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510(k) Data Aggregation
(131 days)
BioTAB, LLC
The PnueAira device and garments for legs and core are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:
- Lymphedema
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sports issues
- Post immobilization edema
- Venous insufficiency
- Reducing wound healing time
- Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial ulcers, and diabetic leg ulcers
- Lipedema
The PnueAira (PNCU-01) is a pneumatic compression device that uses air to systematically compress a patient's limbs affected by lymphedema and/or similar conditions. The control unit is placed on a table near the user and plugged into a power outlet. The patient wears the desired garment (i.e., core or full leg) and attaches it to the control unit via the connectors located on the garment. The patient uses the control unit to select the appropriate prescribed treatment profile, as shown on the device display, to begin their therapy profile. The device supports Peristaltic (i.e., a chamber is inflated and deflated before moving to the next chamber in a particular sequence) and Non-Peristaltic, sometimes known as sequential (i.e., all chambers are inflated in order, then all chambers are deflated simultaneously) compression modes.
The PnueAira device is designed for at-home treatment of lower extremity lymphedema. It assists in reducing lymphedema-related swelling by directing excess fluid from an impaired lymphatic area to healthier parts of the body.
The PnueAira system consists of the following components:
- Control unit
- Power Adapter
- Garments - Core and Full-leg
- Y-Connector Accessory
The provided FDA 510(k) clearance letter for PnueAira (PNCU-01) does not include information about a clinical study or human reader performance. This device is a Class II Compressible Limb Sleeve, and the clearance is based on substantial equivalence to predicate devices, primarily the AIROS 6P Sequential Compression Device.
The submission relies on non-clinical testing to demonstrate safety and effectiveness, rather than clinical trials or studies involving human readers and AI assistance. The information presented specifically details the acceptance criteria regarding the device's functional performance and compliance with relevant electrical safety, usability, home use, and biocompatibility standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from human reader studies, or details regarding sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance, as these were not part of the documented submission for this particular device.
Here's a breakdown of the information that can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document outlines functional and performance testing conducted to ensure the device meets its design specifications and complies with relevant standards. These serve as the "acceptance criteria" for non-clinical performance characteristics.
| Acceptance Criteria Category | Specific Tests/Standards | Reported Device Performance |
|---|---|---|
| Functional Performance | Pressure Profile and Overpressure Testing | "Testing was performed to ensure that the system meets its design specifications." (General statement, specific values not detailed) |
| Treatment Duration Testing | "Testing was performed to ensure that the system meets its design specifications." | |
| Mechanical Connections and Integrity Testing | "Testing was performed to ensure that the system meets its design specifications." | |
| Display and User Interface Testing | "Testing was performed to ensure that the system meets its design specifications." | |
| Therapy Time Accuracy | "Testing was performed to ensure that the system meets its design specifications." | |
| Garment Design and Garment Pressure Integrity Testing | "Testing was performed to ensure that the system meets its design specifications." | |
| Data Integrity USB-C Security Testing | "Testing was performed to ensure that the system meets its design specifications." | |
| Device Longevity Testing | "Testing was performed to ensure that the system meets its design specifications." | |
| Transportation and Shipping | "Other tests completed, such as transportation and shipping (ASTM D1469), demonstrate that design outputs meet user needs and design inputs." | |
| Electrical Safety | IEC 60601-1:2005/AMD2:2020 | "Electrical safety... testing were performed to demonstrate conformity to IEC 60601-1..." (Implies conformity achieved) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014/AMD1:2020 | "EMC testing were performed to demonstrate conformity to IEC 60601-1-2 standards." (Implies conformity achieved) |
| Usability | IEC 60601-6:2010/AMD2:2020 | Demonstrated conformity (Implied by inclusion as a standard used for testing) |
| Home Use | IEC 60601-1-11:2015/AMD1:2020 | Demonstrated conformity (Implied by inclusion as a standard used for testing) |
| Biocompatibility | ISO 10993-1:2018 (Cytotoxicity, Sensitization, and Irritation) | "All intact skin contacting materials used in the PnueAira device are listed in Section B of Annex G of the FDA Guidance Document..." (Implies compliance with biocompatibility requirements for these materials) |
| Firmware | IEC 62304:2015 | "Firmware verification and validation testing were performed per IEC 62304:2015, and therefore, the methods are acceptable." (Implies compliance and proper functioning) |
Information Not Applicable/Provided in the Document:
The following points are typically associated with AI/ML-based medical devices or devices requiring clinical effectiveness studies. This 510(k) submission for the PnueAira (PNCU-01) does not describe such studies.
- Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this device's non-clinical testing. The submission does not mention clinical test sets or patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of clinical expert review is not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI-assisted diagnostic or interpretive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical pneumatic compression system, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the non-clinical testing described. For device performance, the "ground truth" would be established by validated measurement equipment and adherence to standard specifications.
- The sample size for the training set: Not applicable. This device does not use an AI/ML model trained on data.
- How the ground truth for the training set was established: Not applicable.
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