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510(k) Data Aggregation
(142 days)
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.
Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in durable Polypropylene (PP) bottles, which are resistant to breakage and designed for safe and easy handling. The bottles are available with two types of closures:
- A 36 mm PP screw cap with a PP/PET aluminium induction seal .
- A 28mm bromobutyl stopper with an aluminium seal .
The bottles are available in the following volume configurations: - . 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
- 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-. evident plastic shrink wrap.
Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.
The provided text describes a 510(k) summary for a medical device called "Laboratorios Biogalenic Sterile Water for Inhalation, USP." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
It's important to note that this document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance evaluation. Instead, it's a regulatory submission demonstrating the substantial equivalence of a general medical device (sterile water for inhalation) to an existing one. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, not performance metrics like sensitivity, specificity, or AUC as seen in AI/ML device evaluations.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the information provided in this document as it relates to an AI/ML device.
However, I can extract information related to the "performance testing" conducted for this non-AI/ML device to demonstrate its substantial equivalence to the predicate device.
Summary of Acceptance Criteria and Device Performance (Non-AI/ML Device)
The "Laboratorios Biogalenic Sterile Water for Inhalation, USP" is a non-AI/ML medical device. Its acceptance criteria and performance are assessed through physicochemical, biological, packaging, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria (Implied by "demonstrated that the device functions as intended" and "compliance with requirements") | Reported Device Performance (Summary) |
|---|---|---|---|
| Physicochemical & Biological Testing (USP Methods) | Total Organic Carbon (TOC) | Meets USP methods and internally validated procedures. | Functions as intended. |
| Water Conductivity | Meets USP methods and internally validated procedures. | Functions as intended. | |
| Process Bioburden | Meets USP methods and internally validated procedures. | Functions as intended. | |
| Volume in Container | Meets USP methods and internally validated procedures. | Functions as intended. | |
| Sterility | Meets USP methods and internally validated procedures (e.g., SAL of 10⁻⁶). | Sterile (no growth of Geobacillus stearothermophilus after sterilization). | |
| Bacterial Endotoxin | Meets USP methods and internally validated procedures. | Functions as intended. | |
| Appearance | Meets USP methods and internally validated procedures. | Functions as intended. | |
| Packaging Tests | Resistance to Leakage (ASTM D3078-02) | No leaking or deformation. | No leaking or deformation of bottles. |
| Hermeticity (ASTM F1929-23) | Compliance with hermeticity requirements. | Compliance with hermeticity requirements. | |
| Resistance to Pressure (ASTM F1140/F1140M) | Withstands required pressure limits. | The device withstands the required pressure limits. | |
| Resistance to Rupture (ASTM D642) | Resists rupture under specified conditions. | The device resists rupture under specified conditions. | |
| Resistance to Damage from Dropping Tests (ISO 15747:2018) | Remains intact and functional. | The device remains intact and functional. | |
| Biocompatibility | In Vitro Cytotoxicity (ISO 10993-5) | Meets requirements of ISO 10993-1:2018. | Testing performed to demonstrate substantial equivalence. |
| Sensitization (ISO 10993-10) | Meets requirements of ISO 10993-1:2018. | Testing performed to demonstrate substantial equivalence. | |
| Intracutaneous Reactivity (ISO 10993-12) | Meets requirements of ISO 10993-1:2018. | Testing performed to demonstrate substantial equivalence. | |
| Material Mediated Pyrogenicity (ISO 10993-11) | Meets requirements of ISO 10993-1:2018. | Testing performed to demonstrate substantial equivalence. | |
| Extractable/leachable testing (ISO 10993-18) | Meets requirements of ISO 10993-1:2018. | Testing performed to demonstrate substantial equivalence. | |
| Toxicological risk assessment (ISO 10993-17) | Meets requirements of ISO 10993-1:2018. | Testing performed to demonstrate substantial equivalence. | |
| Sterilization Validation | Sterility Assurance Level (SAL) | Achieves SAL of 10⁻⁶. | Achieved SAL of 10⁻⁶ (no Geobacillus stearothermophilus growth). |
2. Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" in the context of an AI/ML algorithm. The tests described are laboratory-based validation tests performed on samples of the manufactured device.
- The provenance of the data (e.g., country of origin, retrospective/prospective) is not detailed for these specific tests. These are standard validation tests for manufacturing processes and product integrity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable as there is no "ground truth" derived from expert consensus for a diagnostic medical device in this context. The validity of the tests (e.g., sterility, leak resistance) is determined by established scientific methods and standards (USP, ASTM, ISO).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The tests are laboratory-based with objective outcomes against defined standards.
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, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by scientific standards and analytical methods defined in regulations and industry standards (e.g., USP for sterility, ASTM for packaging, ISO for biocompatibility and sterilization). It's not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device. There is no training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device.
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