(194 days)
Not Found
No
The summary describes a physical medical device (embolization coils) and its delivery system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on physical and biological properties, not algorithmic performance.
Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, and for vascular occlusion, which are therapeutic interventions.
No
The Optima Coil System is a therapeutic device used for the endovascular embolization and occlusion of intracranial aneurysms and other neurovascular abnormalities. It is designed to treat conditions by obstructing blood flow, not to diagnose them.
No
The device description explicitly states it is a series of specialized coils made of platinum/tungsten, which are physical hardware components. The summary also details performance studies related to the physical properties and biological interactions of these coils and a detachment controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for endovascular embolization within the body to physically obstruct blood flow. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The device description details a physical implant (coils) inserted into the vasculature. This is consistent with an in vivo medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions by examining these types of samples.
Therefore, the Optima Coil System is an in vivo medical device used for therapeutic purposes (embolization), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic visualization
Anatomical Site
intracranial, neurovascular system, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing and Animal Testing: Results of the performance benching testing and animal testing indicate that Optima Coil System meets established performance requirements, and is substantially equivalent for its intended use.
Performance Bench Testing:
- Corrosion Resistance: All test samples passed testing.
- Advancement and Retraction Force: All test samples passed testing.
- MRI Compatibility: All test samples passed testing. MR Conditional.
- MRI Artifact: All test samples passed testing.
- Detachment Temperature Characterization: All test samples passed testing.
- Simulated Use testing: All test samples passed testing.
- Usability - XCEL Detachment Controller: All test samples passed testing.
- Particulate Characterization: All test samples passed testing.
- Design Verification and Packaging Validation: All test samples passed testing.
Performance Animal Testing:
- Animal Testing (GLP): All test samples passed testing.
Biocompatibility:
Optima Coil Implant:
- Cytotoxicity - MEM Elution (GLP) - 72 hour extract ISO 10993-5: Non-cytotoxic
- Sensitization - ISO Guinea Pig Maximization Sensitization Test (GLP-2 extract) ISO 10993-10: Did not elicit sensitization response
- Irritation or Intracutaneous irritation reactivity - ISO Intracutaneous Irritation Test (GLP-2 Extracts) ISO 10993-10: Non-irritant
- Acute systemic toxicity - ISO Acute Systemic Injection Test (GLP-2 Extracts) ISO 10993-11: No signs of toxicity
- Acute systemic toxicity - ISO Material Mediated Rabbit pyrogen (GLP) ISO 10993-11: Non-pyrogenic
- Hemocompatibility - ASTM Hemolysis Assay – Direct Contact and Extract Method (GLP) ISO 10993-4: Non-hemolytic
- Hemocompatibility - Prothrombin Time (PT) -GLP ISO 10993-4: No adverse effect on prothrombin coagulation
- Hemocompatibility - Complement Activation SC5b-9 Assay with Sponsor-Supplied Comparison Article (GLP) ISO 10993-4: Exhibited activation not significant/Passed
- Genotoxicity - ISO In Vitro Mouse Lymphoma with Extended Treatment (GLP) ISO 10993-3: Non-mutagenic and non-clastogenic
- Genotoxicity ISO Bacterial Mutagenicity Test – Ames assay (GLP-4 Salmonella Strains and 1 E. Coli Strain - 2 Extracts) ISO 10993-3: Non-mutagenic
- Genotoxicity - ISO In Vivo Mouse Micronucleus Assay (GLP-2 Extracts) ISO 10993-3: Non-mutagenic
- Implantation - ISO Intramuscular Implantation Test with Histopathology – 4 Week – 3 Rabbits (GLP) ISO 10993-6: Pass (comparable irritation scores)
- Implantation - ISO Intramuscular Implantation with Histopathology – 13 Week – 4 Rabbits ISO 10993-6: Pass (comparable irritation scores)
- Carcinogenicity ISO 10993-18 ISO 10993-17: Non-carcinogenic
- Subacute/Subchronic Toxicity ISO 10993-11: Pass
- Chronic Toxicity ISO 10993-11: Pass
Delivery Pusher:
- Cytotoxicity - ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP) ISO 10993-5: Non-cytotoxic
- Sensitization - ISO Guinea Pig Maximization Sensitization Test (GLP-2 extract) ISO 10993-10: Did not elicit sensitization response
- Irritation or Intracutaneous irritation reactivity - ISO Intracutaneous Irritation Test (GLP-2 Extracts) ISO 10993-10: Non-irritant
- Acute systemic toxicity - ISO Acute Systemic Injection Test (GLP-2 Extracts) ISO 10993-11: No signs of toxicity
- Acute systemic toxicity - ISO Materials Mediated Rabbit ISO 10993-11: Non-pyrogenic
- Hemocompatibility Hemolysis Assay - Direct Contact and Extract Method (GLP) ISO 10993-4: Non-hemolytic
- Hemocompatibility Complement Activation - SC5b-9 Assay with Sponsor-Supplied Comparison Article (GLP) ISO 10993-4: Exhibited activation not significant
- Hemocompatibility - Prothrombin Time (PT) – GLP ISO 10993-4: No adverse effect on prothrombin coagulation
- Hemocompatibility - Thromboresistance Evaluation (GLP -4 Hour – 2 Dog) ISO 10993-4: Thrombus formation not significant/Passed
- Hemocompatibility - ISO in Vitro Mouse Lymphoma with Extended Treatment (GLP) ISO 10993-3: Non-mutagenic and non-clastogenic
- Genotoxicity - ISO Bacterial Mutagenicity Test – Ames assay (GLP-4 Salmonella Strains and 1 E. Coli Strain - 2 Extracts) ISO 10993-3: Non-mutagenic
Sterilization:
- Sterilization – Optima Coil System: All test samples passed testing.
