(91 days)
The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
The reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Proposed Device") is identical to the Original Monarch Bronchoscope, MBR-000211-A, (hereafter referred to as "Predicate Device"), which is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that can be reprocessed up to one (1) time.
The Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the predicate Monarch Platform bronchoscope.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Cleaning Validation | Worst-case device conditioning was considered. | Device is adequately cleaned | Pass |
| Functional Performance and System Compatibility | Performance of the Proposed Device was verified to not be negatively impacted by reprocessing. Worst-case device conditioning was considered. | No negative impact from reprocessing | Pass |
| Electromagnetic Compatibility and Electrical Safety | Evaluated for electrical safety and EMC compliance to AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-18. Worst-case device conditioning was considered. | Compliance with standards | Pass |
| Biocompatibility | Evaluates the end-of-life biocompatibility of the limited-contact device in accordance with ISO 10993-1:2018. Worst-case device conditioning was considered. | Compliance with ISO 10993-1 | Pass |
| Sterilization | Assessed in accordance with ISO 11135:2018. Sterilization residuals assessed in accordance with ISO 10993-7:2008. Uses a validated Ethylene oxide sterilization process with a half-cycle overkill approach to achieve a minimum sterility assurance level of 10-6. | Sterility Assurance Level of 10-6 and compliance with standards | Pass |
Note: The document implies the acceptance criteria through the description of the tests and the "Pass" results. Specific numerical or qualitative thresholds for "Pass" are not detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size used for the test set for each performance test. It mentions "worst case device conditioning" for several tests, implying that specific devices were subjected to these conditions.
Regarding data provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for reprocessing validation, it would typically involve prospective testing of reprocessed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given text. The tests described are primarily engineering and safety validation tests (cleaning, functional, electrical, biocompatibility, sterilization) rather than clinical studies requiring expert interpretation of results to establish ground truth in a diagnostic context.
4. Adjudication Method for the Test Set:
This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement needs resolution. The described tests are objective performance tests which would not typically involve such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission focuses on demonstrating the safety and effectiveness of a reprocessed bronchoscope compared to its original form, primarily through laboratory and performance testing, not direct comparative clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable to the device described. The Monarch Bronchoscope is a physical medical device, specifically a reprocessed bronchoscope, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance tests described (cleaning, functional, electrical, biocompatibility, sterilization) are evaluations of the hardware itself.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests is established by:
- Engineering Specifications/Design Requirements: Functional and system compatibility tests verify performance against the original design.
- International Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 for electrical safety and EMC, ISO 10993-1:2018 for biocompatibility, and ISO 11135:2018 for sterilization.
- Validated Processes: For cleaning and sterilization, the ground truth is established by the successful validation of the reprocessing protocol itself, ensuring devices meet specified cleanliness and sterility levels (e.g., SAL of 10-6).
8. The Sample Size for the Training Set:
This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm.
§ 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.