(67 days)
The Nipro® SafeTouch Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit or larger volumes of blood. Secondly, it is designed with an active sharp safety feature requiring physical action by the clinician to aid in the prevention of accidental needle stick injuries.
The Nipro® SafeTouch Safety Fistula Needle includes arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540. The fistula needle included in this 510(k) is modified to include a change in material of the Safety AVF hub from ABS to PMMA compounds consisting of Methyl Methacrylate Polymer and Butadiene Polymer and a change in the shape of the Safety AVF stopper to enhance the activation of the safety mechanism. The sharps injury prevention system is connected between winged needle and polyvinyl chloride tubing and consists of three parts, the Safety Hub, Safety Stopper and Safety Protector. The needle is attached to the Safety Hub and is connected to the Safety Stopper. The Safety Protector then covers the Safety Hub. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover latches into place. The Nipro® SafeTouch Safety Fistula Needle includes 2 basic types of design with clamps which remain the same: fixed wing type (stationary) and turnable wing type (rotating) which is offered in 96 configurations with options within it to include needle gauge, needle length, type of needle, and tubing length availability. The devices are packaged sterile and are labeled for single use only.
The provided text describes a 510(k) summary for the Nipro® SafeTouch Safety Fistula Needle, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through detailed clinical studies.
Therefore, the input document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.
Specifically:
- No acceptance criteria or reported device performance table: The document does not list any specific performance metrics or thresholds for the device.
- No sample size or data provenance for a test set: The document refers to the device being a modified version of a previously cleared one (K002813) and mentions "biocompatibility data support the equivalence," but provides no details of a test set, its size, or origin.
- No information on experts for ground truth or adjudication methods: Since no details of a performance study are provided, this information is not present.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned or implied.
- No standalone (algorithm only) performance study: This device is a physical medical instrument, not a software algorithm, so this type of study is irrelevant and not included.
- No information on the type of ground truth used: As details of a performance study are missing, information about the ground truth is also absent.
- No sample size for the training set or how ground truth was established for it: The concept of "training set" and associated ground truth establishment is typically relevant to machine learning/AI devices, which this is not. The document focuses on demonstrating equivalence through design and material changes rather than a new performance evaluation with a training set.
The document primarily focuses on:
- Device Classification and Intended Use: Defining what the device is and what it's used for.
- Device Description and Characteristics: Highlighting changes from the predicate device (e.g., material change from ABS to PMMA for the Safety AVF hub, and a change in the shape of the Safety AVF stopper).
- Substantial Equivalence Argument: Stating that the modified device is substantially equivalent to the predicate in terms of intended use, materials, biocompatibility, and overall performance. Biocompatibility data is mentioned as supporting this equivalence, but no detailed study results or acceptance criteria are presented.
In summary, the provided filing is a 510(k) summary, which aims to demonstrate substantial equivalence to an existing device rather than presenting a de novo performance study against defined acceptance criteria. Therefore, the detailed information requested about acceptance criteria and associated study specifics is not available in this document.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).