(37 days)
- To be used for control of posterior nasal epistaxis.
- To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration.
The Post-Stop™ Epistaxis Catheter is a single balloon catheter with integral suction catheter designed for control of posterior intra-nasal hemorrhaging. It can also be used as an inter-operative packing to aid in prevention of fluid aspiration. The balloon is designed to control bleeding in the posterior chamber. The multi-port suction/irrigator catheter can be used to keep the nasal area clear and to help prevent the catheter from clogging. An internal guide wire is included to help direct the catheter into the posterior chamber and is removed after catheter placement. The Post-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.
The provided text describes a 510(k) submission for the Post-Stop™ Epistaxis Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics in the way a clinical trial for a new drug or novel medical device might.
Therefore, many of the requested categories are not applicable or cannot be extracted from this document because it is a regulatory summary for a device seeking substantial equivalence, not a standalone clinical study report.
Here's an attempt to address the request based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or specific performance metrics in the format of a clinical study. The "acceptance criteria" for a 510(k) submission are typically met by demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (from document) |
|---|---|
| Substantially equivalent to predicate device (Invotec International, Inc. Product No. 20-10710) in intended use, technological characteristics, and safety/effectiveness. | "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." |
| Constructed from well-established medical grade materials. | "Device is constructed using well-established medical grade silicone." |
| Effective for control of posterior nasal epistaxis. | Intended Use: "To be used for control of posterior nasal epistaxis." (Performance implied by intended use and substantial equivalence) |
| Effective as an inter-surgical posterior nasal packing to help prevent fluid aspiration. | Intended Use: "To be used as an inter-surgical posterior nasal packing to help prevent fluid aspiration." (Performance implied by intended use and substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The 510(k) summary does not describe a clinical test set in the traditional sense. It relies on the claimed substantial equivalence to a predicate device, which implies that the predicate device's performance data (or general understanding of such devices) is the basis for equivalence, not a new test set for this specific device.
- Data Provenance: Not applicable. No specific clinical data from a "test set" is presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As no new clinical test set is described, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set is described.
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
- Not applicable. This is a medical device (catheter) and the submission refers to a 510(k) for substantial equivalence, not an AI-powered diagnostic or therapeutic device. No MRMC study or AI component is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
- Not applicable in the context of a new clinical study. The "ground truth" for a 510(k) submission is the established safety and effectiveness of the predicate device that the new device is compared against.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.