0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP

• K Number: K974056
• Device Name: 0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
• Manufacturer: HOLOPACK INTERNATIONAL, LP
• Date Cleared: 1998-01-21 ( 86 days)
• Product Code: CAF
• Regulation Number: 868.5630
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K884359 , K870332

Intended Use

The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage. The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

Device Description

The single-use device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free. The single-use containers are embossed with identifying product text and level markings. The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: "0.9% Sodium Chloride Inhalation Solution, USP". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance or efficacy through extensive clinical studies like those for new drug applications or high-risk devices.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
• Information on expert adjudication methods or multi-reader multi-case studies.
• Results of standalone algorithm performance.
• Sample sizes for a training set or ground truth establishment for a training set.

Instead, the document focuses on demonstrating substantial equivalence to existing devices through:

• Comparison of intended use: The intended use of the device ("as accessory to medicinal nonventilatory nebulizers; in respiratory therapy; for tracheal irrigation or lavage") is stated to be identical to the predicate devices.
• Technological characteristics: The device's container materials, solution components (0.9% USP Sodium Chloride), and manufacturing process (blow-fill-seal technology) are described and compared to predicate devices. It emphasizes compliance with USP monograph requirements for the solution.
• Non-Clinical and Clinical Testing: The document explicitly states: "Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence."

Key Takeaways from the Document Regarding "Acceptance Criteria" (Implicit for 510(k) Submission):

The acceptance criteria are implicitly tied to demonstrating that the device is as safe and effective as its predicate devices, primarily through meeting established standards and specifications for its components and manufacturing.

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit from text):
     • Compliance with USP monograph requirements for 0.9% Sodium Chloride Inhalation Solution.
     • Container materials meet criteria for direct food and drug contact and USP container testing.
     • Finished devices undergo testing to meet stated USP monograph and container criteria (e.g., assay, fill uniformity, sterility, container integrity, solution properties, unit configuration).
     • Sterile and pyrogen-free.
     • No preservative.
     • Manufactured under current Good Manufacturing Practices (cGMP).
     • Technological characteristics are "identical or better" than predicate devices.
   • Reported Device Performance: The document states that the device "meets the current USP specifications" and "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." No specific performance metrics or values are provided; rather, it refers to compliance with established standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. The document explicitly states that clinical testing (which would typically involve test sets) was not necessary. The evaluation relied on in vitro analytical methods and physical-chemical characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. No ground truth established through expert review for a test set was mentioned, as clinical testing was not performed.

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

   • Not Applicable. No test set or expert adjudication was performed.

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:

   • Not Applicable. This device is a medical solution (0.9% Sodium Chloride) used with nebulizers, not an AI or imaging diagnostic device. MRMC studies are not relevant.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • The "ground truth" here is the established USP (United States Pharmacopeia) monograph criteria and other regulatory standards for Sodium Chloride Inhalation Solution and its container components. This is verified through "in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration)."

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not Applicable. No training set exists for this type of device submission.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).