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510(k) Data Aggregation
(88 days)
A HaloLite Adaptive Aerosol Delivery, (AAD) system, a handheld nebulizer system including a dedicated compressor is designed to aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment. The new dedicated compressor provides a compressed air source similar to the original predicate device compressed air sources, Invacare Mobilaire and regulated wall air.
The Medic-Aid HaloLite AAD system with dedicated compressor is a single patient use, prescribed portable nebulizer designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a hand-piece containing a pressure transducer, a microprocessor control system, a medication chamber, and dedicated compressor to provide a compressed air source. Other compressed air sources can be -Invacare Mobilaire (50 psi compressor) and regulate wall compressed air. The HaloLite system analyses the patient's breathing pattern to determine the aerosol pulse time. The system then pulses aerosol during inspiration only. Each pulse of aerosol is matched according to the inspiratory time. HaloLite continues to monitor the breathing pattern in order to adapt to changes in breathing throughout the treatment. When the preset dose has been delivered, the system indicates that the treatment is complete.
This document is a 510(k) premarket notification for a nebulizer system, specifically the Medic-Aid HaloLite AAD with a dedicated compressor. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study with acceptance criteria and performance data for a new AI/software device.
Therefore, many of the requested sections (acceptance criteria, specific study details like sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance for an AI/software device) are not applicable and cannot be extracted from the provided text.
The document describes a medical device (nebulizer) and its functional characteristics, comparing them to existing predicate devices to show equivalence. It is not a study assessing the performance of software against clinical acceptance criteria.
Here's what can be extracted based on the provided text, with clarifications where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the context of specific acceptance criteria and performance metrics for the HaloLite AAD system as a new measurement or diagnostic device. The document focuses on demonstrating equivalence to predicate devices rather than meeting new, explicit performance targets.
Instead, the document implicitly demonstrates "acceptance" by showing that the new device operates similarly to existing, legally marketed devices.
| Attribute / Comparison Point | Predicate Devices (HaloLite AAD System K981772 + wall supply/Medi-Pump K950867) | New Device (HaloLite AAD Compressor System) | Statement of Equivalence/Acceptance |
|---|---|---|---|
| Intended Use | Aerosolization of commonly prescribed liquid drug (except Pentamidine) for inhalation by the patient. | Aerosolization of commonly prescribed liquid drug (except Pentamidine) for inhalation by the patient. | Yes (identical) |
| Environment of Use | Single patient / multi-use for Home, Hospitals and Nursing Homes | Single patient / multi-use for Home, Hospitals and Nursing Homes | Yes (identical) |
| Patient Population | Patients requiring nebulized drug delivery via a mouthpiece. | Patients requiring nebulized drug delivery via a mouthpiece. | Yes (identical) |
| Nebulizes Drugs | Yes | Yes | Yes (identical) |
| Synchronized Delivery | Yes (via patient inhalation airway pressure signal) | Yes (via patient inhalation airway pressure signal) | Yes (identical) |
| Drug Delivery on Demand | Yes | Yes | Yes (identical) |
| Dynamic Pressure at Nebulizer Jet | 1.75 bar | 1.75 bar | Yes (identical) |
| Gas Source | Compressed Air (wall supply or Medi-Pump) | Compressed Air (dedicated compressor) | Yes (similar function, different source but equivalent output pressure) |
| Software Driven | Microprocessor | Microprocessor | Yes (identical, implying similar control logic) |
| Materials/Packaging | No significant changes / Provided clean, non-sterile | No significant changes / Provided clean, non-sterile | Yes (identical) |
| Overall Performance, Safety, Efficacy | Not explicitly quantified for predicate | Not explicitly quantified for new device | "There are no differences in performance, safety, or efficacy between the new dedicated compressor and the Invacare compressor or regulated wall gas." (Statement of Equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- This document does not describe a "test set" in the context of evaluating a new device's performance against ground truth data. It is a 510(k) submission focused on substantial equivalence.
- Therefore, no sample size for a test set is provided.
- Data provenance is not applicable as there isn't a dataset being analyzed for performance. The comparison is based on device specifications and intended functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "test set" requiring expert ground truth establishment for an AI/software device. The document is about a nebulizer's functional equivalence.
4. Adjudication Method for the Test Set
- Not applicable. No test set or expert ground truth requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This document is for a nebulizer, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Not applicable. This document is for a nebulizer, not an algorithm. The "software-driven" aspect refers to a microprocessor controlling the nebulizer's physical operation (pulsing aerosol during inspiration), not an interpretive algorithm.
7. The Type of Ground Truth Used
- Not applicable. The "ground truth" in this context is the functional behavior and specifications of the predicate devices. The new device is considered "equivalent" if its design and function match or perform similarly to the predicates.
8. The Sample Size for the Training Set
- Not applicable. This document is for a nebulizer and does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set mentioned, this question is not relevant.
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