(56 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid delivery aspects, with no mention of AI or ML.
No.
This device is a delivery system for hemostatic agents, not a therapeutic device itself. The therapeutic action comes from the hemostatic agent it delivers.
No
Explanation: The device is used for delivering hemostatic agents to bleeding sites, which is a therapeutic function, not a diagnostic one. It does not gather information about a patient's condition.
No
The device description clearly outlines physical components (applicator device with cannula, syringe) and mechanical actions (Luer lock connection, depressing plunger, actuating trigger handle) for delivering a substance. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver compatible hemostatic agents to bleeding sites". This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a delivery system for a hemostatic agent. It physically delivers a substance to a site within the body. This is not the function of an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a surgical delivery system used during a procedure to control bleeding.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bleeding sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted to evaluate the functional performance of the EASYGRIP FLO-41 Precision MIS Delivery System. All tests met the acceptance criteria.
Trigger Force to Deliver Hemostatic Matrix: The Trigger Force Test evaluated with 95% confidence that for 95% of the devices the force required to deliver hemostatic matrix is less than 30 lbf.
Malleable Tip Bend and Robustness Test: The Malleable Tip Bend and Robustness Test demonstrated with 95% confidence that 95% of the malleable tips shall not kink when bent to 90 degrees and will be able to deliver the product.
Device Interface Leak test: The Device Interface Leak Test demonstrated with 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.
Saline Retainment inside the Device after Residual Flush: The Saline Retainment Test demonstrated with 95% confidence that 90% of the devices would retain the 1.5 ml Saline within the device after the residual hemostatic matrix is delivered.
Cannula Bend Test at Various Trocar Positions: The Cannula Bend Test demonstrated with 95% confidence that 95% of the devices would not break and leak at the device connections after being subjected to the bend test.
Device Tensile Strength: The Device Tensile Strength Test demonstrated with 95% confidence that 95% of the device connections can withstand the tensile pull force of 5lb without failure.
Consecutive Delivery of Hemostatic Agent: The Consecutive Delivery Test demonstrated with 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).
Intermittent Delivery of Hemostatic Agent: The Intermittent Delivery Test demonstrated with 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).
Device Functionality to Start and Stop Delivery of Hemostatic Matrix: The Device Functionality Test demonstrated with 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.
Dual Check Valve Function Test: The Dual Check Valve Test demonstrated with 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.
Material Compatibility with Thrombin: The Material Compatibility with Thrombin Test demonstrated with 95% confidence that for 90% of the devices there 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 and ISO 594-2: Tested in accordance to ISO 594-1 and 594-2
Reservoir Syringe Fill Capacity: The Reservoir Syringe Fill Capacity Test demonstrated with 95% confidence that 90% of the reservoir syringes can accommodate at least 5ml of product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
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 |
4
PREDICATE DEVICE:
The predicate device, the Malleable Tip Endoscopic Applicator, is manufactured by Micromedics Inc., dba Nordson Medical.
| Trade Name | Company | Predicate
510(k) | Clearance
Date |
|----------------------------------------|------------------------------------------|---------------------|-------------------|
| Malleable Tip Endoscopic
Applicator | Micromedics, Inc. dba Nordson
Medical | 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.
5
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.
6
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 Device
Cleared under K123847 | Proposed Device
EasyGrip FLO-41 Precision MIS
Delivery System | Assessment of Differences |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Malleable Tip Endoscopic Applicator
is intended for use in delivering hemostatic
agents to bleeding surgical sites through a
5mm or larger trocar | The EASYGRIP FLO-41 Precision
MIS Delivery System is intended
for delivering compatible
hemostatic agents to bleeding sites
through a 5mm or larger trocar. | Not Applicable |
| Indications for
Use | The Malleable Tip Endoscopic Applicator
is intended for use in delivering hemostatic
agents to bleeding surgical sites through a
5mm or larger trocar | The EASYGRIP FLO-41 Precision
MIS Delivery System is indicated
for delivering compatible
hemostatic agents to bleeding sites
through 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 vinyl
ester resin | Sheath (Tube):
Same | The proposed device's collar, malleable tip
tubing and adhesive material have passed
functional 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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Image /page/7/Picture/2 description: The image contains the word "Baxter" in a bold, blue font. The word is the primary focus of the image and is centrally located. The font appears to be sans-serif and has a slightly italicized appearance.
| Features | Predicate Device
Cleared under K123847 | Proposed Device
EasyGrip FLO-41 Precision MIS
Delivery System
(cannula/collar and collar/malleable
tip)
Loctite M-31CL | Assessment of Differences |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Luer Lock
Connector
(overmolded on
Cannula) | Acrylonitrile Butadiene Styrene (ABS) | Same | Not Applicable |
| Stylet | PolyMed® composite rod
Acrylonitrile Butadiene Styrene (ABS) tip
Acrylonitrile Butadiene Styrene (ABS)
handle | Proposed device doesn't have a
stylet | The proposed device doesn't have a stylet.
