Search Results

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."

Ask a specific question about this device

The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.

A compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table. The C-Quest system is operated through interaction with an acquisition and processing computer system (NuQuest) or dedicated handheld controller or touch screen.

Here's a breakdown of the acceptance criteria and study information for the C-Quest System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are inferred from the predicate device's performance, as the document states that the C-Quest system performs "as well as the predicate device" and provides a direct comparison table of technical characteristics. The C-Quest device generally shows performance that is either comparable to or slightly different from the predicate, but implicitly accepted as meeting the "as well as" criterion for 510(k) substantial equivalence. For spatial resolution (FWHM, FWTM), the C-Quest performs worse in the center FOV compared to the predicate, but better in the useful FOV. For spatial linearity and uniformity, the C-Quest's reported maximums are often higher than the predicate's reported values, indicating slightly worse performance in some technical aspects, yet still deemed substantially equivalent.

2. Sample size used for the test set and the data provenance

The provided 510(k) summary does not contain information about a test set involving patient data for clinical performance evaluation. The study presented focuses on a technical comparison of intrinsic device characteristics against a predicate device. Therefore, clinical sample size and data provenance are not applicable to the information given.

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

Not applicable. The study does not involve expert review of patient data to establish ground truth.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process is mentioned.

5. 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

No. This document does not mention an MRMC comparative effectiveness study. This device is a cardiac gamma camera system, not an AI-assisted diagnostic tool for human readers.

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

Yes, in essence. The evaluation presented is a standalone technical performance study of the C-Quest system's physical characteristics (e.g., spatial resolution, linearity, uniformity) compared to its predicate. It is not evaluating an algorithm in isolation, but rather the intrinsic imaging capabilities of the hardware.

7. The type of ground truth used

The "ground truth" for this technical study is established by physical measurements and phantom studies for parameters like intrinsic spatial resolution, linearity, and uniformity, conforming to industry standards for gamma cameras. The 510(k) summary implicitly uses the established performance of the predicate device (Cardiocam) as a benchmark.

8. The sample size for the training set

Not applicable. This document describes a medical imaging device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this device is not an AI model, there is no training set mentioned or ground truth associated with it.

Ask a specific question about this device

The 4R and 5 mobile x-ray unit with image intensifier system has been designed for diagnosis, suitable for x-ray and radioscopy, and radiography dedicated to:

• Traumatology .
• Paediatrics
• Interventional radiology
• Peace maker implantation
• Operating theater
• Intensive care .
• Respiratory system ●
• Skeleton .

This device does not foresee any interaction with medicine, while the possibility of an interface with some devices like VCR or THERMAL PRINTER is foreseen.

C-Quest 4R and 5 mobile x-ray unit with image intensifier system

The provided document is a 510(k) premarket notification letter from the FDA for a device called "C-Quest 4R and C-Quest 5." This document grants market clearance based on substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study demonstrating the device meets acceptance criteria.

The 510(k) clearance process primarily evaluates substantial equivalence to existing legally marketed devices, focusing on indications for use and safety/effectiveness concerns addressed through general controls and potentially special controls for Class II devices. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) might.

Therefore, I cannot extract the requested information from the provided text. The document is essentially an FDA clearance letter, not a study report.

Ask a specific question about this device