(264 days)
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.
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.
The provided document is a 510(k) summary for a medical device (SOFIA 88 Catheter), demonstrating its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on performance (benchtop) and pre-clinical (animal) testing rather than clinical studies with human subjects or AI algorithm performance.
Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample size for test sets (human data), number of experts for ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this specific document as it pertains to a physical medical device (catheter) and not an AI/ML powered device.
However, I can extract the relevant information regarding the performance and equivalency testing conducted for the SOFIA 88 Catheter.
Device: SOFIA 88 Catheter
Type of Device: Percutaneous Catheter (physical medical device)
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by the "Pass" result for each test, indicating that the device met the pre-defined standards for each physical and functional characteristic. The document doesn't explicitly state quantitative acceptance limits for each test but rather confirms successful completion.
| Test Title | Test Method Summary | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Measured catheter length, proximal and distal outer diameters, and distal inner diameter. | Pass |
| Coating Lubricity and Durability | Evaluated hydrophilic coating for frictional force and durability. | Pass |
| Simulated Use | Evaluated performance under simulated use in a tortuous anatomical model to assess preparation, introduction, tracking, and support of the device. | Pass |
| Dynamic and Static Burst Pressure | Subjected device to rated burst pressures to test catheter integrity. | Pass |
| Air Leakage | Tested device for air leakage requirements. | Pass |
| Liquid Leakage | Tested device for liquid leakage requirements. | Pass |
| Tensile Strength | Tensile tested device to failure, recorded the force at breakage. | Pass |
| Flexural Fatigue | Subjected device to flexural fatigue from repeated bending during simulated use testing and from repeated hoop stress on the catheter from pressure testing. | Pass |
| Particulate Testing | Measured number and size of particulates generated during simulated use in a tortuous anatomical model and compared results with the predicate device. | Pass |
| Kink Resistance | Evaluated device for kink resistance after simulated use testing. | Pass |
| Torque Strength | Evaluated device for torque strength by measuring the number of catheter rotations until failure after tracking through a tortuous anatomical model. | Pass |
| Radio Detectability | Evaluated device visibility under fluoroscopy. | Pass |
| Corrosion Resistance | Evaluated device corrosion after immersion in saline. | Pass |
| Small-bore Connector | Evaluated luer connector for dimensional and performance requirements per reference standard. | Pass |
| Stiffness Profile | Compared catheter stiffness profile along proximal and distal sections to the reference device. | Pass |
| Biocompatibility Tests | ||
| Cytotoxicity | L-929 mouse fibroblast cells (MEM) with 6.0 cm²/mL at 37°C for 24 hrs. | Non-cytotoxic |
| Irritation Reactivity | Normal saline and sesame seed oil (SSO) on New Zealand White Rabbits with 6.0 cm²/mL at 50°C for 72 hrs. | Non-irritant |
| Maximization | Normal saline and sesame seed oil (SSO) on Guinea Pigs with 6.0 cm²/mL at 50°C for 72 hrs. | Non-sensitizing |
| Systemic Toxicity | Normal saline and sesame seed oil (SSO) on Albino outbred strain (ND4) mice with 6.0 cm²/mL at 50°C for 72 hrs. | Non-acute systemically toxic |
| Pyrogenicity | Normal saline on New Zealand White Rabbits with 6.0 cm²/mL at 50°C for 72 hrs. | Non-pyrogenic |
| Hemocompatibility (Blood Loop) | Loop system circulated with freshly drawn sheep blood; test article exposed to circulating blood at 37°C for 4 hrs. | Thromboresistant |
| Hemolysis Assay | PBS – Phosphate Buffered Saline / Blood from Three New Zealand White Rabbits; 6.0 cm²/mL at 50°C for 72 hrs. | Non-hemolytic |
| Complement Activation Assay | Normal Human Serum (NHS); 6.0 cm²/mL at 37°C for 60 min. | Non-activator of complement system |
| Partial Thromboplastin Time (PTT) Assay | Human Plasma / Freshly Drawn Human Plasma; 6.0 cm²/mL at 37°C for 15 min. | No effect on the PTT |
| Heparinized Blood Platelet and Leukocyte Count Assay | Human Blood / Freshly Drawn Human Blood; 12 cm²/mL at 37°C for 60 min. | Pass |
| Animal Study | ||
| Acute Animal Testing | Comparison of SOFIA 88 Catheter to SOFIA 6F DAC for catheter tracking and tip stability in a porcine model. GLP-compliant. Examined for dissection/perforation, vasospasm, hemorrhage, necrosis, edema. | Performed equally (SOFIA 88 Catheter and SOFIA 6F DAC). Found comparable. No issues noted. |
2. Sample size used for the test set and the data provenance
- Benchtop Testing: While specific sample sizes for each benchtop test are not provided in this summary, these tests generally involve a statistically significant number of device units (e.g., n=3, 5, or more depending on the test and standard requirements) to ensure reproducibility and reliability. The provenance is internal laboratory testing by MicroVention, Inc. and its contracted labs.
