(151 days)
The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing.
The RTC 26-C Inline Aerosol 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 26-C Inline Aerosol Adapter is a single-patient reuse device intended to provide an access port in a ventilator circuit to facilitate the administration of Combivent® (ipratropium bromide and albuterol) Respimat® medication to mechanically ventilated patients.
The provided text describes a 510(k) premarket notification for a medical device, the RTC 26-C Inline Aerosol Adapter. The information needed to answer the prompt, particularly regarding acceptance criteria and a study proving the device meets those criteria, is limited and does not align with the typical structure of an AI/ML medical device submission.
This document details the substantial equivalence of a new device (RTC 26-C Inline Aerosol Adapter) to a predicate device (RTC 22-D Metered Dose Inhaler Adapter) based on performance testing and material compatibility, rather than a study proving an AI/ML device meets specific performance metrics against a defined ground truth.
Therefore, many of the requested items (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of traditional medical device submission.
However, I can extract the relevant information from the provided document as it pertains to the device's performance characteristics and how they compare to a predicate device.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Evaluation)
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a predicate device, the RTC 22-D Metered Dose Inhaler Adapter, particularly in terms of safety and effectiveness related to its intended use and functional characteristics. The study presented is a series of performance tests comparing the new device (RTC 26-C) to the predicate device (RTC 22-D).
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Aspect | Implicit Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device Performance (RTC 26-C vs. RTC 22-D) |
|---|---|---|
| Ease of Setup & Usage | Similar user experience and functionality to predicate device. | "The set-up and usage of the RTC 26-C was no more difficult than that of the predicate in its typical circuit set-up." Also, the Respimat inhaler was "easily and securely placed." |
| Ventilator Cycling Durability and Integrity | Maintain secure placement, no dislodged caps, proper medication dispersion under prolonged ventilator use and environmental changes. | "Each adapter tested remained secure within the test-set; No caps became dislodged. Every medication dose dispersed properly." |
| Airflow Resistance | Acceptable (ideally lower or comparable) resistance to airflow. | "The RTC 26-C Adapter had less resistance than that of the predicate device for every trial run at both 60 and 80 lpm peak flow settings." |
| Cap Security/Leakage | Cap provides secure fit and minimal leakage under high pressure and changing conditions. | "the cap of the RTC 26-C adapter fits more securely, and leaks less than the cap of the predicate device" |
| Temperature Extremes Functionality | Device maintains functionality across extreme temperature fluctuations. | "Both new and predicate adapters cycled through extreme low and high temperatures performed equally well." |
| Shipping Durability | Withstand shipping rigors and maintain fit with ventilator components. | "Test results indicate that the RTC 26-C withstands the rigors of shipping and handling, will continue to fit 22mm mating components..." |
| Adapter Cap Tether Strength | Tether maintains integrity under strain. | "No negative consequences were seen after stretching tethers to twice their normal length." |
| PEEP Loss Management | Any potential PEEP loss (if cap is open) is manageable/preventable by the ventilator. | Test determined PEEP loss "is small enough to be entirely prevented by the ventilator." |
| Drop Durability | Materials and design are durable. | "The materials and design of the RTC 26-C are durable and raise no new safety and effectiveness issues." |
| Respimat® Inhaler Attachment Durability | Medication inlet port withstands repeated attachment cycles without damage, and medication dosage dispersion remains successful. | "After 500 attachment cycles, there was no damage to the medication inlet port of any of the 10 samples tested. Medication dosage dispersion testing was also successful for every trial." |
| Port Connection Durability | Adapter ports retain secure fit after repeated connection cycles. | "the adapters retained their secure fit to mating connectors after 25 cycles, fitting as snugly as they did after the first one." |
| Aerosol Performance (Total Delivered Dose) | Delivered dose of medication remains within acceptable range and is comparable to predicate, ideally with better delivery efficiency. | RTC 26-C generally shows better performance or comparable performance for the intended medication (Combivent Respimat®) than the predicate with its MDI counterparts. |
- Albuterol (RTC 26-C vs. RTC 22-D): Total Delivered Dose (58.1-67.2 µg vs. 50.9-62.3 µg), % Reduction from SMI/MDI alone (27.8% vs. 45.5%).
- Ipratropium (RTC 26-C vs. RTC 22-D): Total Delivered Dose (11.4-13.9 µg vs. 10.4-11.9 µg), % Reduction from SMI/MDI alone (34.0% vs. 40.4%). |
| Aerosol Performance (Respirable Particle Mass/Fraction) | Higher respirable fraction is desirable. | - Albuterol (RTC 26-C vs. RTC 22-D): Respirable Particle Mass (24.7-28.5 µg vs. 16.6-20.9 µg), Respirable Fraction (42.4% vs. 33.0%). - Ipratropium (RTC 26-C vs. RTC 22-D): Respirable Particle Mass (5.0-5.9 µg vs. 1.6-3.1 µg), Respirable Fraction (43.7% vs. 21.4%). |
| Biocompatibility | Materials are suitable for prolonged contact in a medical device and do not raise new safety issues. | Materials (thermoplastic elastomer and polystyrene butadiene) are "previously used in the manufacture of medical devices, specifically the predicate device (K991355)." Categorized as "External Communicating Device" with "Prolonged (>24 hours to 30 days)" contact duration. |
2. Sample Size and Data Provenance:
- Placement and Usage Trials: Not specified, but involved "two typical types of ventilator circuits."
- Ventilator Cycling Test: Not specified, but involved "RTC 26-C Adapters and the predicate device."
- Adapter Resistance Test & Cap Pressure/Leak Test: "Every trial run" implies multiple runs, but specific number of samples
or trials not quantified. - Respimat® Inhaler Attachment Trials: 10 samples tested, 500 attachment cycles each.
- Port Connection Trials: "RTC 26-C samples" tested, 25 cycles each.
- Adult Aerosol Performance Comparison Testing:
- RTC 26-C: One Combivent Respimat SMI, three samples of RTC 26-C, three tests per sample = 9 measurements per medication/output variable.
- RTC 22-D: Two drugs (Ventolin HFA and Atrovent), three samples of RTC 22-D, three tests per device sample = 9 measurements per medication/output variable.
- Data Provenance: The tests are described as "laboratory and simulated usage testing." Given the context of a 510(k) submission, this data is prospective and conducted specifically for the submission. No specific country of origin for data is stated beyond the company's location (Pennsylvania, USA).
3. Number of Experts and Qualifications for Ground Truth:
- This is not applicable. The ground truth for this device's performance is established through direct physical/biomedical engineering measurements and comparisons to a known predicate device's performance, not expert-labeled clinical data.
4. Adjudication Method for the Test Set:
- This is not applicable. There is no "test set" in the sense of a set of cases requiring expert review and adjudication. The data are quantitative measurements from instrumental tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for this device. The device is a mechanical adapter, not an AI/ML diagnostic tool assisting human readers.
6. Standalone Performance:
- The "standalone" performance is assessed by the device's physical and aerosol delivery characteristics (e.g., resistance, delivered dose, particle size distribution) through the various tests described. This is the direct, unassisted performance of the device artifact itself. The human element comes into play only in administering the associated medication.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is primarily quantitative physical measurements (e.g., airflow resistance, delivered dose, particle sizes) obtained from standard engineering and aerosolization test methods, compared against established baseline expectations (e.g., historical performance of the predicate device, general principles of fluid dynamics and aerosol mechanics). No clinical outcomes data or pathology reviews are mentioned for establishing device performance.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no training set mentioned for this 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).