(176 days)
No
The summary describes a physical catheter and its performance in benchtop and animal studies, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for facilitating advancement of catheters and introduction of diagnostic agents, rather than directly treating a disease or condition. While it aids in procedures that might be therapeutic, it is itself a navigation component.
No
The device is a navigation catheter used to facilitate the advancement of other catheters and introduce diagnostic agents, but it does not perform diagnostic functions itself.
No
The device description clearly describes a physical catheter with hardware components like braiding, coating, a lumen, a radiopaque section, and a Luer hub.
Based on the provided information, the ISAAC™ Neurovascular Navigation Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents." This describes a device used within the body for navigation and delivery, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an in vivo device.
- Anatomical Site: The specified anatomical site is "neuro and peripheral vasculature," which are locations within the living body.
- Input Imaging Modality: The mention of "X-ray fluoroscopy" indicates a method used to visualize the device's position within the body during a procedure.
- Performance Studies: The studies described involve "benchtop testing and acute animal testing in a porcine model," which are typical for evaluating the physical performance and safety of an in vivo medical device.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The ISAAC™ catheter's function is entirely focused on interacting with the patient's internal anatomy during a medical procedure.
N/A
Intended Use / Indications for Use
The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.
Product codes
DQY, QJP
Device Description
The ISAAC™ Neurovascular Navigation Catheter) is a braid-reinforced variable stiffness catheter with a pre-shaped distal segment. The distal end of the catheter is coated with a hydrophilic coating around the curve of the pre-shaped section of the Simmons (SIM) configuration. It is a single lumen catheter with a radiopaque distal coiled section and a Luer hub on the proximal end. The ISAAC Catheter is sterile, non-pyrogenic and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing Summary:
- Physical Attributes: The usable length, proximal and distal outer diameters, distal length, and inner diameters were measured. (Pass)
- Tip Flexibility: The device shall have less force to bend at the distal tip than the comparator reference device. (Pass)
- Simulated Use: The performance of the catheter was rated during simulated-use testing in benchtop vessel model. (Pass)
- Radio Detectability: The catheter must be visible under X-ray fluoroscopy. (Pass)
- Kink Resistance: Kink resistance was measured by subjecting the device to bending in simulated tortuous anatomy. (Pass)
- Static Burst: The distal tip of the catheter was occluded, and fluid was injected into the lumen at increasing pressure until the catheter burst. (Pass)
- Liquid Leakage: The distal tip of the catheter was occluded, and fluid was injected. Pressure was maintained for 30 seconds, and the device was inspected for leakage per ISO 10555-1. (Pass)
- Leakage and Damage Under High Static Pressure Conditions: Dyed fluid was injected into the lumen until the rated burst pressure was reached and the pressure was held for 10 seconds while the distal tip is occluded. (Pass)
- Air Leakage: A vacuum was applied to the catheter and observed for air bubbles, per ISO 80369-7 and ISO 10555-1. (Pass)
- Dynamic Burst: The catheter was injected with fluid at a set pressure and inspected for damage. (Pass)
- Force at Break (Hub/Distal): The distal and proximal sections of the catheter are secured into a tensile test machine. The machine pulled until the catheter broke, and the pull force was recorded. (Pass)
- Particulate Testing: The catheter underwent simulated-use testing in a benchtop model and was evaluated for particulates. (Pass)
- Surface Contamination: Device must be free from visible surface defects. (Pass)
- Corrosion Resistance: The catheter was tested to evaluate corrosion resistance per ISO 10555-1 and ISO 11070. (Pass)