Design control activities have been conducted
and have confirmed that the different
technological characteristics of the new device
do not raise different questions of safety and
effectiveness. |
| 1.5 mL empty
flush syringe | Not applicable | Barrel: Polycarbonate | The predicate device does not have a 1.5 mL
empty flush syringe. Design control activities
have been conducted and have confirmed that
the different technological characteristics of
the new device do not raise different questions
of safety and effectiveness. |
| | | Plunger:Polycarbonate + 10% Glass
Filled
Piston Seal:Thermoplastic elastomer | |
Table 3. Device Comparison
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Table 3. Device Comparison
| Features | Predicate Device
Cleared under K123847 | Proposed Device
EasyGrip FLO-41 Precision MIS
Delivery System | Assessment of Differences |
|-------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dual check valve | Not applicable | Body: Polycarbonate
Swivel Nut: Copolyester
Female Luer Ports: Polycarbonate
Valve: Silicone | The predicate device does not have a dual
check valve. Design control activities have
been conducted and have confirmed that the
different technological characteristics of the
new device do not raise different questions of
safety and effectiveness. |
| Reservoir Syringe | Not applicable | Plunger: Polypropylene
homopolymer
Barrel: Polypropylene
Piston Seal: Thermoplastic
elastomer | The predicate device does not have a reservoir
syringe. Design control activities have been
conducted and have confirmed that the
different technological characteristics of the
new device do not raise different questions of
safety and effectiveness. |
9
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 with |
| 95% confidence that for 95% of the | |
| devices the force required to deliver | |
| hemostatic matrix is less than 30 lbf. | |
| Malleable Tip Bend and Robustness Test | The Malleable Tip Bend and Robustness |
| Test demonstrated with 95% confidence | |
| that 95% of the malleable tips shall not | |
| kink when bent to 90 degrees and will be | |
| able to deliver the product. | |
| Device Interface Leak test | The Device Interface Leak Test |
| demonstrated with 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. | |
| Saline Retainment inside the Device after Residual Flush | The Saline Retainment Test |
| demonstrated with 95% confidence that | |
| 90% of the devices would retain the 1.5 | |
| ml Saline within the device after the | |
| residual hemostatic matrix is delivered. | |
| Cannula Bend Test at Various Trocar Positions | The Cannula Bend Test demonstrated |
| with 95% confidence that 95% of the | |
| devices would not break and leak at the | |
| device connections after being subjected | |
| to the bend test. | |
| Device Tensile Strength | The Device Tensile Strength Test |
| demonstrated with 95% confidence that | |
| 95% of the device connections can | |
| withstand the tensile pull force of 5lb | |
| without failure. | |
| Consecutive Delivery of Hemostatic Agent | The Consecutive Delivery Test |
| demonstrated with 95% confidence that | |
| 95% of the devices will be able to | |
| Test | Acceptance Criteria |
| 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). | |
| Intermittent Delivery of Hemostatic Agent | The Intermittent Delivery Test |
| demonstrated with 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). | |
| Device Functionality to Start and Stop Delivery of | |
| Hemostatic Matrix | The Device Functionality Test |
| demonstrated with 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. | |
| Dual Check Valve Function Test | The Dual Check Valve Test |
| demonstrated with 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. | |
| Material Compatibility with Thrombin | The Material Compatibility with |
| Thrombin Test demonstrated with 95% | |
| confidence that for 90% of the devices | |
| there 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 and
ISO 594-2 | Tested in accordance to ISO 594-1 and
594-2 |
| Reservoir Syringe Fill Capacity | The Reservoir Syringe Fill Capacity Test
demonstrated with 95% confidence that
90% of the reservoir syringes can
accommodate 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
11
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 (