(39 days)
The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope (A1**A series). A number of components and accessories are also necessary for this system.
● EndoArm
This product has been designed for manipulation and positioning of the Neuroendoscope during neurosurgery and spinesurgery.
● Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A)
The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as observation and diagnosis of lumber and cervical spine, such as herniated disc material, nerve roots and nucleus material.
Subject device is a neurological endoscopy system, which consists of EndoArm, a stabilizing fixation component (adapter) and a family of rigid neurological endoscope. A number of component and accessories are also necessary for this system.
(1) EndoArm:
Mechanical: The Endoarm counter balance arm is designed to deliver smooth endoscope movement and steady fixation by use of compressed nitrogen gas to control the arm movement. The shape of the stand differs from the predicate device in that the predicate device is a bedside fixed design and subject device is a floor stand type. This allows physicians to move the endoscope near the target site only.
Illumination: The illumination is supplied by the Neuroendoscope through the light guide cable connected to the separate high intensity light source, OLYMPUS CLV-S40. This light source utilizes a Xenon 300W bulb.
Imaging: Another significant difference from the predicate device is the ability of the EndoArm to manage image data from the Neuroendoscope and allow the user to adjust zoom, focus and manage intego adda resiste the EndoArm from fine adjustment of the endoscope potion to image adjustment by one hand. This feature is accomplished by the connection of the Neuroendoscope through the adapter (A81020A) on the EndoArm. The image from the distal end of Neuroendoscope is transmitted to the monitor via the CCD of OTV-S7V camera head, mounted in the EndoArm.
(2) Neuroendoscope ( model: A81000A, A81001A, A81002A,A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A): Ten telescope models are discussed in this premarket notification. The range of specifications covers two different insertion diameters ( ø 2.7mm / ø 4mm), five different working lengths (107mm/ 110mm / 112mm/134mm/ 137mm) and five different fields of view (0/ 30/ 70/ -30/-70 ( rorme). The crank shaped endoscope offers the largest operation space and microscopic dog. The craint on onail. In one doscope models are substantially equivalent to the predicate Neuroendoscope (#K971340).
(3) Adapter ( model: A81020A): The subject device is an adapter for connecting the Neuroendoscope A810**A series to the EndoArm stabilizing fixation device.
This submission is a 510(k) premarket notification for the OLYMPUS EndoArm, a neurological endoscopy system. The provided document does not contain specific acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with clinical performance studies for AI/ML devices.
The submission is a declaration of substantial equivalence to previously marketed predicate devices (K971340, K982133, K991989). For such devices, acceptance criteria are primarily related to safety, operational specifications, and performance being equivalent to the predicate devices, rather than a clinical performance study with specific metrics like sensitivity or specificity.
Here's an analysis based on the information provided, highlighting why certain questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k) "Substantial Equivalence") | Reported Device Performance (from "Comparison Technological Characteristics") |
|---|---|
| EndoArm (Manipulation and Positioning) | |
| Materials contacting patient: None | None |
| Support system: Floor stand | Floor stand (different from predicate's bedside fixed design) |
| Driving power: Compressed Nitrogen gas | Compressed Nitrogen gas |
| Attachment of TV camera: Attached to the Grip of the Arm | Attached to the Grip of the Arm (different from predicate's direct attachment to endoscope) |
| Zooming capability: Equipped | 2 times (predicate: Not equipped) |
| Image rotation capability: Equipped | 360 degrees (predicate: Not equipped) |
| Design compliance with safety standards | Meets IEC60601-1, IEC60601-1-1, IEC60601-2-18 |
| Neuroendoscopes (Observation and Diagnosis) | |
| Range of Directions of View | 0°, 30°, 70°, -30°, -70° (similar to predicate's 0°, 30°, 70° but expanded) |
| Range of Working Lengths | 107mm, 110mm, 112mm, 134mm, 137mm (different from predicate's 155mm, 158mm) |
| Range of Outer Diameters | 2.7mm, 4mm (similar to predicate's 4mm but expanded) |
| Biocompatibility of patient-contacting materials | Identical materials to cleared 510(k)s, confirmed with ISO 10993-1 |
Study Proving Acceptance Criteria:
The document explicitly states: "Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device." This indicates that a formal clinical study to prove acceptance criteria in the context of diagnostic or treatment efficacy was not performed or required for this 510(k) submission. Instead, the "study" is a technical comparison and demonstration of substantial equivalence to existing legally marketed devices, primarily focusing on design, materials, and functional specifications, along with compliance to relevant safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No clinical test set or data for performance evaluation (e.g., diagnostic accuracy) was used. The submission relies on technical specifications and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No ground truth establishment related to clinical diagnostic accuracy was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is a neuroendoscopy system, not an AI/ML diagnostic or assistive device. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is a medical device (endoscopy system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided for clinical performance. The "ground truth" for this submission revolves around established engineering and material standards (e.g., IEC standards, ISO 10993-1) and the functional specifications of the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
Summary of the "Study" for this 510(k) Submission:
The "study" presented in this 510(k) summary is a technical comparison against predicate devices and adherence to recognized safety standards. The manufacturer asserts that the OLYMPUS EndoArm is substantially equivalent to the identified predicate devices by demonstrating:
- Similar Intended Use: The intended uses for manipulation and positioning of neuroendoscopes and for observation/diagnosis are clearly stated and aligned with the general use of neurological endoscopes.
- Technological Characteristics Comparison: Detailed tables compare the EndoArm and Neuroendoscopes to their respective predicates, highlighting similarities and differences in features like support systems, driving power, imaging capabilities (zoom, rotation), directions of view, working lengths, and outer diameters. Differences are argued not to affect safety or effectiveness.
- Materials Equivalence and Biocompatibility: Patient-contacting materials are stated to be identical to previously cleared devices and confirmed with ISO 10993-1.
- Safety Standards Compliance: The device meets international safety standards (IEC60601-1, IEC60601-1-1, IEC60601-2-18).
The conclusion explicitly states that "When compared to the predicate devices, EndoArm does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness. Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device." This confirms that the substantiation for this 510(k) relies on comparison to predicates and adherence to standards, not on new clinical performance data.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).