(236 days)
No
The summary describes a physical catheter device and its performance in bench, biocompatibility, and animal studies. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device description states it can "facilitate introduction of diagnostic agents or therapeutic devices," indicating it is a delivery or access device, not a therapeutic one itself.
No
The SOFIA® EX Catheter is described as a device that "can be used to facilitate introduction of diagnostic agents or therapeutic devices." It is a delivery device, not a diagnostic one.
No
The device description clearly indicates it is a physical catheter with hardware components (coil, braid reinforcement, hydrophilic coating, radiopaque marker). The performance studies also focus on physical properties and biological interactions, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general intravascular use, including the neuro and peripheral vasculature" and "to facilitate introduction of diagnostic agents or therapeutic devices." This describes a device used within the body for procedural support, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a flexible shaft, reinforcement, hydrophilic coating for navigation, and a radiopaque marker for visualization under fluoroscopy. These are characteristics of an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the SOFIA® EX Catheter is an invasive medical device used for accessing and navigating within blood vessels, not a device used for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.
Product codes
DOY,DQY
Device Description
The SOFIA® EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The device is provided sterile and for single use. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier tyvek pouch and placed in a carton box.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Study:
- Dimensional Inspection: The usable length, proximal and distal outer diameters, distal length and inner diameters were measured and recorded. Device met acceptance criteria for length, inner and outer diameters. The device size (5F) comparable to the 5F predicate and reference devices. The inner diameter is larger than the predicate device, while the outer diameter is larger, but still compatible with tested 6F guiding sheaths.
- Catheter Tip Stability: Simulated use of the delivery of a braided device is performed in a tortuous anatomical benchtop model and the movement of the subject device is measured and recorded. Device met acceptance criteria for tip stability. The device is able to support the delivery of braided devices and stent-retrievers without losing distal tip position. The stability of the distal tip was better (less movement) than the predicate device.
- Simulated Use and Physician Simulated Use: The device is put through simulated use. The device is navigated through a tortuous benchtop model to assess preparation, introduction, tracking, and support of the device. Device met acceptance criteria.
- Dynamic Burst Testing: Device hub is connected to a pressure control machine and was tested under pressures experienced during worst-case dynamic injections. Device met acceptance criteria and was able to withstand pressures experienced during worst-case dynamic injections.
- Liquid Leakage: Device was tested per ISO 10555-1, Annex C liquid leakage testing. Device is connected at hub and is pressurized with fluid and maintains the pressure for a specified duration of time. Device met acceptance criteria.
- Liquid Leakage at Rated Burst Pressure: Device was tested per ISO 10555-2 Annex A, liquid leakage testing. Device is connected at hub and is pressurized with fluid and maintains rated burst pressure for a specified duration of time. Device met acceptance criteria and does not leak fluids at rated burst pressure.
- Air Leakage: Device was tested per ISO 594-2. Device is connected at hub and subjected to negative pressure and any air leaking into the device is recorded. Device met acceptance criteria. Device does not allow air to leak into the device when subjected to negative pressure.
- Static Burst: Device was connected at hub and tested under full-length static conditions to burst. Device met acceptance criteria. All devices burst above the rated burst pressure and had better results than the predicate device.
- Tensile Strength: Device was tested per ISO 11070. The device is tensile tested to failure and the force at break is measured and recorded. Device met acceptance criteria.
- Tip Buckling: Distal tip buckling force under compressive load was evaluated for stiffness. Device met acceptance criteria. Device has a softer distal tip than the reference device.
- Torque Response: Device was tested for full-length torque response. The device is tracked through a tortuous benchtop model and the proximal hub is turned, the distal tip torque response is measured and recorded. Device met acceptance criteria. Device has better torque response than the reference device.
- Radio-detectability: Device is put under fluoroscope to assess visibility. Device met acceptance criteria. Device is visible under fluoroscopy.
- Coating Lubricity and Durability: Device coating was evaluated for frictional force and durability. Device met acceptance criteria. Average friction is comparable to predicate device.
- Particulate Testing: Device was evaluated for particulate generation under simulated use in a representative tortuous anatomical model per USP. Number of particulates generated met acceptance criteria and is within the limits per USP and is comparable to the predicate and reference devices.
- Kink Resistance: Device is evaluated for kink resistance by subjecting the device to bending experienced in tortuous anatomy. Device met acceptance criteria. Results matched results of the predicate device.
- Corrosion Resistance: Device is tested per ISO 10555-1, Annex A and ISO 11070, Annex B to evaluate corrosion resistance. Device met acceptance criteria. Device is resistant to corrosion.
