(45 days)
The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The ENDOALPHA integrated electrosurgical system has the following system functions.
- Centralized control from a non-sterilized area
2} Centralized control from a sterilized area - Centralized display
- Message display
- Voice reply .
- Automatic settings
- Scene settings
- Display customization
- Still image viewing
- Automatic smoke evacuation
The modifications made to the subject device are as follows:
A) Addition or deletion of recommended ancillary equipment
B) A change involving the communication interface
C) A change in the design of the Graphical User interface (GUI)
D) Addition of a voice reply function
E) Deletion of Surgeon's controller for EndoALPHA (MAJ-1140)
F) Transfer of Input/Output function for video signals to the Advanced system
G) Addition of additional connectable touch panel
H) Addition of Scene settings function
l) Addition of system components
Changes to the specifications of system components S
This document is a 510(k) summary for the Olympus Systems Integration ENDOALPHA, a system designed to integrate and control various ancillary equipment used with Olympus endoscopes. The summary focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert qualifications, MRMC study, standalone performance, and training set details) are not available in the provided text because the 510(k) premarket notification process for this type of device (an integration system, not a diagnostic or AI-driven tool) does not typically require such detailed performance studies in the same way as, for example, an AI diagnostic algorithm. The primary goal here is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
However, I can extract the available information and explain why other details are absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Not explicitly stated in this document as performance metrics) | Reported Device Performance (Summary of functional capabilities) |
|---|---|---|
| Primary Goal | Substantial Equivalence to Predicate Device (Olympus Integrated Endosurgery System EndoALPHA - K051613) | Concluded to be substantially equivalent based on intended use and operating principle. |
| Intended Use | To be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation. | Device has been designed for this intended use, which is identical to the predicate. |
| Operating Principle | Same operating principle as the predicate device. | Device uses the same operating principle as the predicate. |
| Functional Capabilities | Demonstrate integrated control and display of ancillary equipment, automatic settings, etc. | Offers centralized control (from non-sterilized and sterilized areas), centralized display, message display, voice reply, automatic settings, scene settings, display customization, still image viewing, and automatic smoke evacuation. |
| Safety and Effectiveness | General controls provisions of the Act (e.g., registration, listing, GMP, labeling, MDR). | Implied compliance with general controls to be marketed. No specific safety/effectiveness performance metrics are reported in this summary. |
| Modifications | Modifications should not raise new questions of safety or effectiveness. | Modifications A-I are listed (e.g., added/deleted ancillary equipment, GUI changes, added functions like voice reply and scene settings). The overall conclusion is substantial equivalence. |
Explanation for Missing "Acceptance Criteria" Details:
For a device like the ENDOALPHA, which is an integration and control system, "acceptance criteria" for demonstrating substantial equivalence are typically evaluated against the predicate device's functionality and safety profile, rather than quantitative performance metrics like accuracy or sensitivity. The FDA's review for a 510(k) largely focuses on whether the new device is as safe and effective as the predicate. The "performance" in this context refers to its functional capabilities and how they compare to the predicate, and whether any changes introduce new risks or questions of effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided in the document.
This document does not describe a clinical performance study using a test set of data (e.g., images, patient records). The evaluation for this device appears to be based on engineering verification and validation, functional testing, and comparison to the predicate device's specifications and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided in the document.
Since there's no clinical performance study involving a "test set" with "ground truth" (e.g., diagnosing conditions), expert review for establishing ground truth is not part of this 510(k) summary for the ENDOALPHA system.
4. Adjudication Method for the Test Set
Not applicable/Not provided in the document.
No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No.
This document does not mention or report the results of an MRMC study. The device is a system integration tool, not a diagnostic aid that would typically involve human readers interpreting output to improve diagnostic performance.
6. Standalone Performance Study
Not applicable/Not provided in the document in the context of diagnostic performance.
While the system itself has standalone functional performance (e.g., its ability to control equipment, display messages), the concept of "standalone performance" as it relates to AI algorithms or diagnostic tools (i.e., algorithm only without human-in-the-loop performance) is not relevant or evaluated for this type of system in this document. The document describes its functional capabilities in isolation and in integration.
7. Type of Ground Truth Used
Not applicable/Not provided in the document.
There is no mention of "ground truth" (e.g., pathology, outcomes data) as this pertains to diagnostic accuracy studies. For this system, the "truth" would refer to whether the system correctly performs its programmed functions (e.g., does it centralize control as intended, do automatic settings work). This is validated through engineering and functional testing rather than clinical "ground truth" data.
8. Sample Size for the Training Set
Not applicable/Not provided in the document.
This device is an integration and control system, not an AI/machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the document.
As there is no training set mentioned, this information is not relevant.
§ 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.