(176 days)
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.
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.
The FDA 510(k) summary for the MicroVention, Inc. ISAAC Neurovascular Navigation Catheter (K222115) indicates that a range of performance testing was conducted to demonstrate the device's substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|---|
| Physical Attributes | Measurement of usable length, proximal/distal outer diameters, distal length, and inner diameters. | Pass |
| Tip Flexibility | Device shall have less force to bend at the distal tip than the comparator reference device. | Pass |
| Simulated Use | Performance rated during simulated-use testing in benchtop vessel model. | Pass |
| Radio Detectability | Catheter must be visible under X-ray fluoroscopy. | Pass |
| Kink Resistance | Kink resistance measured by subjecting the device to bending in simulated tortuous anatomy. | Pass |
| Static Burst | Fluid injected into the lumen at increasing pressure until catheter burst while distal tip occluded. | Pass |
| Liquid Leakage | Pressure maintained for 30 seconds with occluded distal tip; device inspected for leakage per ISO 10555-1. | Pass |
| Leakage and Damage Under High Static Pressure Conditions | Dyed fluid injected until rated burst pressure reached and held for 10 seconds while distal tip occluded. | Pass |
| Air Leakage | Vacuum applied; observed for air bubbles per ISO 80369-7 and ISO 10555-1. | Pass |
| Dynamic Burst | Catheter injected with fluid at a set pressure and inspected for damage. | Pass |
| Force at Break (Hub/Distal) | Hub/distal sections secured into tensile test machine; pulled until catheter broke, pull force recorded. | Pass |
| Particulate Testing | Catheter underwent simulated-use testing in a benchtop model and evaluated for particulates. | Pass |
| Surface Contamination | Device must be free from visible surface defects. | Pass |
| Corrosion Resistance | Catheter tested per ISO 10555-1 and ISO 11070. | Pass |
| Coating Durability and Lubricity | Device secured to tensile machine, hydrated, force to slide through clamp recorded (20 cycles for lubricity, 100 cycles for durability). | Pass |
| Catheter Flexural Fatigue | Tensile strength and pressure characteristics measured per ISO 10555-1. | Pass |
| Hub and Luer Connector | Luer connector tested to dimensional and performance requirements per ISO 80369-7. | Pass |
| Stiffness | Catheter stiffness profile compared to the reference device. | Pass |
| Torque Strength | Evaluated by measuring number of catheter rotations until failure after tracking through a tortuous anatomical model. | Pass |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Irritation Reactivity) | Non-irritant | Non-irritant |
| Biocompatibility (Maximization - Sensitization) | Non-sensitizing | Non-sensitizing |
| Biocompatibility (Systemic Toxicity) | Non-acute systemically toxic | Non-acute systemically toxic |
| Biocompatibility (Pyrogenicity) | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility (Hemocompatibility In-Vitro Blood Loop Assay) | Thrombogenic risk potential similar to the predicate | Similar to predicate |
| Biocompatibility (Hemocompatibility Hemolysis Assay) | Non-hemolytic | Non-hemolytic |
| Biocompatibility (Hemocompatibility Complement Activation Assay) | Non-activator of complement system | Non-activator of complement system |
| Biocompatibility (Hemocompatibility Partial Thromboplastin Time (PTT) Assay) | No effect on the PTT | No effect on PTT |
| Biocompatibility (Hemocompatibility Heparinized Blood Platelet and Leukocyte Count Assay) | Pass | Pass |
| Animal Study (Tracking Performance, Support, Safety) | Perform comparably to the control article (Chaperon Guiding Catheter) in terms of tracking, support, and safety. | Performed comparably |
| Animal Study (Device-associated Complications) | No significant device-associated complications (dissection, perforation, embolic debris, thrombus, hemorrhage, ischemia, necrosis, fibrin deposition, IEL rupture, EEL rupture, mineralization, neointimal maturation, medial/adventitial injury/fibrosis). | No significant complications |
2. Sample Size Used for the Test Set and Data Provenance:
- Benchtop and Biocompatibility Testing: The specific sample sizes for each individual benchtop and biocompatibility test are not explicitly detailed in this summary. However, these tests are generally conducted on a statistically significant number of device units or material samples to ensure representativeness and reproducibility.
- Animal Study: The animal study was conducted using a "porcine model." The exact number of animals involved is not specified, but it's referred to as an "acute animal testing" in a "porcine model."
- Data Provenance:
- Benchtop Testing: Likely laboratory-generated data from MicroVention, Inc., performed under controlled conditions.
- Biocompatibility Testing: Performed on material extracts or the device itself, likely by specialized laboratories following ISO standards.
