(229 days)
The Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-V MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation. The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22 mm outer-diameter adapter. The RTC 24-V KIT is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 24-V metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 24-V metered dose inhaler adapter kit is comprised of the Instrumentation Industries, Inc. components normally used by respiratory therapists to integrate our existing actuators into a ventilator circuit. The kit includes one RTC 24-V MDI adapter, one 4 inch length of 22mm ID tubing and one 15mm ID/22mm OD adapter.
The provided text describes a 510(k) summary for a medical device called the "RTC 24-V MDI Adapter and RTC 24-V MDI Adapter Kit." This summary details the device's characteristics, intended use, and a comparison to a predicate device (RTC 22-D). It also includes information about aerosol performance testing.
Here's an analysis of the acceptance criteria and the study based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as strict pass/fail thresholds with numerical values in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (RTC 22-D) in terms of aerosol performance. The reported device performance is a comparison of the new device (RTC 24-V) to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (RTC 24-V vs. RTC 22-D) |
|---|---|
| Aerosol Performance Equivalence to Predicate Device | |
| Particle Size (MMAD) | Actual differences were not statistically significant. |
| Geometric Standard Deviation (GSD) | Actual differences were not statistically significant. |
| Medication Captured on USP Throat | Actual differences were not statistically significant. |
| Superiority in Specific Aerosol Performance Metrics (Optional but shown) | |
| Total Dose Delivered | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
| Respirable Fraction | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
| Total Respirable Dose Delivered | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
| Medication Retained in Device | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
Study Proving Acceptance Criteria:
The study described is a laboratory performance test comparing the new RTC 24-V MDI adapter to its predicate device, the RTC 22-D.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices or number of tests. The text mentions testing with "the following MDI medications: Ventolin® HFA, Atrovent® HFA, QVAR®." It implies a set of tests were performed for each medication type, comparing the RTC 24-V and RTC 22-D.
- Data Provenance: The study was conducted "in the laboratory." There is no information about the country of origin or whether it was retrospective or prospective. Given it's a lab performance test of physical devices, it's inherently prospective in nature for the performance data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this study. The study focuses on objective, measurable physical parameters (aerosol performance) of the device, not a subjective interpretation requiring expert consensus on a "ground truth" like in imaging studies. The "ground truth" here is the measured physical performance.
4. Adjudication Method for the Test Set
This is not applicable as there is no subjective assessment being made that would require adjudication.
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
This is not applicable. This is a device performance study, not an AI or diagnostic imaging study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device performance study, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study is objective physical measurements of aerosol performance parameters. These measurements are assumed to be accurate representations of the device's output under controlled laboratory conditions.
8. The Sample Size for the Training Set
This is not applicable. This is a device performance study, not a machine learning study that would typically involve a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
§ 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).