(183 days)
No
The device description and performance studies focus on the physical characteristics, materials, and basic functionality of a catheter for CSF drainage. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes.
The device drains cerebrospinal fluid to relieve elevated intracranial pressure, intraventricular hemorrhage, or hydrocephalic shunt infections, which are all conditions that benefit from direct therapeutic intervention.
No
This device is a catheter designed for external drainage of cerebrospinal fluid, not for diagnosing medical conditions.
No
The device description clearly details a physical catheter made of polyurethane, along with several stainless steel and silicone accessories. It is a hardware device for draining CSF.
Based on the provided information, the SureFlo EVD Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the external drainage of cerebrospinal fluid (CSF) from the brain. This is a therapeutic and monitoring procedure performed directly on the patient's body (in vivo).
- Device Description: The device is a catheter designed to be inserted into the brain's ventricular cavity. This is a physical device used for drainage, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like CSF) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. The SureFlo EVD Catheter's function is to drain fluid from the body, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
Product codes
JXG
Device Description
The SureFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through drainage holes near the catheter's bullet shaped tip. Similar to the predicate, the catheter is barium- sulfate- impregnated to provide radiopacity. Black stripes are located every 1 cm between 5 cm and 15 cm from the catheter tip to assist the surgeon in catheter placement. Double stripes and numerical markings are located at 10 cm and 15 cm. (All dimensions are nominal).
The SureFlo EVD Catheter is provided with a stainless steel Stylette, stainless steel Trocar, Barbed Luer Connecter, Male Luer Cap and silicone Suture Clip. The stainless-steel Stylet facilitates catheter placement for introduction of the catheter into the ventricle or other ventricular target site. A Trocar is supplied with the catheter to facilitate subcutaneous tunneling away from the burr hole. The external portion of the catheter may be secured to the scalp by the radiopaque Suture Clip. The Barbed Luer Connector supplied with each SureFlo EVD Catheter will connect the catheter to external drainage systems. The included Male Luer Cap may be used to close (cap) the barbed luer connector until the catheter is connected to a drainage or monitoring device.
The SureFlo EVD Catheter and its accessories are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricular cavity of the brain
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
The SureFlo EVD Catheter was tested per the FDA- recognized consensus standards ISO 7197(2006) and ASTM F647-94(2014) for bench testing. Sterilization validation was performed per ISO 11135:2014. Shelf life and package integrity testing included benchtop testing per ISO 7197(2006) and ASTM F647-94(2014) for real-time aged devices, and package integrity testing per ASTM D4169-16, ASTM F2096-11, F88/F88M-15, and ASTM F1608-16 for accelerated aged products (ASTM F1980-16). Biocompatibility testing was conducted per ISO 10993-1:2009/(R)2013 and specific relevant parts of ISO 10993.
Key results from bench testing (Table 2):
- Pressure and Flow Characteristics (ISO 7197:2006, ASTM F647-94): Pass - Characterization was successfully completed.
- Resistance to Overpressure (ISO 7197:2006): Pass - No significant differences in flow rates and no evidence of damage or leakage.
- Bursting Pressure (ISO 7197:2006): Pass - No evidence of damage or leakage, and mean flow rate did not change beyond allotted value.
- Resistance to Leakage (ISO 7197:2006): Pass - No signs of leakage.
- Durability (ASTM F647-94): Pass - No indication of damage and post-submersion flow rates were not statistically different from pre-submersion.
- Static Breaking Strength (ASTM F647-94): Pass - Disassembled or failed at higher forces than the primary predicate.
- Flexibility (ASTM F647-94): Pass - Obstructed when wrapped around a smaller diameter pin than the predicate device.
- Dynamic Breaking Strength (ISO 7197:2006): Pass - Met the prescribed maximum number of cycles without failure.
- Radiopacity (ISO 7197:2006, ASTM F647-94): Pass - Test articles met or exceeded radiopacity requirements.
Key results from sterility testing (Table 3):
- Ethylene Oxide Sterilization per ISO 11135:2014: Pass - Devices were sterile with an SAL
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
Arkis BioSciences, Inc. Mr. Joseph Howell Ouality and Regulatory Affairs Manager 1059 N. Cedar Bluff Road #157 Knoxville, Tennessee 37923
Re: K170599
Trade/Device Name: SureFlo EVD Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: August 1, 2017 Received: August 2, 2017
Dear Mr. Howell:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
William J. Heetderks -S 2017.08.31 13:28:40 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
SureFlo EVD Catheter Indications for Use (Describe)
The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary 510(k) Number K170599
| | Arkis BioSciences Inc.
