(264 days)
SOFIA 6F PLUS/Distal Access Catheters (K150366)
TracStar™ Large Distal Platform; ZOOM™ 88 Large Distal Platform; ZOOM™ 88-T Large Distal Platform (K203764)
No
The summary describes a physical catheter device and its mechanical and performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The "Intended Use / Indications for Use" section states that the device "can be used to facilitate introduction of diagnostic agents or therapeutic devices," indicating it is a tool for delivering other agents or devices, not a therapeutic device itself.
No
The device is a catheter designed to facilitate the introduction of diagnostic agents or therapeutic devices. It is not described as performing any diagnostic function itself.
No
The device description clearly describes a physical catheter with material components, reinforcement, coating, and a radiopaque marker, indicating it is a hardware device, not software-only.
Based on the provided information, the SOFIA 88 Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general intravascular use, including the neuro and peripheral vasculature" to "facilitate introduction of diagnostic agents or therapeutic devices." This describes a device used within the body for access and delivery, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for navigation within blood vessels.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the catheter itself (lubricity, burst pressure, tracking, stability, etc.) and its interaction with the vasculature, not on the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The SOFIA 88 Catheter is an interventional device used directly within the patient's body.
N/A
Intended Use / Indications for Use
The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY, QJP
Device Description
The SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal seqment is designed to facilitate vessel selection with 60 cm of distal-shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.
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)
Performance testing was conducted to demonstrate the substantial equivalence of the SOFIA 88 Catheter to the predicate device.
The following testing data were provided to evaluate the performance of the SOFIA 88 Catheter.
Test: Dimensional Verification
Test Method Summary: Dimensional specifications were verified by measuring the catheter length, proximal and distal outer diameters, and distal inner diameter.
Results: Pass
Test: Coating Lubricity and Durability
Test Method Summary: The hydrophilic coating was evaluated for frictional force and durability.
Results: Pass
Test: Simulated Use
Test Method Summary: Performance was evaluated under simulated use in a tortuous anatomical model to assess preparation, introduction, tracking, and support of the device.
Results: Pass
Test: Dynamic and Static Burst Pressure
Test Method Summary: Device was subjected to rated burst pressures to test catheter integrity.
Results: Pass
Test: Air Leakage
Test Method Summary: Device was tested for air leakage requirements.
Results: Pass
Test: Liquid Leakage
Test Method Summary: Device was tested for liquid leakage requirements.
Results: Pass
Test: Tensile Strength
Test Method Summary: Device was tensile tested to failure, and recorded the force at breakage.
Results: Pass
Test: Flexural Fatigue
Test Method Summary: Device was subjected to flexural fatigue from repeated bending during simulated use testing and flexural fatigue from repeated hoop stress on the catheter from pressure testing.
Results: Pass
Test: Particulate Testing
Test Method Summary: The number and size of particulates generated during simulated use in a tortuous anatomical model were measured and results were compared with the predicate device.
Results: Pass
Test: Kink Resistance
Test Method Summary: Device was evaluated for kink resistance after simulated use testing.
Results: Pass
Test: Torque Strength
Test Method Summary: Device was evaluated for torque strength by measuring the number of catheter rotations until failure after tracking through a tortuous anatomical model.
Results: Pass
Test: Radio Detectability
Test Method Summary: Device visibility was evaluated under fluoroscopy.
Results: Pass
Test: Corrosion Resistance
Test Method Summary: Device corrosion was evaluated after immersion in saline.
Results: Pass
Test: Small-bore Connector
Test Method Summary: The luer connector was evaluated for dimensional and performance requirements per reference standard.
Results: Pass
Test: Stiffness Profile
Test Method Summary: The catheter stiffness profile along proximal and distal sections was compared to the reference device.
