(263 days)
The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable fiberoptic light source, and a combined disposable balloon dilation catheter. It is intended to transilluminate the esophagus during the fundoplication procedure as well as other thoracoscopic, laparoscopic, or open surgical procedures on the esophagus. The Stryker InfraVision™ Esophageal Kit is intended to help the surgeon identify organs and placement of medical tissue.
The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable fiberoptic light source, and a combined disposable balloon dilation catheter.
The provided documentation for K983220, the Stryker InfraVision™ Esophageal Kit, does not contain information on acceptance criteria or a study proving that the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
Here's a breakdown of why the requested information is absent and what the document does provide:
- Acceptance Criteria & Device Performance: These are not mentioned. The submission's core argument is that the device is "equivalent in safety and effectiveness to currently marketed devices." It does not present novel performance data or specific thresholds it aims to achieve.
- Study Details: No study is described that would involve sample sizes, data provenance, expert ground truth, adjudication methods, MRMC analysis, or standalone algorithm performance. This type of detailed study is typically associated with devices that introduce new mechanisms of action, novel clinical claims, or AI/software components that require empirical validation of performance.
- Ground Truth: Since no performance study is detailed, the concept of ground truth for a test set or training set is not applicable in this submission.
- Training Set Size & Ground Truth (for AI): The device described is an "esophageal transillumination dilation device," a physical medical instrument with a light source and dilator. It is not an AI or software-as-a-medical-device (SaMD) product, therefore, training sets and AI-specific ground truth are irrelevant to this submission.
Summary of Information from the Provided Document:
The 510(k) submission for the Stryker InfraVision™ Esophageal Kit (K983220) focuses on demonstrating substantial equivalence to predicate devices. The arguments presented are:
- Compliance with Standards: The illumination source will comply with 21 CFR 1040.10 Performance Standard for Medical and Dental Equipment.
- Material Equivalence: Constructed of materials with the same manufacturing process, chemical composition, body contact, and sterilization methods as currently marketed and approved medical devices, and are safe, effective, and durable.
- Intended Use: The device is intended to help the surgeon identify organs and placement of medical devices and help illuminate the esophagus during thoracoscopic, laparoscopic, or open surgical procedures (e.g., fundoplication).
- Predicate Devices: Gabriel InfraVision™ Esophageal Kit (K960173), Bard Balloon Dilatation System (K86343), Sherwood Argyle Salem Sump Tube (K810156), BioEnterics EndoLumina Illuminated (K960173, K86343, K810156, 11-12-20148 - this last one seems like a typo/fragment). The submission explicitly states, "this device does not raise new issues when compared to its predicate devices or uses."
Conclusion:
Based on the provided text, the submission for K983220 relies on demonstrating substantial equivalence to existing, legally marketed devices rather than presenting specific acceptance criteria and performance study data for novel claims. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, and expert adjudication is not present in this regulatory document.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.