(177 days)
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.
| Description | Acceptance Criteria (Implied) | Reported Device Performance (Modified MMT-305) |
|---|---|---|
| Classification | Class II | Class II |
| Product Code | KZH | KZH |
| Type of Use | Over the Counter | Over the Counter |
| Compatibility | MiniMed Quick-set Infusion Set, MiniMed Pro-set Infusion Set | MiniMed Quick-set Infusion Set, MiniMed Pro-set Infusion Set |
| Condition of use | Single patient, multi-use | Single patient, multi-use |
| Energy Source | Spring Driven | Spring Driven |
| Mode of action | Manual operation | Manual operation |
| Cocking Force |
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).