description of Similarity: Both the new device and the predicate device are administration sets intended to deliver medications under the skin, connect to a reservoir (e.g., external infusion pump or medical injection), have a stainless steel cannula inserted into subcutaneous tissue, fixed by a circular disk bandage, and tubing made of polyethylene. They also share an identical disconnect/connect mechanism approximately 60 cm from the insertion site.
• Intended Use Statement:
  • "LMT-KATH-S and LMT-KATH-I Infusion Sets are indicated for the infusion and/or injection of medication that is dispensed by means of micro-dosage pump into the body below the surface of the skin. These sets are intended to be used with manual injection and infusion and automated infusion with infusion pumps."
    This intended use directly matches the predicate device's intended use, contributing to the substantial equivalence claim.

In summary, this 510(k) notification is for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. It does not present a de novo performance study with specific acceptance criteria and performance data. Instead, the "acceptance" is based on the comparison of technological features and intended use to the predicate device.

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