(252 days)
The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.
The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.
The provided text describes a 510(k) premarket notification for a medical device, the SOFIA Plus Aspiration Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided does not align with the typical structure of an AI/ML medical device study demonstrating algorithmic performance against acceptance criteria.
The document primarily details the pre-clinical testing on the device itself and an animal study to evaluate its aspiration performance and safety. It does not describe an AI/ML algorithm or a study of its performance.
However, I can extract and structure the information about the acceptance criteria and performance of the physical device based on the provided text, while acknowledging that this is not an AI/ML study.
Here's an interpretation of the request using the available information:
The SOFIA Plus Aspiration Catheter underwent extensive pre-clinical testing to demonstrate its performance and substantial equivalence to a predicate device. The acceptance criteria for these tests were typically defined by established specifications, industry standards (e.g., ISO), or direct comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Cell culture treated with test article exhibited slight reactivity (Grade 1), concluded as non-cytotoxic. PASSED |
| Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization | Weak allergic potential or sensitizing capacity | Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1). PASSED |
| Sensitization/Irritation (ISO 10993-10) - Intracutaneous reactivity | Non-irritant | Extracts of the test article did not show a significantly greater biological reaction than the sites injected with the control article. PASSED |
| Hemocompatibility – Rabbit Blood Direct and Indirect Contact (ISO 10993-4) | Non-hemolytic | Hemolysis index was 0.13% (direct contact) and 0.0% (indirect contact). PASSED |
| Hemocompatibility – Unactivated Partial Thromboplastin Time Assay Direct Contact (ISO 10993-4) | No effect on coagulation | No statistically significant difference found between the Unactivated Partial Thromboplastin Time (UPTT) of the plasma exposed to the test article and that of the plasma exposed to either the negative control or the untreated control. PASSED |
| Hemocompatibility - Complement Activation Assay (ISO 10993-4) | No effect on complement activation | C3a and SC5b-9 levels < negative and untreated controls. PASSED |
| Hemocompatibility - Thrombogenicity Study in Dogs (ISO 10993-4) | No significant thrombosis | Minimal thrombosis observed with a Grade 0 in two out of two test sites and two out of two control sites. PASSED |
| Systemic Toxicity - Systemic Injection Test (ISO 10993-11) | No toxic effects | Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected in Swiss Albino mice. PASSED |
| Systemic Toxicity - Rabbit Pyrogen Test (ISO 10993-11) | Non-pyrogenic | The temperature increases (maximum) was 0.03°C from baseline. PASSED |
| Bench Testing | ||
| Simulated Use | Device performs as intended, demonstrates equivalency to predicate device | Achieved a rating $\geq$ 3 for preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/guidewire removal, removal/aspiration of clot. PASSED |
| Dimensional and Physical Attributes | Device meets specified dimensional requirements, substantially equivalent to predicate device | Met specified dimensional requirements for catheter OD, catheter ID, overall working length, length of distal section, length of distal tip to marker band and total length of hub/strain relief. PASSED |
| Kink Resistance | Device resistant to kinking around small radii turns, same as predicate device | No kinks when wrapped around 0.030 and 0.040-inch pin gauges. No kinks noted during simulated use testing. PASSED |
| Durability/Lubricity of Hydrophilic Coating | Device tracks easily with no coating cracking or separation | Achieved a rating of $\ge$ 3 during simulated use testing for coating durability and lubricity. PASSED |
| Catheter Stiffness | Device tracks in tortuous anatomy while advancing to target site, equivalent to predicate and competitive devices | Device stiffness equivalent to predicate and competitive devices. PASSED |
| Catheter Flexural Fatigue | Device integrity suitable for intended clinical use | No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. PASSED |
| Force at Break (Shaft and hub) | Tensile strength test results meet acceptance criteria and equivalent to predicate and competitive devices | Catheter force at break $\ge$ 15N for shaft section and hub/catheter junction. PASSED |
| Force at Break (After tip shaping) | Device meets acceptance criteria and no difference between pre- and post- force at break | Catheter force at break $\ge$ 15N for distal section assessed pre- and post-tip shaping. PASSED |
| Static Burst Pressure | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 | No damage of pressurized catheter at 46 psi. PASSED |
| Fluid Leakage at > 46 psi | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 | No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. PASSED |
| Air Leakage | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 | No air leakage at hub into syringe for 15 seconds. PASSED |
| Dynamic Burst | Device met labeled maximum infusion pressure of 300 psi | Test articles did not burst at or below 300 psi. PASSED |
| Catheter Collapse | No observation of device collapse, equivalent to predicate device | Test articles were pressurized for a duration of 6 minutes and no observation of catheter collapse. PASSED |
| Vacuum Pressure | No difference was measured between device and predicate | Vacuum pressure testing of catheter at distal tip was compared to vacuum pressure of source. No difference detected. PASSED |
| Torque Response | Equivalent or better than predicate | Catheter torque response was assessed in vascular model and met acceptance criteria. PASSED |
| Torque Strength | Met acceptance criteria | Catheter was torqued and did not break. PASSED |
| Advance/Retract | Met acceptance criteria, equivalent or better than predicate | Catheter was subjected to advance/retraction test in a vascular model and was equivalent or better than predicate. PASSED |
| Radiopacity | Marker band is visible under fluoroscopy | Marker band was detectable under fluoroscopy. PASSED |
| Corrosion Resistance | Catheter is corrosion resistant | Met ISO 10555-1. PASSED |
| Particulate Testing | Catheter does not generate particulate | Met USP <788> criteria. PASSED |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for each bench test. Instead, it refers to "test articles" and general results (e.g., "Test articles achieved a rating...") and in some cases, "two out of two test sites" for the animal study.
