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510(k) Data Aggregation
(285 days)
FOR VISUALIZATION OF AIRWAY ANATOFILY AND INDICATED PLACING AND CONFIRMING PLACEMENT of AID IN THE To ARTIFICIAL AIRWAYS
The Model 30000-V endoscope is a tubular device with a malleable shaft. The optical element of the endoscope consists of a small diameter camera bonded into the distal tip of the endoscope shaft. The removable shaft of the endoscope is attached to the battery and video screen by means of various electrical connectors. Illumination light is provided at the tip of the endoscope for direct viewing. The removable shaft of the endoscope is soakable and can be high-level disinfected. A waterproof cap is provided to protect the connector during the cleaning/disinfection process.
The provided text describes a 510(k) summary for the Clarus Model 30000-V Video Endoscope. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with defined acceptance criteria and statistical analysis of performance against ground truth. Therefore, much of the requested information, particularly regarding detailed performance metrics, ground truth establishment, expert involvement, and MRMC studies, is not present in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity) against a specific ground truth are not provided. The acceptance criteria for this submission are based on demonstrating equivalence to predicate devices and meeting physical and biocompatibility requirements.
| Acceptance Criteria Category | Reported Device Performance (as per submission) |
|---|---|
| Substantial Equivalence to Predicate Devices | The Clarus Model 30000-V is stated to be substantially equivalent to other FDA Cleared video endoscopes on the market for the stated Indications for Use. Similarities in materials, size, configuration, packaging, and disinfection methods are cited. |
| Biocompatibility | "All materials that may come into contact with human tissue during normal use are biocompatible and are suitable for this application." |
| Physical Testing | "Physical testing of the endoscope included: dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study." (Specific pass/fail criteria or quantitative results not provided in the summary.) |
| Indications for Use Equivalence | The clinical Indications for Use are equivalent to those of other FDA Cleared predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not explicitly stated. The submission primarily relies on demonstrating substantial equivalence to predicate devices and meeting physical and biocompatibility testing. There is no mention of a clinical test set with a specific sample size used to evaluate performance against ground truth in a clinical setting.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No clinical test set requiring ground truth establishment by experts is described in this 510(k) summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring expert adjudication is described in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it quantify any effect size. This type of study is more common for AI-driven diagnostic or screening tools.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Standalone Study: No. The device is a video endoscope, a tool used by a human practitioner for visualization. Its performance is intrinsically linked to human-in-the-loop operation, and the concept of an "algorithm only" standalone performance is not relevant to this device type as described.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for clinical performance evaluation. The "ground truth" implicitly used for this 510(k) is the established safety and effectiveness of the identified predicate devices, as well as the successful completion of standard physical and biocompatibility testing.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a traditional medical device (video endoscope), not an AI/ML-driven device that requires a training set for model development.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. As stated above, this is not an AI/ML device requiring a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (in the context of a 510(k) submission) is the demonstration of substantial equivalence to legally marketed predicate devices and the successful completion of physical and biocompatibility testing.
The key elements of this "study" are:
- Comparison to Predicate Devices: The Clarus Model 30000-V Video Endoscope was compared to Vision-Sciences ENT-5000 and ENT-5100 Video ENTS (K072073), Karl Storz Video Bronchoscope System (K071530), Clarus 2127 Murphy Pen (K962255), and ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233. The submission asserts equivalence in materials, sizes, configurations, packaging, disinfection methods, and especially in the "Indications for Use: visualization of airway anatomy to aid in the placing and confirming placement of artificial airways."
- Physical Testing: Included dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study. While specific results are not detailed in this summary, the completion of these tests suggests they met internal specifications.
- Biocompatibility Testing: Confirmed that all materials in contact with human tissue are biocompatible and suitable for the application.
The conclusion drawn from these comparisons and tests is that "this product do not raise any new safety or effectiveness issues," thereby satisfying the requirements for 510(k) clearance by demonstrating substantial equivalence.
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