(107 days)
The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke 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.
The Riptide™ Aspiration System React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The Riptide™ Aspiration System React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath.
The proximal end of the Riptide™ Aspiration System React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The Riptide™ Aspiration System React™ 68 Catheter is designed with a hydrophilic coating. The Riptide™ Aspiration System React™ 68 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.
The document describes the acceptance criteria and supporting studies for the Riptide Aspiration System (React 68 Catheter). However, it's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria for a new AI/software device. The device in question is a medical device (catheter) for stroke revascularization, not an AI/software device that typically has performance metrics like sensitivity, specificity, or F1-score.
The acceptance criteria provided in the document are primarily for bench testing and biocompatibility, and the reported "performance" is whether the device "met the acceptance criteria" or specific qualitative observations, rather than a quantitative measurement against a numerical threshold.
Here's the information extracted from the provided text, structured to best fit your request, with an understanding that the device is a physical catheter and not an AI/software product in the context of typical AI acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
For the Riptide Aspiration System (React 68 Catheter), acceptance criteria are primarily related to bench testing, biocompatibility, and animal testing. The reported "performance" is whether the device met these criteria.
| Test Description | Acceptance Criteria (Implied / Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (Elution Method) | No evidence of causing cell lysis or toxicity (grade of zero reactivity) | Test article extract showed no evidence of causing cell lysis or toxicity and had a grade of zero (no reactivity). Considered non-cytotoxic. |
| Sensitization (Guinea Pig Max. Test) | Grade less than two (mild reactivity) | Test article extract met requirements (grade less than two). Does not elicit a sensitization response. |
| Irritation (Intracutaneous Reactivity) | Difference between test article and control extract mean scores = 0.0 | Difference between test article extract overall mean score and corresponding control extract mean score was 0.0. Considered a non-irritant. |
| Acute Systemic Toxicity (Systemic Toxicity) | No mortality or evidence of systemic toxicity; clinically normal animals | No mortality or evidence of systemic toxicity. All animals clinically normal. Does not indicate signs of toxicity. |
| Hemocompatibility (Hemolysis) | Hemolytic index for direct contact blood < 5% (typically); no hemolysis | Hemolytic index for direct contact with blood was 0.9%, for extract was 0.0%. Considered non-hemolytic. |
| Hemocompatibility (Complement Activation) | Not statistically higher concentration of SC5b-9 than controls | Concentration of SC5b-9 in test article sample was not statistically higher than controls. Not considered potential activators of complement system. |
| Hemocompatibility (Thrombogenicity) | Minimal thrombus formation | Determined to have minimal thrombus formation after four (4) hours. Demonstrates minimal thrombus formation. |
| Pyrogenicity (Material Mediated) | No animal showed a temperature rise of 0.5°C or more above baseline | Not a single animal showed a temperature rise of 0.5°C or more. Total rise was 0.0°C. Considered non-pyrogenic. |
| Bench Performance Data | ||
| Ethylene Oxide Residual | Met acceptance criteria per ISO 10993-7 | Met the acceptance criteria for ethylene oxide residual. |
| Ethylene Chlorohydrin Residual | Met acceptance criteria per ISO 10993-7 | Met the acceptance criteria for ethylene chlorohydrin residual. |
| Bioburden | Met acceptance criteria per ISO 11737-1 | Met the acceptance criteria for bioburden. |
| Bacterial Endotoxin | Met acceptance criteria per ANSI/AAMI ST72 and USP <161> | Met the acceptance criteria for bacterial endotoxin. |
| Visual Inspection | Met acceptance criteria for visual inspection | Met the acceptance criteria for visual inspection. |
| Dimensional Measurements | Met acceptance criteria for dimensional measurements | Met the acceptance criteria for dimensional measurements. |
| Tip Buckling | Met acceptance criteria for maximum compressive force | Met the acceptance criteria for tip buckling. |
| Kink Resistance | Met acceptance criteria for maximum kink diameter | Met the acceptance criteria for kink resistance. |
| Particulate | Met acceptance criteria per USP <788> | Met the acceptance criteria for particulate evaluation. |