Results: Pass
Animal Study: Acute animal testing was conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) comparing the SOFIA 88 Catheter to the SOFIA 6F DAC. The testing was intended to assess preclinical safety and efficacy for catheter tracking and tip stability in a porcine model. The porcine model was chosen since the vessel sizes of the pig model allow for insertion and navigation of standard-sized devices used in humans; porcine vessel diameters are comparable with human vasculature. The tracking results demonstrated that the SOFIA 88 Catheter and SOFIA 6F DAC devices performed equally. Catheter tip stability was found to be comparable for both devices. No dissection/perforation was noted for the test-article- and controltreated vessels. Similar degrees of vasospasm were noted in the vessels instrumented with both devices. During postmortem examination there were no remarkable gross findings for any of the vessel samples for both the test and control devices. There was no hemorrhage, necrosis, or edema in test article-treated and control article-treated arterial sections. Overall, the histologic findings were consistent with routine catheterization procedures, which are commonly observed after interventional procedures in porcine safety models. The results of the present study did not raise any safety issues with either the test SOFIA 88 Catheter or control SOFIA 6F DAC. The devices are deemed equivalent.
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.
SOFIA 6F PLUS/Distal Access Catheters (K150366)
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.
TracStar™ Large Distal Platform; ZOOM™ 88 Large Distal Platform; ZOOM™ 88-T Large Distal Platform (K203764)
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
September 12, 2022
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MicroVention, Inc. Alick Tan, Ph.D. Senior Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656
Re: K214024
Trade/Device Name: SOFIA 88 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: August 12, 2022 Received: August 12, 2022
Dear Alick Tan:
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 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
1
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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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, 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
Enclosure
2
Indications for Use
510(k) Number (if known) K214024
Device Name SOFIA 88 Catheter
Indications for Use (Describe)
The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 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 shows the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic on the left, resembling a series of concentric arcs in shades of blue and gray. To the right of the graphic is the word "MicroVention" in a blue sans-serif font, with "TERUMO" in a smaller, bolder blue font directly underneath.
K214024 510(k) Summary
| 510(k) Owner | MicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
Establishment Registration No: 3013556777 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Alick Tan, PhD
Senior Regulatory Affairs Specialist
Telephone: 949-615-2603
Email: alick.tan@microvention.com |
| Date summary
Prepared | September 12, 2022 |
| Trade Name | SOFIA 88 Catheter |
| Common Name | Catheter, Percutaneous, Neurovasculature |
| Classification | Class II, DQY, QJP |
| Regulation | 21 CFR 870.1250 |
| Predicate Device | Sofia 6F PLUS/Distal Access Catheters (K150366) |
| Reference Device | TracStar™ Large Distal Platform; ZOOM™ 88 Large Distal
Platform; ZOOM™ 88-T Large Distal Platform (K203764) |
Device Description
The SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal seqment is designed to facilitate vessel selection with 60 cm of distal-shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.
Indications for Use
The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries.
Comparison of Indications for Use and Technological Characteristics
Substantial equivalence of the SOFIA 88 Catheter to the predicate Sofia 6F PLUS/Distal Access Catheters (SOFIA 6F DAC) and to the reference device TracStar Large Distal Platform; ZOOM 88 Large Distal Platform; ZOOM 88-T Large Distal Platform (ZOOM 88) was established through an evaluation of the intended use, indications for use, principles of operation, device design, materials of construction, and an assessment of usability, safety, and effectiveness via bench and animal studies.
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Image /page/4/Picture/0 description: The image shows the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic to the left, resembling a circular or orbital design with varying shades of gray and blue. To the right of the graphic, the word "MicroVention" is written in a combination of blue and gray lettering, with "Micro" in blue and "Vention" in gray. Below "MicroVention", the word "TERUMO" is written in blue, in a slightly smaller and bolder font.
The data presented in this submission demonstrates the technological similarity and equivalency of the SOFIA 88 Catheter compared with the predicate device SOFIA 6F DAC (K150366) and the reference device ZOOM 88 (K203764).
The devices:
- . have the same intended use,
- . use the same principle of operation,
- incorporate the same basic design,
- use similar construction and material, and ●
- are ethylene oxide (EtO)-sterilized and packaged using the same processes. ●
Device Comparison Table
| | ZOOM 88 (K203764) | SOFIA 6F DAC
(K150366) | SOFIA 88 Catheter |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Reference Device | Predicate Device | Subject Device |
| Indications for Use | The ZOOM 88 and
ZOOM 88-T Large
Distal Platform are
indicated for the
introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. | 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 SOFIA 88
Catheter is indicated
for general
intravascular use,
including the neuro
and peripheral
vasculature. The
SOFIA 88 Catheter
can be used to
facilitate introduction
of diagnostic agents or
therapeutic devices.