- Coating Durability and Lubricity: Device was secured to a tensile machine and put into heated water bath for hydration. The force to slide through the clamp was recorded as lubricity through 20 cycles. Durability was recorded through 100 cycles. (Pass)
- Catheter Flexural Fatigue: The tensile strength and pressure characteristics were measured per ISO 10555-1. (Pass)
- Hub and Luer Connector: The Luer connector was tested to dimensional and performance requirements per ISO 80369-7. (Pass)
- Stiffness: The catheter stiffness profile was compared to the reference device. (Pass)
- Torque Strength: The device was evaluated for torque strength by measuring the number of catheter rotations until failure after tracking through a tortuous anatomical model. (Pass)
Biocompatibility Testing Summary:
- Cytotoxicity (ISO MEM Elution Test): L-929 mouse fibroblast cells prepared using MEM Maintenance Growth Media with 5% FBS extracted at 37 °C for 24 hrs. (Non-cytotoxic)
- Irritation Reactivity (ISO Intracutaneous Reactivity Test): Normal saline and sesame seed oil (SSO) (tested separately) on New Zealand White Rabbits extracted at 50 ± 2°C for 72 ± 2hrs. (Non-irritant)
- Maximization (ISO Guinea Pig Maximization Test): Normal saline and SSO (tested separately) extracted at 50 ± 2°C for 72 ± 2hrs. (Non- sensitizing)
- Systemic Toxicity (ISO Acute Systemic Toxicity Test): Normal Saline and SSO (tested separately) on Albino outbred strain (ND4) mice (20 male, young adults) extracted at 50 ± 2°C for 72 ± 2hrs. (Non-acute systemically toxic)
- Pyrogenicity (ISO/USP Material Mediated Pyrogenicity Test): Normal saline and SSO (tested separately) on New Zealand White Rabbits extracted at 50 ± 2°C for 72 ± 2hrs. (Non- pyrogenic)
- Hemocompatibility In-Vitro Blood Loop Assay (ISO In-Vitro Blood Loop Assay): A loop system circulated with freshly drawn sheep blood. Direct exposure at 37±2°C for 4 hours ± 30 minutes. (Thrombogenic risk potential similar to the predicate)
- Hemocompatibility Hemolysis Assay (ISO ASTM Hemolysis Assay): Phosphate Buffered Saline (PBS) on New Zealand White Rabbits extracted at 50 ± 2°C for 72 ± 2hrs. (Non- hemolytic)
- Hemocompatibility Complement Activation Assay (ISO Hemocompatibility: Complement Activation Assay (C3a and SC5b-9)): Normal Human Serum (NHS) extracted at 37±2°C for 60 min ± 1 minute. (Non-activator of complement system)
- Hemocompatibility Partial Thromboplastin (ISO Hemocompatibility: Partial Thromboplastin Time (PTT) Assay): Human Plasma extracted at 37±2°C for 60 min ± 1 minute. (No effect on the PTT)
- Hemocompatibility Heparinized Blood Platelet and Leukocyte (Hemocompatibility: Heparinized Blood Platelet and Leukocyte Count Assay): Human Blood extracted at 37±2°C for 60 min ± 1 minute. (Pass)
Animal Study:
Acute animal testing was conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) comparing the ISAAC Catheter to the predicate Chaperon Guiding Catheter and testing with the BOBBY Guiding Catheter. The testing was intended to assess preclinical safety and efficacy for ISAAC Catheter (test article) and the inner catheter of the Chaperon Guiding Catheter (control article) 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 test article performed comparably to the control article with regards to tracking performance, support, and safety in this acute in vivo model. No significant device-associated complications (dissection, perforation, embolic debris, thrombus formation, hemorrhage, ischemia, necrosis, fibrin deposition, internal elastic lamina (IEL) rupture, external elastic lamina (EEL) rupture, mineralization, neointimal maturation, medial injury/fibrosis and adventitial injury/fibrosis) were noted in any of the test article and control article treated vessels. The tracking results demonstrated that the ISAAC Catheter and the Chaperon Guiding Catheter performed equally. The results of the present study did not raise any safety issues with either the test ISAAC Catheter or control Chaperon Guiding Catheter. The devices are deemed equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
January 10, 2023
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 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.
