(219 days)
No
The summary describes a physical catheter with specific material and structural properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and biological characteristics, not algorithmic performance.
No.
The device facilitates the introduction of diagnostic agents and therapeutic devices but is not itself a therapeutic device.
No
The device description indicates that the Slinky Catheter is used to "facilitate introduction of diagnostic agents and therapeutic devices," meaning it delivers diagnostic agents rather than performing diagnosis itself.
No
The device description clearly details a physical catheter with material properties, reinforcement, coatings, and a radiopaque marker. The performance studies focus on bench testing of physical attributes and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use... to facilitate introduction of diagnostic agents and therapeutic devices." This describes a device used within the body for procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter designed for navigating blood vessels, with features like radiopaque markers, lubricious coatings, and reinforcement. These are characteristics of an invasive medical device, not an IVD.
- Anatomical Site: The anatomical site is "Intravascular use," which is within the body. IVDs typically analyze samples taken from the body (like blood, urine, tissue) in a laboratory setting.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the catheter itself (kink resistance, torque strength, flow rate, biocompatibility, etc.) and its performance during simulated use within the vasculature. They do not involve evaluating the device's ability to detect or measure substances in biological samples.
In summary, the Slinky Catheter is an invasive medical device used for accessing and navigating blood vessels to deliver other agents or devices. This is fundamentally different from an In Vitro Diagnostic device, which is used to perform tests on biological samples outside the body to aid in diagnosis.
N/A
Intended Use / Indications for Use
The Slinky Catheter is indicated for general intravascular use. including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.
Product codes
QJP, DQY, DQO
Device Description
The Slinky® Catheter is a single lumen, variable stiffness catheter with a coil and braid reinforcement. It has a radiopaque marker at the distal tip for enhanced fluoroscopic visualization, a lubricious inner, and a hydrophilic coating on the distal 35 cm to enhance lubricity and vascular navigation. The Slinky® Catheter is provided sterile via Ethylene Oxide (EO) sterilization, non-pyrogenic, and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculature
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
To demonstrate the substantial equivalence of the subject Slinky® Catheter to the predicate device, the SOFIA PLUS/Distal Access Catheters, the performance, biocompatibility, and sterility of the Slinky® Catheter were evaluated via the following tests and assessments:
- Design Verification Bench Testing
- Biocompatibility
- Shelf-Life
- Sterilization
- Packaging Validation
Bench Performance Testing:
- Simulated Use: Test articles were used by three trained interventional neuroradiologists in a tortuous anatomical bench test model, demonstrating compatibility with ancillary devices including introducers, microcatheters, and guidewires. Device performed as intended under simulated use conditions.
- Particulate Test: Test articles were tracked multiple times through the tortuous anatomical model with ancillary devices. Devices were inspected for coating anomalies pre- and post-testing. Particulate generation of the subject device was similar to the predicate device.
- Product Compatibility: Simulated use testing by three physicians was conducted, using a full-length silicone anatomical tortuous path model. The procedure included using the test catheter along with worst case ancillary devices (i.e., smallest ID introducer, largest OD guidewire, stiff micro guidewire, large stent-retriever). The device was found to be compatible with ancillary devices.
- Dimensional and Visual Attributes: The physical and dimensional attributes were evaluated and measured. Device met the established dimensional and visual specifications.
- Kink Resistance: The distal, mid, and proximal sections of the catheter were wrapped around varying size pin gauges. Device met the established kink resistance criteria.
- Radio Detectability: The distal marker band and catheter body visibility were evaluated under fluoroscopy. Device radiopacity comparable to the predicate device.
- Catheter Hub: The hub functionality was evaluated during simulated use, freedom from leakage, flow rate, dynamic burst, particulate, and other bench testing completed. Device hub meets the requirements of ISO 80369-7.
- Durability/Lubricity of Hydrophilic Coating: Lubricious coating on the catheter surface was evaluated after simulated use for defects and for friction force. Device met the established friction and lubricity criteria. The friction force was similar to the predicate.
- Tip Flexibility: Device tip stiffness was characterized on a cantilever bend test. The tip stiffness was similar to the predicate.
- Torque Strength: Devices were pre-conditioned by simulated use and torqued to failure inside a tortuous anatomical model with the distal tip held fixed. Device torque strength is the same as the predicate device.
- Force at Break (Distal and Hub): Catheter force at break averaged 8 lbf for the hub and 5-6 lbf for the mid and distal segments and exceeds acceptance criteria determined from withdrawal force measurements. Tensile strength meets the test acceptance criteria.
- Flow Rate: Flow rate was characterized at 100 psi with diagnostic agents (e.g., saline, contrast media). Device meets the specified requirements for delivery of diagnostic agents.
