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The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.

The modified MiniMed Quick-serter (MMT-305) is a non-sterile, single patient, multi-use, hand held accessory product designed to be used as an insertion aid for compatible devices, including specific infusion sets. It is used to insert the introducer needle and cannula through the skin and into the subcutaneous tissue. The MiniMed Quick-serter is intended to be used by a patient or clinician as a means to insert an infusion set with minimum discomfort and technique dependency.

The MiniMed Quick-serter consists of a plastic barrel containing a stainless steel spring and a handle. The device user places and securely seats the infusion set into the MiniMed Quick-serter is loaded and locked by pulling the handle (compressing the spring) until it clicks/locks into place. The serter is placed in contact with the insertion site and fired to release the infusion set. This is done by depressing the green side buttons to release the spring, which drives the infusion set forward and the insertion needle and cannula are inserted into the user's subcutaneous tissue. The release button on the top of the device is then pressed to ease the release of the infusion set from the serter.

The provided text describes a 510(k) submission for the "MiniMed Quick-serter" (MMT-305) and compares it to a predicate device (MMT-395). This device is a syringe needle introducer, and the submission is focused on demonstrating substantial equivalence, not necessarily on detailing a study proving the device meets acceptance criteria in the way one would for a novel AI/software medical device.

Therefore, the information I can extract will be specific to the type of device and submission, which involves engineering and biocompatibility testing rather than clinical study protocols for diagnostic accuracy or comparative effectiveness with human readers.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists performance testing that was conducted to verify the device's mechanical properties and functions. The "acceptance criteria" are implied by the statement "Results from performance testing indicate that the product meets the established performance requirements." Specific numerical acceptance criteria are not explicitly detailed for each test in this summary, but the reported device performance for some characteristics is given in the comparison table.

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The BD FlowSmart™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

The BD FlowSmart™ set is a subcutaneous administration set intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing. The tubing is connected on one end to the medication reservoir of an external infusion pump and on the other end to the patient, attached to the skin by an adhesive base. It is a single-use sterile device.

This document is a 510(k) summary for the BD FlowSmart™ Set, an infusion set. It does not describe an AI/ML powered medical device, therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted.

The document primarily focuses on demonstrating "substantial equivalence" of the BD FlowSmart™ Set to existing predicate devices (Medtronic's MiniMed Quickset and Ypsomed's Orbit Infusion Set). This process typically involves comparing the new device's technological characteristics, intended use, and performance data (often non-clinical testing) to those already cleared devices, rather than establishing acceptance criteria for a novel AI algorithm.

Here's what can be extracted, albeit not directly addressing an AI device's acceptance criteria:

1. Acceptance Criteria and Reported Device Performance (General, not AI-specific): The document states that "Results of these tests were found to be acceptable and demonstrated that the BD FlowSmart™ set met requirements for its intended use and is as safe and as effective as its predicate devices." However, it does not provide a table of specific quantitative acceptance criteria or detailed performance metrics. The testing performed includes broad categories:

   • Biocompatibility: ISO 109993: Biological evaluation of medical devices
   • Functional Performance: ISO 10555-1: Sterile single use intravascular catheters, ISO ID26: Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps, ISO 1135-1: Sterilization of healthcare products
   • Animal Testing: United States Department of Agriculture (USDA) standards, US Animal Welfare Act
   • Human Factor Evaluations: IEC 62366:2007

   The "reported device performance" is a general statement of meeting requirements and being "as safe and as effective," without specific numerical values.

2. Sample Size and Data Provenance for Test Set: This information is not provided for individual tests. The document refers to "non-clinical testing," "animal testing," and "human factor evaluations," but does not specify the sample sizes within these tests or the data provenance (e.g., country of origin, retrospective/prospective). It's likely that for a device like an infusion set, "test set" wouldn't mean a clinical data set in the same way it would for an AI algorithm.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. The "ground truth" for an infusion set would be adherence to scientific and engineering standards (e.g., material properties, flow rates, sterility) rather than expert interpretation of a clinical dataset.

4. Adjudication Method: Not applicable. This concept is typically relevant to clinical studies involving human interpretation or disagreements, which is not the primary focus here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study assesses the impact of AI on human reader performance, which is not relevant for an infusion set.

6. Standalone (Algorithm Only) Performance: Not applicable. The device is a physical infusion set, not an AI algorithm.

7. Type of Ground Truth Used: The "ground truth" for this device would be established by validated scientific and engineering methods, regulatory standards (like ISO standards), and animal models for biocompatibility and function. It's not based on expert consensus, pathology, or outcomes data in the context of an AI system.

8. Sample Size for Training Set: Not applicable. The device is not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document details the submission for a medical device (infusion set) under the 510(k) pathway, focusing on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not involve an AI/ML component, and therefore, the requested information pertinent to AI device evaluation criteria is not present.

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