- Sterilization – XCEL Detachment Controller: All test samples passed testing.
- Bacterial Endotoxin (LAL): All test samples passed testing.
Shelf Life and Packaging:
- Shelf Life- Optima Coil System: All test samples passed testing.
- Shelf Life-XCEL Detachment Controller: All test samples passed testing.
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
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
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February 18, 2018
Blockade Medical, LLC (d.b.a. Balt USA) Rebecca K. Pine Official Correspondent 18 Technology Drive, Suite 169 Irvine, California 92618
Re: K172390
Trade/Device Name: Optima Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: January 18, 2018 Received: January 19, 2018
Dear Rebecca K. Pine:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image contains the text "Carlos L. Pena -S FDA". The text is arranged horizontally, with "Carlos L. Pena" appearing first, followed by "-S", and then "FDA". The text is in a sans-serif font and is black. The background is white.
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) K172390
Device Name Optima Coil System
Indications for Use (Describe)
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
| 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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Optima Coil System 510(k) Summary
This 510(k) summary for Optima Coil System is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance. The 510(k) Program: Evaluating substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
Blockade Medical, LLC (d.b.a. Balt USA) 18 Technology Dr. Ste 169 Irvine, CA 92618
Contact person: Rebecca K Pine Phone: (760) 809-5178 Date prepared: February 12, 2018
DEVICE [807.92(a)(2)]
Name of the device: Optima Coil System Common of usual name: Neurovascular embolization device Classification name: Neurovascular embolization device Vascular embolization device Regulatory Class: Class II Product Code: HCG KRD Submission Type: Traditional 510(k) Regulation Number: 21 CFR 882.5950 Reviewing Product Branch: Division of Neurological and Physical Medicine Devices (Office of Device Evaluation, CDRH)
PREDICATE DEVICE [807.92(a)(31)]
Barricade Embolization Coil System (K151760)
DEVICE DESCRIPTION [807.92(a)(4)]
The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.
4
INDICATIONS FOR USE [807.92(a)(5)]
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(a)(6)]
The technological characteristics of the Optima Coil System is highly analogous to the technological characteristics of the Barricade Embolization Coil System previously cleared (K151760) version of the device, as shown below:
| | Barricade
Embolization Coil
System (K151760)
(Predicate Device) | Optima Coil System
(Subject Device) | Effect on
substantial
equivalence |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | Facilitates
endovascular
embolization of
intracranial
aneurysms and other
vascular
abnormalities | SAME | None. Identical |
| System components | Coil (implant)
Delivery system
Detachment
controller | SAME | None. Identical |
| Coil delivery mechanism | Pusher | SAME | None. Identical |
| Method
of
supply
(coil/delivery system) | Sterile, single use | SAME | None. Identical |
| | Coil (implant) | | |
| Main Coil Material | Platinum/Tungsten
alloy | SAME | None. Identical |
| Primary Coil Diameter | 0.010"-0.014" | SAME | None. Identical |
| Coil Secondary diameter | 1.0mm - 15mm | 1mm-24mm | None. An
increase in
diameter range has
no effect on the
intended
performance of the
device. |
| Coil Wire Diameter | 0.00125"-0.003" | 0.00125"-0.0035" | Minor increase
(0.0005") in
diameter range has |
| | | | no effect on the
intended
performance of the
device |
| Secondary Shapes | Complex/Helical | SAME | None. Identical |
| Coil Types | Framing, Filling,
Finishing | Framing, Filling,
Finishing (standard, soft,
super soft, 18) | None. Identical.
