(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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 8, 2020
Baxter Healthcare Corporation Ms. Jeanette Licata Sr. Associate, Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073
Re: K193137
Trade/Device Name: EASYGRIP FLO-41 Precision MIS Delivery System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 11, 2019 Received: November 13, 2019
Dear Ms. Licata:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193137
Device Name
EASYGRIP FLO-41 Precision MIS Delivery System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the text "Page 1 of 9" at the top. Below that is the word "Baxter" in a stylized, bold, blue font. The word "Baxter" appears to be a logo or brand name. The page number indicates that this is the first page of a nine-page document.
Section 5. 510(k) Summary
November 11, 2019
SPONSOR:
Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, Illinois 60073
Phone: (224) 948 3996 Fax: (224) 270 4119
SPONSOR CONTACT:
Jeanette Licata Sr. Regulatory Associate
Phone: (224) 948 3996 Fax: (224) 270 4119 Email: jeanette licata@baxter.com
IDENTIFICATION OF THE DEVICE:
Common Name: Endoscopic Applicator Trade/Device Name: EASYGRIP FLO-41 Precision MIS Delivery System Classification Panel: 79 General and Plastic Surgery Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ
| Table 1. Code Number for EasyGrip FLO-41 Precision MIS Delivery System | |||||
|---|---|---|---|---|---|
| Code Number | Name |
|---|---|
| ADS201897 | EASYGRIP FLO-41 Precision MIS Delivery System |
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PREDICATE DEVICE:
The predicate device, the Malleable Tip Endoscopic Applicator, is manufactured by Micromedics Inc., dba Nordson Medical.
| Trade Name | Company | Predicate510(k) | ClearanceDate |
|---|---|---|---|
| Malleable Tip EndoscopicApplicator | Micromedics, Inc. dba NordsonMedical | K123847 | 01/08/2013 |
REASON FOR SUBMISSION:
The basis for this premarket notification is a modification to the design of the Malleable Tip Endoscopic Applicator to allow for one handed application of compatible hemostatic agents to bleeding sites.
INDICATIONS FOR USE:
The EASYGRIP FLO-41 Precision MIS Delivery System is indicated for delivering compatible hemostatic agents to bleeding sites through a 5mm or larger trocar.
DESCRIPTION OF THE DEVICE:
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.
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Image /page/5/Picture/1 description: The image shows the text "Page 3 of 9" at the top, indicating it is a page number within a larger document. Below the page number, the word "Baxter" is displayed in a bold, blue font. The word "Baxter" appears to be a logo or brand name.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed device is substantially equivalent to the predicate device, previously cleared under 510(k) premarket notification K123847 on January 8, 2013. The intended use and function of the proposed device are equivalent to the predicate device.
Table 3 is a device comparison table outlining the differences between the predicate and proposed devices.
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Cannula
Malleable Tip Tubing:
Unknown
Image /page/6/Picture/2 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be a corporate logo. The word is horizontally oriented and takes up most of the image space.
Additional testing has confirmed the
biocompatibility of the materials. The different
technological characteristics of the proposed
device do not raise different questions of
safety and effectiveness.
