(90 days)
The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip-style connection.
The ReddyPort Elbow is an NIV elbow that replaces the elements AF541 style masks and AF531 masks with a clip-style comection and provides oral access for clinicians to the patient's airway during CPAP and bi-level therapy. The ReddyPort Elbow is compatible with both Over the Nose (OTN) cushion ((S, M, L, XL sizes) and an Under the Nose (UTN) cushion (A, B, C sizes) configurations of the AF541 EE Mask and AF531 mask with clip-style connection. ReddyPort permanently replaces the conventional elbow on the mask and maintains positive pressure. This elbow allows for respiratory care procedures (e.g. oral care, suctioning, bronchoscopy) to be performed on a patient while the patient is receiving non-invasive ventilation. The elbow contains a duckbill valve that allows the patient's airway and that seals with similar leak rates to conventional NIV elbows. In addition, the elbow includes an anti-asphysia valve to ensure safety of the patient.
Here's an analysis of the provided FDA 510(k) summary regarding the ReddyPort Elbow, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device that interfaces with respiratory therapy equipment. It is not an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (like sample size of test/training sets, expert ground truth, MRMC studies, etc.) are not applicable to this type of traditional medical device submission. This document focuses on the physical and functional equivalence to predicate devices through bench testing and biocompatibility testing, not on algorithmic performance.
I will address the applicable sections of your request based on the provided text.
Device Name: ReddyPort Elbow
Regulation Name: Continuous Ventilator (specifically an accessory/interface)
Regulatory Class: Class II
Product Code: MNS
Applicant: SMD Manufacturing LLC
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't present a formal table of "acceptance criteria" against "reported performance" in the way one might see for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, for this type of mechanical device, the acceptance criteria are generally implied by meeting the requirements of recognized standards (ISO 17510, ISO 5356-1) and demonstrating performance (e.g., leak rates, resistance to flow). The device is deemed acceptable if it meets these standards and is substantially equivalent to predicate devices.
However, based on the "Substantial Equivalence Comparison Table" (pages 4-5) and "Performance Testing" section (page 6), here's an attempt to structure the information in a table format, focusing on quantitative metrics where available:
| Characteristic/Test | Acceptance Criteria (Implied/Standard) | Reported Device Performance (ReddyPort Elbow - Subject Device) | Substantial Equivalence Remarks |
|---|---|---|---|
| Indications for Use | Consistent with predicate devices for CPAP/bi-level therapy interface during other procedures (e.g., oral care, suctioning, bronchoscopy). | Provides interface for CPAP/bi-level therapy during oral care, suctioning, bronchoscopy. | Similar |
| Patient Population | Patients > 40 lbs / 18.2 kg (similar to predicates). | Patients (> 40 lbs / 18.2 kg). | Similar |
| Environment of Use | Hospital/Institutional Environment Only. | Hospital/Institutional Environment Only. | Same |
| Sterility | Provided Non-Sterile (Clean). | Provided Non-Sterile (Clean). | Same |
| Patient Usage Type | Single patient use in hospital/institutional environment. | Single patient use in hospital/institutional environment. | Same |
| Design | Permanent replacement elbow with duckbill and anti-asphyxia valve, clip-style connection (similar to predicate/reference). | Permanent replacement elbow with duckbill and anti-asphyxia valve, clip-style connection. | Similar |
| Valve Type | Duckbill Valve for access (similar to predicate). | Duckbill Valve. | Similar |
| Body Material | Biocompatible material (e.g., Polycarbonate or Polypropylene). | Polypropylene. | Similar (to Philips Respironics) |
| Access Valve Material | Silicone Elastomer. | Silicone Elastomer. | Similar |
| Anti-Asphyxia Valve Material | Silicone Elastomer. | Silicone Elastomer. | Same |
| Elbow Deadspace | Comparable to traditional NIV elbows (implied by "streamlined, low dead-space design"). | 37.59 mL (Predicate: 50.9 mL). Subject device has lower dead space. | Similar (and improved) |
| Leak Rates (4 cmH2O) | Comparable to predicate (e.g., 8.46 L/min for predicate). | 0.6 L/min. (Predicate: 8.46 L/min). Subject device has significantly lower leak rates. | Similar (and improved) |
| Leak Rates (10 cmH2O) | Comparable to predicate (e.g., 7.26 L/min for predicate). | 0.65 L/min. (Predicate: 7.26 L/min). | Similar (and improved) |
| Leak Rates (17 cmH2O) | Comparable to predicate (e.g., 7.65 L/min for predicate). | 0.89 L/min. (Predicate: 7.65 L/min). | Similar (and improved) |
| Leak Rates (24 cmH2O) | Comparable to predicate (e.g., 7.56 L/min for predicate). | 1.11 L/min. (Predicate: 7.56 L/min). | Similar (and improved) |
| Leak Rates (30 cmH2O) | Comparable to predicate (e.g., 7.35 L/min for predicate). | 1.34 L/min. (Predicate: 7.35 L/min). | Similar (and improved) |
| Resistance to Flow (50 L/min) | Low resistance (e.g., 0.223 cmH2O for predicate). | 0.23 cmH2O. (Predicate: 0.223 cmH2O). | Similar |