1059 North Cedar Bluff Rd.
Number 157
Knoxville, TN 37923
(844) 247-5383 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | August 29, 2017 |
| Contact | Joseph Howell
Quality and Regulatory Affairs Manager
(844) 247-5383 ext. 2 |
| Trade Name | SureFlo™ EVD Catheter |
| Common Name | External Ventricular Drainage Catheter |
| Classification | Class II |
| Regulation Number | 21 CFR 882.5550 |
| FDA Product Code | JXG |
| Classification Name | Shunt, Central Nervous System and Components |
| Predicate Device(s): | Primary Predicate: TraumaCath, Integra NeuroSiciences (K972994)
Predicate: Neurocath Ag, Vygon Neuro, (K081942)
Reference Device: NMI PICC III, Navilyst Medical (K121089) |
| Performance
Standards: | Performance standards for external monitoring and drainage systems have not been
established by FDA under Section 514 of the Food, Drug and Cosmetic Act. |
| Device Description | The SureFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter
for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through drainage
holes near the catheter's bullet shaped tip. Similar to the predicate, the catheter is
barium- sulfate- impregnated to provide radiopacity. Black stripes are located every 1 cm
between 5 cm and 15 cm from the catheter tip to assist the surgeon in catheter
placement. Double stripes and numerical markings are located at 10 cm and 15 cm. (All
dimensions are nominal).
The SureFlo EVD Catheter is provided with a stainless steel Stylette, stainless steel Trocar,
Barbed Luer Connecter, Male Luer Cap and silicone Suture Clip. The stainless-steel Stylet
facilitates catheter placement for introduction of the catheter into the ventricle or other
ventricular target site. A Trocar is supplied with the catheter to facilitate subcutaneous
tunneling away from the burr hole. The external portion of the catheter may be secured to
the scalp by the radiopaque Suture Clip. The Barbed Luer Connector supplied with each
SureFlo EVD Catheter will connect the catheter to external drainage systems. The included
Male Luer Cap may be used to close (cap) the barbed luer connector until the catheter is
connected to a drainage or monitoring device.
The SureFlo EVD Catheter and its accessories are provided sterile. |
4
The SureFlo EVD Catheter is constructed of a thermoplastic polyurethane (TPU) elastomer, just as the predicate device, Vygon Neurocath Ag (K081942). The SureFlo EVD Catheter polymer contains barium sulfate for radiopacity.
The SureFlo EVD Catheter additionally contains Endexo polymer; a polymer which is blended into the SureFlo EVD Catheter. The Endexo polymer is present throughout the polyurethane matrix including the bulk of the catheter body, and at any molded / extruded surfaces. The same Endexo polymer technology is used in several class II medical devices, including the cited reference device, Navilyst Medical NMI PICC III (K121089), Navilyst Medical Bioflo Midline Catheter (K150407), and the Navilyst Medical NMI Dialysis Catheter (K131260). Additionally, the same Endexo formulation is used in the cited reference device, Navilyst Medical NMI PICC III (K121089).
The Endexo polymer in polyurethane has been shown to be effective in reducing platelet adhesion in-vitro and thrombus accumulation in vitro [1, 2], and reducing the clinical incidence of thrombus formation as reported in medical literature [3, 4, 5, 6]. Please note:
- . In vitro evaluations and in vivo animal evaluations do not necessarily predict the clinical performance of the SureFlo EVD Catheter with respect to thrombus formation.
- . The incidence of thrombus formation on polyurethane containing Endexo polymer in other medical devices and/or tissues systems does not necessarily predict the clinical performance of the SureFlo EVD Catheter for the intended use of CSF external drainage and monitoring.
REFERENCES:
[1] R. Lareau and F. Facchini, "A New Option for Short- or Long-Term Peripheral Access to the Central Venous System: A product technology overview of the BioFlo PICC with Endexo Technology, with and without PASV Valve Technology," AngioDynamics, Inc., 2014.
