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0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling. total parenteral nutrition, or hemodialysis.

0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:

• 2.5 mL in 3 mL Syringe
• 3 mL in 10 mL Syringe
• 5 mL in 10 mL Syringe
• 10 mL in 10 mL Syringe
  The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.

The provided text does not describe an acceptance criteria or a study proving that a device meets the acceptance criteria for a medical device that utilizes artificial intelligence (AI). The document is a 510(k) premarket notification for a 0.9% Sodium Chloride Injection, USP (a saline vascular access flush). This is a physical, sterile medical product, not an AI-driven device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be extracted from this document.

The document discusses non-clinical testing performed for the saline solution and prefilled syringes, which includes:

• Raw material qualification
• Stability Studies
• Sterilization validation
• Extractables/Leachables

These tests are standard for a sterile drug product/device combination and are not related to AI performance. Biocompatibility testing was deemed not required because the products were considered the same as predicate devices, except for the source of the sodium chloride raw material.

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Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.

This document does not contain information about acceptance criteria and device performance in the context of a study. The provided text is a 510(k) summary for the Heparin Lock Flush, USP, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a specific study with performance metrics against pre-defined acceptance criteria.

The 510(k) summary outlines the following:

• Device Description: The Heparin Lock Flush, USP
• Intended Use/Indications for Use: Flushing of IV catheters and IV tubing for maintaining patency.
• Technological Characteristics: A comparison table with predicate devices (K061497 and K023740) highlighting similarities in solution, concentrations, single-use nature, sterility, barrel material, plunger rod material, piston, tip cap material, tip cap colorants, and packaging.
• Purpose of Submission: To add alternate suppliers of the heparin sodium (USP) raw material.
• Non-Clinical Testing: A list of studies performed or relied upon:
  • Raw material qualification
  • Biocompatibility (ISO 10993-1)
  • Stability Studies
  • Sterilization validation (ISO 17665-1 and -2)
  • Extractables/Leachables
  • Testing of final product to Heparin Lock Flush Solution USP Monograph
• Conclusion: The change in heparin source is supported by the cited studies, and no new questions of safety and effectiveness are raised, leading to the conclusion of substantial equivalence.

The document does NOT include the following information, which would be necessary to answer the prompt:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for any test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This is expected as 510(k) submissions for devices like a Heparin Lock Flush typically rely on demonstrating equivalence to existing devices through material characterization, manufacturing controls, and non-clinical testing rather than clinical performance studies with specific acceptance criteria as one might see for an AI/ML diagnostic device.

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