(67 days)
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient. Patients who require colonoscopy and enteroscopy except as follows: Patients with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator Pregnant women
This instrument has been designed to be used with an Olympus endoscope and the endoscope position detecting unit for detection and display of the location and/or shape of the inserted endoscope.
The Endoscope Position Detecting Unit (UPD-3) has been designed to be used with Olympus endoscope systems and Endoscope Position Marking Probe (MAJ-1878) for the detection and display of the shape of an endoscope once inserted into the patient. The UPD-3 detects the magnetic field generated by magnetic coils built directly into the endoscope or the MAJ-1878 inserted into the endoscope's instrument channel. The position coordinate of each coil is computed by carrying out arithmetic processing and is displayed on the UPD-3 monitor.
The provided document describes a Traditional 510(k) Notification for the ENDOSCOPE POSITION MARKING PROBE (MAJ-1878) and the ENDOSCOPE POSITION DETECTING UNIT (UPD-3) by Olympus Medical Systems, Corp. The submission concludes that the devices are substantially equivalent to their predicate devices and do not incorporate significant changes that would affect safety or effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific performance-based acceptance criteria in numerical terms (e.g., accuracy percentages, precision metrics) for the device's function of detecting and displaying endoscope shape/position.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various non-clinical tests and adherence to standards, implying that meeting these standards and showing no degradation from the predicate constitutes meeting acceptance criteria.
The "reported device performance" is implicitly that the device performs as intended for "detection and display of the shape of an endoscope once inserted into the patient" and maintains the safety and effectiveness of the predicate devices.
| Acceptance Criteria Category | Detail (from document) | Reported Device Performance |
|---|---|---|
| Technological Equivalence (UPD-3) | No technological difference between the subject and predicate devices, except for minor software features that do not affect safety and effectiveness. | The UPD-3 detects the magnetic field generated by magnetic coils and computes/displays the position coordinate of each coil, maintaining the performance and specifications of the predicate device (K103312). |
| Technological Equivalence (MAJ-1878) | Addition of use in the small intestine, and modifications to materials, dimensions, and applicable reprocessing methods, which do not affect safety and effectiveness. | The MAJ-1878, when used with an Olympus endoscope and the UPD-3, facilitates the detection and display of the location and/or shape of the inserted endoscope, performing as intended without compromising safety or effectiveness due to modifications. |
| Bench Testing | Bench test of small intestine model performed. | Implied confirmation that the device functions correctly and safely within the small intestine model. |
| Risk Analysis | Carried out in accordance with ISO 14971:2007, identifying design verification tests and acceptance criteria. | Implied that all identified risks were mitigated to acceptable levels through design and testing. |
| Software Validation | Performed in accordance with FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Minor Level of Concern). | Implied that the software functions reliably and safely as intended, with no identified safety or effectiveness issues. |
| Biocompatibility | Performed in accordance with FDA Guidance, "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1". | Implied that the device materials are biocompatible and safe for patient contact. |
| Reprocessing Validation | Performed in accordance with FDA guidance "Labelling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996" and "Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – May 2011". | Implied that the device can be safely and effectively reprocessed according to manufacturer instructions, maintaining sterility and functionality. |
| Adherence to Standards | Applied various IEC and ISO standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-2, ISO 14971, IEEE Std C95.1 for UPD-3). | Implied that the device meets general safety and performance requirements for medical electrical equipment and risk management. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set that would typically involve patient data or human subjects. The described "tests" are primarily bench tests and validation activities against established standards and internal acceptance criteria.
The data provenance is from non-clinical testing in a controlled environment, including a "bench test of small intestine model." The country of origin of the data is not specified beyond being generated by Olympus Medical Systems Corp. and its manufacturing affiliates (Japan). The data is retrospective in the sense that it evaluates the device against pre-defined specifications and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The nature of the non-clinical tests (bench tests, risk analysis, software validation, biocompatibility, reprocessing validation, adherence to standards) did not involve establishing ground truth through human experts in the way clinical studies or expert review for diagnostic AI would. Decisions were based on engineering specifications, regulatory guidelines, and scientific standards.
4. Adjudication Method for the Test Set
Since the tests described are non-clinical (bench tests, validation against standards), an adjudication method like "2+1" or "3+1" (which typically applies to expert consensus in clinical data review) is not applicable and not mentioned in the document.
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 for substantial equivalence, not a clinical trial involving human readers or comparative effectiveness with or without AI assistance. The device itself is an endoscopy position detecting unit, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. If a Standalone Performance Study Was Done
Yes, in essence, standalone performance demonstrations were done through the described non-clinical testing. The "bench test of small intestine model" and other validation activities (software, biocompatibility, reprocessing) assess the device's inherent functionality and safety characteristics in isolation, without necessarily involving a human operator in a performance-critical decision-making loop beyond operating the device. However, this is not a "standalone performance" in the context of an AI algorithm making a diagnosis without human intervention, but rather the device itself performing its designated function.
7. The Type of Ground Truth Used
The "ground truth" used for these non-clinical tests corresponds to various engineering, regulatory, and scientific standards:
- Bench Test: Ground truth would be defined by the known physical properties and expected outputs of the small intestine model, and the accuracy of the device's position detection against those known parameters.
- Risk Analysis: Ground truth is against ISO 14971:2007 and in-house acceptance criteria that define acceptable risk levels.
- Software Validation: Ground truth is against the defined software requirements specifications and FDA guidance for software in medical devices, ensuring it functions as intended without critical errors.
- Biocompatibility: Ground truth is against toxicological profiles and FDA guidance (G95-1) identifying safe materials.
- Reprocessing Validation: Ground truth is against FDA guidance documents for reprocessing, ensuring sterilization and cleaning efficacy.
- Adherence to Standards: Ground truth is the requirements outlined in standards like IEC 60601 series, ISO 14971, and IEEE Std C95.1 for electrical safety, electromagnetic compatibility, and risk management.
8. The Sample Size for the Training Set
The document does not refer to a "training set" as would be applicable for machine learning or AI models. This device (UPD-3 and MAJ-1878) is described as using magnetic field detection and arithmetic processing for position computation, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/machine learning model, this question is not applicable based on the provided document. The device's functionality is based on established physics and engineering principles, not statistical learning from data.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.