| Coating Lubricity | Met acceptance criteria for average friction forces | Met the acceptance criteria for coating lubricity. |
| Tensile Strength | Met acceptance criteria per ISO 10555-1. Annex B | Met the acceptance criteria for tensile strength at the hub and shaft. |
| Liquid Leak | Met acceptance criteria per ISO 10555-1. Annex C | Met the acceptance criteria for liquid leak. |
| Corrosion Resistance | Met acceptance criteria per ISO 10555-1. Annex A | Met the acceptance criteria for corrosion resistance. |
| Hub Aspiration Resistance | Met acceptance criteria per ISO 10555-1. Annex D | Met the acceptance criteria for hub air aspiration. |
| Radiopacity | Met acceptance criteria for markerband length, wall thickness, and fluoroscopy confirmation | Met the acceptance criteria for radiopacity. |
| Luer Standards | Met acceptance criteria per ISO 594-1 and ISO 80369-7 | Met the acceptance criteria for luer standards. |
| Torque Strength | Able to withstand torsional forces typical of clinical use | Was able to withstand torsional forces that are typical of clinical use. |
| Dynamic Pressure | Able to withstand pressures typical of clinical use | Was able to withstand pressures that are typical of clinical use. |
| Coating Integrity | Coating coverage and lubricity maintained | Remained coated and lubricous. |
| Recanalization | Met acceptance criteria for recanalization | Met the acceptance criteria for recanalization. |
| Vacuum Pressure | Met acceptance criteria for vacuum pressure | Met the acceptance criteria for vacuum pressure. |
| Suction Flow Rate | Met acceptance criteria for suction flow rate | Met the acceptance criteria for suction flow rate. |
| Usability | Met acceptance criteria for maneuverability, flexibility, aspiration, and clot retrieval | Met the acceptance criteria for usability. |
| Animal Testing | ||
| Safety, Efficacy, Usability | Demonstrated comparable safety, efficacy, and usability to predicate device | Evaluated in a porcine model at acute and chronic time points, in presence/absence of simulated clot. This testing supports substantial equivalence. |
2. Sample Sizes and Data Provenance (Not applicable for AI/software test set, but for testing performed)
- Biocompatibility and Bench Testing: The sample sizes are not explicitly stated for individual tests but are implied to be sufficient for standard regulatory testing (e.g., "The test article extract showed no evidence...", "Not a single animal showed..."). These are laboratory tests on physical devices/extracts.
- Animal Testing: Conducted in a porcine model. Data provenance is from non-clinical laboratory studies performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP). This is prospective animal testing.
3. Number of Experts and Qualifications (Not applicable to this type of device submission for establishing ground truth)
This information is typically relevant for AI/software devices where human experts establish ground truth for image or data interpretation. For a physical catheter, ground truth is established through physical measurements, chemical analysis, and physiological responses as per standardized test methods. The document does not mention experts for ground truth establishment in this context.
4. Adjudication Method (Not applicable)
Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human labelers/experts when establishing ground truth for AI/software performance evaluation. Not relevant for this physical device submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not done/applicable)
MRMC studies are typically performed for AI/software devices to assess the impact of AI assistance on human reader performance. This device is a physical catheter, not an AI/software system, so such a study was not performed. The submission is based on demonstrating substantial equivalence to a predicate device through bench and animal testing.
6. Standalone Performance (Algorithm only without human-in-the-loop performance) (Not applicable)
This concept applies to AI/software algorithms. The Riptide Aspiration System is a physical catheter intended for use by a clinician. Its "performance" is inherently linked to its physical properties and interaction within a biological system, not a standalone algorithmic output.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily established by:
- Standardized Test Methods and Criteria: For biocompatibility, microbial, and performance bench tests, "ground truth" is defined by adherence to specific ISO standards (e.g., ISO 10993, ISO 10555, ISO 11737), USP standards, and ANSI/AAMI standards. These standards define the acceptable range or qualitative outcome.
- Physiological Observations and Measurements: In animal studies, ground truth for safety, efficacy, and usability comes from direct observation of animal health, physiological responses, and procedural outcomes.
