(79 days)
K151667 AXS Catalyst Distal Access Catheter
K223545 APRO 70 Catheter and Alembic Aspiration Tubing
No
The description focuses on the physical characteristics and intended use of a catheter for facilitating device insertion and retrieval. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are standard bench and biocompatibility tests for a physical medical device.
No.
The device facilitates the insertion and guidance of interventional devices and retrieves devices, but it does not directly treat a disease or condition itself.
No
Explanation: The device description and intended use clearly state that the APRO 55 Catheter is used to facilitate the insertion and guidance of interventional devices and as a conduit for retrieval devices. It does not mention any function related to diagnosing or identifying medical conditions.
No
The device description clearly describes a physical catheter with material components (braid, coil, hydrophilic coating, radiopaque marker) and includes performance studies related to physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, the APRO 55 Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems" and "as a conduit for retrieval devices." This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for navigation within blood vessels, using fluoroscopy for guidance. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The APRO 55 Catheter does not fit this description.
N/A
Intended Use / Indications for Use
The APRO 55 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Catheter is also indicated for use as a conduit for retrieval devices.
Product codes (comma separated list FDA assigned to the subject device)
DQY, QJP
Device Description
The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 55 Catheter is provided with an Introducer Sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral and neurovascular systems / selected blood vessel in the peripheral and neurovascular systems
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)
Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the APRO 55 Catheter to the legally marketed predicate device.
Design Verification Testing - Non-Clinical Bench:
Performance testing was conducted to support the APRO 55 Catheter submission. The results of the design verification and validation testing performed confirm that the APRO 55 Catheter conforms to the predefined specifications and met test acceptance criteria.
Tests performed include: Visual and Dimensional Characteristics, Particulate, Kink Resistance, Hub Air Leakage, Hub Compatibility, Torque Strength, Dynamic Burst Pressure, Liquid Leakage, Static Burst, Hub and Shaft Tensile Strength, Tip Tensile Strength, Tip Buckling Force, Delivery and Retrieval Force, Simulated Use. All tests met their respective acceptance criteria.
Design Verification Testing - Animal:
Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary.
Sterilization and Shelf-Life:
The APRO 55 Catheter is sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10-6 in accordance with ISO 11135.
Aging studies for the APRO 55 Catheter have established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and the device functionality were performed and met the acceptance criteria.
Biocompatibility:
Biocompatibility testing has been completed for the APRO 55 Catheter in accordance with ISO 10993-1 and the device is deemed non-toxic (local or systemic), non-sensitizing, not locally irritating or otherwise harmful. Test results obtained were acceptable for the intended use. The thrombogenicity evaluation of the APRO 55 Catheter was supplemented by the prior in vivo thrombogenicity evaluation of the reference device, APRO 70 Catheter, in a good laboratory practice animal study.
Tests performed include: Sensitization (Guinea Pig Maximization), Irritation/Intracutaneous Reactivity, Cytotoxicity (MEM Elution, L929 cells), Hemolysis - Indirect, Hemolysis - Direct, Partial Thromboplastin Time (PTT), SC5b9 Complement Activation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity. All tests yielded acceptable conclusions (Non-sensitizing, Non-irritant, Non-cytotoxic, Non-hemolytic, Acceptable clotting times, Acceptable, Non-toxic, Non-pyrogenic respectively).
Clinical Testing:
Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.
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.
K151667 AXS Catalyst Distal Access Catheter
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.
K223545 APRO 70 Catheter and Alembic Aspiration Tubing
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
§ 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
March 15, 2024
Image /page/0/Picture/1 description: The image shows the logo for 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.
Alembic, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services 1000 Westgate Drive, Suite #510k Saint Paul. Minnesota 55114
Re: K234115
Trade/Device Name: APRO 55 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: March 6, 2024 Received: March 6, 2024
Dear Prithul Bom:
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 (QS) 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) K234115
Device Name APRO 55 Catheter
Indications for Use (Describe)
The APRO 55 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Catheter is also indicated for use as a conduit for retrieval devices.
| 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: K234115
This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92.
Submitter information 1)
Date Prepared:
| Submitter: | Alembic, LLC
627 National Ave.
Mountain View, CA 94043 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lisa Yen
Director of Regulatory and Quality
Telephone Number: (650) 388-5087
Fax: (650) 390-0107
Email: lyen@alembicllc.com |
March 13, 2024
2) Device Name and Classification
| Trade/Proprietary Name: | APRO® 55 Catheter |
|---|---|
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21 CFR 870.1250 |
| Catheter, Percutaneous, Neurovasculature, 21 CFR 870.1250 | |
| Regulatory Class: | Class II |
| Product Codes: | DQY, QJP |
| Review Panel: | Cardiovascular, Neurology |
3) Legally Marketed Predicate Device and Reference Device
| Predicate Device: | K151667 AXS Catalyst Distal Access Catheter |
|---|---|
| Reference Device: | K223545 APRO 70 Catheter and Alembic Aspiration Tubing |
4) Device Description
The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 55 Catheter is provided with an Introducer Sheath.