- Biocompatibility Testing: Sample sizes are mentioned for some tests (e.g., New Zealand White Rabbits for irritation/pyrogenicity, Guinea Pigs for maximization, ND4 mice for systemic toxicity, sheep blood for blood loop assay, three rabbits for hemolysis, human serum/plasma for others). The provenance is laboratory testing conducted according to ISO and USP standards.
- Animal Study: The document refers to "a porcine model" without specifying the exact number of animals. It's an acute animal study. The provenance is internal or contracted laboratory animal testing (conducted in accordance with FDA GLP Regulation 21 CFR Part 58).
All data provenance is internal R&D and pre-clinical testing, not human clinical retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the ground truth for a physical medical device like a catheter is established through objective physical and chemical measurements (benchtop tests) and observed physiological responses in animal models, not through expert human interpretation of medical images or data requiring "ground truth" establishment in the context of an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human interpretation or subjective judgment that would require an adjudication method in the context of this device's testing. Measurements are objective and pass/fail criteria are pre-defined.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This device is a physical catheter, not an AI application, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established via objective engineering and material science measurements (e.g., dimensions, pressure, force), validated laboratory biological assays (e.g., cytotoxicity, hemolysis), and observed physiological responses and pathological findings in an animal model. It is not derived from expert consensus, pathology, or outcomes data in the sense of clinical diagnostic accuracy.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML powered device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reason stated above.
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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
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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
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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 EnterpriseAliso Viejo, CA 92656Establishment Registration No: 3013556777 |
|---|---|
| Contact Person | Alick Tan, PhDSenior Regulatory Affairs SpecialistTelephone: 949-615-2603Email: alick.tan@microvention.com |
| Date summaryPrepared | 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 DistalPlatform; 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 andZOOM 88-T LargeDistal Platform areindicated for theintroduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature. | The SOFIAPLUS/Distal AccessCatheters areindicated for generalintravascular use,including the neuroand peripheralvasculature. It can beused to facilitateintroduction ofdiagnostic andtherapeutic agents. Itis not intended for usein coronary arteries. | The SOFIA 88Catheter is indicatedfor generalintravascular use,including the neuroand peripheralvasculature. TheSOFIA 88 Cathetercan be used tofacilitate introductionof diagnostic agents ortherapeutic devices.The SOFIA 88Catheter is notintended for use incoronary arteries. |
| DeviceClassification | Class IIQJP, DQY21 CFR 870.1250 | Class IIDQY, DQO21 CFR 870.125021 CFR 870.1200 | Class IIDQY, QJP21 CFR 870.1250 |
| ZOOM 88 (K203764) | SOFIA 6F DAC(K150366) | SOFIA 88 Catheter | |
| Reference Device | Predicate Device | Subject Device | |
| Catheter Body | Commonly usedmedical grade plastics& metals withhydrophilic coating | Outer layer ofpolyurethaneelastomer, polyetherblock amide, andpolyamide; inner layerof metal braid/coil,PTFE, and polyolefinelastomer | Outer layer ofpolyurethaneelastomer (differentpolyurethaneformulation), polyetherblock amide, andpolyamide; inner layerof metal braid/coil,PTFE, and polyolefinelastomer |
| Marker | - | Platinum/Iridium | Same as SOFIA 6FDAC (K150366) |
| Hub | - | Nylon | Same as SOFIA 6FDAC (K150366) |
| Strain Relief | - | Polyurethane | Same as SOFIA 6FDAC (K150366) |
| Introducer | None | Pebax® | Fluorinated ethylenepropylene |
| Shaping Mandrel | None | Stainless steel | None |
| Catheter size | 8F | 6F | 8F, Same as ZOOM88 (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 (2.59mm) max | |||
| Effective Length | 80–110 cm | 115, 125, 131, 135 cm | 115 cm |
| Coating | Hydrophilic coating | Hydrophilic coating | Same as SOFIA 6FDAC (K150366) |
| Tip Configuration | Beveled distal edge,soft, flexible,atraumatic tip | Straight | Same as SOFIA 6FDAC (K150366) |
| GuidewireCompatibility | ≤ 0.038 in | 0.035 in | ≤ 0.038 in |
| Accessories | Rotating hemostasisvalve (RHV) | Introducer sheath andshaping mandrel | Introducer sheath |
| ZOOM 88 (K203764) | SOFIA 6F DAC(K150366) | SOFIA 88 Catheter | |
| Reference Device | Predicate Device | Subject Device | |
| ConditionSupplied | Sterile and single use | Sterile and single use | Same |
| SterilizationMethod | EtO | EtO | Same |
| PackagingConfiguration | The catheters areplaced in a protectivepolyethylene tube,mounted withaccessory RHV onto apolyethylenepackaging card,placed into a pouch,sealed and labeled.The sealed pouch andIFU are placed in alabeled shelf cartonbox. | Catheter placed into aHDPE dispenser tube.Dispenser tube,introducer andshaping mandrelplaced on apolyethylenepackaging card that isinserted into a Tyvekpouch. Pouch and IFUplaced in bleachedsulfate carton box. | Catheter placed into aHDPE dispenser tube.Dispenser tube andintroducer placed on apolyethylenepackaging card that isinserted into a Tyvekpouch. Pouch and IFUplaced in bleachedsulfate 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 |
