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510(k) Data Aggregation
(294 days)
RHINOGUARD
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.
The device can be used with cuffed and non-cuffed nasal endotracheal tubes.
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to ease the passage of a nasal endotracheal tube from the nares to the oropharynx. The Rhinoguard device is constructed primarily of polyvinylchloride and consists of a tube with a hollow proximal end, a tapered cylindrical body and a closed, rounded distal end. The device has markings to indicate the approximate mating location for corresponding sizes of nasal endotracheal tubes. The device is provided in a small and large size. The small Rhinoguard is intended to mate with 3.0 to 4.5 mm nasal endotracheal tubes and the large Rhinoguard is intended to mate with 5.0 to 8.0 mm nasal endotracheal tubes. The device can be used with cuffed and non-cuffed nasal endotracheal tubes. Prior to using the device, the desired size of the nasal endotracheal tube must be selected and then matched to corresponding Rhinoguard size (large or small). The device is then cut just above the indices (marks) corresponding to the selected endotracheal tube size and connected with the endotracheal tube. Once mated, the distal end of the device is introduced into the naris of choice and gently pushed forward into the oropharynx. Lastly, the distal end of Rhinoguard is grasped and removed from the mouth with the aid of a laryngoscope and McGill forceps.
The provided text describes a 510(k) premarket notification for a medical device called "Rhinoguard," which is a nasal endotracheal tube introducer/dilator. The document details the device, its intended use, comparison to predicate devices, and the non-clinical testing performed to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All performance testing met acceptance criteria defined in protocols." However, it does not explicitly list the quantitative acceptance criteria for each test. It only provides the purpose of each test. Below is a table summarizing the tests, their stated purpose (which implies the performance objective), and the reported outcome.
| Test Category | Test Description / Purpose | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Kink Testing | To confirm that the Rhinoguard meets the pre-determined flexibility requirements and that device performance is equivalent to the predicate device. | Met acceptance criteria; equivalent to predicate device. |
| Disconnection Testing | To confirm that the Rhinoguard meets the pre-determined flexibility requirements and that the device performance is equivalent to the predicate device. (Likely meant to assess the connection between Rhinoguard and ETT) | Met acceptance criteria; equivalent to predicate device. |
| Perforation Testing | To confirm that the Rhinoguard is less of a penetrator than the predicate device. | Met acceptance criteria; less of a penetrator than predicate. |
| Biocompatibility | ||
| Biocompatibility Testing (cytotoxicity, systemic toxicity, intracutaneous, maximization sensitization) | To confirm that the Rhinoguard meets pre-determined biocompatibility requirements. | Met acceptance criteria. |
| Sterilization | ||
| Sterility Testing (bioburden, verification dose, sterility, bacteriostasis/fungistasis) | To confirm that the Rhinoguard can be sterilized to a Sterility Assurance Level (SAL) of 1.0 X 10-6. | Met acceptance criteria; SAL of 1.0 X 10-6 achieved. |
| Shelf Life & Packaging | ||
| Shelf Life Testing (Packaging - label retention, seal strength, bubble leak test, package drum test, dye penetration) | To confirm that the device packaging functionality and performance is acceptable after the desired shelf life of the product. | Met acceptance criteria. |
| Shelf Life Testing (Device — kink, disconnection, and perforation) | To confirm that the device functionality and performance is acceptable after the desired shelf life of the product. | Met acceptance criteria. |
| Usability | ||
| Design (Usability) Validation Testing | To confirm that the Rhinoguard meets the intended use, user needs, and usability requirements when tested under a simulated use environment. | Met acceptance criteria. |
The document states, "In conclusion, the proposed device performed equivalent to or better than the predicate device. All performance testing met acceptance criteria defined in protocols."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the sample size used for any of the non-clinical (bench) tests.
- Data Provenance: The tests are described as "nonclinical (bench) test results." The document does not provide details on the location or nature of laboratories, nor does it specify if the data is retrospective or prospective. Given the nature of bench testing, it is typically prospective and controlled laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not mention using experts to establish ground truth for the performance tests. The evaluation is based on objective bench testing against pre-defined protocols and comparison to predicate devices, not expert consensus on interpretations.
- For the "Design (Usability) Validation Testing," it states it was tested "under a simulated use environment," which implies human interaction, but it does not specify the number or qualifications of users/experts involved in this validation.
4. Adjudication method for the test set
- The document does not describe any adjudication method as typically understood for medical image analysis or diagnostic studies (e.g., 2+1, 3+1). The tests are bench tests with objective outcomes (e.g., meeting a strength threshold, absence of kink, sterility level), not subjective interpretations requiring 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
- No MRMC comparative effectiveness study was done. This device is a physical medical instrument (an introducer/dilator for endotracheal tubes), not an AI/software device intended for diagnostic interpretation or to assist human "readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the Rhinoguard is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" or reference standard for performance is the pre-defined acceptance criteria specified in the test protocols and, for some tests (kink, disconnection, perforation), comparison to the performance of the predicate device. For biocompatibility, it's ISO standards. For sterility, it's an SAL. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these tests.
8. The sample size for the training set
- This question is not applicable as the Rhinoguard is a physical medical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable as the Rhinoguard is a physical medical device, not an AI/software device that requires a training set or ground truth for training.
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