Biocompatibility Study:
- Cytotoxicity (ISO Medium Eluate Method (MEM) Elution Test): 1x CMEM Cell Growth Medium (MEM supplemented with 10% fetal bovine serum extract) L929 Mouse Fibroblast Cell Line. 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37°C/24 hrs. Non-cytotoxic. The test article is considered non-cytotoxic to cells.
- Sensitization (ISO Kligman Maximization Test in Guinea Pigs Sensitization Test): Normal Saline and Vegetable (Cottonseed) Oil Extracts Hartley Guinea Pigs. 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. Non-sensitizing. The test article did not elicit a sensitization response.
- Irritation/Intracutaneous Toxicity (ISO Intracutaneous Injection Test in Rabbits): Normal Saline and Vegetable (Cottonseed) Oil Extracts. 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. Non-irritant. No evidence of irritation.
- Systemic Toxicity (ISO Systemic Injection Test in Mice): Normal Saline and Vegetable (Cottonseed) Oil Extracts Albino Swiss Mice. 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. Non-cytotoxic. No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice.
- Systemic Toxicity (ISO Rabbit Pyrogen (Material-Mediated) Test): Normal Saline New Zealand White Rabbits (2 Male and 2 Female - non-pregnant and nulliparous). 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. Non-pyrogenic. All individual rabbits for both the test article and negative control showed a total rise in temperature of
§ 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
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May 15, 2019
MicroVention, Inc. Tina Ariaee Sr. Manager, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
Re: K182602
Trade/Device Name: SOFIA® EX Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: April 15, 2019 Received: April 16, 2019
Dear Tina Ariaee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
for Carlos L. Peña, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182602
Device Name SOFIA® EX Intracranial Support Catheter
Indications for Use (Describe)
The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter 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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Image /page/3/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized graphic to the left of the text. The text "MicroVention" is in a blue sans-serif font, with the word "TERUMO" in a smaller, bolder, blue sans-serif font directly underneath.
510(k) Summary
l. Submitter
MicroVention, Inc. 1311 Valencia Avenue Tustin, CA 92780 Establishment Registration No: 2032493
Contact Person: Tina Ariaee Senior Manager, Regulatory Affairs Telephone: (714) 247-8000 Ext. 8366 Email: tina.ariaee@microvention.com
Date Prepared: May 12, 2019
II. Device
| Name of Device | SOFIA® EX Intracranial Support Catheter |
|---|---|
| Common Name | Intracranial Support Catheter |
| Classification | |
| Name | Percutaneous Catheter (21 CFR 870.1250) |
| Regulatory Class | Class II |
| Product Code | DQY |
III. Predicate Device
| Predicate Device | SOFIA® Distal Access Catheter (K131482) |
|---|---|
| Reference Device | Navien Intracranial Support Catheter (K161152) |
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Image /page/4/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic to the left of the text. The text "MicroVention" is in a combination of blue and gray, with "Micro" in blue and "Vention" in gray. Below "MicroVention" is the word "TERUMO" in blue, presented in a bold, sans-serif font.
IV. Device Description
The SOFIA® EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The device is provided sterile and for single use. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier tyvek pouch and placed in a carton box.
V. Indications for Use
The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.
VI. Comparison of Technological Characteristics with the Predicate Device
| | Medtronic Navien
Intracranial Support
Catheter (K161152) | SOFIA® Distal Access
Catheter (K131482) | SOFIA® EX Catheter |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Reference Device | Predicate Device | Subject Device |
| Intended Use | The Navien
Intracranial Support
Catheter is indicated
for the introduction of
interventional
devices into the
peripheral and neuro
vasculature. | The SOFIA® Distal Access
Catheter is 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 SOFIA® EX Catheter
is indicated for general
intravascular use,
including the neuro and
peripheral vasculature.