- Test Set Provenance: The tests are pre-clinical bench tests performed by the manufacturer (MicroVention, Inc., Tustin, California, USA) and an animal study (swine model). The information does not specify the country of origin of data in terms of retrospective/prospective human patient data, as this is not a human clinical trial. All tests would have been performed prospectively as part of the device development and submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the document describes pre-clinical physical device testing and an animal study, not an AI/ML algorithm study that requires expert adjudication of image-based ground truth. For the simulated-use tests, the performance ratings (e.g., $\geq3$) would be based on qualitative assessment by trained personnel, but they are not referred to as "experts" in the context of clinical ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/ML algorithm study involving interpretation of clinical data by multiple readers, there is no need for an adjudication method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this was not done. This document pertains to the 510(k) clearance of a physical medical device. MRMC studies are typically performed for AI-driven diagnostic or assistive technologies to assess their impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this was not done. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Engineering Specifications and Standards: For dimensional, mechanical, and safety properties (e.g., ISO standards, specified psi limits, force at break criteria).
- Comparative Performance to Predicate Devices: Performance attributes (e.g., stiffness, vacuum pressure, torque response) were compared to the legally marketed predicate device (Penumbra Reperfusion Catheter ACE64 and ACE68).
- Animal Study Observations: For aspiration performance and histopathological evaluations in a swine model.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML study, therefore there is no training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI/ML algorithm training set.
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June 11, 2018
MicroVention, Inc. Naomi Gong Associate Director, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
Re: K173200
Trade/Device Name: SOFIA Plus Aspiration Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 27, 2018 Received: May 1, 2018
Dear Naomi Gong:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173200
Device Name SOFIA Plus Aspiration Catheter
Indications for Use (Describe)
The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.
| 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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510(k) Summary - K173200
Pursuant to Section 12, Part (a)(i)(3)(A) of the Safe Medical Devices Act of 1990, MicroVention, Inc. is providing this summary of substantial equivalence for the SOFIA™ Plus Aspiration Catheter (21 CFR 807.92).
Applicant Name and Address
MicroVention, Inc. 1311 Valencia Avenue Tustin, California 92780 USA
Contact Information
Naomi Gong Associate Director, Regulatory Affairs Tel: (714) 247-8055 naomi.gong(@microvention.com
Date of Preparation of the 510(k) Summary
June 5. 2018
Device Trade or Proprietary Name
SOFIA Plus Aspiration Catheter
Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Neurology |
| Regulation Name(s): | Percutaneous Catheter |
| Regulation Number(s): | 21 CFR 870.1250 |
| Product Code: | NRY (Catheter, Thrombus Retriever) |
Predicate Device
Penumbra Reperfusion Catheter ACE64 and ACE68 (K152541)
Indications for Use
The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVention Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Device Description
The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.
