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K Number
K962872
Device Name
RESPIFLO
Manufacturer
TYCO HEALTHCARE DEUTSCHALAND GMBH
Date Cleared
1997-02-25

(217 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.

Device Description

This product is Sterile Water for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.

AI/ML Overview

This 510(k) summary describes a device that is Sterile Water for Inhalation Therapy. The "tests" mentioned are for product specifications (sterility, endotoxin levels, stability), not for AI/ML performance. Therefore, the questions related to AI/ML device performance, expert review, training/test sets, and ground truth are not applicable to this submission.

Here's a breakdown of the relevant information provided:

  1. A table of acceptance criteria and the reported device performance
Acceptance CriteriaReported Device Performance
Sterile Water (USP)Meets USP requirements
Endotoxin free (USP)Meets USP requirements
Stability Testing3 year and 5 year stability shown
Closed system and disposableConfirmed
Single useConfirmed

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

    • Not applicable as this is not an AI/ML device. The "test set" refers to product samples tested for quality control. Specific sample sizes for stability or sterility testing are not provided in this summary but would be part of the detailed "Confidential Testing, Methods and Results" in Section 11. Data provenance for such product testing is typically internal to the manufacturer.

  2. 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. This is not an AI/ML device. "Ground truth" for this product is defined by established pharmacopeial standards (USP for sterility and endotoxins).

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

    • Not applicable. This is not an AI/ML device. Adjudication methods are not relevant for product specification testing.

  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 not an AI/ML device.

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

    • Not applicable. This is not an AI/ML device.

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

    • For the product specifications (sterility, endotoxin, etc.), the "ground truth" is defined by established regulatory and pharmacopeial standards (USP - United States Pharmacopeia).

  7. The sample size for the training set

    • Not applicable. This is not an AI/ML device.

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

    • Not applicable. This is not an AI/ML device.

§ 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).