(272 days)
VIDEO SYSTEM CENTER CV-V1: This video system center is intend to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1: This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
COLONOVIDEOSCOPE OLYMPUS CF-LV1L and CF-LV11: This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The primary components of the V1 SYSTEM consists of two Olympus colonovideoscopes; CF-LV1L and CF-LV11 (which are identical except for their working) lengths, an Olympus gastrointestinal videoscope; GIF-LV1 and a video system center. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The V1 SYSTEM is designed to be used with specified monitors, EndoTherapy accessories and other ancillary equipment.
The primary components of the subject system, which are part of this submission, are: VIDEO SYSTEM CENTER OLYMPUS CV-V1 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 COLONOVIDEOSCOPE OLYMPUS CF-LV1L COLONOVIDEOSCOPE OLYMPUS CF-LV11
CV-V1 can be used with Olympus endoscope models, such as gastorointestinal videoscope GIF-LV1 and colonovideoscope CF-LV1L/I. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.
The GIF-LV1, CF-LV1L/I can be used with VIDEO SYSTEM CENTER OLYMPUS CV-V1. The light source and the LG bundle are not used, instead, there are LEDs in the distal end of the scope that runs by electric power from the CV-V1 and light up the distal end. The newly designed one-touch connector is water proof.
The provided 510(k) summary for the V1 SYSTEM describes a modification to an endoscopic video imaging system, specifically regarding a change in the lighting method from an external light source to integrated LEDs within the endoscopes. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for diagnostic accuracy or clinical outcomes.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this document, as the submission does not detail a clinical study of the V1 SYSTEM's diagnostic or therapeutic effectiveness against a specific set of acceptance criteria. The focus is on technical performance relative to safety standards and equivalence to a predicate device.
However, I can extract information related to the technical testing conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria for diagnostic performance or specific clinical outcomes. Instead, it refers to the performance of non-clinical tests based on various standards. The acceptance criteria for these tests would typically be compliance with the specified standard.
| Acceptance Criteria Category | Specific Standard/Test | Reported Performance |
|---|---|---|
| Basic Safety and Performance | IEC 60601-1 | Performed in accordance with standard |
| Basic Safety and Performance | IEC 60601-1-1 | Performed in accordance with standard |
| Basic Safety and Performance | IEC 60601-1-2 | Performed in accordance with standard |
| Basic Safety and Performance | IEC 60601-2-18 | Performed in accordance with standard |
| Mechanical Performance | Verification and comparison studies | Conducted and results provided (details not specified) |
| Functional Performance | Verification and comparison studies | Conducted and results provided (details not specified) |
| Biocompatibility | Intracutaneous Reactivity Test.doc | Results provided (details not specified) |
| Biocompatibility | Cytotoxicity Study.doc | Results provided (details not specified) |
| Biocompatibility | Skin Sensitization Test.doc | Results provided (details not specified) |
| Risk Analysis | ISO 14971:2007 | Carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and acceptance criteria identified and performed. |
The document states, "The newly lighting method has been confirmed that the safety and effectiveness are equivalent i compare with the predicate devices." This implies that the performance of the new lighting method was deemed equivalent to the predicate, likely through technical testing and comparison of image quality, illumination, etc., though specific metrics are not detailed here.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document describes non-clinical testing rather than a clinical study with a patient "test set." The "test set" would refer to the physical devices (V1 SYSTEM components) themselves. No patient data is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The testing described is non-clinical (safety, mechanical, functional, biocompatibility) and does not involve establishing ground truth from expert assessments of clinical data.
4. Adjudication Method
This information is not provided as no expert assessment of clinical data is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The submission is for a medical device (endoscopic system) which is a tool for human examiners, and the focus is on the device's technical equivalence and safety, not on human reader performance with or without AI assistance.
6. Standalone Algorithm Performance
Not applicable. The V1 SYSTEM is an endoscopic video imaging system, not an AI algorithm. It is a device intended for human-in-the-loop use for diagnosis and treatment.
7. Type of Ground Truth Used
Not applicable in the context of a clinical study for diagnostic accuracy. For the non-clinical tests, the "ground truth" would be established by the specifications and standard requirements outlined in the referenced IEC and ISO standards. For example, for biocompatibility tests, the "ground truth" is whether the materials meet the safety thresholds defined by ISO 10993.
8. Sample Size for the Training Set
Not applicable. The V1 SYSTEM is not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The V1 SYSTEM is not an AI algorithm.
§ 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.