| Features | Predicate DeviceCleared under K123847 | Proposed DeviceEasyGrip FLO-41 Precision MISDelivery System | Assessment of Differences |
|---|---|---|---|
| Intended Use | The Malleable Tip Endoscopic Applicatoris intended for use in delivering hemostaticagents to bleeding surgical sites through a5mm or larger trocar | The EASYGRIP FLO-41 PrecisionMIS Delivery System is intendedfor delivering compatiblehemostatic agents to bleeding sitesthrough a 5mm or larger trocar. | Not Applicable |
| Indications forUse | The Malleable Tip Endoscopic Applicatoris intended for use in delivering hemostaticagents to bleeding surgical sites through a5mm or larger trocar | The EASYGRIP FLO-41 PrecisionMIS Delivery System is indicatedfor delivering compatiblehemostatic agents to bleeding sitesthrough a 5mm or larger trocar. | Not Applicable |
| Sterile | Yes | Same | Not Applicable |
| Non-Pyrogenic | Yes | Same | Not Applicable |
| Single Use | Yes | Same | Not Applicable |
| Materials (Fluid Path) | Sheath (Tube):PolyMed® High strength fiber with vinylester resin | Sheath (Tube):Same | The proposed device's collar, malleable tiptubing and adhesive material have passedfunctional testing for their intended use. |
| Collar:Unknown | Collar:Stainless Steel |
Stainless Steel
Malleable Tip Tubing:
Polyurethane tubing with
encapsulated 304 Stainless Steel
wire
Adhesive Epoxy
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| Features | Predicate DeviceCleared under K123847 | Proposed DeviceEasyGrip FLO-41 Precision MISDelivery System(cannula/collar and collar/malleabletip)Loctite M-31CL | Assessment of Differences |
|---|---|---|---|
| Luer LockConnector(overmolded onCannula) | Acrylonitrile Butadiene Styrene (ABS) | Same | Not Applicable |
| Stylet | PolyMed® composite rodAcrylonitrile Butadiene Styrene (ABS) tipAcrylonitrile Butadiene Styrene (ABS)handle | Proposed device doesn't have astylet | The proposed device doesn't have a stylet.Design control activities have been conductedand have confirmed that the differenttechnological characteristics of the new devicedo not raise different questions of safety andeffectiveness. |
| 1.5 mL emptyflush syringe | Not applicable | Barrel: Polycarbonate | The predicate device does not have a 1.5 mLempty flush syringe. Design control activitieshave been conducted and have confirmed thatthe different technological characteristics ofthe new device do not raise different questionsof safety and effectiveness. |
| Plunger:Polycarbonate + 10% GlassFilledPiston Seal:Thermoplastic elastomer |
Table 3. Device Comparison
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Table 3. Device Comparison
| Features | Predicate DeviceCleared under K123847 | Proposed DeviceEasyGrip FLO-41 Precision MISDelivery System | Assessment of Differences |
|---|---|---|---|
| Dual check valve | Not applicable | Body: PolycarbonateSwivel Nut: CopolyesterFemale Luer Ports: PolycarbonateValve: Silicone | The predicate device does not have a dualcheck valve. Design control activities havebeen conducted and have confirmed that thedifferent technological characteristics of thenew device do not raise different questions ofsafety and effectiveness. |
| Reservoir Syringe | Not applicable | Plunger: PolypropylenehomopolymerBarrel: PolypropylenePiston Seal: Thermoplasticelastomer | The predicate device does not have a reservoirsyringe. Design control activities have beenconducted and have confirmed that thedifferent technological characteristics of thenew device do not raise different questions ofsafety and effectiveness. |
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SUMMARY OF SUPPORTING DATA:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed device is appropriately designed for its intended use.
Performance Data:
The following bench tests (Table 4) were conducted to evaluate the functional performance of the EASYGRIP FLO-41 Precision MIS Delivery System. All tests met the acceptance criteria.