MicroVention, Inc. Sona Manickam Manager Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656
Re: K222115
Trade/Device Name: ISAAC Neurovascular Navigation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: December 9, 2022 Received: December 9, 2022
Dear Sona Manickam:
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K222115
Device Name
ISAACTM Neurovascular Navigation Catheter
Indications for Use (Describe)
The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary 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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Image /page/3/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo consists of a circular graphic on the left, followed by the text "MicroVention" in a larger, sans-serif font. Below "MicroVention" is the word "TERUMO" in a smaller, bolder font. The overall design is clean and corporate.
| 510(k) Owner | MicroVention, Inc. |
|---|---|
| 35 Enterprise | |
| Aliso Viejo, CA 92656 | |
| Establishment Registration No: 3013556777 | |
| Contact Person | Sona Manickam |
| Manager Regulatory Affairs | |
| Telephone: (712)-582-8133 | |
| Email: Sona.Manickam@microvention.com | |
| Date Summary Prepared | January 09, 2023 |
| Trade Name | ISAACT™ Neurovascular Navigation Catheter |
| Common Name | Catheter, Percutaneous |
| Classification | Class II, DQY, QJP |
| Regulation | 21 CFR 870.1250 |
| Predicate Device | Chaperon Guiding Catheter (K082385) |
| Reference Devices | Neuron Select Catheter (K083125) |
| Neuron MAX System (K111380) |
K222115 510(k) Summary
Device Description
The ISAAC™ Neurovascular Navigation Catheter) is a braid-reinforced variable stiffness catheter with a pre-shaped distal segment. The distal end of the catheter is coated with a hydrophilic coating around the curve of the pre-shaped section of the Simmons (SIM) configuration. It is a single lumen catheter with a radiopaque distal coiled section and a Luer hub on the proximal end. The ISAAC Catheter is sterile, non-pyrogenic and intended for single use only.
Indications for Use
The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.
Comparison of Indications for Use and Technological Characteristics
The subject device, ISAAC Catheter, and the predicate device, the inner catheter of the Chaperon Guiding Catheter (K082385) are substantially equivalent in that these devices have similar intended use, principles of operation, and fundamental design.
As evidenced by the data, the subject, predicate, and reference devices:
- have similar intended use,
- . use the same principles of operation,
- . incorporate the same basic design,
- . use similar construction and materials,
- . are Ethylene Oxide (EtO)- sterilized and packaged using the same processes.
The following table provides a comparison of the key characteristics of the ISAAC Catheter to the predicate and reference devices.
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Image /page/4/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, circular graphic on the left, followed by the text "MicroVention" in a blue, sans-serif font. Below "MicroVention" is the word "TERUMO," also in blue and in a bolder, sans-serif font. The overall design is clean and corporate, suggesting a company in the medical or technology sector.
Device Comparison Table
| Device
Characteristics | Proposed Device
ISAAC Neurovascular
Navigation Catheter (K222115) | Predicate Device
Chaperon Guiding Catheter
(K082385) | Reference Device
Neuron Select Catheter
(K083125) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The ISAAC Neurovascular
Navigation Catheter is
indicated for use in
facilitating advancement of
catheters through the neuro
and peripheral vasculature
and introduction of
diagnostic agents. The ISAAC
Neurovascular Navigation
Catheter is not intended for
use in the coronary
vasculature. | Chaperon Guiding Catheter is
intended for general
intravascular use, including the
neuro and peripheral