The SOFIA® EX Catheter
can be used to facilitate
introduction of diagnostic
agents or therapeutic
devices. The SOFIA® EX
Catheter is not intended
for use in coronary
arteries. |
| Device
Classification | Class II
DQY
21 CFR 870.1250 | Class II
DQY, DQO
21 CFR 870.1250
21 CFR 870.1200 | Class II
DQY
21 CFR 870.1250 |
| | Medtronic Navien
Intracranial Support
Catheter (K161152) | SOFIA® Distal Access
Catheter (K131482) | SOFIA® EX Catheter |
| | Reference Device | Predicate Device | Subject Device |
| Catheter Body | PTFE lined
polymeric catheter,
with hydrophilic
coating and Nitinol
Support. | Outer layer of polyurethane
elastomer (Polyblend and
Pellethane), polyether block
amide (Pebax) and
polyamide (Grilamid); inner
layer of stainless steel
braid/coil, PTFE and
polyolefin elastomer. | Outer layer of polyolefin
elastomer, polyurethane
elastomer (Pellethane),
polyether block amide
(Pebax) and polyamide
(Grilamid); inner layer of
stainless steel braid,
Nitinol coil, and PTFE. |
| Marker | Platinum | Platinum/Iridium | Same as SOFIA® DAC
(K131482) |
| Hub | | Nylon | Same as SOFIA® DAC
(K131482) |
| Strain Relief | | Polyurethane | Same as SOFIA® DAC
(K131482) |
| Introducer | | Pebax | Same as SOFIA® DAC
(K131482) |
| Shaping Mandrel | none | Stainless steel | None |
| Catheter size | 5F | 5F | Same as SOFIA® DAC
(K131482) and Navien
(K161152) |
| ID | 0.058 inch (1.5 mm) | 0.055 inch (1.4 mm) | Same as Navien
(K161152) |
| OD | 0.070" Max. | 0.068 inch (1.7 mm) | 0.071 inch (1.8 mm) |
| Effective Length | 105,115,125,130cm | 115, 125 cm | 105, 115 cm |
| Coating | Hydrophilic coating | Hydrophilic coating | Same as SOFIA® DAC
(K131482) |
| Tip Construction
and Material | | Outer layer of polyurethane
elastomer, inner layer of
stainless steel braid (entire
shaft)/stainless steel coil
(except for distal 2cm), and
polyolefin elastomer. | Outer layer of polyolefin
elastomer, inner layer of
stainless steel braid
(except for distal 2cm)/
Nitinol coil (entire shaft),
and PTFE. |
| Average Tip
Stiffness (2cm
length) | 44 gf | 16 gf | 31gf |
| | | | |
| | Medtronic Navien
Intracranial Support
Catheter (K161152) | SOFIA® Distal Access
Catheter (K131482) | SOFIA® EX Catheter |
| | Reference Device | Predicate Device | Subject Device |
| Guidewire
Compatibility | 0.038 inch | 0.035 or 0.038 inch | Same as SOFIA® DAC
(K131482) |
| Accessories | Introducer Sheath | Introducer sheath and
shaping mandrel | Introducer sheath |
| Method of Supply | Sterile and single
use | Sterile and single use | Same as SOFIA® DAC
(K131482) |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same as SOFIA® DAC
(K131482) |
| Packaging
Configuration | Catheter in
polyethylene hoop
attached to
packaging card
inside PET/PE/Tyvek
pouch inside SBS
carton. | Catheter placed into a
HDPE dispenser tube.
Dispenser tube, introducer
and shaping mandrel
placed on a polyethylene
packaging card that is
inserted into a Tyvek®
pouch. Pouch and IFU
placed in bleached sulfate
carton box. | Same as SOFIA® DAC
(K131482). No shaping
mandrel. |
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Image /page/6/Picture/0 description: The image features the logo for MicroVention, a company owned by Terumo. The MicroVention logo is in a blue sans-serif font, with the "®" symbol next to it. Below MicroVention is the word "TERUMO" in a larger, bold, blue sans-serif font. To the left of the text is a circular graphic with three curved lines in shades of gray and blue.
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Image /page/7/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic on the left, resembling a series of curved lines in shades of gray and blue. To the right of the graphic, the word "MicroVention" is written in a blue, sans-serif font, with the word "TERUMO" in a bolder, blue font below it.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Bench Study
| Test | Test Method Summary | Results | |
|---|---|---|---|
| Dimensional Inspection | The usable length, proximal and | ||
| distal outer diameters, distal | |||
| length and inner diameters were | |||
| measured and recorded. | Device met acceptance criteria for | ||
| length, inner and outer diameters. | |||
| The device size (5F) comparable to | |||
| the 5F predicate and reference | |||
| devices. The inner diameter is larger | |||
| than the predicate device, while the | |||
| outer diameter is larger, but still | |||
| compatible with tested 6F guiding | |||
| sheaths. | |||
| Catheter Tip Stability | Simulated use of the delivery of | ||
| a braided device is performed in | |||
| a tortuous anatomical benchtop | |||
| model and the movement of the | |||
| subject device is measured and | |||
| recorded. | Device met acceptance criteria for tip | ||
| stability. The device is able to | |||
| support the delivery of braided | |||
| devices and stent-retrievers without | |||
| losing distal tip position. The stability | |||
| of the distal tip was better (less | |||
| movement) than the predicate | |||
| device. | |||
| Simulated Use and | |||
| Physician Simulated | |||
| Use | The device is put through | ||
| simulated use. The device is | |||
| navigated through a tortuous | |||
| benchtop model to assess | |||
| preparation, introduction, | |||
| tracking, and support of the | |||
| device. | Device met acceptance criteria | ||
| Dynamic Burst Testing | Device hub is connected to a | ||
| pressure control machine and | |||
| was tested under pressures | |||
| experienced during worst-case | |||
| dynamic injections. | Device met acceptance criteria and | ||
| was able to withstand pressures | |||
| experienced during worst-case | |||
| dynamic injections. | |||
| Liquid Leakage | Device was tested per ISO | ||
| 10555-1, Annex C liquid leakage | |||
| testing. Device is connected at | |||
| hub and is pressurized with fluid | |||
| and maintains the pressure for a | |||
| specified duration of time. | Device met acceptance criteria | ||
| Liquid Leakage at Rated | |||
| Burst Pressure | Device was tested per ISO | ||
| 10555-2 Annex A, liquid leakage | |||
| testing. Device is connected at | |||
| hub and is pressurized with fluid | Device met acceptance criteria and | ||
| does not leak fluids at rated burst | |||
| pressure. | |||
| and maintains rated burst | |||
| pressure for a specified duration | |||
| of time. | |||
| Air Leakage | Device was tested per ISO 594- |
- Device is connected at hub
and subjected to negative
pressure and any air leaking into
the device is recorded. | Device met acceptance criteria.
