(62 days)
The Intraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the bile duct using HDR brachytherapy.
The Intraluminal Applicator Set is intended for intrapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.
The Intraluminal Applicator Set acts to guide the radioactive source to the correct location for treatment.
Key performance characteristics are as follows:
- . Suitable for treating body sites allowing insertion of a catheter.
- CT compatible. ●
- MR Compatibility: Safe. ●
- Fits a 2 mm diameter bronchoscope biopsy channel allowing for easy insertion.
- Elastomer construction provides increased flexibility for easy placement and luminal rigidity to avoid kinks. ●
- Nylon monofil adds luminal stability during catheter insertion and manipulation. ●
- Comes with 2.8 mm spacing tubes, which minimize surface dose. .
- . Spacing tubes enable secure placement during treatment.
- The bronchial catheter and monofil are supplied sterile, and for single use.
- . The guide tubes, the bronchial catheter, the bite catheters are intended for continuous use for less than 24 hours of contact with patients.
The provided document is a 510(k) Premarket Notification for a medical device called the "Intraluminal Applicator Set." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting effectiveness studies with explicit acceptance criteria and performance metrics.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria for device performance, the specific study design to prove those criteria (like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used.
Instead, the document details non-clinical testing performed to establish the device's safety and effectiveness in comparison to its predicate. The "Summary of Performance Testing (Non-Clinical Testing)" section outlines the types of tests conducted:
- Biocompatibility Testing: Confirms the compatibility of skin-contact components with requirements as per ISO 10993-1. Specific tests included Hypersensitivity, Material Mediated Pyrogen, and Acute Systemic Toxicity.
- Cleaning, Disinfection, and Sterilization Testing: Verifies that components can be effectively sterilized and reused for the specified number of times.
- Human Factors Validation Study: Conducted according to IEC 62366 to ensure the device is safe and effective for intended users, uses, and environments.
- Mechanical and Acoustic Testing: Formal design validation testing to demonstrate the device performs as intended.
- Magnetic Resonance Testing (MR): Confirms the device is MR Safe, complying with ASTM F2503-23.
- Electromagnetic Compatibility (EMC) Testing: Assessed against IEC 60601-2-17 to demonstrate compatibility in an electromagnetic setting.
The "Determination of Substantial Equivalence to the Predicate" section states: "The results of verification as well as conformance to relevant safety standards demonstrate that the safety and performance criteria." This implies that the 'acceptance criteria' for this submission are met when the device successfully passes these non-clinical tests and conforms to the listed standards.
Without the specific details of a clinical performance study with acceptance criteria, I cannot complete the requested tables and information as described in the prompt. The document is a regulatory submission for substantial equivalence based on technical and safety characteristics, not a clinical efficacy trial.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.