(27 days)
The Hydro-Surg Irrigator is designed to be used in conjunction with a laparoscopic probe handle and tip to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
The Hydro-Surg Irrigator uses a mechanical pumping system to generate fluid output. It is powered with four (4) standard AA alkaline batteries with an output amperage of approximately 1.0 amperes, with a voltage of 6 volts, direct current (dc). The batteries power a motor which activates movement of an impeller pump which drives the irrigation fluid to a preattached trumpet valve irrigation probe for delivery to the operative site. The proposed Hydro-Surg Irrigator system is designed for single patient use and allows for activation up to approximately 10 minutes. The flow rate of fluid delivered by the system is controlled by the surgeon with minimum flow rates of approximately 1200 cc/minute dependent on the surgeon's tip selection. Following completion of the procedure, the batteries, which power the Hydro-Surg Irrigator, may be removed for proper disposal by pushing in the tabs located on each side of the battery casing and pulling the battery casing apart.
This is a 510(k) premarket notification for a medical device (Hydro-Surg Laparoscopic Irrigator), not a study evaluating AI performance. Therefore, most of the requested information (such as sample sizes for test/training sets, expert qualifications, MRMC studies, and ground truth establishment) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's performance criteria and the testing conducted to demonstrate its equivalence to predicate devices, which can be interpreted as fulfilling "acceptance criteria" in the context of a 510(k) submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for Hydro-Surg Laparoscopic Irrigator
Based on the 510(k) submission, the "acceptance criteria" can be inferred from the comparison made against predicate devices, focusing on key performance characteristics relevant to safety and effectiveness. The study performed was a laboratory bench testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Predicate Devices) | Reported Device Performance (Hydro-Surg Irrigator) |
|---|---|
| Fluid Flow Rate Capability: Sufficient for controlled powered irrigation during laparoscopic procedures. | Flow Rate: Minimum flow rates of approximately 1200 cc/minute (dependent on surgeon's tip selection). Demonstrated to be substantially equivalent to predicate devices (Endo-Flo and StrykeFlow). |
| Product Longevity: Sufficient for the duration of laparoscopic procedures. | Longevity: Designed for single-patient use, allowing activation up to approximately 10 minutes. Demonstrated to be substantially equivalent to predicate battery-powered predicate device (StrykeFlow). |
| Biocompatibility: Fluid-contacting materials deemed safe for medical use. | Biocompatibility: Testing performed in accordance with ODE memorandum #G95-1 (ISO-10993, Part 1). Results demonstrated materials are suitable for intended use as a tissue/bone/dentin externally communicating device of limited duration. |
| Intended Use: Consistent with providing controlled powered irrigation during laparoscopic surgical procedures (e.g., cholecystectomy, gynecological procedures), hydrodissection, and peritoneal lavage. | Intended Use: Designed for the same intended use as predicate devices, providing controlled powered irrigation during laparoscopic surgical procedures, hydrodissection, and peritoneal lavage. |
Study Proving Device Meets Acceptance Criteria: Laboratory Bench Testing
The study conducted was laboratory bench testing.
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of clinical studies. The testing involved comparing the Hydro-Surg Irrigator against the predicate devices (Endo-Flo Irrigator and Stryker StrykeFlow) in a laboratory setting. The number of units tested for each device is not specified.
- Data Provenance: The testing was conducted in a laboratory setting by Davol Inc. (the manufacturer). This is prospective in the sense that tests were specifically performed for this submission, but not in the context of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For laboratory bench testing of physical device performance (flow rate, longevity), "ground truth" is established by direct measurement using calibrated equipment, not by expert consensus or clinical evaluation of, for example, images.
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Adjudication method for the test set:
- Not Applicable. As per point 2, adjudication is not relevant for this type of objective performance measurement.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This was a laboratory bench test comparing physical device characteristics, not a clinical study involving human readers or AI algorithms.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This document describes a physical medical device, not an AI algorithm.
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The type of ground truth used:
- For fluid flow rates and product longevity, the "ground truth" was established through objective physical measurements using laboratory equipment.
- For biocompatibility, the "ground truth" was established through standardized biological testing in accordance with ISO-10993, Part 1.
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The sample size for the training set:
- Not Applicable. This document describes a physical medical device and its bench testing, not an AI development process requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.