4
5) Indications for Use
The APRO 55 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Catheter is also indicated for use as a conduit for retrieval devices.
6) Technological Characteristics Comparison
Alembic has demonstrated that the APRO 55 Catheter is substantially equivalent to the predicate device based on the similarity in materials, similarity in design concept, and the same fundamental operating principles. A comparison of the APRO 55 Catheter with the predicate device and reference device is summarized in Table 1 below.
| Category | Subject Device
APRO 55 Catheter | Predicate Device
AXS Catalyst Distal Access
Catheter | Reference Device
APRO 70 Catheter and
Alembic Aspiration Tubing |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K234115 | K151667 | K223545 |
| Regulatory Class | Class II, 21 CFR 870.1250,
DQY, QJP | Class II, 21 CFR 870.1250,
DQY | Class II, 21 CFR 870.1250,
NRY |
| Indications for
Use | The APRO 55 Catheter is
indicated for use in
facilitating the insertion and
guidance of appropriately
sized interventional devices
into a selected blood vessel in
the peripheral and
neurovascular systems. The
APRO 55 Catheter is also
indicated for use as a conduit
for retrieval devices. | The AXS Catalyst Distal
Access Catheter is indicated for
use in facilitating the insertion
and guidance of appropriately
sized interventional devices into
a selected blood vessel in the
peripheral and neurovascular
systems. The AXS Catalyst
Distal Access Catheter is also
indicated for use as a conduit
for retrieval devices. | The APRO 70 Catheter with an
aspiration pump and the Alembic
Aspiration Tubing is intended for
use in the revascularization of
patients with acute ischemic stroke
secondary to intracranial large
vessel occlusive disease (within the
internal carotid, middle cerebral -
M1 and M2 segments, basilar, and
vertebral arteries) within 8 hours of
symptom onset. Patients who are
ineligible for intravenous tissue
plasminogen activator (IV t-PA) or
who fail IV t-PA therapy are
candidates for treatment.
The Alembic Aspiration Tubing is
intended to connect the APRO 70
Catheter to the aspiration pump. |
| Materials | | | |
| Hub | Nylon | Nylon | Polycarbonate |
| Adhesive | Cyanoacrylate | None | Cyanoacrylate |
| Strain Relief | Thermoplastic elastomer | Thermoplastic rubber | Thermoplastic elastomer |
| Liner | Polytetrafluoroethylene
(PTFE)/Tecoflex composite | PTFE | PTFE/Tecoflex composite |
| Shaft Coil or
Braid | 304V stainless steel braid
304V stainless steel coil | Stainless steel with nitinol wire
and polymer fiber | 304V stainless steel braid
304V stainless steel coil |
| Extrusions | Thermoplastic polyurethanes,
thermoplastic elastomer | Pebax, Nylon | Thermoplastic polyurethanes,
thermoplastic elastomer |
| Marker Band | Platinum/ iridium | Platinum/ iridium | Platinum/ iridium |
| Adhesive | None | Cyanoacrylate | None |
| Coating | Hydrophilic coating, identical | Hydrophilic coating | Hydrophilic coating |
Table 1 - APRO 55 Catheter Comparison with the Predicate Device and Reference Device
5
| Category | Subject Device
APRO 55 Catheter | Predicate Device
AXS Catalyst Distal Access
Catheter | Reference Device
APRO 70 Catheter and
Alembic Aspiration Tubing |
|------------------------------|--------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------|
| | to reference device | | |
| Dimensions | | | |
| Proximal Outer
Diameter | 0.066 inch | 5.6 F (0.073 inch)
6.0 F (0.078 inch) | 0.083 inch |
| Distal Outer
Diameter | 0.066 inch | 5.3 F (0.069 inch)
5.4 F (0.070 inch) | 0.083 inch |
| Inner Diameter | 0.055 inch | 0.058 inch, 0.060 inch | 0.070 inch |
| Effective Lengths | 125, 137 cm | 115, 132 cm | 125, 132, 135 cm |
| Coated Length | 90, 102 cm | 65, 82 cm | 90, 97, 100 cm |
| Tip Shape | Straight | Straight | Straight |
| Accessories | | | |
| Introducer Sheath | Yes | Yes | Yes |
| Rotating
Hemostasis Valve | None | Yes | None |
| Packaging Materials | | | |
| Pouch | Nylon/polyethylene/ Tyvek | Nylon/polyethylene/ Tyvek | Nylon/polyethylene/ Tyvek |
| Packaging Tube | Polyethylene | Polyethylene | Polyethylene |
| Packaging Card | Yes | Yes | Yes |
| Shelf Carton | Solid bleached sulfate
paperboard | Solid bleached sulfate
paperboard | Solid bleached sulfate
paperboard |
| Other | | | |
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| Shelf Life | 6 months | 2 years | 6 months |
| Use Conditions | Sterile, single use, disposable | Sterile, single use, disposable | Sterile, single use, disposable |
Performance Data 7)
Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the APRO 55 Catheter to the legally marketed predicate device.
