(225 days)
Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.
Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.
Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.
Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.
Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.
Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.
Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.
The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called the MiniSpacer Dual Spray MDI Adapter. This document is a regulatory submission for a device, which typically describes an engineering verification and validation study rather than a clinical study for AI software.
Therefore, the requested information regarding acceptance criteria and performance against those criteria, especially details such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set information (which are all highly relevant to AI/ML device evaluations), is not present in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and general performance, rather than AI-specific metrics.
However, I can extract the following relevant information based on the request, reinterpreting some categories in the context of a non-AI medical device submission:
Acceptance Criteria and Device Performance
- Product: MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
- Study Type: This document describes a premarket notification (510(k)) to establish substantial equivalence to predicate devices, not a clinical trial or AI performance study. The "study" here refers to the engineering verification and biocompatibility assessment for the physical device.
| Acceptance Criterion (Standard or Predicate Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence: | |
| - Body Material: Modified SBC performance equivalent to | Toxicological assessment supports substantial equivalence and |
| Legacy SBC. | biological safety for the intended device population compared to |
| - Other Materials (Actuator, Cap): ABS, SEBS equivalent | predicate devices. |
| to predicate. | |
| Functional Equivalence: | The subject device shares the same intended use, indications for |
| - Dispensing pMDI medication into breathing circuit. | use, common name, classification, and regulatory status as the |
| - Single patient, disposable. | predicate devices. It also maintains the same dimensions and dual |
| - Prescription device. | spray orifice nozzle design. |
| - Non-sterile. | |
| Biocompatibility: | |
| - Meeting biocompatibility standards for external | A thorough toxicological assessment was performed, and the data |
| communicating, tissue, long-term (> 30 days) contact. | supports substantial equivalence and biological safety for the |
| intended device population, despite a change in the body resin. |
Additional Requested Information (as applicable to this document):
-
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified in the document. The testing described appears to be bench testing for material and functional equivalence.
- Data Provenance: Not explicitly stated, but the toxicological assessment and comparisons against predicate devices would be based on internal testing and regulatory standards. It's a regulatory submission, not a clinical trial, so "country of origin" of data or "retrospective/prospective" does not apply in the typical sense for patient data.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable in the context of this device. Ground truth is established through engineering specifications, material standards, and regulatory requirements (e.g., biocompatibility testing interpreted by toxicologists) rather than expert consensus on medical images or patient outcomes.
-
Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations. Compliance is determined by engineering testing and regulatory assessment.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No, an MRMC study was not done. This device is a physical medical component (an actuator for MDI medication), not an AI diagnostic or treatment planning system that would involve human readers interpreting data.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI component.
-
The type of ground truth used:
- For material and functional performance, the "ground truth" is defined by established engineering specifications, performance standards, mechanical testing results, and toxicological assessment standards. For regulatory approval, the ultimate "ground truth" is established by demonstrating substantial equivalence to legally marketed predicate devices through comparative analysis and testing.
-
The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).