- Static Burst Pressure: Device can withstand static pressure above labeled 100 psi maximum with margin of safety. Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Freedom from Leakage: Testing followed the methods and criteria defined in EN ISO 10555-1 after pre-conditioning by simulated use. Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Air Leakage: No air leakage at hub into syringe for 15 seconds. Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Dynamic Burst: Devices were pre-conditioned by simulated use. Test devices were then connected to a pressurized fluid source, starting with 250 psi and further increased every 10 seconds until a maximum of 600 psi was applied. Device met labeled maximum infusion pressure of 100 psi.
- Peak Tensile Force: Devices were pre-conditioned by simulated use. Tensile testing was then conducted per the methods defined in EN ISO 10555-1. Device met acceptance criteria determined from withdrawal force testing.
Biocompatibility:
- Cytotoxicity (ISO 10993-5) - MEM Elution Assay: Cell culture observed for cytotoxic reactivity following exposure to test extract with Grade , ISO 10993-11): Study animals observed for individual temperature rise following intravenous injection of test extracts. Non-pyrogenic.
- Hemolysis (ASTM F756, ISO10993-4) – Direct and Indirect (extract) Hemolysis: The difference between the hemolytic indexes of the subject device and the negative control was evaluated after exposure to test extracts and direct exposure to test article. Direct contact - Non-hemolytic, Indirect contact - Non-hemolytic.
- SC5b-9 Complement Activation Assay (ISO 10993-4): Using an enzyme immunoassay, SC5b-9 concentration following exposure of test article extracts to normal human serum (NHS) compared to SC5b-9 concentration of the control article exposed to NHS. Not considered to be a potential activator of the complement system.
- Thrombogenicity (ASTM F2382) - Partial Thromboplastin Time: Thrombogenicity potential of test article compared to control articles. Acceptable results.
- Platelet and Leukocyte Count (ASTM F2888-19, ISO 10993-4) In vitro Blood Loop.
Sterilization and Shelf-Life:
The Slinky® Catheter is labeled as a single-use sterile device with shelf-life of 12 months. The sterilization process has been validated and process monitoring controls are in place to assure that the device is EO sterilized to achieve a minimum sterility assurance level (SAL) of 10 ° Shelf-life studies have been conducted and demonstrate that the product and packaging remain functional and sterile for the shelf-life period of 12 months.
Key Metrics
Not Found
Predicate Device(s)
SOFIA PLUS/Distal Access Catheters (K150366)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
December 1, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Anoxia Medical, Inc. % Bosmat Friedman, MSc Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Road Charlotte, North Carolina 28269
Re: K231179
Trade/Device Name: Slinky Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY, DQO Dated: November 1, 2023 Received: November 1, 2023
Dear Bosmat Friedman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231179
Device Name Slinky Catheter
Indications for Use (Describe)
The Slinky Catheter is indicated for general intravascular use. including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.
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
510(k) Summary
510(k) Number: K231179
Date Prepared: November 30, 2023
| Submitter/Manufacturer | Anoxia Medical, Inc. |
|---|---|
| 3475 Investment Boulevard, Suite #9 | |
| Hayward, CA 94545 | |
| Contact | Henry Nita |
| Telephone: 650-430-2045 | |
| Trade Name | Slinky Catheter |
| Common/Usual Name | Distal Access Catheter |
| Regulation Description | Percutaneous Catheter |
| Regulation Number | 21 CFR 870.1250; 21 CFR 870.1200 |
| Product Code | QJP, DQY, DQO |
| Device Class | Class II |
| Classification Panel | Neurology, Cardiovascular |
| Predicate Devices | SOFIA PLUS/Distal Access Catheters (K150366) |
Device Description:
The Slinky® Catheter is a single lumen, variable stiffness catheter with a coil and braid reinforcement. It has a radiopaque marker at the distal tip for enhanced fluoroscopic visualization, a lubricious inner, and a hydrophilic coating on the distal 35 cm to enhance lubricity and vascular navigation. The Slinky® Catheter is provided sterile via Ethylene Oxide (EO) sterilization, non-pyrogenic, and is for single use only.
Indications for Use:
The Slinky Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.
Comparison of Technological Characteristics with the Predicate Device:
The Slinky® Catheter has similar indications for use and technological characteristics as the predicate device as presented in the following table. The differences do not raise new questions of safety or effectiveness.
