(179 days)
SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter.
SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and pediations greater than one (1) year of age receiving intermittent or continuous infusions with an electronic pump.
SafeBreak® Vascular is placed in-line with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device has been shown to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter.
SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.
The purpose of this 510(k) submission is to expand the indications for use of the product to include pediatric populations greater than one (1) year of age.
The provided text is a 510(k) Summary for the SafeBreak® Vascular device and focuses on establishing substantial equivalence to a previously cleared predicate device (K222791), primarily to expand its Indications for Use to include pediatric populations greater than one year of age.
The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The "device" in this context is a physical medical device (an intravenous catheter force-activated separation device), not an algorithm or AI system. Therefore, the requested information points regarding AI/ML study design, such as sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document.
The "clinical data" section merely states that:
- Randomized and non-randomized clinical studies sponsored by Lineus Medical for a previous submission (DEN190043, which likely led to K222791) support the safety and effectiveness of the device in adolescents and adults.
- Review of clinical literature supports extrapolating adult data to pediatric populations.
This is a regulatory filing for a physical device, based on prior clinical data (not detailed here) and literature review for an expanded indication, rather than a performance study of a new AI/ML algorithm.
Therefore, I cannot provide the requested information based on the provided text, as it describes a non-AI/ML medical device and its predicate comparison.
§ 880.5220 Intravenous catheter force-activated separation device.
(a)
Identification. An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Separation force testing;
(ii) Validation of anti-reconnect features;
(iii) Air and liquid leakage testing, both before and after separation;
(iv) Luer connection testing;
(v) Flow rate testing;
(vi) Particulate testing; and
(vii) Microbial ingress testing.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate that the device is sterile and non-pyrogenic.
(5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(6) Device labeling must include:
(i) Instructions for use; and
(ii) A discussion of catheter dressings intended to be used with the device.