(88 days)
The KSEA DCI Endoscope is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Specific Indications for Use
- unexplained pelvic pain (acute, chronic)
- infertility work-up
- tubal sterilization
- unexplained primary or secondary amenorthea
- diagnosis and/or treatment of ectopic pregnancy
- evaluation, diagnosis and/or treatment of small pelvic tumors, including myomata
- evaluation of congenital anomalies of the pelvic organs
- retrieval of foreign bodies
- determination of the presence and extent of pelvic endometriosis
- determination of the presence and extent of pelvic inflammatory disease
- laparoscopic assisted vaginal hysterectomy
- visualization, diagnosis and/or treatment of perforate abdominal organs
The KSEA DCI Endoscope is comprised of a rigid, panoramic tolescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria for the Karl Storz Direct Coupled Interface (DCI) Endoscope.
Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a device already legally marketed. It typically does not involve independent studies with specific performance metrics against acceptance criteria in the same way a Premarket Approval (PMA) application would.
Therefore, I cannot fulfill the request for the following sections as the information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document states "minor differences...raise no new issues of safety and effectiveness" because "these design differences have no affect on the performance, function or intended use of the devices," implying that performance is considered equivalent to the predicate without specifying new performance metrics.
- Sample sizes used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable as no test set or ground truth is described.
- 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 device is an endoscope, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.
- The type of ground truth used: Not applicable as no ground truth is described.
- The sample size for the training set: Not applicable as no training set is described.
- How the ground truth for the training set was established: Not applicable as no training set is described.
Summary of what is available from the text:
- Device Name: Karl Storz Direct Coupled Interface (DCI) Endoscope
- Intended Use/Indications for Use: For use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures. Specific indications include unexplained pelvic pain, infertility work-up, tubal sterilization, amenorrhea, ectopic pregnancy, small pelvic tumors (myomata), congenital anomalies, foreign body retrieval, pelvic endometriosis, pelvic inflammatory disease, laparoscopic assisted vaginal hysterectomy, and visualization/diagnosis/treatment of perforate abdominal organs.
- Regulatory Pathway: 510(k) Premarket Notification, asserting substantial equivalence to predicate devices.
- Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
§ 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.