vasculature. Chaperon Guiding
Catheter can be used to
facilitate introduction of
diagnostic or therapeutic
devices. Chaperon Guiding
Catheter is not intended for use
in coronary arteries. | The Neuron Intracranial
Access System is indicated
for the introduction of
interventional devices into
the peripheral, coronary
and neuro vasculature. |
| Device Class | Class II DQY, QJP
21 CFR 870.1250 | Class II DQY
21 CFR 870.1250 | Class II DQY
21 CFR 870.1250 |
| Catheter Body | Braid: Stainless Steel
Catheter:
Polytetrafluoroethylene
(PTFE)
Coiling: Tungsten
Outer: Polymer | Braid: Stainless Steel
Catheter: PTFE | Braid: Stainless Steel
Catheter: PTFE |
| Marker | Radiopaque coil | Radiopaque marker | Radiopaque jacket |
| Hub | Nylon | Nylon | Nylon |
| Strain Relief | Polyurethane | Polyurethane | Polyurethane |
| Inner Diameter | 6F: 1.02 mm (0.040") | 5F: 1.22 mm (0.048") | 6F: 1.02 mm (0.040") |
| Outer Diameter | 6F: 2.11 mm (0.083") | 5F: 1.70 mm (0.067") | 6.5F: 2.16 mm (0.085") |
| Effective Length | SIM2-3D: 150 cm
SIM3-3D: 150 cm
TIP45: 140 cm | 117 cm | 125 cm |
| Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Tip
Configuration | Variable Tip Shape & Size | Variable Tip Shape & Size | Variable Tip Shape & Size |
| Guidewire
Compatibility | 0.035" and 0.038" | 0.035" and 0.038" | 0.035" and 0.038" |
| Accessories | Not applicable | Not applicable | Not applicable |
| Method of
Supply | Sterile and single use | Sterile and single use | Sterile and single use |
| Sterilization
Method | Sterilized using 100%
Ethylene Oxide | Sterilized using 100%
Ethylene Oxide | Sterilized using 100%
Ethylene Oxide |
| Device
Characteristics | Proposed Device | Predicate Device | Reference Device |
| Packaging
Configuration | ISAAC Neurovascular
Navigation Catheter
(K222115) | Chaperon Guiding Catheter
(K082385) | Neuron Select Catheter
(K083125) |
| | Placed on mounting card,
Tyvek pouch, shipping
carton | Placed on mounting card,
Tyvek pouch, shipping
carton | Placed on mounting card,
Tyvek pouch, shipping
carton |
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Image /page/5/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized graphic of concentric circles on the left. To the right of the graphic is the text "MicroVention" in a blue sans-serif font, with the trademark symbol to the upper right. Below "MicroVention" is the word "TERUMO" in a bolder, blue sans-serif font.
Performance Testing Summary
The following performance testing was conducted to support the ISAAC Catheter and demonstrate that it performs as intended:
| Test | Test Method Summary | Results |
|---|---|---|
| Physical Attributes | The usable length, proximal and distal outer diameters, distal length, and | |
| inner diameters were measured. | Pass | |
| Tip Flexibility | The device shall have less force to bend at the distal tip than the | |
| comparator reference device. | Pass | |
| Simulated Use | The performance of the catheter was rated during simulated-use testing | |
| in benchtop vessel model. | Pass | |
| Radio Detectability | The catheter must be visible under X-ray fluoroscopy. | Pass |
| Kink Resistance | Kink resistance was measured by subjecting the device to bending in | |
| simulated tortuous anatomy. | Pass | |
| Static Burst | The distal tip of the catheter was occluded, and fluid was injected into the | |
| lumen at increasing pressure until the catheter burst. | Pass | |
| Liquid Leakage | The distal tip of the catheter was occluded, and fluid was injected. | |
| Pressure was maintained for 30 seconds, and the device was inspected | ||
| for leakage per ISO 10555-1. | Pass | |
| Leakage and Damage | ||
| Under High Static | ||
| Pressure Conditions | Dyed fluid was injected into the lumen until the rated burst pressure was | |
| reached and the pressure was held for 10 seconds while the distal tip is | ||
| occluded. | Pass | |
| Air Leakage | A vacuum was applied to the catheter and observed for air bubbles, per | |
