(71 days)
Primary intended use: Cord-Stick™ Multiple Draw System is intended for obtaining two samples of venous umbilical cord blood after delivery of a newborn infant. Secondary intended use: Cord-Stick™ Multiple Draw System aids in the prevention of needle stick injury.
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This document is a 510(k) premarket notification letter from the FDA for a medical device called the "Cord Stick™ Multiple Draw System." This type of letter generally approves a device for marketing by demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and supporting studies as would be found in a clinical trial report or a more extensive submission.
Therefore, the provided text does not contain the information required to answer your specific questions about acceptance criteria and detailed study results.
Here's why and what kind of information is missing:
- Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices. It doesn't present specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantifiable measures of needle stick injury reduction) or define acceptance criteria for those metrics.
- Sample Size, Ground Truth, Adjudication, MRMC studies, Standalone performance, Training set details: These are all elements of a clinical study or performance evaluation. A 510(k) summary (which is typically a separate document and not fully provided here) might reference such studies, but the letter itself does not detail them. The "Specific Intended Use" enclosure only describes the function of the device.
To answer your questions, you would typically need to consult a more detailed 510(k) summary, clinical study reports, or performance evaluation documents that would have been submitted as part of the 510(k) application. This letter is the FDA's response to such an application, confirming market clearance.
In summary, based only on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).