4
| Comparison to the Predicate Device | ||
|---|---|---|
| Characteristic | Predicate Device | |
| SOFIA PLUS/Distal Access | ||
| Catheters | ||
| K150366 | Subject Device | |
| Slinky® Catheter | ||
| K231179 | ||
| Classification, | ||
| Product Code | Class II, DQY, DQO | Class II, QJP, DQY, DQO |
| Generic Name | Percutaneous Catheter | Same |
| Regulation | ||
| Number | 21 CFR 870.1250; 21 CFR 870.1200 | Same |
| Classification | ||
| Panel | Neurology, Cardiovascular | Same |
| Indications | ||
| For Use | The SOFIA PLUS/Distal Access | |
| Catheters are indicated for general | ||
| intravascular use, including the neuro | ||
| and peripheral vasculature. It can be | ||
| used to facilitate introduction of | ||
| diagnostic and therapeutic agents. It is | ||
| not intended for use in coronary | ||
| arteries. | The Slinky Catheter is indicated for | |
| general intravascular use, including | ||
| the neuro and peripheral vasculature. | ||
| It can be used to facilitate introduction | ||
| of diagnostic agents and therapeutic | ||
| devices. It is not intended for use in | ||
| coronary arteries. | ||
| DIMENSIONS: | ||
| Catheter Size | 6F | 6F |
| Catheter | ||
| Effective Length | 115-135 cm | 132 cm |
| Proximal ID | 0.070" | 0.075" |
| Proximal OD | 0.0825" | 0.086" |
| Tip Configuration | Steam shapeable by user | Straight-cut or 30°-cut atraumatic soft |
| tip configurations | ||
| MATERIALS: | ||
| Catheter Body | ||
| Outer Layer | Polyurethane elastomer (Polyblend | |
| and Pellethane), polyether block amide | ||
| (Pebax) and polyamide (Grilamid) | Pebax® 55D, Pebax® 63D, Grilamid™ | |
| L25, QFLEX 85A/Polyblend 60A, | ||
| Pellathane® 80A, Pebax® 35D | ||
| Catheter Body | ||
| Inner Layer | Stainless steel braid/coil, PTFE and | |
| polyolefin elastomer | Braid and coil: 304 V Stainless Steel, | |
| PTFE, QFLEX 75A/Polyblend 60A | ||
| Marker | Platinum/Iridium | Platinum/Iridium |
| Hub | Nylon | Acrylic |
| Strain Relief | Polyurethane | Polyolefin |
| Shaping Mandrel | Stainless steel | N/A |
| Coating | Hydrophilic coating: Hydak® | Hydrophilic coating: Harland |
| Guidewire | ||
| Compatibility | 0.035" | 0.014", 0.035", 0.038" |
| Method of | ||
| Supply | Sterile and Single Use | Same |
| Sterilization Method | Ethylene oxide | Same |
| Packaging Card | Polyethylene | Same |
| Packaging Hoop | HDPE | Polyethylene |
| Packaging Pouch | Tyvek® | Nylon and LDPE (top) |
| Tyvek® 1073B (bottom) | ||
| Packaging Carton Box | Pouch and IFU placed in carton box | Same |
| Shelf Life | Not specified | 12 Months |
| Accessories Included | Introducer sheath, shaping mandrel | None |
5
Performance Testing:
To demonstrate the substantial equivalence of the subject Slinky® Catheter to the predicate device, the SOFIA PLUS/Distal Access Catheters, the performance, biocompatibility, and sterility of the Slinky® Catheter were evaluated via the following tests and assessments:
- Design Verification Bench Testing ●
- Biocompatibility .
- Shelf-Life .
