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The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.

Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule.

This document is a 510(k) summary for a medical device: Spectra Medical's Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

This document describes a pharmaceutical product (sterile saline solution for flushing), not an AI/ML powered medical device. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway for low-risk medical devices in the US. This pathway typically involves comparing the new device's indications, technological characteristics, and performance data to a legally marketed predicate, rather than conducting new performance studies with specific acceptance criteria that would be relevant for an AI/ML system.

Therefore, I cannot populate the requested table and answer the study-related questions, as they are not applicable to the content of this 510(k) summary. The document explicitly states:

• "There has been no change to the performance characteristics of the device system." (Section 6)
• "There has been no change to the fundamental scientific technology." (Section 7)

These statements indicate that no new performance studies (of the kind expected for an AI/ML device) were conducted or are being presented in this submission. The device is claimed to be "identical to the predicate device" with only a difference in ampule size.

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