A. Design Verification Testing - Non-Clinical Bench
Performance testing was conducted to support the APRO 55 Catheter submission. The results of the design verification and validation testing performed confirm that the APRO 55 Catheter conforms to the predefined specifications and met test acceptance criteria. A summary of the testing is shown in Table 2.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Visual and Dimensional | ||
| Characteristics | Catheter meets the visual and dimensional | |
| specifications. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Particulate | Catheter meets the acceptance criteria. | |
| Subject device was evaluated with a | ||
| predicate device under the same test | ||
| conditions. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Kink Resistance | Catheter shaft shall not kink at clinically | |
| relevant radii. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Hub Air Leakage | Catheter does not leak air into hub | The APRO 55 Catheter met the |
Table 2 – Summary of Non-Clinical Bench Test Results
6
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Hub Compatibility | assembly with methods specified in ISO | |
| 10555-1, Annex D. | acceptance criteria. | |
| Torque Strength | Catheter meets the requirements specified | |
| in ISO 80369-7. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Dynamic Burst Pressure | Catheter must withstand the minimum | |
| required number of rotations without | ||
| breakage and without kinking compared to | ||
| legally marketed devices. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Liquid Leakage | No damage to catheter with dynamic | |
| pressure. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Static Burst | Catheter must withstand pressure | |
| with methods specified in ISO 10555- | ||
| 1, Annex C. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Hub and Shaft Tensile | ||
| Strength | Catheter must withstand pressures | |
| anticipated for clinical use. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Tip Tensile Strength | Catheter hub and shaft must meet tensile | |
| strength specification. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Tip Buckling Force | Catheter tip must meet tip tensile strength | |
| specification. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Delivery and Retrieval | ||
| Force | Catheter tip buckling force must be | |
| acceptable. Forces were compared to a | ||
| predicate. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| Simulated Use | Catheter delivery and retrieval force must | |
| be acceptable. Forces were compared to a | ||
| predicate. | The APRO 55 Catheter met the | |
| acceptance criteria. | ||
| When used per the Instructions for Use | ||
| with accessory devices in an anatomical | ||
| neurovascular model, the Catheter must | ||
| meet functionality specifications. | The APRO 55 Catheter met the | |
| acceptance criteria. |
B. Design Verification Testing - Animal
Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary.
C. Sterilization and Shelf-Life
The APRO 55 Catheter is sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10-6 in accordance with ISO 11135.
Aging studies for the APRO 55 Catheter have established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and the device functionality were performed and met the acceptance criteria.
D. Biocompatibility
Biocompatibility testing has been completed for the APRO 55 Catheter in accordance with ISO 10993-1 and the device is deemed non-toxic (local or systemic), non-sensitizing, not locally irritating or otherwise harmful. Test results obtained were acceptable for the intended
7
use as shown in Table 3. The thrombogenicity evaluation of the APRO 55 Catheter was supplemented by the prior in vivo thrombogenicity evaluation of the reference device, APRO 70 Catheter, in a good laboratory practice animal study.
| Test | Results | Conclusions |
|---|---|---|
| Sensitization | ||
| (Guinea Pig Maximization) | The APRO 55 Catheter did not elicit a | |
| sensitization response. | Non-sensitizing | |
| Irritation/Intracutaneous | ||
| Reactivity | The APRO 55 Catheter demonstrated no | |
| evidence of irritation. | Non-irritant | |
| Cytotoxicity | ||
| (MEM Elution, L929 cells) | The APRO 55 Catheter did not elicit a | |
| cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic | |
| Hemolysis - Indirect | There were no significant differences between | |
| the test article extract and negative control | ||
| article results. | Non-hemolytic | |
| Hemolysis - Direct | There were no differences between the | |
| hemolytic index of the test article and the | ||
| negative control. | Non-hemolytic | |
| Partial Thromboplastin | ||
| Time (PTT) | The average clotting time of the test article was | |
| greater than vehicle control and negative | ||
| control. | Acceptable clotting | |
| times | ||
| SC5b9 Complement | ||
| Activation | The Sc5b9 concentration of the test article was | |
| statistically less than the positive control and was | ||
| not statistically higher than the negative control. | Acceptable | |
| Acute Systemic Toxicity | No weight loss, mortality, or evidence of | |
| systemic toxicity from the extract exposure to | ||
| the mice. | Non-toxic | |
| Material-Mediated | ||
| Pyrogenicity | All individual rabbits for both the test article | |
| and negative control showed a total rise in | ||
| temperature of |