| ISO 80369-7 and ISO 10555-1. | Pass | |
| Dynamic Burst | The catheter was injected with fluid at a set pressure and inspected for | |
| damage. | Pass | |
| Force at Break | ||
| (Hub/Distal) | The distal and proximal sections of the catheter are secured into a tensile | |
| test machine. The machine pulled until the catheter broke, and the pull | ||
| force was recorded. | Pass | |
| Particulate Testing | The catheter underwent simulated-use testing in a benchtop model and | |
| was evaluated for particulates. | Pass | |
| Surface Contamination | Device must be free from visible surface defects. | Pass |
| Corrosion Resistance | The catheter was tested to evaluate corrosion resistance per ISO 10555-1 | |
| and ISO 11070. | Pass | |
| Coating Durability and | ||
| Lubricity | Device was secured to a tensile machine and put into heated water bath | |
| for hydration. The force to slide through the clamp was recorded as | ||
| lubricity through 20 cycles. Durability was recorded through 100 cycles. | Pass | |
| Catheter Flexural | ||
| Fatigue | The tensile strength and pressure characteristics were measured per ISO | |
| 10555-1. | Pass |
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Image /page/6/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, circular graphic on the left, composed of curved lines suggesting movement or flow. To the right of the graphic, the word "MicroVention" is written in a blue sans-serif font, with the "®" symbol next to it. Below "MicroVention", the word "TERUMO" is written in a bolder, blue sans-serif font.
| Test | Test Method Summary | Results |
|---|---|---|
| Hub and Luer | ||
| Connector | The Luer connector was tested to dimensional and performance | |
| requirements per ISO 80369-7. | Pass | |
| Stiffness | The catheter stiffness profile was compared to the reference device. | Pass |
| Torque Strength | The device was evaluated for torque strength by measuring the number of | |
| catheter rotations until failure after tracking through a tortuous | ||
| anatomical model. | Pass |
Biocompatibility Testing Summary
The biological safety of the ISAAC Catheter was verified in accordance with ISO 10993-1 categorized as an externally communicating device directly contacting blood for a limited duration (≤ 24 hours). All ISAAC Catheter materials have a history of use in medical devices. The table below illustrates specific tests performed.
| Test Method Summary | |||
|---|---|---|---|
| Test | Extract(s) & Test Systems | Extraction Conditions | Results |
| 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 ± 2°C for 72 | |||
| ± 2hrs. | Non-irritant | ||
| Maximization | |||
| (ISO Guinea Pig Maximization | |||
| Test) | Normal saline and SSO (tested | ||
| separately) | 6.0 cm2/mL (exposed surface area | ||
| to extraction medium volume | |||
| ratio), extracted at | |||
| 50 ± 2°C for 72 ± 2hrs. | Non- sensitizing | ||
| Systemic Toxicity | |||
| (ISO Acute Systemic | |||
| Toxicity Test) | Normal Saline and SSO (tested | ||
| separately) | |||
| Albino outbred strain (ND4) | |||
| mice (20 male, young | |||
| adults) | 6.0 cm2/mL (exposed surface area | ||
| to extraction medium volume | |||
| ratio), extracted at 50 ± 2°C for 72 | |||
| ± 2hrs. | Non-acute | ||
| systemically toxic | |||
| Pyrogenicity | |||
| (ISO/USP Material Mediated | |||
| Pyrogenicity Test) | Normal saline and SSO (tested | ||
| separately) | |||
| New Zealand White Rabbits | 6.0 cm2/mL (exposed surface area | ||
| to extraction medium volume | |||
| ratio), extracted at 50 ± 2°C for 72 | |||
| ± 2hrs. | Non- pyrogenic |
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Image /page/7/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a circular design on the left, with the text "MicroVention" in a combination of blue and gray. Below "MicroVention" is the word "TERUMO" in blue, indicating a partnership or affiliation between the two entities.
