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The InfraVision Ureteral Kit with the InfraVision IR Illuminator is intended to transilluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038"-guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.

The Stryker Ureteral IIIumination System IV consists of an open-ended ureteral catheter, which allows the use of a guidewire (up to 0.038" dia), is composed of Pellethane™ with a hydrophilic coating to ease insertion into the ureters and incorporates a fiberoptic light guide that is used with the InfraVision IR llluminator to transluminate the ureter during surgical procedures. It can be used for either open surgical or laparoscopic access and is distributed as a sterile, single use disposable product. The device is validated for EtO sterilization to a SAL of 10°.

The provided text is a 510(k) summary for the Stryker Ureteral Illumination System IV. It describes the device's intended use and claims substantial equivalence to a predicate device, the Stryker Ureteral Illuminator System III (K982542).

However, the document does NOT contain any information regarding specific acceptance criteria for performance, a study detailing device performance against those criteria, sample sizes, expert ground truth establishment, or any of the other detailed study parameters requested in your prompt.

The 510(k) summary primarily focuses on:

• Device Name and Classification: Identifying the device and its regulatory classification.
• Intended Use: Stating what the device is for (transilluminating the ureter during surgical procedures).
• Technological Characteristics: Describing the components (catheter, guidewire compatibility, materials, hydrophilic coating, fiberoptic light guide) and sterilization method.
• Substantial Equivalence Claim: Asserting that the device is as safe and effective as the predicate device and that technological differences do not affect safety or efficacy.
• Standards Conformance: Listing general safety and performance standards the device will conform to (e.g., ISO, AAMI, ASTM).

Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text, as this information is not present. The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting de novo clinical performance data against specific acceptance criteria for a novel device.

Summary of available information from the text:

• Acceptance Criteria & Reported Device Performance: Not explicitly stated or detailed. The submission relies on claiming substantial equivalence to a predicate device.
• Sample Size (test set) & Data Provenance: Not mentioned. No specific "test set" or performance study is described.
• Number of experts and qualifications for ground truth: Not applicable, as no ground truth establishment for a performance study is described.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable; this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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