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.

Device Description

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.

AI/ML Overview

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.

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.
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.
Adjudication method for the test set:
- Not Applicable. As per point 2, adjudication is not relevant for this type of objective performance measurement.
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.
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.
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.
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.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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Davol Inc. Subsidiary of C. R. Bard, Inc 100 Sockanossett Crossroad O. Box 8500 Cranston, RI 02920 401 463-7000

Hydro-Surg® Laparoscopic Irrigator

Section VII.

510(k) Summary of Safety and Effectiveness Information

A. Submitter Information

Submitter's Name: Address:

Telephone No. Fax No. Contact Person: Date of Preparation: Jeannette G. Cloutier Davol Inc. 100 Sockanossett Crossroad Cranston, RI 02920 401-463-7000, Ext. 2728 401-463-3845 Jeannette G. Cloutier April 5, 1996

B. Device Name

Hydro-Surg Laparoscopic Irrigator Trade Name: Laparoscopic Irrigator Common/Usual Name: Endoscope and Accessories Classification Name: Gynecologic Laparoscope and Accessories

C. Predicate Device Names

Trade Name:

Endo-Flo Irrigation System (Davol Inc.)

StrykeFlow Disposable Suction Irrigator (Stry cer Endoscopy)

D. Device Description

Image /page/0/Picture/20 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and prominent appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.

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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

Intended Use of the Device E.

F. Summary of Similarities and Differences

The 510(k) Substantial Equivalence Decision-Making Process (Detailed) decision tree (ODE guidance memo #K86-3) was utilized to rnake a determination of substantial equivalence (see Exhibit VII-I). The answers to the following questions from this decision tree lead to a determination of substantial equivalence.

1. Does New Device Have Same Indication Statements?

Yes. The proposed Hydro-Surg Irrigator and the Predicate Endo-Flo are designed to be used in conunction 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 unit label of the Predicate StrykeFlow does not specifically set out its intended use. However, from its description, the intended use of the Predicate StrykeFlow appears to be identical to the proposed Hydro-Surg Irrigator.

1. Does New Device Have the Same Technological Characteristics, e.g., Design, Materials, etc.?

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Though the three systems have the same basic components (i.e., power source, No. pump, irrigation/suction tubing set), the design of these components may vary. However, all three pumps have been designed to be completely disposable and are for single patient use only.

The currently marketed Predicate Endo-Fio has a diaphragm pump powered by a compressed gas source (pneumatic pump) and is a positive displacement type pump. Therefore, its technological characteristics differ from the battery-powered systems. Both the Hydro-Surg Irrigator and the Predicate StrykeFlow are battery-powered devices which utilize an impeller pump for fluid output. However, the materials of manufacture may be different and some of the internal pumping components may differ. Examples of differences between the two devices include that the Predicate StrykeFlow is powered by eight (8) AA alkaline batteries; whereas, the Hydro-Surg Irrigator utilizes four (4). The batteries in the Hydro-Surg Irrigator can be removed for proper disposal by the user; but the batteries in the Predicate StrykeFlow cannot be removed from its casing. Additionally, the Hydro-Surg Irrigator contains a smaller motor than the Predicate StrykeFlow.

3. Could the New Characteristics Affect Safety or Effectiveness?

Yes. The differences between the proposed Hydro-Surg compared to the Predicate Endo-Flo and Predicate StrykeFlow could affect both safety and effectiveness.

Do the New Characteristics raise New Types of Safety or Effectiveness 4. Questions?

No. Irrigators, such as the proposed Hydro-Surg Irrigator, are generally intended to provide controlled powered irrigation during laparoscopic surgical procedures. The safety and effectiveness questions are not new and include questions concerning fluid flow rates deliverable and product longevity.

ડ. Do Accepted Scientific Methods Exist for Assessing Effects of the New Characteristics?

Yes. The assessment of the effects of the characteristics of the proposed Hydro-Surg Irrigator can be determined using relatively simple experimental methods for determination of fluid output and product longevity. Industry standards exist for the biological evaluation of the product's fluid contacting materials to assure that materials are suitable for their intended use.

6. Are Performance Data Available to Assess Effects of New Characteristics?

Yes. Laboratory bench testing was performed to assess the effects of the new characteristics of the proposed Hydro-Surg Irrigator. These tests compared the proposed Hydro-Surg Irrigator against the Predicate Endo-Flo and Predicate

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StrykeFlow. The objective of the laboratory testing was to determine substantial equivalence of the performance characteristics between the HYDRO-SURG Laparoscopic Irrigator and the predicate devices, Endo-Flo Irrigator and Stryker StrykeFlow. Specific performance characteristics evaluated included assessment of fluid flow rates (all three irrigators evaluated) and product longevity (battery-powered units only).

In addition, biocompatibility testing, performed in accordance with ODE memorandum #G95-1 (International Standard ISO-10993, Part 1), has been performed on the fluid contacting materials used to manufacture the proposed Hydro-Surg Irrigator.

7. Does Performance Data Demonstrate Equivalence?

Yes. The test data demonstrate that the performance of the HYDRO-SURG Laparoscopic Irrigator in terms of flow rate capability and product longevity is suitable for its intended use, and the device is substantially equivalent to the predicate Endo-Flo and StrykeFlow irrigators. Furthermore, results from biocompatibility testing performed from this testing have demonstrated that the materials are suitable for their intended use as a tissue/bone/dentin externally communicating device of limited duration.

Conclusion:

Based on the FDA's decision tree, the subject device, the Hydro-Surg Laparoscopic Irrigator, is substantially equivalent to the predicate devices. Endo-Flo and StrykeFlow irrigators.

Contact Person: Annette S. Cloutier

Jeannette G. Cloutier Regulatory Affairs Administrator Dated:

Regulation Number and Section

§ 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.