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NaturaLyte® Dry Bicarbonate Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Dry Bicarbonate Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.

NaturaLyte Dry Bicarbonate Concentrate is a non-sterile, single use device composed of United States Pharmacopeia (USP) grade sodium bicarbonate. NaturaLyte Dry Bicarbonate Concentrate products are packaged in either bags or cartons. The two (2) bag configurations are constructed from identical materials and only differ in the mass of dry bicarbonate powder contained within. The cartons are used for preparation of individual batches of bicarbonate concentrate.

NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

The provided document is a 510(k) Premarket Notification from the U.S. FDA for a medical device called "NaturaLyte Dry Bicarbonate Concentrate." This document pertains to the substantial equivalence determination of a dry bicarbonate concentrate used in hemodialysis systems, not an AI/ML-driven device.

Therefore, the specific information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this type of medical device.

The document describes performance testing relevant to a chemical concentrate and its packaging, such as:

• Stability Design Verification: To support a 24-month (2-year) shelf life, monitored as part of routine production testing using real-time stability evaluations.
• Shipping Verification: Performed in accordance with ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) to ensure packaging withstands distribution.
• Biocompatibility Testing: Assessed endpoints including chemical characterization, cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity, and hemocompatibility, along with a toxicological risk assessment.
• Human Factors Validation Testing: Validated for safe and effective use in accordance with FDA guidance for medical devices.

The document explicitly states:

• "Electrical Safety and Electromagnetic Compatibility: Not applicable. The NaturaLyte Dry Bicarbonate Concentrate is not an electrical mechanical device."
• "Software Verification and Validation Testing: Not applicable. The NaturaLyte Dry Bicarbonate Concentrate does not contain software."
• "Animal Studies: No animal studies were performed for NaturaLyte Dry Bicarbonate Concentrate."
• "Clinical Studies: No clinical studies were performed for NaturaLyte Dry Bicarbonate Concentrate."

Conclusion:

The NaturaLyte Dry Bicarbonate Concentrate is a chemical concentrate, not a device that involves AI/ML, image analysis, or human reader performance. As such, the requested details regarding AI/ML acceptance criteria, study design, expert involvement, and ground truth for AI algorithms are not present or relevant in this 510(k) submission.

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