(88 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion™ Endoluminal System (Model IF1000) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The Model IF 1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, and Swivel Connector facilitate use of the Model IF1000 Instruments.
The provided text is a 510(k) Summary for the Intuitive Surgical Ion™ Endoluminal System (Model IF1000). This submission specifically focuses on adding an alternative automated microbicidal reprocessing method for certain components (Catheter and Vision Probe) compared to the previously cleared manual method.
Therefore, the acceptance criteria and study proving the device meets them are related to demonstrating that this new reprocessing method does not negatively impact the device's safety and effectiveness and that the device, when reprocessed by the automated method, remains substantially equivalent to the device reprocessed by the manual method.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All testing passed the predetermined acceptance criteria" for each category. Specific numerical acceptance criteria or performance metrics are not provided in this summary. Instead, the performance is reported as meeting the criteria.
| Test Category | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Demonstrate efficacy of automated reprocessing in disinfecting/sterilizing the devices per AAMI TIR12:2010. | All testing passed the predetermined acceptance criteria. Device efficacy for disinfection/sterilization demonstrated. |
| Biocompatibility | Assess biological responses to patient contact from chemical residuals per ISO 10993-5:2009 (Cytotoxicity). | All testing passed the predetermined acceptance criteria. No adverse biological responses detected. |
| Bench Testing | Verify and validate existing functional requirements met after automated microbicidal process. | All testing passed the predetermined acceptance criteria. Functional requirements continue to be met. |
| Usability Testing | Intended users can successfully understand and perform reprocessing procedure safely and effectively following instructions. | The study demonstrates the intended users can successfully understand and perform the intended reprocessing procedure safely and effectively while following the reprocessing instructions manuals. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Reprocessing Validation: "3 automated reprocessing equipment were validated." The sample size for devices reprocessed with each equipment is not specified (e.g., number of cycles, number of devices).
- Biocompatibility: "Testing was performed on the Model IF1000 devices subjected to each representative automated reprocessing equipment." Specific sample size not detailed.
- Bench Testing: The document lists "Design Verification Testing" and "Reliability Testing" for both the Catheter and Vision Probe. Specific sample sizes for each test are not detailed.
- Usability Testing: The sample size of users involved in the human factors study is not provided.
- Data Provenance: Not explicitly stated, but implicitly, given the nature of a 510(k) submission for a US market, the testing would be conducted within a controlled environment compliant with US regulatory standards. It's a prospective study designed to validate the new reprocessing method for market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable in this Context: This submission is focused on the device's ability to withstand a new reprocessing method and maintain its original safety and performance characteristics, rather than making a diagnostic claim or requiring human expert interpretation for "ground truth" in the typical sense of an AI/ML device study.
- The "ground truth" here is objective: whether the device is successfully disinfected/sterilized, retains its functionality, and is safe for patient contact. This is established through validated testing protocols, not expert consensus on diagnostic images.
4. Adjudication Method for the Test Set:
- Not Applicable (or Implicit/Internal): Since the studies described are primarily engineering and reprocessing validation, they involve objective measurements against predetermined acceptance criteria. There's no mention of an external adjudication panel of experts for subjective interpretation, as might be found in a clinical imaging study involving human readers. Any "adjudication" would be internal to the testing process, ensuring that results consistently meet the established pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:
- No: An MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI algorithm on human reader performance for diagnostic tasks. This 510(k) is for a physical device with a new reprocessing method validation, not for an AI/ML diagnostic aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Implicit: This is not an AI/ML device being evaluated for standalone performance. The "Ion Endoluminal System" does have software (PlanPoint™ and System Software), but the focus of this 510(k) is on the reprocessing of physical instruments. The software's performance itself (e.g., navigation accuracy) was likely evaluated in the original K182188 clearance. Bench testing for the physical components did evaluate their functional performance after reprocessing (which could be considered a form of "standalone" evaluation of the physical device's characteristics).
7. The Type of Ground Truth Used:
- Objective, Measured Parameters:
- Reprocessing Validation: Microbial load reduction (e.g., sterilization/disinfection effectiveness confirmed by microbiological assays).
- Biocompatibility: Absence of cytotoxicity (confirmed by cellular assays).
- Bench Testing: Device functional specifications (e.g., mechanical integrity, electrical performance, dimensional accuracy) met after reprocessing (confirmed by engineering measurements and tests).
- Usability Testing: Successful completion of tasks by intended users as per instructions (confirmed by observation and task analysis).
8. The Sample Size for the Training Set:
- Not Applicable: This submission does not pertain to an AI/ML device that requires a training set of data. The device itself is a bronchoscope system.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no AI/ML training set, there is no ground truth to be established for it in this context.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.