(40 days)
The Esophagus Bougie Set was designed to treat cancer of the esophagus. The Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation source to the esophagus when used in conjunction with a Varian high dose rate afterloader.
The Varian Medical Esophagus Bougie is an HDR applicator designed to facilitate delivery of radiation to the Esophagus and has been modified to work with Varian Medical afterloaders. The bougie tube and catheter can be cleaned and disinfected with high level disinfectants and has a maximum insertion time of 24 hours. The clamping screw, bite protector and threaded ring can be steam sterilized. The fixation strap and guide wire are single use. The device does not contain any electronics or software. A high activity radioactive source is placed within the applicator which has previously been placed for a specified clinical purpose in a patient. The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into the applicator within the patient. The length of time and position that the High Dose Rate source spends within the applicator is controlled in accordance with an Irradiation Treatment Prescription.
Here's an analysis of the provided text regarding the Varian Esophagus bougie, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Met pre-defined acceptance criteria for cleaning and disinfection of bougie tube and catheter per DIN EN ISO 17664 (July 2004). | Non-clinical testing showed the test articles met the pre-defined acceptance criteria, demonstrating the effectiveness of the cleaning and disinfection process and agents. |
| Biocompatibility | Met requirements in accordance with ISO 10993-1, 10993-5, and 10993-10. | Biocompatibility testing showed the device is safe for bodily contact. |
| Material Performance | Reformulated material did not impact device performance. | Non-clinical testing showed the test articles met the pre-defined acceptance criteria, demonstrating the reformulated material did not impact device performance. |
| Material Biocompatibility | Reformulated material did not impact biocompatibility. | Non-clinical testing showed the test articles met the pre-defined acceptance criteria, demonstrating the reformulated material did not impact biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "test articles" but does not quantify the number of bougies or materials tested for efficacy, biocompatibility, or material performance.
- Data Provenance: The studies were non-clinical testing performed by Varian Medical Systems, Inc. The country of origin is not specified but is presumably where Varian conducts its internal testing. The studies are by nature prospective as they were specifically designed and executed to evaluate the device changes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The studies described are non-clinical engineering and bench tests, not clinical studies involving human patients or expert review of outputs like images. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation does not apply here. The "ground truth" would be established by validated laboratory testing methods and standards.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies described are non-clinical engineering and bench tests, not clinical studies requiring adjudication of human interpretations or outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing related to sterilization, biocompatibility, and material changes. There is no mention of human readers or comparative effectiveness studies with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device (Esophagus bougie) is a physical medical device and is not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant to this submission.
7. The Type of Ground Truth Used
- The ground truth used for these non-clinical tests would be:
- Validated laboratory and engineering standards: For sterilization efficacy (DIN EN ISO 17664), biocompatibility (ISO 10993-1, 10993-5, 10993-10), and material performance. The "ground truth" is defined by the successful adherence to these recognized standards and the absence of deleterious effects.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As this is not an AI or machine learning model, there is no training set or corresponding ground truth establishment process in this context.
§ 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.