| Test | Acceptance Criteria |
|---|---|
| Trigger Force to Deliver Hemostatic Matrix | The Trigger Force Test evaluated with95% confidence that for 95% of thedevices the force required to deliverhemostatic matrix is less than 30 lbf. |
| Malleable Tip Bend and Robustness Test | The Malleable Tip Bend and RobustnessTest demonstrated with 95% confidencethat 95% of the malleable tips shall notkink when bent to 90 degrees and will beable to deliver the product. |
| Device Interface Leak test | The Device Interface Leak Testdemonstrated with 95% confidence that95% of the device interfaces between thecannula, dual check valve and syringewill not leak during the use of the device. |
| Saline Retainment inside the Device after Residual Flush | The Saline Retainment Testdemonstrated with 95% confidence that90% of the devices would retain the 1.5ml Saline within the device after theresidual hemostatic matrix is delivered. |
| Cannula Bend Test at Various Trocar Positions | The Cannula Bend Test demonstratedwith 95% confidence that 95% of thedevices would not break and leak at thedevice connections after being subjectedto the bend test. |
| Device Tensile Strength | The Device Tensile Strength Testdemonstrated with 95% confidence that95% of the device connections canwithstand the tensile pull force of 5lbwithout failure. |
| Consecutive Delivery of Hemostatic Agent | The Consecutive Delivery Testdemonstrated with 95% confidence that95% of the devices will be able to |
| Test | Acceptance Criteria |
| successfully deliver 3 consecutiveapplications of the hemostatic matrixwithout device failure (Failure is definedas unable to deliver the product,mechanical component failure, syringedamage leak at connections, clogged tip). | |
| Intermittent Delivery of Hemostatic Agent | The Intermittent Delivery Testdemonstrated with 95% confidence that95% of the devices were able to deliverthe hemostatic matrix over the range of 2hours without device failure (Failure isdefined as unable to deliver the product,mechanical component failure, syringedamage leak at connections, clogged tip). |
| Device Functionality to Start and Stop Delivery ofHemostatic Matrix | The Device Functionality Testdemonstrated with 95% confidence that95% of the devices were able to stop thedelivery of the hemostatic matrixthrough the device within 5 seconds,when the force on the trigger wasreleased from the device. |
| Dual Check Valve Function Test | The Dual Check Valve Testdemonstrated with 95% confidence that90% of the devices would require lessthan 17.3lbf force to fill the reservoirsyringe with hemostatic matrix throughthe check valve. |
| Material Compatibility with Thrombin | The Material Compatibility withThrombin Test demonstrated with 95%confidence that for 90% of the devicesthere is no statistical significance in the |
| Cannula Luer Test for compliance with ISO 80369-7 | Tested in accordance to ISO 80369-7 |
| 1.5 ml Syringe Test for compliance to ISO 80369-7 | Tested in accordance to ISO 80369-7 |
| Dual Check Valve Test for compliance to ISO 594-1 andISO 594-2 | Tested in accordance to ISO 594-1 and594-2 |
| Reservoir Syringe Fill Capacity | The Reservoir Syringe Fill Capacity Testdemonstrated with 95% confidence that90% of the reservoir syringes canaccommodate at least 5ml of product. |
Table 4. Performance Data Summary for Proposed Device
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Table 4. Performance Data Summary for Proposed Device
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Biocompatibility:
For the device fluid path, biocompatibility assessments were conducted to meet an ISO 10993-1 Qualification of External Communicating Devices; Tissue, Bone, Dentin; Limited (<24 hrs) contact. Biocompatibility assessments were conducted on final, finished and sterilized devices for all fluid path materials of EASYGRIP FLO-41 Precision MIS Delivery System. The following tests were conducted as part of the biocompatibility testing for the device fluid path of the EASYGRIP FLO-41 Precision MIS Delivery System:
- Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Intracutaneous (Irritation) Reactivity ISO 10993-10
- Systemic Toxicity (acute) ISO 10993-11
- Materials Mediated Pyrogen ISO 10993-11
Based upon the results of this limited duration, external communicating, tissue, bone, dentin testing, the EASYGRIP FLO-41 Precision MIS Delivery System has been shown to be biocompatible and appropriate for its intended use.
CONCLUSION:
The performance testing, (e.g., Interface Leak Test, Tensile Strength Test, Consecutive Delivery of Hemostatic Agent Test), summarized in Table 4, support that the EASYGRIP FLO-41 Precision MIS Delivery System performs comparably to the predicate device. Additional supporting data, such as the biocompatibility testing, demonstrate the safety of the EASYGRIP FLO-41 Precision MIS Delivery System. The performance and safety data support that the EASYGRIP FLO-41 Precision MIS Delivery System does not raise different questions of safety and effectiveness and is substantially equivalent to the predicate device that is currently marketed for the same intended use.
§ 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.