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510(k) Data Aggregation
(126 days)
Chemo Mouthpiece, LLC
The Chemo Mouthpiece is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.
The Chemo Mouthpiece is a device that reduces the temperature in the oral cavity to reduce the incidence and severity of oral mucositis (OM) associated with chemotherapy. The device is completely passive (e.g. there are no electrical components) and is designed to manually circulate saline solution and purified water inside a mouthpiece worn by the patient. The Chemo Mouthpiece (CMP) is designed with an inner chamber, an outer chamber, and breathing tubes. Prior to use the device is placed inside a standard freezer for a minimum of 6 hours, which freezes the water solid in the inner chamber, while the saline solution chamber in the outer chamber becomes cold but remains in liquid form. The device is then retrieved from the freezer and placed by the user in the oral cavity per the instructions for use. Cryotherapy is maintained continuously as the user squeezes the device to circulate the cold saline solution around the in the device. Breathing tubes that run throughout the length of the device facilitate breathing during device use.
The Chemo Mouthpiece is intended to cool the oral mucosa to reduce the incidence and severity of chemotherapy-induced oral mucositis in adult patients. The 510(k) summary provides details of the non-clinical performance testing conducted to demonstrate that the device meets its performance specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied / Stated) | Reported Device Performance | Conclusion |
|---|---|---|---|
| Device Cooling Test | Ability to characterize the cooling capacity and demonstrate surface temperatures cooler than the predicate device, meeting design specifications. | The results indicated that the Chemo Mouthpiece met its design specifications and demonstrated surface temperatures that were cooler than that of the predicate device. | Pass |
| Mechanical Integrity Testing | Demonstration of mechanical durability and meeting mechanical integrity requirements under simulated worst-case conditions. | The results indicated that the Chemo Mouthpiece device design met its mechanical integrity requirements when used under stimulated worst case conditions. | Pass |
| Shelf Life and Package Integrity Testing | Package seal integrity after accelerated aging (to support 24-month shelf-life) and continued thermal performance of aged samples. | Results indicated that following accelerated aging package seal met its design requirements and thermal testing on the aged samples indicated that the device continued to meet its design specifications in terms of its cooling capacity. | Pass |
| Biocompatibility | Patient-contacting components (silicone, PVC, and polypropylene) to be found biocompatible according to specific ISO and USP standards (Cytotoxicity, Sensitization, Irritation, Acute Systemic, Pyrogenicity). | Patient contacting component was found to be biocompatible. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text only refers to non-clinical performance testing. It does not mention a "test set" in the context of clinical data, nor does it provide sample sizes for any of the non-clinical tests. Therefore, there is no information about data provenance (country of origin, retrospective/prospective) related to a test set of patient data. The tests are laboratory-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The reported studies are non-clinical performance tests (cooling capacity, mechanical integrity, shelf-life, biocompatibility) of the device itself, not studies evaluating diagnostic or therapeutic accuracy against a clinical ground truth.
4. Adjudication Method for the Test Set:
Not applicable. There is no clinical test set with associated ground truth requiring adjudication. The studies are technical performance evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance of the device and its substantial equivalence to a predicate, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm only without Human-in-the-Loop Performance) Was Done:
Not applicable. The Chemo Mouthpiece is a passive medical device, not an algorithm or AI system. Its performance is evaluated directly through physical and chemical testing, not through algorithmic output.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by the technical specifications and standards against which the device's performance is measured.
- Device Cooling Test: Ground truth is the defined temperature range or cooling capacity that the device is expected to achieve, and comparison to the predicate device's cooling.
- Mechanical Integrity Testing: Ground truth is the defined mechanical durability and integrity requirements under simulated worst-case conditions.
- Shelf Life and Package Integrity Testing: Ground truth includes the defined package seal integrity after accelerated aging and the thermal specifications for the aged device.
- Biocompatibility: Ground truth is established by the specified ISO and USP standards (ISO 10993-5, ISO 10993-10, ISO 10993-11, USP).
8. The Sample Size for the Training Set:
Not applicable. This is a passive medical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is relevant for this device.
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