(57 days)
PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4
The proposed inhaled saline solutions are in 0.9%, 3%, 3.5%, 6%, 7%, and 10% concentrations with a pH of 7.4. They are packaged sterile in 4 ml vials for use as indicated.
This document describes a 510(k) submission for an inhaled saline solution device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and testing are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device as being "substantially equivalent" to predicate devices, focusing on meeting established standards rather than setting new performance "acceptance criteria" in the sense of a novel device's performance metrics. The "performance" assessment is based on compliance with USP specifications and similarity to the predicate device.
| Feature / Criteria | Reported Device Performance (PulmoSal™ Inhaled Saline Solution) | Predicate Device (PharmaCaribe K101424, K113033, and Pulmicort Respules) |
|---|---|---|
| Indications for Use | Used in conjunction with a nebulizer for the induction of sputum production. Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4. | Identical to PharmaCaribe K101424 for sputum induction with a nebulizer. (0.9% saline and pH of 7.4 are additions/match other predicates). |
| Technology of Manufacturing | Homogeneous aqueous mixtures of sterile water and saline. | Identical to PharmaCaribe K101424. |
| Mode of Action | Used with a nebulizer to increase sputum production. | Identical to PharmaCaribe K101424. |
| Formulation | Based upon USP specification except pH of 7.4 (matches pH of lungs). Concentrations: 3%, 3.5%, 6%, 7% and 10% (identical to K101424), 0.9% (identical to K113033). | Predicate concentrations: 3%, 3.5%, 6%, 7% and 10% (K101424). 0.9% (K113033). Predicate pH: USP 4.5 to 7.0 for K101424/K113033; pH of 7.4 for Pulmicort Respules (NDA # N020929). |
| Materials | Blow-fill-sealed low density polyethylene (LDPE) vial containing sterile, preservative-free, clear, colorless, aqueous solution of sodium chloride. No additives. | Identical to PharmaCaribe K101424. |
| Environment of Use | Hospital, home, sub-acute care settings. | Identical to PharmaCaribe K101424. |
| Patient Population | Any patient requiring induction of sputum production. | Identical to PharmaCaribe K101424. |
| Sterility | Sterile, as per USP . | Sterile. |
| pH | 7.4 | USP 4.5 to 7.0 (for K101424). Note: The 7.4 pH is presented as a feature matching the pH of the lungs and the predicate drug Pulmicort Respules (NDA # N020929). |
| Salinity | Meets USP Specifications (except pH). | Meets USP Specifications. |
| Identification of Sodium | Per USP (191). | (Implied by USP monograph adherence for predicate). |
| Sodium Chloride Assay | Per USP Monograph. | Per USP Monograph. |
| Manufacturing | Per USP monograph (except pH). | Per USP monograph. |
| Prescription | Yes | Yes |
| Contraindications | None | None |
| Materials in fluid contact | Vial LDPE | Vial LDPE |
| Used with a nebulizer | Yes | Yes |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a saline solution, and the testing described is non-clinical (lot release, in-process, and finished product testing) focused on chemical properties and sterility, not clinical efficacy or diagnostic performance. There is no "test set" of patient data in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth for a diagnostic test set is established in this submission.
4. Adjudication method for the test set:
Not applicable.
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 is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used:
The "ground truth" for this device is based on United States Pharmacopeia (USP) specifications for saline solutions and analytical testing results (e.g., salinity, pH, identification of sodium, sodium chloride assay, sterility). The comparison to predicate devices also serves as a "ground truth" for substantial equivalence.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for this device is the established pharmaceutical manufacturing processes and USP standards.
9. How the ground truth for the training set was established:
Not applicable. The manufacturing processes are established by pharmaceutical standards and quality control protocols.
Summary of the Study/Testing:
The study proving the device meets the acceptance criteria is a non-clinical testing summary that demonstrates the product's physicochemical properties and sterility align with relevant standards (USP) and are substantially equivalent to predicate devices. This involves:
- Lot Release Testing by Asept Pak: This ensures each lot meets specifications.
- In Process Testing: Includes incoming resin certification, water testing, pH measurement, appearance checks, salinity, environmental monitoring, container fill weight monitoring, and visual inspection.
- Finished Product Tests: Includes salinity, identification of sodium (USP 191), sodium chloride assay (USP Monograph), and sterility (USP ).
The conclusion is based on this performance testing, design features, and comparison to predicate devices, leading to a finding of substantial equivalence. The "study" here is essentially a comprehensive quality control and analytical chemistry assessment, rather than a clinical trial or AI/ML performance study.
§ 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).