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Technological Characteristics Comparison Table
| Penumbra Reperfusion CatheterACE 64/68(K152541 predicate device) | SOFIA Plus Aspiration Catheter(subject device) | ||
|---|---|---|---|
| Indication | The Penumbra System is intended for usein the revascularization of patients withacute ischemic stroke secondary tointracranial large vessel occlusive disease(within the internal carotid, middlecerebral - M1 and M2 segments, basilar,and vertebral arteries) within 8 hours ofsymptom onset. | SAME:The SOFIA Plus Aspiration Catheter with theGomco 405 Aspiration Pump andMicroVention Tubing Kit is intended for use inthe revascularization of patients with acuteischemic stroke secondary to intracranial largevessel occlusive disease (within the internalcarotid, middle cerebral - M1 and M2segments, basilar, and vertebral arteries) within8 hours of symptom onset. Patients who areineligible for intravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PA therapyare candidates for treatment. | |
| Material | |||
| Catheter body | Outer layer of polyurethane elastomer(Tecoflex and Pellethane), polyether blockamide (Pebax) and polyamide (Vestimid);inner layer of stainless steel and/or NiTicoil | Outer layer of polyurethane elastomer(Polyblend and Pellethane), polyether blockamide (Pebax) and polyamide (Grilamid); innerlayer of stainless steel braid/coil, PTFE andpolyolefin elastomer | |
| Marker band | Pt/Ir | Pt/Ir | |
| Hub | Nylon (Grilamid) | Nylon | |
| Strain relief | Nylon (Grilamid)/SS304 | Polyurethane | |
| Introducer | PTFE | Pebax | |
| Shaping mandrel | Stainless Steel | Stainless steel | |
| ID | ACE64:Prox = 0.068 in. MinDistal = 0.064 in. Min | ACE68:0.068 in. Min | 0.070 in. |
| OD | ACE64:Prox = 0.084 in. MaxDistal = 0.080 in. Max | ACE68:0.084 in. Max | Prox: 0.083 in.Distal: 0.082 in. |
| Effective Length | 115 - 132 cm | 125 - 131 cm | |
| Coating | Hydrophilic coating (SRDX Harmony) | Hydrophilic coating (Hydak®) | |
| Tip Configuration | Steam shapeable by user | Steam shapeable by user | |
| Accessories | Peelable sheath, rotating hemostatic valve,shaping mandrel | Introducer sheath and shaping mandrel | |
| Method of Supply | Sterile and single use | Sterile and single use | |
| Sterilization Method | Ethylene oxide | Ethylene oxide | |
| PackagingConfiguration | Polyester/polyethylene/Tyvek® pouch,Polyethylene hoop, polyethylene card,paperboard carton. | Polyester/polyethylene/Tyvek® pouch,Polyethylene tube, polyethylene card, paperboarcarton. | |
| Components | |||
| Aspiration Pump | Penumbra Aspiration PumpVacuum of -25 in Hg | Gomco 405 Aspiration Pump | |
| Aspiration Tubing | 112 inch lengthTubing ID = 0.110 inch | Same |
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Summary of Pre-Clinical Testing
Included in this section are summary descriptions of the non-clinical testing which substantiates the performance of the subject device, the SOFIA Plus Aspiration Catheter:
| Biocompatibility | Results | Conclusions |
|---|---|---|
| Cytotoxcitiy (ISO 10993-5)- MEM elution assay | Cell culture treated with test articleexhibited slight reactivity (Grade 1) | Non-cytotoxicPASSED |
| Sensitization/Irritation (ISO 10993-10)- Guinea pig maximizationsensitization | Extracts of the test article elicited noreaction at the challenge (0%sensitization) following the inductionphase (Grade 1). | Weak allergicpotential orsensitizingcapacityPASSED |
| Sensitization/Irritation (ISO 10993-10)- Intracutaneous reactivity | Extracts of the test article did not show asignificantly greater biological reactionthan the sites injected with the controlarticle | Non-irritantPASSED |
| Hemocompatibility – Rabbit BloodDirect and Indirect Contact (ISO10993-4) | The hemolysis index was 0.13% (directcontact) and 0.0% (indirect contact) | Non-hemolyticPASSED |
| Hemocompatibility – UnactivatedPartial Thromboplastin Time AssayDirect Contact (ISO 10993-4) | No statistically significant differencefound between the Unactivated PartialThromboplastin Time (UPTT) of theplasma exposed to the test article andthat of the plasma exposed to either thenegative control or the untreated control | No effect oncoagulationPASSED |
| Hemocompatibility - ComplementActivation Assay (ISO 10993-4) | C3a and SC5b-9 levels < negative anduntreated controls | No effect oncomplementactivationPASSED |
| Hemocompatibility - ThrombogenicityStudy in Dogs (ISO 10993-4) | Minimal thrombosis observed with aGrade 0 in two out of two test sites andtwo out of two control sites | No significantthrombosisPASSED |
| Systemic Toxicity - Systemic InjectionTest (ISO 10993-11) | Extracts of test article did not induce asignificantly greater biological reactionthan the control extracts when injectedin Swiss Albino mice | No toxic effectsPASSED |
| Systemic Toxicity - Rabbit PyrogenTest (ISO 10993-11) | The temperature increases (maximum)was 0.03°C from baseline | Non-pyrogenicPASSED |
Biocompatibility Testing:
Verification and Test Summary:
