(223 days)
Endomat Select is intended to:
• provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
• provide liquid distention of the uterus for diagnostic and operative hysteroscopy
• provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery
• provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery
• provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery
The Endomat Select is a multi-functional, pressure- controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) interventions. In addition the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348]. The device protects the patient from overpressure via software means. The software controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally the device has high pressure alarms to alert the operating room staff of a high pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.
The Endomat Select (Model Number: UP210) is a multi-functional pressure-controlled irrigation and suction pump. The device received FDA clearance K180735 on October 31, 2018.
Acceptance Criteria and Device Performance:
The device's performance was evaluated through a series of bench tests. The detailed acceptance criteria are implied by the "Pass" status for each performance and safety test. The reported device performance is that it Passed all these tests.
| Acceptance Criteria (Performance/Safety Test) | Reported Device Performance |
|---|---|
| Performance: Pressure Control | Pass |
| Performance: Flow Limitation | Pass |
| Performance: Flow Control | Pass |
| Performance: Pressure Limitation | Pass |
| Performance: Suction Control | Pass |
| Safety: Overpressure Warning (in pressure relevant GYN and URO interventions) | Pass |
| Safety: Overpressure Warning (in pressure relevant ARTHRO interventions) | Pass |
| Safety: Overpressure Alarm (in pressure relevant GYN and URO interventions) | Pass |
| Safety: Pressure Relief (in pressure relevant GYN and URO interventions) | Pass |
Study Details:
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Sample size used for the test set and data provenance:
The document states that "Additional bench testing was performed to ensure the device met its design specifications." and "The bench testing performed verified and validated that the Endomat Select has met all its design specification and is substantially equivalent to its predicate devices." However, specific sample sizes for these bench tests are not provided in this document. The data provenance is also not explicitly stated beyond being "bench testing." It is implied to be from the manufacturer, Karl Storz SE & Co. KG, located in Germany. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the evaluation was based on non-clinical bench testing against design specifications and established standards, rather than expert-derived ground truth from a test set involving human interpretation. -
Adjudication method for the test set:
This information is not applicable as the evaluation was based on objective bench tests against pre-defined engineering and safety standards, rather than subjective interpretation requiring adjudication. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This device is a medical pump, not an algorithm or AI-powered system designed for diagnostic aid or similar tasks that would have standalone algorithm-only performance. Its performance is inherent in its mechanical and software functions. The "Performance" and "Safety" tests listed above can be considered standalone performance evaluations of the device's functional capabilities. -
The type of ground truth used:
The ground truth for the verification of the Endomat Select was based on design specifications and compliance with FDA recognized consensus standards and FDA Guidances. These include:- Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8)
- Software Verification and Validation Testing (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005)
- Summative Usability Testing (IEC 62366)
- Performance Testing for Hysteroscopic and Laparoscopic Insufflators (Submission Guidance For A 510(K), August 1, 1995 for Product Code HIG)
- Additional bench testing against design specifications.
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The sample size for the training set:
This information is not applicable as the device is not an AI/ML product developed using a training set in the conventional sense. Its development involved engineering design, software development, and testing against specifications. -
How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. 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.