8. Sample Size for the Training Set (Not applicable)
This concept is for AI/machine learning models. The Riptide Aspiration System is a physical medical device. It does not have a "training set" in the context of AI. Design and manufacturing improvements would be based on engineering principles and iterative testing.
9. How the Ground Truth for the Training Set was Established (Not applicable)
Again, this is an AI/ML concept. The "ground truth" for the development of catheter designs comes from engineering specifications, material science, and prior knowledge of predicate devices and clinical needs, rather than a labeled training set.
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Image /page/0/Picture/0 description: The image shows 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 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.
July 4, 2018
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney Senior Regulatory Affairs Specialist 9775 Toledo Wav Irvine, California 92618
Re: K180705
Trade/Device Name: Riptide Aspiration System (React 68 Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 4, 2018 Received: June 6, 2018
Dear Ryan Kenney:
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, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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) K180705
Device Name Riptide Aspiration System (React 68 Catheter)
Indications for Use (Describe)
The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke 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.
| 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: K180705
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
|---|---|
| 9775 Toledo Way | |
| Irvine, CA 92618 | |
| Establishment Registration No.: 2029214 | |
| Contact Person: | Ryan Kenney |
| Senior Regulatory Affairs Specialist | |
| Telephone: (949) 297-5489 | |
| Email: ryan.j.kenney@medtronic.com | |
| Date SummaryPrepared: | June 25, 2018 |
| Trade Name ofDevice: | RiptideTM Aspiration System (React 68 Catheter) |
| Common Name ofDevice: | Catheter, Thrombus Retriever |
| Review Panel: | Neurology |
| Product Code: | NRY |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Predicate Device(s): | Penumbra System® ACE 68 Reperfusion Catheter510(k)#: K161064 |
| Reference Device(s): | RiptideTM Aspiration System510(k)#: K172448ArcTM Intracranial Support Catheter510(k)#: K150107 |
Device Description:
The Riptide™ Aspiration System React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The Riptide™ Aspiration System React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath.
The proximal end of the Riptide™ Aspiration System React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The Riptide™ Aspiration System React™ 68 Catheter is designed with a hydrophilic coating. The Riptide™ Aspiration System React™ 68 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.
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Indications for Use:
The Riptide™ Aspiration System 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.
| Penumbra System® ACE 68Reperfusion Catheter | React™ 68 Catheter | |
|---|---|---|
| Indication for Use (IFU)Statement | The Penumbra System® isintended for use in therevascularization of patients withacute ischemic stroke secondaryto intracranial large vesselocclusive disease (within theinternal carotid, middle cerebral –M1 and M2 segments, basilar,and vertebral arteries) within 8hours of symptom onset. | The Riptide™ Aspiration Systemis intended for use in therevascularization of patients withacute ischemic stroke secondaryto intracranial large vesselocclusive disease (within theinternal carotid, middle cerebral –M1 and M2 segments, basilar,and vertebral arteries) within 8hours of symptom onset. Patientswho are ineligible for intravenoustissue plasminogen activator (IVt-PA) or who fail IV t-PA therapyare candidates for treatment. |
| Materials | ||
| Proximal Hub | Grilamid™ | Trogamid® |
| Strain Relief(Hub Sleeve) | Grilamid™ | DynaFlex® |
| Strain Relief | 304 Stainless Steel | N/A |
| Inner Diameter Band | Polyolefin, PET Yellow(Black Ink) | N/A |
| Liner | PTFE | Same |
| Braid Reinforcement | N/A | Nitinol |