| Test Method Summary | ||||
|---|---|---|---|---|
| Test | Extract(s) & Test Systems | Extraction Conditions | Results | |
| Hemocompatibility In-Vitro | ||||
| Blood Loop Assay | ||||
| (ISO In-Vitro Blood Loop | ||||
| Assay) | A loop system circulated with | |||
| freshly drawn sheep blood | Direct exposure at 37±2°C for 4 | |||
| hours ± 30 minutes. | Thrombogenic | |||
| risk potential | ||||
| similar to the | ||||
| predicate | ||||
| Hemocompatibility Hemolysis | ||||
| Assay | ||||
| (ISO ASTM Hemolysis Assay) | Phosphate Buffered Saline | |||
| (PBS) | ||||
| New Zealand White Rabbits | 6.0 cm²/mL (exposed surface area | |||
| to extraction medium volume | ||||
| ratio), extracted at 50 ± 2°C for 72 | ||||
| ± 2hrs. | Non- hemolytic | |||
| Hemocompatibility | ||||
| Complement Activation Assay | ||||
| (ISO Hemocompatibility: | ||||
| Complement Activation Assay | ||||
| (C3a and SC5b-9)) | Normal Human Serum (NHS) | 6.0 cm²/mL (exposed surface area | ||
| to extraction medium volume | ||||
| ratio) extracted at 37±2°C for 60 | ||||
| min ± 1 minute. | Non-activator of | |||
| complement | ||||
| system | ||||
| Hemocompatibility Partial | ||||
| Thromboplastin | ||||
| (ISO Hemocompatibility: | ||||
| Partial Thromboplastin | ||||
| Time (PTT) Assay) | Human Plasma | 6.0 cm²/mL (exposed surface area | ||
| to extraction medium volume | ||||
| ratio) extracted at 37±2°C for 60 | ||||
| min ± 1 minute. | No effect on the | |||
| PTT | ||||
| Hemocompatibility | ||||
| Heparinized Blood Platelet | ||||
| and Leukocyte | ||||
| (Hemocompatibility: | ||||
| Heparinized Blood Platelet | ||||
| and Leukocyte Count Assay) | Human Blood | 6.0 cm²/mL (exposed surface area | ||
| to extraction medium volume | ||||
| ratio) extracted at 37±2°C for 60 | ||||
| min ± 1 minute. | Pass |
Animal Study
Acute animal testing was conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) comparing the ISAAC Catheter to the predicate Chaperon Guiding Catheter and testing with the BOBBY Guiding Catheter. The testing was intended to assess preclinical safety and efficacy for ISAAC Catheter (test article) and the inner catheter of the Chaperon Guiding Catheter (control article) 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 test article performed comparably to the control article with regards to tracking performance, support, and safety in this acute in vivo model. No significant device-associated complications (dissection, perforation, embolic debris, thrombus formation, hemorrhage, ischemia, necrosis, fibrin deposition, internal elastic lamina (IEL) rupture, external elastic lamina (EEL) rupture, mineralization, neointimal maturation, medial injury/fibrosis and adventitial injury/fibrosis) were noted in any of the test article and control article treated vessels. The tracking results demonstrated that the ISAAC Catheter and the Chaperon Guiding Catheter performed equally. The results of the present study did not raise any safety issues with either the test ISAAC Catheter or control Chaperon Guiding Catheter. The devices are deemed equivalent.
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Image /page/8/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, circular graphic element on the left, composed of curved lines in shades of gray and blue, suggesting movement or connectivity. To the right of this graphic is the word "MicroVention" in a blue, sans-serif font, with the "®" symbol next to it. Below "MicroVention" is the word "TERUMO" in a bolder, blue, sans-serif font.
Clinical Testing: No clinical testing was deemed necessary to support the substantial equivalence of t ISAAC Catheter.
Conclusion
MicroVention concludes through a review of the benchtop testing, non-clinical animal study assessments, the comparison of the device classifications for use, operating principles, technological characteristics, sterility, and biocompatibility testing that the ISAAC Neurovascular Navigation Catheter is substantially equivalent to the predicate Chaperon Guiding Catheter (K082385). Any differences between the subject device and the predicate device do not raise different questions of safety and effectiveness.