- Sterilization ●
- Packaging Validation ●
Bench Performance Testing
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Simulated Use | Test articles were used by three trained interventional | |
| neuroradiologists in a tortuous anatomical bench test | ||
| model, demonstrating compatibility with ancillary | ||
| devices including introducers, microcatheters, and | ||
| guidewires. | Device performed as intended | |
| under simulated use conditions. | ||
| Particulate Test | Test articles were tracked multiple times through the | |
| tortuous anatomical model with ancillary devices. | ||
| Devices were inspected for coating anomalies pre- and | ||
| post-testing. | Particulate generation of the | |
| subject device was similar to | ||
| the predicate device. | ||
| Product Compatibility | Simulated use testing by three physicians was | |
| conducted, using a full-length silicone anatomical | ||
| tortuous path model. The procedure included using the | ||
| test catheter along with worst case ancillary devices | ||
| (i.e., smallest ID introducer, largest OD guidewire, | ||
| stiff micro guidewire, large stent-retriever). | The device was found to be | |
| compatible with ancillary | ||
| devices. | ||
| Dimensional and Visual | ||
| Attributes | The physical and dimensional attributes were | |
| evaluated and measured. | Device met the established | |
| dimensional and visual | ||
| specifications. | ||
| Test | Test Method Summary | Conclusions |
| Kink Resistance | The distal, mid, and proximal sections of the catheter | |
| were wrapped around varying size pin gauges. | Device met the established | |
| kink resistance criteria. | ||
| Radio Detectability | The distal marker band and catheter body visibility | |
| were evaluated under fluoroscopy. | Device radiopacity comparable | |
| to the predicate device. | ||
| Catheter Hub | The hub functionality was evaluated during simulated | |
| use, freedom from leakage, flow rate, dynamic burst, | ||
| particulate, and other bench testing completed. | Device hub meets the | |
| requirements of ISO 80369-7. | ||
| Durability/Lubricity of | ||
| Hydrophilic Coating | Lubricious coating on the catheter surface was | |
| evaluated after simulated use for defects and for | ||
| friction force. | Device met the established | |
| friction and lubricity criteria. | ||
| The friction force was similar | ||
| to the predicate. | ||
| Tip Flexibility | Device tip stiffness was characterized on a cantilever | |
| bend test. | The tip stiffness was similar to | |
| the predicate. | ||
| Torque Strength | Devices were pre-conditioned by simulated use and | |
| torqued to failure inside a tortuous anatomical model | ||
| with the distal tip held fixed. | Device torque strength is the | |
| same as the predicate device. | ||
| Force at Break (Distal | ||
| and Hub) | Catheter force at break averaged 8 lbf for the hub and | |
| 5-6 lbf for the mid and distal segments and exceeds | ||
| acceptance criteria determined from withdrawal force | ||
| measurements. | Tensile strength meets the test | |
| acceptance criteria. | ||
| Flow Rate | Flow rate was characterized at 100 psi with diagnostic | |
| agents (e.g., saline, contrast media). | Device meets the specified | |
| requirements for delivery of | ||
| diagnostic agents. | ||
| Static Burst Pressure | Device can withstand static pressure above labeled | |
| 100 psi maximum with margin of safety. | Device integrity is suitable for | |
| intended clinical use and met | ||
| requirements of ISO 10555-1. | ||
| Freedom from Leakage | Testing followed the methods and criteria defined in | |
| EN ISO 10555-1 after pre-conditioning by simulated | ||
| use. | Device integrity is suitable for | |
| intended clinical use and met | ||
| requirements of ISO 10555-1. | ||
| Air Leakage | No air leakage at hub into syringe for 15 seconds. | Device integrity is suitable for |
| intended clinical use and met | ||
| requirements of ISO 10555-1. | ||
| Dynamic Burst | Devices were pre-conditioned by simulated use. Test | |
| devices were then connected to a pressurized fluid | ||
| source, starting with 250 psi and further increased | ||
| every 10 seconds until a maximum of 600 psi was | ||
| applied. | Device met labeled maximum | |
| infusion pressure of 100 psi. | ||
| Peak Tensile Force | Devices were pre-conditioned by simulated use. | |
| Tensile testing was then conducted per the methods | ||
| defined in EN ISO 10555-1. | Device met acceptance criteria | |
| determined from withdrawal | ||
| force testing. | ||
| Test | Test Method Summary | Conclusions |
| Cytotoxicity (ISO | ||
| 10993-5) - MEM | ||
| Elution Assay | Cell culture observed for cytotoxic reactivity | |
| following exposure to test extract with Grade | ||
| , ISO 10993-11) | Study animals observed for individual | |
| temperature rise following intravenous | ||
| injection of test extracts. | Non-pyrogenic | |
| Hemolysis (ASTM | ||
| F756, ISO10993-4) – | ||
| Direct and Indirect | ||
| (extract) Hemolysis | The difference between the hemolytic indexes | |
| of the subject device and the negative control | ||
| was evaluated after exposure to test extracts | ||
| and direct exposure to test article. | Direct contact - Non-hemolytic | |
| Indirect contact - Non-hemolytic | ||
| SC5b-9 Complement | ||
| Activation Assay (ISO | ||
| 10993-4) | Using an enzyme immunoassay, SC5b-9 | |
| concentration following exposure of test article | ||
| extracts to normal human serum (NHS) | ||
| compared to SC5b-9 concentration of the | ||
| control article exposed to NHS. | Not considered to be a potential | |
| activator of the complement system | ||
| Thrombogenicity | ||
| (ASTM F2382) - Partial | ||
| Thromboplastin Time | Thrombogenicity potential of test article | |
| compared to control articles. | Acceptable results | |
| Platelet and Leukocyte | ||
| Count (ASTM F2888-19, | ||
| ISO 10993-4) | ||
| In vitro Blood Loop |
6
Biocompatibility
Biocompatibility was assessed in accordance with ISO 10993-1 guidelines for a limited exposure (