(48 days)
The HydroFlex LI System is designed to provide controlled irriqation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.
The Davol HydroFlex LI system and the Davol Endo-Flo are intended to provide controlled irrigation during laparoscopic procedures. The devices flush blood and tissue debris from the operative site during laparoscopy to aid in visualizatior and may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.
The HydroFlex LI System is designed to provide controlled irriqation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.
The HydroFlex LI disposable Fumping Chamber/Tubing Set is intended for use with the HydroFlex irrigation pump Controller. Pressure in the pumping chamber is determined by the setting on the main Controller which is calibrated to account for two feet of baq height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the pre-attached probe tip is limited to approximately 500 mmHg, or 10.C psig, by the main controller. The controller defaults to gravity at an input pressure less Rate of flow is dependent upon pressure than 70mmHq. selection on the controller and probe tip selection.
Fluid will not flow when the back pressure in the system equals the pressure setting on the controller, e.g., when the in the off position. Under static pressure probe is conditions with no outflow, this will equal the controller setting. The impeller continues to spin even with flow stopped, and, in this way, the selected pressure i s maintained. Flow will automatically resume when system back pressure falls below the selected pressure, e.q., when the probe is open to flow.
The HydroFlex LI system is driven by an impeller pump which is powered by an electronic Controller (electromechanical control is similar to U.S. Endoscopy Group's Laparoscopic Irrigation System and Suction Irrigation Tubing Set and the Linvatec Apex™ Universal Irrigation The input pressure is determined by the user System). selected setting on the electronic Controller. The Controller determines the speed of the impeller pump which drives the flow of irrigant.
In addition, the design of the HydroFlex system reusable main Controller is such that it can be used as a multipurpose fluid irrigation system (dependent on the disposable Pump Tubing set used with the Controller).
Both systems contain fluid contact components made from cyrolite and polyvinylchloride. Other materials of the HydroFlex LI system differ from the Endo-Flo system.
This 510(k) premarket notification describes the Davol HydroFlex LI System, a laparoscopic irrigation system. The document focuses on establishing substantial equivalence to predicate devices, particularly the Davol Endo-Flo system.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with specific numerical targets. Instead, it relies on demonstrating that the new device performs adequately relative to predicate devices, particularly in terms of "adequate irrigant flow rate."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Provide controlled irrigation during laparoscopic procedures. | The HydroFlex LI System is designed for this purpose, similar to the predicate devices. It flushes blood and tissue debris, aids visualization, and can be used for hydrodissection, hydrodissolution, and peritoneal lavage. |
| Provide adequate flow rates for laparoscopic procedures. | The document states, "The change in pump mechanism and power source could affect the effectiveness of the irrigation device's ability to provide an adequate irrigant flow rate for laparoscopic procedures." It then indicates that "Accepted Scientific Methods Exist for Assessing Effects of the New Characteristics," specifically mentioning, "The assessment of the characteristics of a laparoscopic irrigation system (adequate flow rates) can be performed by utilizing relatively simple experimental methods." While the document confirms that methods exist for assessment, it does not report the actual flow rates achieved or provide data demonstrating that these rates meet any specific acceptance criteria. It implies this testing was done and showed satisfactory results to support substantial equivalence. |
| Pressure Control: | Maximum static pressure (all outflow closed and no fluid flow) applied to the pre-attached probe tip is limited to approximately 500 mmHg, or 10.0 psig, by the main controller. The controller defaults to gravity at an input pressure less than 70mmHg. |
| Biocompatibility: | The use of different fluid contact materials (Cyrolite and Polyvinylchloride in both; other materials unspecified for HydroFlex) could affect safety. The document states, "Well accepted tests are available for assessing the biocompatibility of new materials for use in medical devices." It implicitly suggests these tests were performed and demonstrated biocompatibility. No specific test results or acceptance criteria are provided. |
| Electrical Safety: | Relevant for the electro-mechanical pump. The document states, "Electrical safety standards are available for devices such as the HydroFlex LI system (UL 2601-1, ES1-1993: ANSI/AAMI Safe Current Limits for Electromechanical Apparatus)." This implies testing against these standards was conducted, and the device met them. No specific test results or acceptance criteria are provided. |
| Misuse Mitigation: | The device's multi-purpose controller raises concerns about misuse. The response is that the Davol HydroFlex LI disposable Pump Chamber/Tubing set will be labeled with a Contraindication "Not for use in Hysteroscopy or Cavity Distention" and will be provided with a pre-attached laparoscopic suction/irrigation probe. This is a design and labeling control rather than a performance criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a "test set" in the context of clinical data or patient samples. The "tests" described are primarily engineering performance tests (flow rates, pressure, electrical safety, biocompatibility) of the device itself. Therefore, sample sizes for a clinical test set are not applicable and not provided. The data provenance is also not applicable for a clinical test set in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the nature of the submission (510(k) for a medical device that performs irrigation), there is no mention of "experts" establishing ground truth in the way one might for an AI/diagnostic study. The "ground truth" for this device would be established by objective measurements and standardized tests rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission is for a physical medical device (laparoscopic irrigation system), not an AI/diagnostic software. Therefore, an MRMC study and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence is based on objective engineering and laboratory test measurements (e.g., pressure readings, flow rate measurements, electrical safety test results, material biocompatibility test results). It is not based on expert consensus, pathology, or outcomes data in a clinical trial sense. The "ground truth" is that the device can reliably provide controlled irrigation within safe and effective parameters, comparable to predicate devices, as validated by standardized testing methods.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of AI or machine learning for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.