(56 days)
The EASYGRIP FLO-41 Precision MIS Delivery System is indicated for delivering compatible hemostatic agents to bleeding sites through a 5 mm or larger trocar.
The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe.
The EASYGRIP FLO-41 System is used to deliver compatible hemostatic agents to bleeding sites. After preparation of compatible hemostatic agent per the instructions, the proposed device is filled by first attaching the compatible hemostatic agent syringe to the syringe port by a Luer lock connection and depressing the syringe plunger, which then fills the enclosed 5 mL reservoir syringe with the hemostatic matrix. The delivery of hemostatic agent to the bleeding site would be performed by actuating the device trigger handle, which can be performed using one hand. As an optional step, if application of the residual hemostatic agent that remains within the cannula is needed, an empty, disposable 1.5 mL syringe is provided and would be filled with non-heparinized saline. Following the same steps as with the hemostatic agent, the reservoir syringe would be filled with 1.5 mL of saline and the residual hemostatic agent would be expelled from the cannula by actuating the device trigger handle.
The provided document describes the acceptance criteria and a summary of the performance study for the EASYGRIP FLO-41 Precision MIS Delivery System. The study primarily focuses on bench tests to demonstrate the functional performance and biocompatibility of the device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Trigger Force to Deliver Hemostatic Matrix | 95% confidence that for 95% of the devices the force required to deliver hemostatic matrix is less than 30 lbf. | "All tests met the acceptance criteria." (Specific numerical result not provided, but stated that it passed the criteria) |
| Malleable Tip Bend and Robustness Test | 95% confidence that 95% of the malleable tips shall not kink when bent to 90 degrees and will be able to deliver the product. | "All tests met the acceptance criteria." |
| Device Interface Leak test | 95% confidence that 95% of the device interfaces between the cannula, dual check valve and syringe will not leak during the use of the device. | "All tests met the acceptance criteria." |
| Saline Retainment inside the Device after Residual Flush | 95% confidence that 90% of the devices would retain the 1.5 ml Saline within the device after the residual hemostatic matrix is delivered. | "All tests met the acceptance criteria." |
| Cannula Bend Test at Various Trocar Positions | 95% confidence that 95% of the devices would not break and leak at the device connections after being subjected to the bend test. | "All tests met the acceptance criteria." |
| Device Tensile Strength | 95% confidence that 95% of the device connections can withstand the tensile pull force of 5lb without failure. | "All tests met the acceptance criteria." |
| Consecutive Delivery of Hemostatic Agent Test | 95% confidence that 95% of the devices will be able to successfully deliver 3 consecutive applications of the hemostatic matrix without device failure (Failure is defined as unable to deliver the product, mechanical component failure, syringe damage, leak at connections, clogged tip). | "All tests met the acceptance criteria." |
| Intermittent Delivery of Hemostatic Agent Test | 95% confidence that 95% of the devices were able to deliver the hemostatic matrix over the range of 2 hours without device failure (Failure is defined as unable to deliver the product, mechanical component failure, syringe damage, leak at connections, clogged tip). | "All tests met the acceptance criteria." |
| Device Functionality to Start and Stop Delivery of Hemostatic Matrix | 95% confidence that 95% of the devices were able to stop the delivery of the hemostatic matrix through the device within 5 seconds, when the force on the trigger was released from the device. | "All tests met the acceptance criteria." |
| Dual Check Valve Function Test | 95% confidence that 90% of the devices would require less than 17.3lbf force to fill the reservoir syringe with hemostatic matrix through the check valve. | "All tests met the acceptance criteria." (Specific numerical result not provided for force, but stated that it passed the criteria) |
| Material Compatibility with Thrombin | 95% confidence that for 90% of the devices there is no statistical significance in the (unspecified outcome, likely related to material degradation or thrombin efficacy). | "All tests met the acceptance criteria." (Specific details of the outcome and statistical significance not provided, but stated that it passed the criteria) |
| Cannula Luer Test for compliance with ISO 80369-7 | Tested in accordance to ISO 80369-7 | "All tests met the acceptance criteria." |
| 1.5 ml Syringe Test for compliance to ISO 80369-7 | Tested in accordance to ISO 80369-7 | "All tests met the acceptance criteria." |
| Dual Check Valve Test for compliance to ISO 594-1 and ISO 594-2 | Tested in accordance to ISO 594-1 and 594-2 | "All tests met the acceptance criteria." |
| Reservoir Syringe Fill Capacity | 95% confidence that 90% of the reservoir syringes can accommodate at least 5ml of product. | "All tests met the acceptance criteria." |
| Biocompatibility | The device fluid path materials meet ISO 10993-1 Qualification for External Communicating Devices; Tissue, Bone, Dentin; Limited ( |
§ 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.