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The LifeOutcomes C-Quest Blood Culture Sampling Device intended to collect a patient blood sample and sequester the first portion of the sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. It is used in conjunction with either a scalp vein set for venipuncture or access to an existing patient IV using an extension set. C-Quest may be used with a blood culture tube or a standard blood collection syringe.

The LifeOutcomes LLC (LO) C-Quest™ Blood Culture Sampling Device (C-Quest) is a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample. This reduces the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. C-Quest is intended for use by medical professionals. The C-Quest consists of three (3) major components: • the tee body assembly. • a universal culture tube holder, and - a third-party, FDA cleared, 5 ml diversion syringe.

The provided text describes the 510(k) premarket notification for the LifeOutcomes C-Quest™ Blood Culture Sampling Device (K231282). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense for a diagnostic algorithm.

Here's a breakdown of the requested information based on the provided text. It's important to note that many of these points are not directly addressed as there was no clinical data submitted for this device, and the focus is on device function rather than diagnostic performance.

Acceptance Criteria and Device Performance (Based on Device Characteristics and Bench Testing):

Since no clinical data was submitted, the "acceptance criteria" are derived from the functional requirements and comparisons to the predicate device, as demonstrated through bench testing and compliance with standards.

Detailed Study Information:

The provided document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence. It explicitly states: "No clinical data was submitted in this submission." Therefore, information typically associated with a diagnostic performance study (like sample sizes for test/training sets, expert readers, ground truth methods, MRMC studies, or standalone performance) is not applicable to this submission as described.

Here's what can be inferred or explicitly stated:

1. Sample size used for the test set and the data provenance:

   • Not Applicable. No clinical test set data was submitted. The "test set" for this device constitutes the number of units or materials subjected to bench testing (e.g., sterilization validation, biocompatibility tests, performance bench tests). The document does not specify the number of units tested for these bench activities, only that they comply with standards.
   • Data Provenance: Not applicable for clinical data. For bench testing, it would be laboratory testing conducted by the manufacturer or accredited labs.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. No clinical ground truth was established as no clinical data was submitted.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No clinical test set.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This is a medical device for blood collection, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device, not an algorithm. Bench testing demonstrates its standalone functional performance (e.g., sequestration, sterility).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. For the functional tests, the "ground truth" would be the specified characteristics or performance metrics defined by relevant standards (e.g., SAL of 10^-6 for sterility, specific volume for sequestration, passing biocompatibility tests). Outcomes data regarding reduction in blood culture contamination would be the ultimate clinical ground truth, but this was not provided in this submission.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not Applicable. This is not an AI/machine learning device.

Conclusion from the document:

The LifeOutcomes C-Quest™ Blood Culture Sampling Device gained 510(k) clearance by demonstrating substantial equivalence to a legally marketed predicate device (Steripath® Gen2 Blood Collection System, K192247) through:

• Similar indications for use (with a subset of the predicate's indications, specifically excluding infusion).
• Similar technological characteristics (e.g., mechanism of action, single use, sterilization method).
• Bench testing and compliance with recognized standards for critical device attributes such as:
  • Sterilization efficacy (SAL 10^-6, EO).
  • Shelf-life (18 months).
  • Biocompatibility of materials.
  • Performance (sequestration verification, actuation force, backflow prevention).
  • Packaging integrity.

The FDA's determination is based on the argument that "The differences between the predicate and the subject device do not raise new or different questions of safety or effectiveness."

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