[2] See test reports in the FDA cleared 510(k) application K121089 "Navilyst Medical NMI PICC III".
[3] L. Sustar and M. Kertesz, "Anti-Thrombogenic Non-Eluting Polyurethane PICC vs. Conventional Polyurethane PICC Upper Extremity DVT Rate," in Association for Vascular Access 2013 Annual Scientific Meeting, Nashville, TN, 2013.
[4] J. Webb and S. Rineair, "Changing the Outcome for the Pediatric Peripherally Inserted Central Catheter Patient: Decreasing Occlusion Complications with the Implementation of the BioFlo Peripherally Inserted Central Catheter with Pressure Activated Safety Valve," in Association For Vascular Access 2013 Annual Scientific Meeting, Nashville, TN, 2013.
[5] H. Polenakovik, A. Patton and J. Jenkins, "Incidence Rates of Symptomatic Peripherally Inserted Central Catheter - Related Deep Vein Thrombosis in Hospitalized Non-trauma Patients – Comparison Study of Two PICC Designs," in Association For Vascular Access 2014 Annual Scientific Meeting, National Harbor, MD, 2014.
[6] L. Crites, "Reducing Catheter-Related Complications with New Anti-Thrombogenic PICC," Journal of the Association for Vascular Acess, vol. 30, no. 4, p. 256, 2015.
Indication for Use The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
5
Comparison of Technological Characteristics with the Predicate Devices
At a high level, the SureFlo EVD Catheter (subject device), the primary predicate (Integra TraumaCath (K972994)), and the predicate device (Neurocath Ag Vygon (K081942)), are based on the following same technological elements:
- . The subject device, primary predicate, and predicate device utilize the same mode of action.
- Dimensions between the subject device and the primary predicate device are identical.
- The number of flow holes between the subject device, primary predicate, and predicate device are the same.
- The catheter from the subject device, primary predicate device, and predicate device have depth markings applied to the exterior of the catheter.
- The subject device and the primary predicate utilize the same type and number of accessories.
The following technological differences exist between the subject device (Arkis SureFlo EVD Catheter), primary predicate (Integra TraumaCath (K972994)), and the predicate (Vygon Neurocath Ag (K081942)):
- The catheter material utilized in the subject device (SureFlo EVD Catheter), the primary predicate Integra TraumaCath (K972994), and the predicate device Vygon Neurocath Ag (K081942) are different. Consequently, the SureFlo EVD Catheter was evaluated for biocompatibility and bench-top performance and was found to be biocompatible for its intended use.
Table 1 contains a summary of technological similarities and differences for the SureFlo EVD Catheter, the primary predicate, and the predicate device.
| Technological
Characteristic | SureFlo EVD Catheter Set
Arkis Biosciences
(Subject Device) | TraumaCath
Integra NeuroSicences
(K972994)
Primary Predicate Device | Neurocath Ag
Vygon 8835.239
(K081942)
Predicate Device |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter
Dimensions | | | |
| Outer
Diameter: | 3.3 mm | 3.3 mm | 2.9 mm |
| Inner
Diameter: | 1.9 mm | 1.9 mm | 1.8 mm |
| Length: | 35 cm | 35 cm | 32 cm |
| Flow Holes | 16 | 16 | 16 |
| Set Contents | One Each of the Following
Catheter
Stainless Steel Stylette
Stainless Steel Trocar
Barbed Luer Connector
Male Luer Cap
Silicone Suture Clip | One Each of the Following
Catheter
Stainless Steel Stylette
Stainless Steel Trocar
Barbed Luer Connector
Male Luer Cap
Silicone Suture Collar | One Each of the Following
Catheter
Stainless Steel Stylette
Stainless Steel Trocar
Male Luer Connector
Slitted Wing
Compression Hub |
Table 1: Comparison and Differences of Technological Characteristics.
6
| Technological
Characteristic | SureFlo EVD Catheter Set
Arkis Biosciences
(Subject Device) | TraumaCath
Integra NeuroSicences
(K972994)
Primary Predicate Device | Neurocath Ag
Vygon 8835.239
(K081942)
Predicate Device |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Catheter
Markings
(listed as
distance from
the tip) | Black stripes are located
every cm between 5 cm and
15 cm from the catheter tip.
