(442 days)
This instrument is intended to be used with a video system center, light source, documentation equipment, monitor. hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
The LTF-S190-5 is a video endoscope consisting of three parts: the control section, the insertion section, and the connector section. The device uses an objective lens and light guide lens for capturing images/videos from the distal end of the endoscope.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Device Performance / Result |
|---|---|
| Reprocessing | All reprocessing methods (Sterilizer/Sterilization process) were validated following FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). The acceptance criteria were met. |
| Biocompatibility | Tested in accordance with FDA's Guidance for Industry and FDA Staff, Use of International Standard ISO 10993-1, and specific sub-parts: |
| - Cytotoxicity (ISO 10993-5:2009) | |
| - Intracutaneous (ISO 10993-10:2010) | |
| - Sensitization (ISO 10993-10:2010) | |
| - Acute Systemic Toxicity (ISO 10993-11:2006) | |
| - Rabbit Pyrogen (USP , USP ) | |
| The device was shown to be non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic, and non-pyrogenetic. | |
| Software V&V | Software verification and validation testing conducted following FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The device met all requirements. |
| Electrical Safety | Tested in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, and IEC 60601-2-18:2009. The system complies with these standards. |
| EMC | Tested in accordance with IEC 60601-1-2:2014. The system complies with this standard. |
| Bench Performance | Bench testing included: |
| - Thermal safety test | |
| - Composite durability test | |
| - Color (imaging) performance | |
| - Photobiological Safety | |
| Device performance was assessed against design requirements, including process verification, design verification, and design validation. The device met all acceptance criteria. |
2. Sample Size for Test Set and Data Provenance
The provided text describes various engineering and performance tests (reprocessing, biocompatibility, software V&V, electrical safety, EMC, and bench performance). These types of tests typically do not involve "test sets" in the clinical sense with human data. Instead, they involve testing the physical device, its materials, and its software against established technical and safety standards.
- No "sample size" for a clinical test set is mentioned.
- No "data provenance" (e.g., country of origin, retrospective/prospective) for clinical data is mentioned, as clinical data was not part of this submission's performance data section. The submission focuses on substantial equivalence based on technical characteristics and non-clinical performance data.
3. Number of Experts and Qualifications for Ground Truth Establishment
Not applicable. The performance data presented are based on engineering tests and adherence to recognized standards, not on expert-established ground truth from clinical cases.
4. Adjudication Method for Test Set
Not applicable. There is no clinical test set requiring adjudication in the provided performance data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This evaluation focuses on the safety and effectiveness of the device itself, rather than comparing human reader performance with and without AI assistance. The device is a videoscope, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical videoscope, not an algorithm, so a standalone algorithm-only performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the various performance tests is defined by:
- Established national and international standards (e.g., FDA guidance documents, ISO 10993, ANSI/AAMI ES 60601-1, IEC 60601-1-2)
- Manufacturer's design specifications and requirements.
8. Sample Size for Training Set
Not applicable. This device is a physical videoscope, not a machine learning model, so there is no concept of a "training set."
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this device.
§ 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.