|---|---|---|
| DimensionalVerification | Dimensional specifications were verified bymeasuring the catheter length, proximal and distalouter diameters, and distal inner diameter. | Pass |
| Coating Lubricityand Durability | The hydrophilic coating was evaluated for frictionalforce and durability. | Pass |
| Simulated Use | Performance was evaluated under simulated use ina tortuous anatomical model to assess preparation,introduction, tracking, and support of the device. | Pass |
| Dynamic and StaticBurst Pressure | Device was subjected to rated burst pressures totest 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 recordedthe force at breakage. | Pass |
| Flexural Fatigue | Device was subjected to flexural fatigue fromrepeated bending during simulated use testing andflexural fatigue from repeated hoop stress on thecatheter from pressure testing. | Pass |
| Particulate Testing | The number and size of particulates generatedduring simulated use in a tortuous anatomical modelwere measured and results were compared with thepredicate device. | Pass |
| Kink Resistance | Device was evaluated for kink resistance aftersimulated use testing. | Pass |
| Torque Strength | Device was evaluated for torque strength bymeasuring the number of catheter rotations untilfailure after tracking through a tortuous anatomicalmodel. | Pass |
| Radio Detectability | Device visibility was evaluated under fluoroscopy. | Pass |
| Corrosion Resistance | Device corrosion was evaluated after immersion insaline. | Pass |
| Small-bore Connector | The luer connector was evaluated for dimensionaland performance requirements per referencestandard. | Pass |
| Stiffness Profile | The catheter stiffness profile along proximal anddistal sections was compared to the referencedevice. | 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) & TestSystems | Extract Conditions | ||
| Cytotoxicity(ISO MEM ElutionTest) | L-929 mousefibroblast cellsprepared using MEMMaintenance GrowthMedia with 5% FBS | 6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 37 °C for24 hrs | Non-cytotoxic |
| Irritation Reactivity(ISO IntracutaneousReactivity Test) | Normal saline andsesame seed oil(SSO) (testedseparately)New Zealand WhiteRabbits | 6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50 °C for72 hrs | Non-irritant |
| Maximization(ISO Guinea PigMaximization Test) | Normal saline andsesame seed oil(SSO) (testedseparately)Guinea Pig | 6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50 °C for72 hrs | Non-sensitizing |
| Systemic Toxicity(ISO AcuteSystemic ToxicityTest) | Normal saline andsesame seed oil(SSO) (testedseparately)Albino outbred strain(ND4) mice | 6.0 cm2/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50 °C for72 hrs | Non-acutesystemically toxic |
| Pyrogenicity(ISO/USP MaterialMediatedPyrogencity Test) | Normal salineNew Zealand WhiteRabbits | 6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50 °C for72 hrs | Non-pyrogenic |
| Test | Test Method Summary | Results | |
| Extract(s) & Test Systems | Extract Conditions | ||
| HemocompatibilityIn-Vitro Blood LoopAssay(ISO In-vitro BloodLoop Assay withComparison Article) | A loop systemcirculated with freshlydrawn sheep blood | The test article isexposed to thecirculating blood thatfills to the capacity ofthe loop at 37 °C for4 hrs | Thromboresistant |
| HemocompatibilityHemolysis Assay(ISO ASTMHemolysis Assay) | PBS – PhosphateBuffered SalineBlood - Three NewZealand WhiteRabbits | 6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50 °C for72 hrs | Non-hemolytic |
| HemocompatibilityComplementActivation Assay(ISOHemocompatibility:ComplementActivation Assay(SC5b-9)) | Normal HumanSerum (NHS) | 6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 37 °C for60 min | Non-activator ofcomplement system |
| HemocompatibilityPartialThromboplastin(ISOHemocompatibility:PartialThromboplastinTime (PTT) Assay) | Human PlasmaFreshly DrawnHuman Plasma | 6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 37 °C for15 min | No effect on the PTT |
| Test | Test Method Summary | Results | |
| Extract(s) & Test Systems | Extract Conditions | ||
| HemocompatibilityHeparinized BloodPlatelet andLeukocyte | Human Blood | 12 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37 °C for 60 min | Pass |
| Freshly DrawnHuman Blood | |||
| (Hemocompatibility:Heparinized BloodPlatelet andLeukocyte CountAssay) |
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Image /page/9/Picture/0 description: The image contains the logo for MicroVention, a Terumo company. The logo features a stylized, abstract graphic to the left of the text "MicroVention". Below "MicroVention" is the word "TERUMO", indicating that MicroVention is associated with Terumo Corporation. The text is in a blue font.
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Image /page/10/Picture/0 description: The image shows the logo for MicroVention TERUMO. The word "MicroVention" is written in a combination of blue and gray letters, with "Micro" in blue and "Vention" in gray. To the left of the word is a circular graphic made of curved lines in shades of gray and blue. Below "MicroVention" is the word "TERUMO" in blue, in a smaller, bolder font.
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.
§ 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).