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K Number
K984590
Device Name
0.9% SODIUM CHLORIDE FLUSH SYRINGE
Manufacturer
BAXTER HEALTHCARE CORP.
Date Cleared
1999-10-07

(283 days)

Product Code
FOZ
Regulation Number
880.5200
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Device Description

The proposed device consists of various sizes and fill volumes of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a 0.9% Sodium Chloride Flush Syringe. This type of regulatory submission is for medical devices and does not typically include information about studies related to AI/ML device performance or clinical outcomes.

The document discusses nonclinical tests to ensure the device meets safety and performance requirements for a sterile saline flush syringe. These tests focus on aspects like stability, container/closure suitability, and functional requirements.

Therefore, I cannot provide the requested information about acceptance criteria and studies as it pertains to AI/ML device performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance), because this type of information is not relevant or present in this specific regulatory document for a non-AI/ML device.

Here's a breakdown of what can be inferred from the document regarding the device's validation, but without the AI/ML specific details:

  • Acceptance Criteria and Reported Device Performance: This would relate to the nonclinical tests.

    • Acceptance Criteria (Inferred): The device is expected to meet or exceed "all functional requirements," and demonstrate "stability" and "container/closure suitability." These criteria would be defined internally by Baxter Healthcare Corporation based on relevant standards for medical devices of this type.
    • Reported Device Performance: "Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use." Specific quantitative results or detailed criteria are not provided in this summary.

  • Study That Proves the Device Meets Acceptance Criteria:

    • Type of Study: Nonclinical tests (stability testing, container/closure suitability testing, performance testing).
    • Description: "Test data have been generated for stability and container/closure suitability. Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use."

Regarding the specific questions asked that are relevant to AI/ML devices, the information is not applicable or present in this document:

  1. A table of acceptance criteria and the reported device performance: As explained above, the acceptance criteria are general ("all functional requirements," "stability," "container/closure suitability") and specific performance metrics are not detailed.
  2. Sample sized used for the test set and the data provenance: Not relevant for this type of device.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for this type of device.
  4. Adjudication method: Not relevant for this type of device.
  5. Multi reader multi case (MRMC) comparative effectiveness study: Not relevant for this type of device.
  6. Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant for this type of device.
  7. The type of ground truth used: Not relevant for this type of device. The "ground truth" for this device would be established by physical, chemical, and biological testing against product specifications.
  8. The sample size for the training set: Not relevant for this type of device.
  9. How the ground truth for the training set was established: Not relevant for this type of device.

This document clearly describes a conventional medical device (a pre-filled syringe) and its regulatory pathway based on substantial equivalence to a predicate device, not an AI/ML powered diagnostic or therapeutic device.

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).