The SOFIA 88
Catheter is not
intended for use in
coronary arteries. |
| Device
Classification | Class II
QJP, DQY
21 CFR 870.1250 | Class II
DQY, DQO
21 CFR 870.1250
21 CFR 870.1200 | Class II
DQY, QJP
21 CFR 870.1250 |
| ZOOM 88 (K203764) | SOFIA 6F DAC
(K150366) | SOFIA 88 Catheter | |
| Reference Device | Predicate Device | Subject Device | |
| Catheter Body | Commonly used
medical grade plastics
& metals with
hydrophilic coating | Outer layer of
polyurethane
elastomer, polyether
block amide, and
polyamide; inner layer
of metal braid/coil,
PTFE, and polyolefin
elastomer | Outer layer of
polyurethane
elastomer (different
polyurethane
formulation), polyether
block amide, and
polyamide; inner layer
of metal braid/coil,
PTFE, and polyolefin
elastomer |
| Marker | - | Platinum/Iridium | Same as SOFIA 6F
DAC (K150366) |
| Hub | - | Nylon | Same as SOFIA 6F
DAC (K150366) |
| Strain Relief | - | Polyurethane | Same as SOFIA 6F
DAC (K150366) |
| Introducer | None | Pebax® | Fluorinated ethylene
propylene |
| Shaping Mandrel | None | Stainless steel | None |
| Catheter size | 8F | 6F | 8F, Same as ZOOM
88 (K203764) |
| ID | 0.088 in (2.2 mm) | 0.070 in (1.8 mm) | 0.0875 in (2.22 mm)
min |
| OD | 0.110 in (2.79 mm)
max | 0.0825 in (2.10 mm) | Proximal: 0.108 in
(2.74 mm) max |
| | | | Distal: 0.102 in (2.59
mm) max |
| Effective Length | 80–110 cm | 115, 125, 131, 135 cm | 115 cm |
| Coating | Hydrophilic coating | Hydrophilic coating | Same as SOFIA 6F
DAC (K150366) |
| Tip Configuration | Beveled distal edge,
soft, flexible,
atraumatic tip | Straight | Same as SOFIA 6F
DAC (K150366) |
| Guidewire
Compatibility | ≤ 0.038 in | 0.035 in | ≤ 0.038 in |
| Accessories | Rotating hemostasis
valve (RHV) | Introducer sheath and
shaping mandrel | Introducer sheath |
| | ZOOM 88 (K203764) | SOFIA 6F DAC
(K150366) | SOFIA 88 Catheter |
| | Reference Device | Predicate Device | Subject Device |
| Condition
Supplied | Sterile and single use | Sterile and single use | Same |
| Sterilization
Method | EtO | EtO | Same |
| Packaging
Configuration | The catheters are
placed in a protective
polyethylene tube,
mounted with
accessory RHV onto a
polyethylene
packaging card,
placed into a pouch,
sealed and labeled.
The sealed pouch and
IFU are placed in a
labeled shelf carton
box. | 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. | Catheter placed into a
HDPE dispenser tube.
Dispenser tube and
introducer placed on a
polyethylene
packaging card that is
inserted into a Tyvek
pouch. Pouch and IFU
placed in bleached
sulfate carton box. |
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Image /page/5/Picture/0 description: The image contains the logo for MicroVention, a company that specializes in neurovascular products. The logo features a stylized graphic of interconnected blue and gray circles on the left. To the right of the graphic is the company name "MicroVention" in blue, with the registered trademark symbol. Below the company name is the word "TERUMO" in blue, which is the parent company of MicroVention.
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Image /page/6/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a circular graphic on the left side, composed of overlapping curved lines in shades of gray and blue, creating a sense of motion or rotation. To the right of the graphic, the word "MicroVention" is written in a blue sans-serif font, with a small registered trademark symbol next to it. Below "MicroVention", the word "TERUMO" is written in a larger, bolder blue sans-serif font.
Performance Testing
Performance testing was conducted to demonstrate the substantial equivalence of the SOFIA 88 Catheter to the predicate device.
