(84 days)
Sheath with integrated stopcocks are used in conjunction with a hysteroscope to permit direct viewing of the cervical canal and the uterine cavity to perform diagnostic and surgical procedures.
The subject device is a reusable sheath (Part WA4777A) and stopcock (Part WA47778A), provided non-sterile and labeled for reprocessing via cleaning and steam sterilization. The sheath is a rigid instrument made from stainless steel. The sheath has a working length of 206.7 ± 0.15 mm. The sheath has a single lumen shaped to allow for both, insertion of one 3 mm hysteroscope as well as a 5 Fr instrument channel for the instrument and irrigation inflow. There are three ports, one for irrigation, one for instruments, and one for the hysteroscope. There is no outflow channel for the irrigation fluid; the irrigation fluid flows out between the sheath and the cervix channel. A hysteroscope can be inserted into the hysteroscope channel of the sheath from the proximal end to provide an endoscopic image during the procedure. The endoscopic image can be viewed using the ocular or by connecting a compatible camera head. Compatible surgical instruments can be inserted into the instrument channel of the sheath. The irrigation stopcock made from stainless steel and polyether ether ketone (PEEK) can be used to control the inflow of the irrigation fluid. The instrument stopcock controls the passage of the surgical instruments.
The provided text describes the 510(k) premarket notification for a "Sheath and Stopcock Accessory" and does not contain information about an AI/ML powered device, therefore the request cannot be fully answered. This document purely focuses on a traditional medical device, specifically a reusable sheath and stopcock for hysteroscopes.
However, based on the information provided regarding the "Sheath and Stopcock Accessory," here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | |
| Intracutaneous Irritation (ISO 10993-10:2010) | Non-irritating | |
| Mechanical Performance | Mechanical resistance of inflow interface, scope interface, instrument interface | Demonstrated comparable mechanical performance |
| Resistance of sheath tube | Demonstrated comparable mechanical performance | |
| Resistance of supporting ring of optic guide plate | Demonstrated comparable mechanical performance | |
| Resistance against repeated assembly/disassembly | Demonstrated comparable mechanical performance | |
| Irrigation inflow and outflow (comparable flow during operation) | Bench tests demonstrated comparable flow could be achieved during operation | |
| Electrical & Thermal Safety | Heat hazard assessment (AAMI/ANSI ES60601-1:2005/(R)2012 and updates) | Evaluated to demonstrate not a heat hazard, compatible with energized devices |
| Safety with electrocautery devices (AAMI/ANSI IEC 60601-2-2:2017) | Evaluated to demonstrate not a heat hazard, compatible with energized devices | |
| Basic endoscopic safety (IEC 60601-2-18:2009) | Evaluated to demonstrate not a heat hazard, compatible with energized devices | |
| Reprocessing/Sterilization | Reprocessing instructions and method validation (FDA guidance, March 17, 2015) | Validated and documentation provided |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set. It mentions "comparative validation testing" for mechanical performance and "risk analysis" for electrical/thermal safety, and "method validation testing" for reprocessing. The provenance of the data is from internal testing conducted by Olympus Winter & Ibe GmbH. No country of origin for the data is explicitly mentioned, but the manufacturer is based in Hamburg, Germany. The studies are assumed to be prospective experiments or tests designed specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided because the device is a physical medical instrument, not an AI/ML diagnostic tool requiring human expert interpretation for ground truth. The "ground truth" for this device is established through objective physical, chemical, and electrical measurements and adherence to recognized standards.
4. Adjudication method for the test set
Not applicable, as this is not an interpretive diagnostic device requiring adjudication of human-labeled data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device, not an AI/ML system, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI/ML system.
7. The type of ground truth used
The ground truth for this device's performance evaluation is based on objective physical measurements, chemical analyses (for biocompatibility), and adherence to established international and national standards (ISO, AAMI/ANSI, IEC, FDA guidance documents). For example, "non-cytotoxic" is a measurable outcome, and "comparable flow" is determined by direct measurement during bench testing.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/ML powered device.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.