Search Results

The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location.

The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.

This document describes a 510(k) premarket notification for a medical device called the "Nasal Scavenging Circuit." This type of submission focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its independent safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA) application.

Therefore, the study conducted is not a traditional performance study comparing specific metrics against pre-defined acceptance criteria in the way an AI/ML device would be. Instead, the "study" is a set of non-clinical bench tests designed to show that the new device does not raise new issues of safety or effectiveness compared to its predicate.

Here's an analysis based on the provided text, addressing your specific questions to the best extent possible given the nature of a 510(k) submission for this type of device:

1. A table of acceptance criteria and the reported device performance

The device's technological characteristics, indications for use, and performance specifications are stated to be the same as the predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)), implying that it performs at least as safely and effectively as the predicate.

Adherence to pertinent sections of voluntary standards (NIOSH Publication No. 94-129, ISO 5356-1, ISO 5367, ANSI Z79.11-1982, CGA V-5) for design indicates meeting established safety and performance benchmarks for components and functionality. |
| Effectiveness: Device performs its intended function for removal of expired/excess gases. | "The indications for use, the technology, and the performance specifications are the same for the Nasal Scavenging Circuit and the predicate device." This statement is the core of the substantial equivalence claim, meaning its effectiveness is considered equivalent to the predicate.

The bench testing would have demonstrated functional performance, such as gas flow, scavenging efficiency, and connection integrity, consistent with the predicate device and relevant voluntary standards, though specific numerical performance metrics are not detailed in this summary. |
| Substantial Equivalence: Device does not raise new issues of safety or effectiveness. | The FDA’s letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices," based on the provided data from the manufacturer. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of human data. The "test set" consisted of physical devices subjected to non-clinical bench testing. The number of units tested is not specified in this summary.
• Data Provenance: The testing was "bench testing" meaning it was conducted in a laboratory setting. The location of MINRAD Inc. (Orchard Park, New York, USA) suggests the testing likely occurred in the USA or a facility associated with the company.
• Retrospective or Prospective: Not applicable for bench testing. It's a controlled experimental evaluation of the physical device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is a physical device being evaluated for substantial equivalence through non-clinical bench testing, not an AI/ML diagnostic device requiring expert interpretation of clinical data to establish ground truth. The "ground truth" (or performance standard) would be defined by the technical specifications of the predicate device and the relevant voluntary standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like "2+1" typically apply to expert reviews of clinical cases (e.g., in radiology studies) where there might be disagreement among reviewers on a diagnosis or finding. This submission involves bench testing of a physical device. Performance would be an objective measurement against a standard, not a subjective interpretation 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. An MRMC study is not relevant for this device. This is a physical gas scavenging circuit, not an AI/ML-driven diagnostic tool that assists human readers in interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical product, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this 510(k) submission is effectively the performance and safety profile of the predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)) and adherence to relevant voluntary standards (e.g., NIOSH, ISO, ANSI, CGA V-5). The bench tests verify that the new device meets or is equivalent to these established engineering and safety standards.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. No training set exists for this type of device submission.

Ask a specific question about this device