Nomenclature has
merely been
updated |
| Coil length | 1cm – 50cm | 1cm – 65cm | None. An
increase in length
range has no effect
on the intended
performance of the
device. |
| Stretch
resistance/attachment
thread | .0022” Polyolefin
Engage thread
.0009” PET thread | .0022” Polyolefin Engage
thread | None. Minor
change to
accommodate
thermal
detachment
mechanism |
| Coupler | N/A | 90%/10% Pt/Ir
Markerband | None. Minor
change to
accommodate
thermal
detachment
mechanism |
| Detachment Zone | .020" (nominal) | 0.050" (nominal) | None. Minor
change to
accommodate
thermal
detachment
mechanism |
| Delivery System | | | |
| Construction/Design | SSTL core wire | Body coil laser welded to
hypotube | None. Minor
change to
accommodate
thermal
detachment
mechanism.
Change has no
effect on the
intended
performance of the
device. |
| Body coil | RO Coil (92/8 Pt/W) | 4-part coil
A. Heater coil (92/8 Pt/W)
B. Distal Coil (SSTL)
C. Radio-opaque (RO) Coil (92/8 Pt/W) | None. Minor
change to
accommodate
thermal
detachment |
| | | D. Proximal Coil (SSTL) | mechanism.
Change has no
effect on the
intended
performance of the
device. |
| Hypotube | N/A | SSTL hypotube | None. Minor
change to
accommodate
thermal
detachment
mechanism.
Change has no
effect on the
intended
performance of the
device. |
| Connector | N/A | Gold plated, SSTL
hypotube | None. Minor
change to
accommodate
thermal
detachment
mechanism.
Change has no
effect on the
intended
performance of the
device. |
| Adhesive | Dymax 1128A-M | Dymax 1128A-M-VT | None. Minor
change in adhesive
viscosity does not
affect the intended
performance of the
device. |
| Jacket | PET | Same | None. Identical |
| Flouro safe markers | Pad Printed PET
Shrink tube | Same | None. Identical |
| Epoxy | N/A | Epoxy 353 ND | None. Minor
change to
accommodate
thermal
detachment
mechanism.
Change has no
effect on the
intended
performance of the
device. |
| Lead wires | N/A | Polyimide coated silver
lead wires | None. Minor |
| | | accommodate
thermal
detachment
mechanism.
Change has no
effect on the
intended
performance of the
device. | |
| Heater coil coating | N/A | Polyimide coating | None. Minor
change to
accommodate
thermal
detachment
mechanism.
Change has no
effect on the
intended
performance of the
device. |
| Detachment Controller | | | |
| Coil detachment | Electrolytic via
detachment controller | Thermal via detachment
controlled | None. Change in
detachment
method does not
alter the intended
performance of the
device. |
5
6
7
The implant segment detaches via a thermal detachment mechanism upon activation of the XCEL Detachment Controller. The predicate device, Barricade Coil System implant segment detaches via an electrolytic detachment mechanism upon activation of the detachment controller. The device is designed to be deployed and detached in the neuro and peripheral vasculature to permanently obstruct blood flow. The difference in detachment mechanism does not alter the intended performance of the device; therefore, the change in detachment mechanism does not affect the safety, effectiveness, and benefit/risk profile of the Optima Coil System.
PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance benching testing and animal testing indicate that Optima Coil System meets established performance requirements, and is substantially equivalent for its intended use.