The following testing data were provided to evaluate the performance of the SOFIA 88 Catheter.
| Test | Test Method Summary | Results |
|---|---|---|
| Dimensional | ||
| Verification | Dimensional specifications were verified by | |
| measuring the catheter length, proximal and distal | ||
| outer diameters, and distal inner diameter. | Pass | |
| Coating Lubricity | ||
| and Durability | The hydrophilic coating was evaluated for frictional | |
| force and durability. | Pass | |
| Simulated Use | Performance was evaluated under simulated use in | |
| a tortuous anatomical model to assess preparation, | ||
| introduction, tracking, and support of the device. | Pass | |
| Dynamic and Static | ||
| Burst Pressure | Device was subjected to rated burst pressures to | |
| test catheter integrity. | Pass |
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Image /page/7/Picture/0 description: The image contains the logo for MicroVention, a company that is part of Terumo. The logo features a stylized graphic of three curved lines that resemble a swirl or a vortex. To the right of the graphic is the word "MicroVention" in a blue sans-serif font. Below "MicroVention" is the word "TERUMO" in a smaller, bolder, blue sans-serif font.
| Test | Test Method Summary | Results |
|---|---|---|
| Air Leakage | Device was tested for air leakage requirements. | Pass |
| Liquid Leakage | Device was tested for liquid leakage requirements. | Pass |
| Tensile Strength | Device was tensile tested to failure, and recorded | |
| the force at breakage. | Pass | |
| Flexural Fatigue | Device was subjected to flexural fatigue from | |
| repeated bending during simulated use testing and | ||
| flexural fatigue from repeated hoop stress on the | ||
| catheter from pressure testing. | Pass | |
| Particulate Testing | The number and size of particulates generated | |
| during simulated use in a tortuous anatomical model | ||
| were measured and results were compared with the | ||
| predicate device. | Pass | |
| Kink Resistance | Device was evaluated for kink resistance after | |
| simulated use testing. | Pass | |
| Torque Strength | Device was evaluated for torque strength by | |
| measuring the number of catheter rotations until | ||
| failure after tracking through a tortuous anatomical | ||
| model. | Pass | |
| Radio Detectability | Device visibility was evaluated under fluoroscopy. | Pass |
| Corrosion Resistance | Device corrosion was evaluated after immersion in | |
| saline. | Pass | |
| Small-bore Connector | The luer connector was evaluated for dimensional | |
| and performance requirements per reference | ||
| standard. | Pass | |
| Stiffness Profile | The catheter stiffness profile along proximal and | |
| distal sections was compared to the reference | ||
| device. | Pass |
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Image /page/8/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic to the left, resembling interconnected circles or orbits in shades of gray and blue. To the right of the graphic is the word "MicroVention" in a blue sans-serif font, with "TERUMO" in a bolder, blue font positioned directly below it.
Biocompatibility Results
| Test | Test Method Summary | Results | |
|---|---|---|---|
| Extract(s) & Test | |||
| Systems | Extract Conditions | ||
| Cytotoxicity | |||
| (ISO MEM Elution | |||
| Test) | L-929 mouse | ||
| fibroblast cells | |||
| prepared using MEM | |||
| Maintenance Growth | |||
| Media with 5% FBS | 6.0 cm²/mL (exposed | ||
| surface area to | |||
| extraction medium | |||
| volume ratio), | |||
| extracted at 37 °C for | |||
| 24 hrs | Non-cytotoxic | ||
| Irritation Reactivity | |||
| (ISO Intracutaneous | |||
| Reactivity Test) | Normal saline and | ||
| sesame seed oil | |||
| (SSO) (tested | |||
| separately) | |||
| New Zealand White | |||
| Rabbits | 6.0 cm²/mL (exposed | ||
| surface area to | |||
| extraction medium | |||
| volume ratio), | |||
| extracted at 50 °C for | |||
| 72 hrs | Non-irritant | ||
| Maximization | |||
| (ISO Guinea Pig | |||
| Maximization Test) | Normal saline and | ||
| sesame seed oil | |||
| (SSO) (tested | |||
| separately) | |||
| Guinea Pig | 6.0 cm²/mL (exposed | ||
| surface area to | |||
| extraction medium | |||
| volume ratio), | |||
| extracted at 50 °C for | |||
| 72 hrs | Non-sensitizing | ||
