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510(k) Data Aggregation
(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 (<24 hrs) contact, as shown by specific tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Materials Mediated Pyrogen). | The EASYGRIP FLO-41 Precision MIS Delivery System fluid path materials "has been shown to be biocompatible and appropriate for its intended use" based on the conducted tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Materials Mediated Pyrogen). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample size ("n") for each specific performance test. However, it consistently uses statistical confidence levels for the acceptance criteria, such as "95% confidence that 95% of the devices" or "95% confidence that 90% of the devices." This implies that a sufficient sample size was used to achieve these confidence levels, likely determined by statistical power calculations for device testing.
The data provenance is retrospective in the sense that the testing was conducted by Baxter Healthcare Corporation to support their 510(k) submission. The data originates from the manufacturer's internal testing. There is no information regarding country of origin of the data beyond "Baxter Healthcare Corporation" being based in Round Lake, Illinois, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device (an endoscopic applicator) and the conducted studies. The studies are bench tests evaluating mechanical and material performance, as well as biocompatibility. They do not involve clinical assessments, interpretation of medical images or patient outcomes that would require expert "ground truth" establishment in the way it is typically applied to diagnostic AI/ML devices.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Bench tests and biocompatibility assessments do not involve adjudication by multiple experts. The "ground truth" for these tests is based on objective measurements and established standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is an endoscopic applicator, a physical medical device, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As stated, the device is a physical endoscopic applicator, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests in this submission is based on:
- Objective measurements and engineering specifications: For tests like trigger force, tensile strength, leak tests, fill capacity, and bend tests, the "ground truth" is derived from direct measurement against predefined numerical targets and physical integrity.
- Compliance with international standards: For luer lock and check valve tests, the "ground truth" is defined by adherence to specific ISO standards (ISO 80369-7, ISO 594-1, ISO 594-2).
- Established biological safety criteria: For biocompatibility tests, the "ground truth" is based on the results of standardized assays (ISO 10993-5, 10993-10, 10993-11) demonstrating non-cytotoxicity, non-sensitization, non-irritation, and acceptable systemic toxicity and pyrogenicity.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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