| Resistance to Flow (100 L/min) | Low resistance (e.g., 0.217 cmH2O for predicate). | 0.13 cmH2O. (Predicate: 0.217 cmH2O). Subject device has lower resistance. | Similar (and improved) |
| Resistance Under Single Fault (Inspiratory) | Acceptable (e.g., 0.6 cmH2O for predicate). | 1.23 cmH2O. (Predicate: 0.6 cmH2O). This shows higher resistance compared to the predicate, but is still considered acceptable under ISO standards. | Similar |
| Resistance Under Single Fault (Expiratory) | Acceptable (e.g., 0.5 cmH2O for predicate). | 0.43 cmH2O. (Predicate: 0.5 cmH2O). | Similar |
| Safety Valve | Includes anti-asphyxia valve (similar to predicate). | Includes anti-asphyxia valve. | Same |
| Duration of Replacement | In place for entirety of NIV therapy (similar to predicate). | In place for entirety of NIV therapy. | Similar |
| Intentional Vent Holes | No vent holes (similar to predicate). | No vent holes. | Same |
| Pressure Range | 4 to 30 cmH2O (similar to predicate). | 4 to 30 cmH2O. | Same |
| Patient Circuit Connection | 22mm Connection. | 22mm Connection. | Same |
Conclusion from section "Performance Testing": "The ReddyPort Elbow met all applicable requirements and acceptance criteria."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. For this type of device, "test set" refers to physical samples of the device undergoing bench testing, not a dataset of patient cases. The number of physical units tested is not specified but is assumed to be sufficient for engineering and regulatory standards (e.g., multiple units to ensure consistency and robustness, per standard requirements like ISO).
- Data Provenance: Not applicable. This is not clinical data. The data comes from bench testing performed by the manufacturer, likely in a controlled laboratory setting (e.g., specific to the manufacturing facility or a third-party testing lab). The document does not specify a country of origin for the testing, but it is for a US regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in the context of an AI/ML device refers to a definitive 'correct answer' for a diagnostic task, often established by expert consensus or pathology results. For this mechanical device, the "truth" is established by physical measurement against engineering standards and specifications. Engineers and technicians, not medical experts as defined in the prompt, perform these tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers in diagnostic tasks, which is characteristic of AI/ML performance studies. This device's evaluation is based on objective physical measurements via bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a mechanical accessory, not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. There is no algorithm or AI component in this device. The performance data presented (leak rates, resistance, dead space) is indeed "standalone" in the sense that it's the raw physical performance of the device without human interaction being assessed as part of the primary outcome, but this is standard bench testing, not AI standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by:
- Engineering Specifications and Design Requirements: What the device is designed to do.
- Recognized International Standards: Such as ISO 17510 (Medical devices -- Sleep apnoea breathing therapy Masks and application accessories) and ISO 5356-1 (Anaesthetic and respiratory equipment Conical connections). These standards specify acceptable ranges for performance characteristics like leak rates and resistance.
- Performance of Legally Marketed Predicate Devices: Especially the primary predicate (ReddyPort NIV Access Elbow, K171827) and reference devices (AF541 EE Full Face Mask, K150639; BRONCHOSCOPY ELBOW, K132168). The subject device must perform as well as or better than these predicates to prove substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a manufactured physical device, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a mechanical device.
Summary of Acceptance and Proof for ReddyPort Elbow:
The ReddyPort Elbow's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices. This is proven through:
- Bench Testing: As detailed in the table above, the device's physical performance characteristics (dead space, leak rates, resistance to flow) are measured and shown to be comparable to, and in some cases better than, the predicate devices, while meeting the requirements of relevant ISO standards. The document explicitly states: "The ReddyPort Elbow met all applicable requirements and acceptance criteria."
- Biocompatibility Testing: The materials used in the device meet the requirements of ISO 10993 series and ISO 18562 series, indicating the device is biologically safe for its intended use and contact duration.
- No Clinical Testing: The FDA determined that no clinical testing was required, implying that the bench testing and comparison to predicates provided sufficient evidence of safety and effectiveness for a 510(k) clearance.
In essence, the "study" proving the device meets acceptance criteria consists of these comprehensive engineering, performance, and biocompatibility tests conducted according to recognized standards, demonstrating the device's functional and safety equivalence to previously cleared devices.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).