Double stripes and
numerical markings are
located at 10 cm and 15 cm. | Markings every cm from 3 to
15 cm ± 1.5 mm with number
located at odd markings, and
dots located at even markings. | Markings at 3, 4, 5, 6, 7, 8, 9, 10,
15, and 20 cm. A specific marking
is added 7.5 cm from the tip |
| Catheter
Materials | Polyurethane with
Barium Sulfate
Endexo polymer
Blue colorant | Barium Striped Silicone
Tantalum impregnated tip | Polyurethane
Silver ions (for radiopacity) |
Bench testing of the Arkis SureFlo EVD Catheter per ISO 7197:2006 and ASTM F647-94(2014), and biocompatibility testing per ISO 10993-1:2009/(R)2013 demonstrate that the difference in material does not raise any new or different questions of safety or effectiveness compared to the primary predicate Integra TraumaCath (K972994).
Performance Data
Performance Testing - Bench
The SureFlo EVD Catheter was tested per the FDA- recognized consensus standards ISO 7197(2006) and ASTM F647-94(2014). The testing was performed to verify the performance specifications of the SureFlo EVD Catheter and to demonstrate equivalence in function to the predicate external ventricular drainage catheters.
The SureFlo EVD Catheter meets all of the performance specifications given in ISO 7197(2006) and ASTM F647-94(20014). Where no specific performance specification was given in the standards, the SureFlo EVD Catheter was found to have equivalent performance to the predicate ventricular drainage catheter to which it is being compared.
Table 2 summarizes the benchtop performance testing of the Arkis SureFlo EVD Catheter.
Performance Testing - Sterility
The SureFlo EVD Catheter is sterilized using ethylene oxide in per ISO 11135:2014. Sterilization validation demonstrated that the selected sterilization process achieves a sterility assurance level (SAL) of Pass: Samples did not show any
indication of leakage. No change from
non-aged samples. |
| Test Description | Test Summary | Results |
| Dynamic
Breaking
Strength
ISO 7197:2006 | Real-time aged devices were tested. Catheter + luer
barb assemblies were subjected to a dynamic
longitudinal load (up to 5 N or 10% of elongation) for a
prescribed maximum number of cycles or until failure
occurs. | Pass: The samples tested met the
prescribed maximum number of cycles
without failure. No change from non-
aged samples. |
| Static Breaking
Strength
ASTM F647-94 | Real-time aged devices were tested. Catheter + luer
barb were loaded with an increasing longitudinal force
until the catheter disassembled from the luer, or until
the catheter or luer fractures. | Pass: The Arkis SureFlo EVD Catheter
assemblies tested disassembled or failed
at higher forces than the primary
predicate assemblies tested for
comparison. No change from non-aged
samples. |
| Flexibility
ASTM F647-94 | Real-time aged devices were tested. Catheter + luer
barb were wrapped around pins and a positive air
pressure was applied to the inside of the catheter. The
catheter was wrapped around decreasing pin diameters
until the catheter became obstructed. | Pass: Arkis SureFlo EVD Catheter
samples tested were obstructed when
wrapped around a smaller diameter pin
than the predicate device. No change
from non-aged samples. |
| Accelerated
Aging
ASTM F1980-16 | Accelerated aging conducted prior to distribution and
package integrity testing. | Pass: Accelerated aging completed at
specified parameters. |
| Distribution
Simulation
ASTM D4169-16 | Testing performed on accelerated aged products.
Distribution simulation of shipper boxes containing
individual device packages per ASTM D4169
distribution cycle 13 with Schedule I omitted and
Schedule J not performed. | Pass: Shipping unit remained intact with
no rips, punctures, tears, or crushing.
Shipping unit met the same
specifications as non-aged samples. |
| Bubble Emission
Test
ASTM F2096-11 | Testing performed on accelerated aged and distributed
products. Detects leaks in sterile barrier pouches
through the emission of bubbles when the pouches are
inflated and placed underwater. | Pass: No bubbles were emitted from any
of the tested packaging. Meets same
specifications as non-aged/distributed
samples. |
| Pouch Seal Test
ASTM
F88/F88M-15 | Testing performed on accelerated aged and distributed
products. Determines the strength sterile barrier
(pouch) seal by mechanically pulling on sections of the
pouch seal. | Pass: The sterile barrier seal strength
exceeded the minimum specification for
non-aged/distributed samples. |
| Microbial
Ranking
ASTM F1608-16 | Testing performed on accelerated aged and distributed
products. Quantifies the log reduction value in number
of aerosolized bacterial spores passing through porous
sterile barrier materials. | Pass: The porous sterile barrier material
met the same performance specification
as non-aged/distributed sterile barrier. |
9
Biocompatability
The Arkis SureFlo EVD Catheter was evaluated following ISO 10993-1:2009/(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" per the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.""