- Animal Study: Conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58), indicating a prospective study specifically designed to assess the device. The provenance is internal to the controlled study environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Benchtop and Biocompatibility Testing: The summary does not specify the use of "experts" to establish a ground truth in the traditional sense (e.g., for image interpretation). Instead, these tests rely on objective, measurable criteria defined by established international standards (e.g., ISO, ASTM). The "ground truth" would be the direct measurement or observation of the device's physical, mechanical, and biological properties against predefined limits or comparison with a predicate.
- Animal Study: The evaluation of the animal study results regarding complications and performance comparability would involve veterinarians and potentially pathologists who are experts in animal physiology and disease interpretation. Their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set Without Explanation:
- Benchtop and Biocompatibility Testing: An "adjudication method" in the sense of resolving discrepancies between multiple expert interpretations is generally not applicable to the objective measurements performed in these tests. Results are typically pass/fail based on predetermined specifications or direct comparison to controls/predicates.
- Animal Study: While not explicitly stated, observations in animal studies, especially pathological findings, often involve review by multiple experts (e.g., veterinary pathologists). If discrepancies occur, an adjudication process involving consensus or a tie-breaking expert would likely be in place, though this is not detailed in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not Applicable. The ISAAC Neurovascular Navigation Catheter is a physical medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Benchtop Testing: Objective physical and mechanical measurements, adherence to industry standards, and comparison to predicate device characteristics.
- Biocompatibility Testing: Results obtained from standardized biological assays (e.g., cell cultures, animal models for irritation/sensitization) providing objective data on biological reactions, evaluated against established acceptance criteria (e.g., "non-cytotoxic," "non-irritant").
- Animal Study: Direct observation of device performance (tracking, support) and histological/pathological assessment for complications (e.g., dissection, thrombus, tissue injury) in a living porcine model, compared against the control article.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical medical device, and the concept of a "training set" for an AI algorithm is not relevant here. The device design and manufacturing process would involve extensive engineering development and iterative testing (developmental testing) which is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no "training set" in the context of an AI algorithm for this device, a method for establishing its ground truth is not relevant. The device development relies on engineering principles, material science, and performance testing against established standards and predicate device characteristics.
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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
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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
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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
| DeviceCharacteristics | Proposed DeviceISAAC NeurovascularNavigation Catheter (K222115) | Predicate DeviceChaperon Guiding Catheter(K082385) | Reference DeviceNeuron Select Catheter(K083125) |
|---|---|---|---|
| Indications forUse | The ISAAC NeurovascularNavigation Catheter isindicated for use infacilitating advancement ofcatheters through the neuroand peripheral vasculatureand introduction ofdiagnostic agents. The ISAACNeurovascular NavigationCatheter is not intended foruse in the coronaryvasculature. | Chaperon Guiding Catheter isintended for generalintravascular use, including theneuro and peripheralvasculature. Chaperon GuidingCatheter can be used tofacilitate introduction ofdiagnostic or therapeuticdevices. Chaperon GuidingCatheter is not intended for usein coronary arteries. | The Neuron IntracranialAccess System is indicatedfor the introduction ofinterventional devices intothe peripheral, coronaryand neuro vasculature. |
| Device Class | Class II DQY, QJP21 CFR 870.1250 | Class II DQY21 CFR 870.1250 | Class II DQY21 CFR 870.1250 |
| Catheter Body | Braid: Stainless SteelCatheter:Polytetrafluoroethylene(PTFE)Coiling: TungstenOuter: Polymer | Braid: Stainless SteelCatheter: PTFE | Braid: Stainless SteelCatheter: 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 cmSIM3-3D: 150 cmTIP45: 140 cm | 117 cm | 125 cm |
| Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| TipConfiguration | Variable Tip Shape & Size | Variable Tip Shape & Size | Variable Tip Shape & Size |
| GuidewireCompatibility | 0.035" and 0.038" | 0.035" and 0.038" | 0.035" and 0.038" |
| Accessories | Not applicable | Not applicable | Not applicable |
| Method ofSupply | Sterile and single use | Sterile and single use | Sterile and single use |
