(27 days)
Not Found
No
The device description focuses on a mechanical pumping system powered by batteries and a motor. There is no mention of AI, ML, image processing, or any computational decision-making based on data. The performance studies also focus on mechanical characteristics like flow rate and longevity.
Yes.
The device is used to provide controlled powered irrigation during laparoscopic surgical procedures, perform hydrodissection, and peritoneal lavage, all of which are considered therapeutic interventions.
No
The device is described as an irrigator used for therapeutic procedures (e.g., irrigation during laparoscopic surgery, hydrodissection, peritoneal lavage) and does not mention any diagnostic functions.
No
The device description explicitly details a mechanical pumping system powered by batteries, a motor, and an impeller pump, all of which are hardware components. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed for controlled powered irrigation during laparoscopic surgical procedures. This is a surgical tool used directly on the patient during a procedure.
- Device Description: The description details a mechanical pumping system for delivering fluid to an operative site. This is consistent with a surgical irrigation device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze biological samples.
The device is clearly intended for use in vivo (within the body) during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
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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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 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. 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.
Key Metrics
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Predicate Device(s)
Endo-Flo Irrigation System, StrykeFlow Disposable Suction Irrigator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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8961492
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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:
Trade Name:
Endo-Flo Irrigation System (Davol Inc.)
StrykeFlow Disposable Suction Irrigator (Stry cer Endoscopy)
D. 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.
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.
1
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.
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.
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.
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- Does New Device Have the Same Technological Characteristics, e.g., Design, Materials, etc.?
2
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: