(58 days)
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.
The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.
| CONTENTS | VOLUME | CONTAINER |
|---|---|---|
| 0.45% Sodium Chloride Inhalation Solution, USP | 3mL fill | Green / Embossed label |
| 0.45% Sodium Chloride Inhalation Solution, USP | 5mL fill | Green / Embossed label |
| 0.9% Sodium Chloride Inhalation Solution, USP | 3mL fill | Pink / Embossed label |
| 0.9% Sodium Chloride Inhalation Solution, USP | 5mL fill | Pink / Embossed label |
The provided document is a 510(k) Premarket Notification for Sodium Chloride Inhalation Solutions. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. It does not typically involve clinical trials or a study to prove performance against specific acceptance criteria in the way a novel AI/software device would. Instead, substantial equivalence is demonstrated through comparative analysis of technological characteristics and non-clinical testing.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable to this particular submission type and product.
Here's a breakdown based on the provided text, indicating where information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Intended Use: As accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage. | "The intended use of these sterile devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage." (Section 5) This is identical to predicate devices. |
| Composition (Solution): Meets USP monograph requirements for Sodium Chloride Inhalation Solution at 0.45% and 0.9%. | "The solutions component, at the stated concentration of Sodium Chloride Inhalation Solution, meet the USP monograph requirements." (Section 6) "The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria. Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria." (Section 7) "These devices are designed to meet the current USP specifications." (Summary Conclusions 8) |
| Composition (Container): Formed of polyethylene resins meeting direct food and drug contact criteria. | "The subject unit dose devices of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units meet the criteria for direct food and drug contact as prefilled unit containers." (Section 6) "The component materials of the accessory device container have been substantiated to each meet criteria for direct food and drug contact or additive respectively." (Section 7) |
| Sterility: Sterile and pyrogen-free. | "They are sterile and pyrogen-free." (Section 4) "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." (Summary Conclusions 8) ("Sterility" is mentioned as an in vitro analytical method in Section 7 as evidence of equivalence.) |
| Preservative-free: Contains no preservative. | "The devices contain no preservative." (Section 4) |
| Container Integrity: Maintained. | ("Container integrity" is mentioned as an in vitro analytical method in Section 7 as evidence of equivalence.) |
| Fill Uniformity: Maintained. | ("Fill uniformity" is mentioned as an in vitro analytical method in Section 7 as evidence of equivalence.) |
| Technological Characteristics: Similar to predicate devices, leveraging advanced blow-fill-seal technology. | "The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices." (Section 6) "The technological improvements relate to the method of manufacture... The blow-fill-seal systems... represent technological advances in this type of production and in the control of the manufacturing environment." (Section 6) "Performance characteristics of the devices... are identical or better than the predicate devices." (Section 6) "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." (Summary Conclusions 8) |
| Manufacturing Standards: Manufactured under current Good Manufacturing Practices (cGMP) and aseptic conditions. | "The devices are manufactured under conditions of current Good Manufacturing Practices (cGMP)." (Section 6) "The devices, as manufactured by Holopack, are produced using dark-side/white-side blow-fill-seal technology on rommeLag® machines specifically designed for aseptic filling operations." (Summary Conclusions 8) |
| Labeling/Identification: Embossed with identifying product text, level markings, and color-coded. | "The single-use containers are embossed with identifying product text and level markings." (Section 6) "The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled..." (Section 4) "The device containers have embossed unit identification and shelf carton labeling so that label requirements are met." (Summary Conclusions 8) |
| Limitations: Not for parenteral use; requires prescription. | "These devices are not for parenteral use nor for preparations intended for parenteral use." (Section 5.1 & Statement of Intended Use) "The use of these devices requires prescription." (Section 5.1) "Sale of the device is restricted by or on the order of a physician." (Statement of Intended Use) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A): This submission is for a pharmaceutical/delivery device (inhalation solution), not an AI/software device that would use a "test set" in this manner. Substantial equivalence was demonstrated through non-clinical laboratory testing and adherence to USP standards. No clinical trials or patient data sets (retrospective/prospective) are mentioned.
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)
- N/A: No "ground truth" for a test set in the context of an AI/software device. The compliance is against established USP monographs and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: Not applicable to this type of device and submission.
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
- N/A: This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Standard Specifications and Monograph Requirements: The "ground truth" (or benchmark for performance) for this device is based on established USP (United States Pharmacopeia) monograph requirements for Sodium Chloride Inhalation Solution and criteria for direct food and drug contact for the container materials. It also relies on the performance characteristics of predicate devices (K884359, K870332, Travenol Laboratories pre-1976, Wyeth Laboratories pre-1976).
8. The sample size for the training set
- N/A: This is not an AI/software device that uses a "training set."
9. How the ground truth for the training set was established
- N/A: Not applicable to this type of device and submission.
§ 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).