Device does not allow air to leak into
the device when subjected to
negative pressure. | |
| Static Burst | Device was connected at hub
and tested under full-length
static conditions to burst. | Device met acceptance criteria. All
devices burst above the rated burst
pressure and had better results than
the predicate device. | |
| Tensile Strength | Device was tested per ISO - The device is tensile
tested to failure and the force at
break is measured and
recorded. | Device met acceptance criteria. | |
| Tip Buckling | Distal tip buckling force under
compressive load was evaluated
for stiffness. | Device met acceptance criteria.
Device has a softer distal tip than the
reference device. | |
| Torque Response | Device was tested for full-length
torque response. The device is
tracked through a tortuous
benchtop model and the
proximal hub is turned, the distal
tip torque response is measured
and recorded. | Device met acceptance criteria.
Device has better torque response
than the reference device. | |
| Radio-detectability | Device is put under fluoroscope
to assess visibility. | Device met acceptance criteria.
Device is visible under fluoroscopy. | |
| Coating Lubricity and
Durability | Device coating was evaluated
for frictional force and durability. | Device met acceptance criteria.
Average friction is comparable to
predicate device. | |
| Particulate Testing | Device was evaluated for
particulate generation under
simulated use in a
representative tortuous
anatomical model per
USP. | Number of particulates generated
met acceptance criteria and is within
the limits per USP and is
comparable to the predicate and
reference devices. | |
| Kink Resistance | Device is evaluated for kink
resistance by subjecting the
device to bending experienced
in tortuous anatomy. | Device met acceptance criteria.
Results matched results of the
predicate device. | |
| Corrosion Resistance | Device is tested per ISO 10555-
1, Annex A and ISO 11070,
Annex B to evaluate corrosion
resistance. | Device met acceptance criteria.
Device is resistant to corrosion. | |
| Test | Test Method Summary | | Results |
| | Extract(s) & Test
Systems | Extract Conditions | |
| Cytotoxicity
(ISO Medium Eluate
Method (MEM) Elution
Test) | 1x CMEM Cell Growth
Medium (MEM
supplemented with 10%
fetal bovine serum
extract)
L929 Mouse Fibroblast
Cell Line | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 37°C/24
hrs. | Non-cytotoxic
The test article is
considered non-cytotoxic
to cells. |
| Sensitization
(ISO Kligman
Maximization Test in
Guinea Pigs
Sensitization Test) | Normal Saline and
Vegetable (Cottonseed)
Oil Extracts
Hartley Guinea Pigs | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 50°C/72
hrs. | Non-sensitizing
The test article did not
elicit a sensitization
response. |
| Irritation/
Intracutaneous Toxicity
(ISO Intracutaneous
Injection Test in
Rabbits) | Normal Saline and
Vegetable (Cottonseed)
Oil Extracts | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 50°C/72
hrs. | Non-irritant
No evidence of irritation. |
| Systemic Toxicity
(ISO Systemic Injection
Test in Mice) | Normal Saline and
Vegetable (Cottonseed)
Oil Extracts
Albino Swiss Mice | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 50°C/72
hrs. | Non-cytotoxic
No weight loss, mortality,
or evidence of systemic
toxicity from the extract
exposure to the mice. |
| Systemic Toxicity
(ISO Rabbit Pyrogen
(Material-Mediated)
Test) | Normal Saline
New Zealand White
Rabbits (2 Male and 2
Female - non-pregnant
and nulliparous) | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 50°C/72
hrs. | Non-pyrogenic
All individual rabbits for
both the test article and
negative control showed
a total rise in temperature
of