| Performance Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Corrosion Resistance | The deployed coil was placed in a | |
| sodium phosphate buffered saline | ||
| solution and the resting potential | ||
| (Er) is recorded for one (1) hour in | All test samples passed testing. | |
| an open circuit configuration and allowed to plateau. | ||
| Advancement and | ||
| Retraction Force | The test represents the maximum force required to advance and retract the coil through the microcatheter | All test samples passed testing. |
| MRI Compatibility | SAR patterns and temperature rises were evaluated under MRI conditions using RF coils at 64-MHz and 128 MHz and to determine the magnetic field interactions, heating, and artifacts. for the Optima Coil System. The SEMCAD software package was used to evaluate surface heating patterns for the Optima Coil when placed inside the gel of the ASTM phamtom under 1.5T and 3-T MRI systems. | All test samples passed testing. MR Conditional. |
| MRI Artifact | The MRI artifact was evaluated under predetermined magnetic resonance angiography (MRA) imaging parameters. | All test samples passed testing. |
| Detachment | ||
| Temperature | ||
| Characterization | The temperature characterization of the Optima Coil System's delivery pusher during the detachment cycle was evaluated by comparing the temperature of the delivery pusher to commercially available thermal detachment coils. | All test samples passed testing. |
| Simulated Use testing | Simulated use testing is to demonstrate that the device will meet the requirements of the product specifications and to demonstrate that the device will meet the product specifications requirements when tested in worst case tortuosity vessel. | All test samples passed testing. |
| Usability - XCEL | ||
| Detachment Controller | The clinical results of the usability of XCEL Detachment Controller were evaluated in accordance to IEC 60601-1-6:2010 + AMD1:2013 and IEC 62366-1:2015. | All test samples passed testing. |
| Particulate | ||
| Characterization | Particulate matter in injections of the device were quantified after advancement/retraction procedures. | All test samples passed testing. |
| Design Verification and | This test is to evaluate the device | All test samples passed testing. |
| Packaging Validation | design and packaging design and | |
| to demonstrate that the device will | ||
| meet the product specification | ||
| requirements at t=0-year time- | ||
| point after exposing to 1x Gamma | ||
| sterilization. Bubble immersion, | ||
| seal peel strength, simulated use, | ||
| detachment, SR tensile test and DZ | ||
| tensile strength testing were | ||
| performed. | ||
| Performance Animal Testing | ||
| Animal Testing (GLP) | Animal testing is to evaluate the in vivo performance of the Optima | |
| Coil System and XCEL | ||
| Detachment Controller in an acute | ||
| porcine model. Performance | ||
| metrics such as Introduction, | ||
| Tracking, Deployment, Reposition, | ||
| and Detachment within an | All test samples passed testing. |
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Biocompatibility:
| Biocompatibility Test | Results | Conclusion |
|---|---|---|
| Optima Coil Implant | ||
| Cytotoxicity - MEM Elution | ||
| (GLP) - 72 hour extract |
ISO 10993-5 | The test article scored '0' at 24,
48 and 72±4 hours | Non-cytotoxic |
| Sensitization - ISO Guinea Pig
Maximization Sensitization Test
(GLP-2 extract)
ISO 10993-10 | None of the extracts of the test
article exhibited a sensitization
response greater than '0'. | Did not elicit sensitization
response |
| Irritation or Intracutaneous
irritation reactivity - ISO
Intracutaneous Irritation Test
(GLP-2 Extracts)
ISO 10993-10 | The difference in the mean test
and control scores of the extract
dermal observations were less
than 1.0. | Non-irritant |
| Acute systemic toxicity - ISO
Acute Systemic Injection Test
(GLP-2 Extracts)
ISO 10993-11 | None of the test article treated
animals were observed with
clinical signs consistent with
toxicity at any of the
observation periods. | No signs of toxicity |
| Acute systemic toxicity - ISO
Material Mediated Rabbit
pyrogen (GLP) | None of the test article extracts
had a temperature rise > 0.5 °C
at the required observation time
points. | Non-pyrogenic |
| ISO 10993-11 | | |
| Hemocompatibility - ASTM
Hemolysis Assay – Direct
Contact and Extract Method
(GLP) | Based on the validity of the
assay, the test article is
considered non-hemolytic under
the test conditions employed. | Non-hemolytic |
| ISO 10993-4 | | |
| Hemocompatibility -
Prothrombin Time (PT) -GLP | No statistically significant
difference was observed
between the plasma exposed to
the test article, predicate and
control. | No adverse effect on
prothrombin coagulation |
| ISO 10993-4 | | |
| Hemocompatibility -
Complement Activation SC5b-9
Assay with Sponsor-Supplied
Comparison Article (GLP) | When compared to the reference
control data the test article and
comparison article results for the
SC5b9 assay showed no
statistically significant
difference between the results
(p 0.5 0C | Non-pyrogenic |
| ISO 10993-11 | | |
| Hemocompatibility
Hemolysis Assay - Direct
Contact and Extract Method
(GLP) | Based on the validity of the
assay, the test article is
considered non-hemolytic under
the test conditions employed. | Non-hemolytic |
| ISO 10993-4 | | |
| Hemocompatibility
Complement Activation - SC5b-
9 Assay with Sponsor-Supplied
Comparison Article (GLP) | The SC5b-9 assay results for the
reference control and the results
of test article were not
statistically significant ( $p>0.05$ )
and is considered satisfactory
under the test conditions
employed. The SC5b-9 assay
results for the comparison article
were statistically significantly
( $p