The physical and mechanical properties of the SOFIA Plus Aspiration Catheter device were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Bench Testing | ||
|---|---|---|
| Test | Results | Conclusions |
| Simulated Use | Test articles achieved a rating $\geq$ 3 forpreparation/ease of assembly, introducersheath interaction, introducer peel away,tracking with guidewire/microcatheter,microcatheter/guidewire lockup, lubricity anddurability of hydrophilic coating,microcatheter/ guidewire removal, removal/aspiration of clot. | Device performs as intendedand demonstrates equivalencyto its predicate devices undersimulated use conditions |
| Dimensional and PhysicalAttributes | Test articles met the specified dimensionalrequirements for catheter OD, catheter ID, | Device met establisheddimensional and physical |
| Bench TestingTest | Results | Conclusions |
| overall working length, length of distalsection, length of distal tip to marker band andtotal length of hub/strain relief | specifications and issubstantially equivalent to thepredicate device | |
| Kink Resistance | No kinks when wrapped around 0.030 and0.040-inch pin gaugesNo kinks noted during simulated use testing | Device resistant to kinkingaround small radii turnsSame as predicate device |
| Durability/Lubricity ofHydrophilic Coating | Test article achieved a rating of $\ge$ 3 duringsimulated use testing for coating durabilityand lubricity. | Device tracks easily with nocoating cracking or separation |
| Catheter Stiffness | Device stiffness equivalent to predicate andcompetitive devices | Device tracks in tortuousanatomy while advancing totarget site |
| Catheter Flexural Fatigue | No flexural fatigue following repeatedbending during simulated use testing andrepeated hoop stress following pressure andair aspiration testing | Device integrity suitable forintended clinical use |
| Force at Break (Shaft and hub) | Catheter force at break $\ge$ 15N for shaft sectionand hub/catheter junction | Tensile strength test resultsmeet acceptance criteria andequivalent to predicate andcompetitive devices |
| Force at Break (After tipshaping) | Catheter force at break $\ge$ 15N for distalsection assessed pre- and post-tip shaping | Device meets acceptancecriteria and no differencebetween pre- and post- forceat break |
| Static Burst Pressure | No damage of pressurized catheter at 46 psi | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Fluid Leakage at > 46 psi | No liquid leakage from hub and catheter shaftat 46 psi for 30 seconds | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Air Leakage | No air leakage at hub into syringe for 15seconds | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Dynamic Burst | Test articles did not burst at or below 300 psi | Device met labeled maximuminfusion pressure of 300 psi |
| Catheter Collapse | Test articles were pressurized for a duration of6 minutes and no observation of cathetercollapse | No observation of devicecollapse, equivalent topredicate device |
| Vacuum Pressure | Vacuum pressure testing of catheter at distaltip was compared to vacuum pressure ofsource. No difference detected. | No difference was measuredbetween device and predicate |
| Torque Response | Catheter torque response was assessed invascular model and met acceptance criteria. | Equivalent or better thanpredicate |
| Torque Strength | Catheter was torqued and did not break | Met acceptance criteria |
| Advance/Retract | Catheter was subjected to advance/retractiontest in a vascular model and was equivalent orbetter than predicate | Met acceptance criteria |
| Radiopacity | Marker band was detectable underfluoroscopy | Marker band is visible underfluoroscopy |
| Corrosion Resistance | Met ISO 10555-1 | Catheter is corrosion resistant |
| Particulate Testing | Met USP <788> criteria | Catheter does not generateparticulate |
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Animal Study:
The SOFIA Plus Aspiration Catheter was evaluated in a comparative animal study that was conducted to evaluate its aspiration performance and its safe use in a swine model. Histopathological evaluations of the affected vasculature using the device were also performed as part of the study.
Summary of Clinical Data:
Not applicable
Summary of Substantial Equivalence
The data presented in this submission demonstrate the technological similarity and performance equivalency of the SOFIA Plus Aspiration Catheter when compared with the predicate device, the Penumbra Reperfusion Catheter ACE 64 and ACE 68 (K152541).
The devices:
- . Have the same intended use and indications for use,
- Have the same mode of action,
- Use the same operating principle, ●
- Incorporate the same basic design, materials, dimensional and physical characteristics, and
- Are packaged and sterilized using same methods, with similar shelf-life. .
In summary, the SOFIA Plus Aspiration Catheter described in this substantially equivalent to its predicate device, Penumbra Reperfusion Catheter ACE 64 and ACE 68 (K152541).
§ 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).