The biocompatibility assessments demonstrated that the SureFlo EVD Catheter and the accessories included in the set are biocompatible for their intended use.
The biocompatibility testing is summarized in Table 5.
10
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity | ||
| ISO 10993-5:2009 | The viability percentage of the cells exposed to the 100% (neat) test article extract was within acceptable limits. | Pass: Non-cytotoxic |
| Sensitization | ||
| ISO 10993-10:2010 | Extracts of the test articles elicited no reaction at the test challenge (0% sensitization). | Pass: Non-sensitizing |
| Irritation or | ||
| Intracutaneous | ||
| Reactivity | ||
| ISO 10993-10:2010 | Extracts of the test articles were evaluated for their potential to produce irritation. The test articles did not show a significantly greater biological reaction than the sites injected with the control article. | Pass: Non-irritating |
| Acute Systemic Toxicity | ||
| ISO 10993-11:2006 | Extracts of the test articles did not induce a significantly greater biological reaction than that of the control extracts. | Pass: No Acute System Toxicity |
| Material-Mediated | ||
| Pyrogenicity | ||
| ISO 10993-11:2006 | Extracts of the test articles did not produce a pyrogenic response when tested. | Pass: Non-pyrogenic |
| Genotoxicity | ||
| (Ames Assay) | ||
| ISO 10993-3:2014 | Extracts of the test articles did not induce a biologically significant increase in the number of revertant (mutated) bacterial colonies. | Pass: Non-mutagenic |
| Genotoxicity | ||
| (Micronucleus Assay) | ||
| ISO 10993-3:2014 | Extracts of the test articles did not induce a statistically significant increase in the percentage of reticulocytes containing micronuclei and test articles did not induce a clastogenic effect in maturing erythrocytes. | Pass: Non-clastogenic |
| Genotoxicity | ||
| (Mutagenesis Assay) | ||
| ISO 10993-3:2014 | The increased mutant frequency (IMF) of cells exposed to test article extracts was less than the test criteria for the main and confirmation assays for all concentrations tested. | Pass: Non-mutagenic |
| Hemocompatibility | ||
| (Complement | ||
| Activation) | ||
| ISO 10993-4:2002 | The concentrations of C3A and SC5B-9 in the plasma exposed to the test article was not significantly increased from the concentrations in the negative and untreated controls. | Pass: Did not activate complement system in plasma |
| Hemocompatibility | ||
| (Hemolysis) | ||
| ISO 10993-4:2002 | ||
| ASTM F756-13 | The test article exhibited a hemolysis index of that was not significantly above the negative control for the direct and indirect contact methods. | Pass: Non-hemolytic |
| Hemocompatibility | ||
| (In Vitro) | ||
| ISO 10993-4:2002 | The concentration of White Blood Cells (WBC) and Platelets (Plt) exposed to the test article was not significantly decreased in comparison to the negative control article and was not statistically significantly decreased in comparison to the untreated control. | Pass: No effect on selected hematological parameters |
| Hemocompatibility | ||
| (Unactivated Partial | ||
| Thromboplastin Time) | ||
| ISO 10993-4:2002 | The Unactivated Partial Thromboplastin Time (UPTT) was not significantly decreased in comparison to the negative and untreated controls. | Pass: No effect on coagulation |
| Subacute Toxicity via | ||
| Brain and Subcutaneous | ||
| Implantation | ||
| ISO 10993-6:2007 | ||
| ISO 10993-11:2006 | For all parameters tested, animals implanted with the test article did not demonstrate any differences considered attributable to the test article compared to those animals implanted with the control article. | Pass: No local or systemic sign of toxicity |
11
- Conclusion The SureFlo EVD Catheter is substantially equivalent to the primary predicate Integra TraumaCath (K972994), per the criteria given in FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]".
Note: Trademarks cited for predicates are owned by the respective companies.