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JMS Planecta® Stopcock (PNSC) is indicated for fluid flow directional control and for providing access port(s) for administration of solutions, withdrawal of fluids and pressure monitoring. JMS Planecta® Stopcock can be used by itself, or as component to administration/extension set, and aids in the prevention of needle stick injuries.

The JMS Planecta® Stopcock is a disposable device for one time use. The device consists of a body with integrated female and male connector at extreme ends, a handle (either 1-bar or 3-bar types), pre-slit septum, access port cap and a rotatable lock nut for locking over the female connector of another component. The device contains three channels for fluid flow. The handle/swivel nut contains two independent passageways. A fluid pathway can be achieved by rotating the handle to one of the three channels. There are 'arrow' marks on the handle of 3-bar type and 'OFF' indication on the 1-bar handle to indicate the 'open' and 'closed' position of fluid path, respectively.

JMS Planecta® Stopcock, incorporated with an injection/sampling port accessible with a needleless syringe or regular male connector. JMS Planecta® Stopcock keeps the system closed and the minimal dead space at the access port reduces the chances of bacteremia caused by bacterial proliferation. Contamination by environmental microbes is also reduced by the resealability characteristics of the pre-slit rubber septum.

The provided document is a 510(k) summary for the JMS Planecta® Stopcock. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, biocompatibility, and overall performance characteristics. It does not contain the level of detail typically found in a clinical study report regarding specific acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about specific study design elements like sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth establishment for either test or training sets from this document.

The document indicates that the device's substantial equivalence was demonstrated through comparisons of its characteristics and performance to legally marketed predicate devices, but it does not detail the specific tests conducted or their results in a quantitative manner that would allow filling in the requested information.

The key takeaway from the document regarding performance is:

• Overall Performance Characteristics: "JMS Planecta® Stopcock demonstrates substantial equivalence to the said predicate devices with regards to intended use, material, biocompatibility, and overall performance characteristics." (Page 2)

This statement implies that performance studies were conducted, but the specifics are not included in this summary. For a medical device like a stopcock, performance characteristics would typically include things like flow rate, connection integrity, leak resistance, pressure limits, and compatibility with various fluids and administration sets. However, the document does not list these as explicit acceptance criteria or provide quantitative results.

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