(333 days)
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
This instrument must not to be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10 is a flexible video endoscope used for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs which is basically identical to predicate device LTF-VH, for the same application area.
The subject device LTF-S190-10 is utilized with the OLYMPUS OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER and OLYMPUS CLV-S190 VISERA ELITE XENON LIGHT SOURCE. The subject endoscope LTF-S190-10 connects to the VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190 through the light guide connector and the video plugs into video system processors, OTV-S190.
The compatible VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190 and VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190 are intended for endoscopic diagnosis, treatment and video observation.
The OTV-S190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS OTV-S190 allows image displav on HDTV (16:9).
In addition, both the OTV-S190 and CLV-S190 can be used with any specified Olymous flexible and rigid endoscope models, including rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.
This document, K111425, describes the Olympus LTF-S190-10 ENDOEYE FLEX Deflectable Videoscope, OTV-S190 VISERA ELITE Video System Center, and CLV-S190 VISERA ELITE Xenon Light Source. These are medical devices used for endoscopy and endoscopic surgery. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on novel performance claims.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices, meaning the new device performs at least as well as the already approved predicate devices. The acceptance criteria for this type of submission are generally that the device meets safety and effectiveness requirements and is "substantially equivalent" in design, materials, and technological characteristics to a legally marketed predicate device.
The reported device performance, in this context, is that the subject devices are largely identical to their predicates, with some enhancements.
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance (Summary of Differences/Improvements) |
|---|---|
| Intended Use: Identical to predicate device. | LTF-S190-10: Identical intended use. |
| Specifications: Similar to predicate device. | LTF-S190-10: Wider field of view, additional reprocessing method (steam sterilization), incorporation of Fog Free Function. |
| Safety and Effectiveness: No significant changes that affect safety or effectiveness. | OTV-S190: Improved high-quality endoscopic image (noise reduction, pre-freeze image capture, brighter/more contrasted NBI observation), incorporation of Fog Free Function. |
| Material: Identical to predicate device. | CLV-S190: Built-in power fuse, provides high-definition images when connected to OTV-S190 and LTF-S190-10, allows for brighter NBI image, no air feeding pump. |
| Design: Identical to predicate device. | No significant design changes affecting safety/effectiveness beyond those listed above. |
| Biocompatibility: Meets applicable standards. | Passed Cytotoxicity, Sensitization, Intracutaneous Reaction tests. |
| Software Validation: Meets FDA guidance. | Software validation performed; considered "Minor Level of Concern." |
| Bench Testing: Satisfies safety and performance. | Mechanical durability, electrical safety, EMC, thermal safety, Fog Free Function effectiveness/performance, image quality/spectrum testing, phototoxicity analysis tests completed. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the traditional sense of patient data. The evaluation relies on bench testing and biocompatibility testing to demonstrate the safety and performance of the device's components and overall system.
- Bench Test Samples: The specific sample sizes for mechanical durability, electrical safety, EMC, thermal safety, image quality, and phototoxicity analysis are not explicitly stated in this summary. These typically involve a number of units of the device or its components sufficient to demonstrate statistical confidence or compliance with specific testing standards.
- Biocompatibility Samples: Samples of the new patient-contacting material were used for cytotoxicity, sensitization, and intracutaneous reaction tests. The exact number of samples or subjects (e.g., animals for sensitization/intracutaneous tests) is not specified in this summary.
- Data Provenance: The bench tests and biocompatibility tests were conducted by the manufacturer, primarily in Japan given the company headquarters. The data is prospective in the sense that these tests were specifically performed for this 510(k) submission. There is no indication of external or retrospectively collected data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission does not describe a clinical study with a "test set" that requires ground truth established by human experts for diagnostic accuracy or similar performance metrics. Instead, the evaluation is based on engineering and biocompatibility standards. Therefore, information on the number and qualifications of experts for ground truth establishment is not applicable to this type of submission.
4. Adjudication Method for the Test Set
Since there is no "test set" requiring human expert interpretation or consensus, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. The submission focuses on substantial equivalence through bench testing, not on improved human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a hardware and software system for medical imaging and observation, not an AI algorithm intended for standalone diagnostic interpretation. Therefore, a "standalone algorithm performance" study is not applicable. The performance refers to the improved image quality and functional aspects of the videoscope and video system.
7. Type of Ground Truth Used
As mentioned, there isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy. The "ground truth" for this submission is based on:
- Engineering Standards: Compliance with established international and national standards (e.g., IEC 60601 series, ISO 14971, ASTM E1837-96, ANSI/AAMI/ISO 11135-1, ISO 10993 series) for electrical safety, EMC, mechanical durability, thermal safety, and image quality parameters.
- Biocompatibility Test Results: Objective measurements from standardized cytotoxicity, sensitization, and intracutaneous reaction tests.
- Functional Performance Specifications: Objective measurements demonstrating the performance of features like the "Fog Free Function" and image quality improvements.
8. Sample Size for the Training Set
This submission does not involve a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training set" concept is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, the method of establishing its ground truth is not applicable.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.