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510(k) Data Aggregation
(464 days)
Spirale DDS is a collapsible volumising chamber for the delivery of aerosolized micro drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously-breathing or ventilated patient.
The purpose of a drug nebuliser device is to facilitate the nebulisation of respiratory drugs and non-pharmacological (placebo) solutions and to allow the transfer of these preparations to patients via the drug nebuliser. Usage is predominantly for patients receiving treatment in anaesthetic and intensive care settings within hospital theatres, intensive care units, and accident and emergency departments. Spirale DDS is a collapsible volumising chamber for the delivery of aerosolized micro drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously-breathing or ventilated patient.
The provided documentation describes the Armstrong Medical Spirale Drug Delivery System (Spirale DDS), which is a nebulizer accessory. The 510(k) submission (K111246) focuses on demonstrating substantial equivalence to a predicate device, the Trudell Aerovent collapsible Holding Chamber. This type of submission relies on non-clinical tests to show that the new device is as safe and effective as the predicate, rather than extensive clinical studies with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance |
|---|---|
| Working Environment: Device must withstand insertion and removal forces associated with normal use. | "All tests were carried out and passed." (Implies the device met this criterion.) |
| Handling and Transportation Conditions: Must withstand temperature range of -40°C to +20°C. | "All tests were carried out and passed." (Implies the device met this criterion. Note: The document states 200°C, which is likely a typo and should be 20°C based on typical device handling conditions. I will assume 20°C as a more plausible figure for normal handling and transportation.) |
| Physical Requirements: Jet orifice and canister interface to be designed to be geometrically equivalent to Aerovent chamber from Trudell Medical to ensure safety and effectiveness. | "Key elements are the same such as jet orifice diameter, total volume collapsed and expanded, distance of nozzle travel canister depression and manufacturing material." (Implies this was met by design and confirmed.) |
| Physical Requirements: Spirale connectors and supplied adaptors to be compatible with existing Armstrong Medical ventilator circuit connections. | "Spirale DDS is compatible with circuits marketed under the 510(k) reference numbers listed below: K922789 (KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT), K920885 (VITAL SIGNS, INC. VENTILATOR CIRCUIT), K812774 (HUDSON OXYGEN THERAPY SALES CO. VENTILATOR CIRCUIT)." (Implies this was met.) |
| Product Testing: Glued seams to be leak-free at pressures up to 60cmH2O in both the open and closed/locked positions to withstand normal operating conditions. | "Spirale must be airtight to ensure no leakage of respiratory drugs and non-pharmacological solutions... "All tests were carried out and passed." (Implies the device met this criterion.) |
| Product Testing: Collapsible. | "Product must also expand and collapse during use without any difficulty... "All tests were carried out and passed." (Implies the device met this criterion.) |
| Product Testing: Lock and unlock positions easily identifiable, easily released from locked. | "All tests were carried out and passed." (Implies the device met this criterion.) |
| Functional Equivalence: Device performs as safe and effective as the predicate. | "As the predicate devices have been on the market for many years with no reportable incidences in this time, we can assumed from the bench tests carried out to evaluate the performance of the device under actual clinical working conditions, that the Spirale DDS will perform as safe and effective as the predicate." (This is the overall conclusion based on the non-clinical tests and predicate device history.) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of a patient population for clinical trials. The evaluation was primarily based on non-clinical bench tests performed on the Spirale DDS device itself. Therefore, the "sample size" would refer to the number of devices tested during these non-clinical evaluations. This information is not explicitly provided in the summary.
Data provenance is also not applicable in the traditional sense of patient data. The non-clinical tests were conducted by Armstrong Medical Ltd. in Northern Ireland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation was based on non-clinical bench testing for product performance and design specifications, not expert interpretation of clinical data or images. Ground truth for these types of tests typically relies on engineering specifications and direct measurement.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring expert adjudication. The non-clinical tests likely followed internal Armstrong Medical protocols for verification and validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device is a physical medical device (drug delivery system), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this 510(k) submission was primarily based on:
- Engineering specifications and design requirements: For criteria like jet orifice diameter, volume, and material compatibility.
- Measured performance against predefined thresholds: For tests such as leak-free performance at specified pressures, temperature resistance, and ease of collapse/lock.
- Equivalence to a legally marketed predicate device: The fundamental "ground truth" for substantial equivalence is that the new device performs at least as safely and effectively as the predicate, which has a history of safe use.
8. The Sample Size for the Training Set
This information is not applicable. There was no "training set" in the context of machine learning or AI models. The device's design and manufacturing process would have undergone various development and testing phases, but these are not referred to as training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8. The "ground truth" for the device's design and manufacturing was established through engineering principles, regulatory requirements, and established industry standards for medical device development and quality control.
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