(179 days)
The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. It is intended for use only when connected to ventilator tubing or tracheal tubes.
The SMDIA-1000 MDI adaptor is single patient use, disposable.
The Southmedic SMDIA-1000 is an adaptor which acts as an actuator for intermittent delivery of prescribed aerosol medications dispensed by meter dose inhalers (MDI). The SMDIA-1000 is connected to ventilator tubing and the MDI connected when drug delivery into the circuit is required. The SMDIA-1000 adaptor may also be connected to the endotracheal tube.
This document describes the regulatory submission for the Southmedic SMDIA-1000, an adaptor for intermittent delivery of aerosol medications from Metered Dose Inhalers (MDIs) when connected to ventilator or tracheal tubes. The submission aims to demonstrate substantial equivalence to predicate devices, not an AI device. As such, information regarding AI-specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," and sample sizes/ground truth for training/test sets, is not applicable or present in this document.
Here's the breakdown of the provided information relevant to acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily established through comparative performance testing against predicate devices and adherence to internal pass/fail criteria for various engineering tests.
| Acceptance Criteria (What was tested) | Reported Device Performance (Southmedic SMDIA-1000) |
|---|---|
| Indications for Use | The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. They are intended for use only when connected to ventilator tubing or tracheal tubes. (Identical to predicate K091111 - RTC-24V) |
| Technology / Design | Tee design with a port which is capped when not in use. (Identical to predicate K091111 - RTC-24V) |
| Materials (specifically those in gas or fluid pathway) | Materials in the gas or fluid pathway have been tested per ISO 10993 for Cytotoxicity, Irritation, and Sensitization. (Implies meeting safety standards) |
| Environment of Use | Expected clinical environment is critical care and / or long or short term ventilation, which can occur in hospitals, ICU, sub-acute centers, and home settings. (Substantially equivalent to predicate K091111 - RTC-24V) |
| Comparative Particle Characterization via Cascade Impactor | 3 samples with 3 different drugs MDI burst. Demonstrated that the performance of the proposed device and the predicate were equivalent. (Predicate: 3 drug types, 1 sample each, implying comparable results were expected and achieved) |
| Simulated Life Cycle Testing | Same sample testing for intra-sample variability. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate). |
| Environmental Testing | Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate). |
| Operational Testing | Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate). |
| Drop Testing | Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate). |
| Canister Activation Testing | Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate). |
| Connection Trial Testing | Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate). |
| Inter- and Intra-sample Variability Testing | Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate). |
| Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization) | Tested per ISO 10993. (Implies acceptable results were achieved for these safety parameters). |
| Other Design Features (e.g., Placed in breathing circuit) | Yes (Identical to predicate). |
| May attach to a tracheal tube | Yes (Identical to predicate). |
| Tee with standard 15 mm / 22 mm fittings | Yes (Identical to predicate). |
| Fitting for adaption to MDI | Yes (Identical to predicate). |
| Cap when not in use | Yes (Identical to predicate). |
| Single patient use, disposable | Yes (Identical to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Particle Characterization via Cascade Impactor: 3 samples with 3 different drugs were tested for the proposed device (SMDIA-1000). The predicate used 3 drug types, 1 sample each.
- Other Performance Testing (Simulated life cycle, environmental, operational, drop, canister activation, connection trial, inter- and intra-sample variability): Not explicitly stated, but the document mentions "same sample testing for intra-sample variability" for simulated life cycle, implying repeated tests on the same units. The exact number of units or test cycles for these other tests is not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based prospective engineering/performance studies rather than clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. This is a submission for a physical medical device (an MDI adaptor), not an AI device or diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is objective measurements (e.g., particle size distribution, durability under stress, material biocompatibility) and comparison to established predicate device functionality, not expert consensus on diagnostic images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as the tests are objective engineering and performance evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers are interpreting images or data. This document pertains to a physical medical device where effectiveness is demonstrated through engineering performance and substantial equivalence to a predicate.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" used for evaluating the SMDIA-1000 appears to be:
- Objective Engineering Measurements: Particle size distribution (via Cascade Impactor), durability (simulated life cycle, drop tests), functional integrity (operational, canister activation, connection trials).
- Biocompatibility Testing: Adherence to ISO 10993 standards for cytotoxicity, irritation, and sensitization.
- Predicate Device Performance: The performance of the predicate devices (K991355 - RTC-22-D and K091111 - RTC-24V) served as the benchmark for demonstrating substantial equivalence. The predicate performance would also have been established through similar objective engineering and biocompatibility tests.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/machine learning device.
§ 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).