| Systemic Toxicity | |||
| (ISO Acute | |||
| Systemic Toxicity | |||
| Test) | Normal saline and | ||
| sesame seed oil | |||
| (SSO) (tested | |||
| separately) | |||
| Albino outbred strain | |||
| (ND4) mice | 6.0 cm2/mL (exposed | ||
| surface area to | |||
| extraction medium | |||
| volume ratio), | |||
| extracted at 50 °C for | |||
| 72 hrs | Non-acute | ||
| systemically toxic | |||
| Pyrogenicity | |||
| (ISO/USP Material | |||
| Mediated | |||
| Pyrogencity Test) | Normal saline | ||
| New Zealand White | |||
| Rabbits | 6.0 cm²/mL (exposed | ||
| surface area to | |||
| extraction medium | |||
| volume ratio), | |||
| extracted at 50 °C for | |||
| 72 hrs | Non-pyrogenic | ||
| Test | Test Method Summary | Results | |
| Extract(s) & Test Systems | Extract Conditions | ||
| Hemocompatibility | |||
| In-Vitro Blood Loop | |||
| Assay | |||
| (ISO In-vitro Blood | |||
| Loop Assay with | |||
| Comparison Article) | A loop system | ||
| circulated with freshly | |||
| drawn sheep blood | The test article is | ||
| exposed to the | |||
| circulating blood that | |||
| fills to the capacity of | |||
| the loop at 37 °C for | |||
| 4 hrs | Thromboresistant | ||
| Hemocompatibility | |||
| Hemolysis Assay | |||
| (ISO ASTM | |||
| Hemolysis Assay) | PBS – Phosphate | ||
| Buffered Saline |
Blood - Three New
Zealand White
Rabbits | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 50 °C for
72 hrs | Non-hemolytic |
| Hemocompatibility
Complement
Activation Assay
(ISO
Hemocompatibility:
Complement
Activation Assay
(SC5b-9)) | Normal Human
Serum (NHS) | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 37 °C for
60 min | Non-activator of
complement system |
| Hemocompatibility
Partial
Thromboplastin
(ISO
Hemocompatibility:
Partial
Thromboplastin
Time (PTT) Assay) | Human Plasma
Freshly Drawn
Human Plasma | 6.0 cm²/mL (exposed
surface area to
extraction medium
volume ratio),
extracted at 37 °C for
15 min | No effect on the PTT |
| Test | Test Method Summary | | Results |
| | Extract(s) & Test Systems | Extract Conditions | |
| Hemocompatibility
Heparinized Blood
Platelet and
Leukocyte | Human Blood | 12 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37 °C for 60 min | Pass |
| | Freshly Drawn
Human Blood | | |
| (Hemocompatibility:
Heparinized Blood
Platelet and
Leukocyte Count
Assay) | | | |
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Animal Study
Acute animal testing was conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) comparing the SOFIA 88 Catheter to the SOFIA 6F DAC. The testing was intended to assess preclinical safety and efficacy for catheter tracking and tip stability in a porcine model. The porcine model was chosen since the vessel sizes of the pig model allow for insertion and navigation of standard-sized devices used in humans; porcine vessel diameters are comparable with human vasculature. The tracking results demonstrated that the SOFIA 88 Catheter and SOFIA 6F DAC devices performed equally. Catheter tip stability was found to be comparable for both devices. No dissection/perforation was noted for the test-article- and controltreated vessels. Similar degrees of vasospasm were noted in the vessels instrumented with both devices. During postmortem examination there were no remarkable gross findings for any of the vessel samples for both the test and control devices. There was no hemorrhage, necrosis, or edema in test article-treated and control article-treated arterial sections. Overall, the histologic findings were consistent with routine catheterization procedures, which are commonly observed after interventional procedures in porcine safety models. The results of the present study did not raise any safety issues with either the test SOFIA 88 Catheter or control SOFIA 6F DAC. The devices are deemed equivalent.
Conclusion
MicroVention concludes through a review of the benchtop testing, non-clinical animal study assessments, the comparison of the device classification, indications for use, operating principles, technological characteristics, sterility, and biocompatibility testing that the SOFIA 88 Catheter is substantially equivalent to the predicate SOFIA 6F DAC. Any differences between the subject device and the predicate device do not raise different questions of safety and effectiveness.