| SterilizationMethod | Sterilized using 100%Ethylene Oxide | Sterilized using 100%Ethylene Oxide | Sterilized using 100%Ethylene Oxide |
| DeviceCharacteristics | Proposed Device | Predicate Device | Reference Device |
| PackagingConfiguration | ISAAC NeurovascularNavigation Catheter(K222115) | Chaperon Guiding Catheter(K082385) | Neuron Select Catheter(K083125) |
| Placed on mounting card,Tyvek pouch, shippingcarton | Placed on mounting card,Tyvek pouch, shippingcarton | Placed on mounting card,Tyvek pouch, shippingcarton |
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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, andinner diameters were measured. | Pass |
| Tip Flexibility | The device shall have less force to bend at the distal tip than thecomparator reference device. | Pass |
| Simulated Use | The performance of the catheter was rated during simulated-use testingin 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 insimulated tortuous anatomy. | Pass |
| Static Burst | The distal tip of the catheter was occluded, and fluid was injected into thelumen 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 inspectedfor leakage per ISO 10555-1. | Pass |
| Leakage and DamageUnder High StaticPressure Conditions | Dyed fluid was injected into the lumen until the rated burst pressure wasreached and the pressure was held for 10 seconds while the distal tip isoccluded. | Pass |
| Air Leakage | A vacuum was applied to the catheter and observed for air bubbles, perISO 80369-7 and ISO 10555-1. | Pass |
| Dynamic Burst | The catheter was injected with fluid at a set pressure and inspected fordamage. | Pass |
| Force at Break(Hub/Distal) | The distal and proximal sections of the catheter are secured into a tensiletest machine. The machine pulled until the catheter broke, and the pullforce was recorded. | Pass |
| Particulate Testing | The catheter underwent simulated-use testing in a benchtop model andwas 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 10555-1and ISO 11070. | Pass |
| Coating Durability andLubricity | Device was secured to a tensile machine and put into heated water bathfor hydration. The force to slide through the clamp was recorded aslubricity through 20 cycles. Durability was recorded through 100 cycles. | Pass |
| Catheter FlexuralFatigue | The tensile strength and pressure characteristics were measured per ISO10555-1. | 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 LuerConnector | The Luer connector was tested to dimensional and performancerequirements 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 ofcatheter rotations until failure after tracking through a tortuousanatomical 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 cellsprepared using MEMMaintenance Growth Mediawith 5% FBS | 6.0 cm2/mL (exposed surface areato extraction medium volumeratio), extracted at 37 °C for 24 hrs. | Non-cytotoxic |
| Irritation Reactivity(ISO IntracutaneousReactivity Test) | Normal saline and sesameseed oil (SSO) (testedseparately)New Zealand White Rabbits | 6.0 cm2/mL (exposed surface areato extraction medium volumeratio), extracted at 50 ± 2°C for 72± 2hrs. | Non-irritant |
| Maximization(ISO Guinea Pig MaximizationTest) | Normal saline and SSO (testedseparately) | 6.0 cm2/mL (exposed surface areato extraction medium volumeratio), extracted at50 ± 2°C for 72 ± 2hrs. | Non- sensitizing |
| Systemic Toxicity(ISO Acute SystemicToxicity Test) | Normal Saline and SSO (testedseparately)Albino outbred strain (ND4)mice (20 male, youngadults) | 6.0 cm2/mL (exposed surface areato extraction medium volumeratio), extracted at 50 ± 2°C for 72± 2hrs. | Non-acutesystemically toxic |
| Pyrogenicity(ISO/USP Material MediatedPyrogenicity Test) | Normal saline and SSO (testedseparately)New Zealand White Rabbits | 6.0 cm2/mL (exposed surface areato extraction medium volumeratio), 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-VitroBlood Loop Assay(ISO In-Vitro Blood LoopAssay) | A loop system circulated withfreshly drawn sheep blood | Direct exposure at 37±2°C for 4hours ± 30 minutes. | Thrombogenicrisk potentialsimilar to thepredicate | |
| Hemocompatibility HemolysisAssay(ISO ASTM Hemolysis Assay) | Phosphate Buffered Saline(PBS)New Zealand White Rabbits | 6.0 cm²/mL (exposed surface areato extraction medium volumeratio), extracted at 50 ± 2°C for 72± 2hrs. | Non- hemolytic | |
| HemocompatibilityComplement Activation Assay(ISO Hemocompatibility:Complement Activation Assay(C3a and SC5b-9)) | Normal Human Serum (NHS) | 6.0 cm²/mL (exposed surface areato extraction medium volumeratio) extracted at 37±2°C for 60min ± 1 minute. | Non-activator ofcomplementsystem | |
| Hemocompatibility PartialThromboplastin(ISO Hemocompatibility:Partial ThromboplastinTime (PTT) Assay) | Human Plasma | 6.0 cm²/mL (exposed surface areato extraction medium volumeratio) extracted at 37±2°C for 60min ± 1 minute. | No effect on thePTT | |
| HemocompatibilityHeparinized Blood Plateletand Leukocyte(Hemocompatibility:Heparinized Blood Plateletand Leukocyte Count Assay) | Human Blood | 6.0 cm²/mL (exposed surface areato extraction medium volumeratio) extracted at 37±2°C for 60min ± 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.
§ 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).