| Coil Reinforcement | 304V Stainless SteelNickel (55%)/Titanium (45%) | Nitinol |
| Proximal Extrusions | Vestamid®Pebax® 72D | Grilamid™Pebax® 45DPebax® 55DPebax® 63DPebax® 72D |
| Distal Extrusions | Pebax® 35DPebax® 40DPebax® 55DPebax® 63DPellathane® 80ATecoflex® 80A | Pebax® 25DPebax® 35D |
| Penumbra System® ACE 68Reperfusion Catheter | React™ 68 Catheter | |
| Extrusion Colorants | Clear/Natural or Purple | Clear/Natural or Green |
| Markerband | Platinum (90%)/Iridium (10%) | Same |
| Coating | SRDX Harmony | Surmodics Serene® |
| Working Length | 132 cm | Same |
| Proximal Inner Diameter(ID) | 0.068" (Min.) | 0.068" (Min.) |
| Proximal Outer Diameter(OD) | 0.084" (Max.) | 0.083" (Max.) |
| Distal Inner Diameter (ID) | 0.068" (Min.) | 0.068" (Min.) |
| Distal Outer Diameter(OD) | 0.084" (Max.) | 0.083" (Max.) |
| Coating Length | 30cm | 40cm |
| Tip Shape | Straight | Same |
| Accessories | ||
| Peelable Sheath | PTFE | Same |
| Rotating Hemostasis Valve | Polycarbonate Silicone O-Ring | N/A |
| Shaping Mandrel | 0.038" OD Stainless Steel | N/A |
| Packaging | ||
| Carton | SBS Paperboard | Same |
| Packaging Card | Polyethylene | Same |
| Packaging Hoop | Polyethylene | Same |
| Packaging Tray | PolyethyleneTerephthalatePolystrene | N/A |
| Pouch | PolyesterPolyethyleneTyvek® | NylonTyvek® |
| Other | ||
| Shelf Life | 8 Months | 3 Months |
| Sterilization | Ethylene Oxide (EO) | Same |
| Use | Single Use, Disposable | Same |
Device Comparison:
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Biocompatibility:
Biocompatibility was conducted for the React™ 68 Catheter. The React™ 68 Catheter is categorized as a limited exposure (< 24 hours), external communicating device contacting circulating blood. The following biocompatibility was conducted for the React™ 68 Catheter:
| Test Description | Results | Conclusions |
|---|---|---|
| Cytotoxicity(Elution Method) | The test article extract showedno evidence of causing celllysis or toxicity and had agrade of zero (no reactivity). | The React TM 68 Catheter isconsidered non-cytotoxic. |
| Test Description | Results | Conclusions |
| Sensitization(Guinea Pig Maximization Test) | The test article extract met therequirements of the test sincethe grade was less than a gradetwo (mild reactivity). | The ReactTM 68 Catheter doesnot elicit a sensitizationresponse. |
| Irritation(Intracutaneous Reactivity) | The difference between eachtest article extract overallmean score and correspondingcontrol extract overall meanscore was 0.0 and 0.0 for thesodium chloride and sesameoil test article extracts,respectively. | The ReactTM 68 Catheter isconsidered a non-irritant. |
| Acute Systemic Toxicity(Systemic Toxicity) | There was no mortality orevidence of systemic toxicityfrom the extracts injected. Allanimals were clinically normalthroughout the study. | The ReactTM 68 Catheter doesnot indicate signs of toxicity. |
| Hemocompatibility(Hemolysis) | The hemolytic index for thetest article in direct contactwith blood was 0.9%, and thehemolytic index for the testarticle extract was 0.0%. | The ReactTM 68 Catheter isconsidered non-hemolytic. |
| Hemocompatibility(Complement Activation) | The concentration of SC5b-9in the sponsor providedcontrol sample was notstatistically higher than theactivated normal human serumcontrol or the negative control.The concentration of SC5b-9in the test article sample wasnot statistically higher than theactivated normal human serumcontrol, the negative control orthe sponsor provided control. | The control and test articlesamples are not considered tobe potential activators of thecomplement system. |
| Hemocompatibility(Thrombogenicity) | The thrombogenic potential ofthe control article wasevaluated in comparison to thetest article. Both the controland test articles were | The ReactTM 68 Catheterdemonstrates minimalthrombus formation. |
| Test Description | Results | Conclusions |
| determined to have minimalthrombus formation after four(4) hours (±30 minutes)without anticoagulation. | ||
| Pyrogenicity(Material Mediated) | Not a single animal showed atemperature rise of 0.5°C ormore above its baselinetemperature. The total rise ofthe temperature during three(3) hours was 0.0°C. | The React™ 68 Catheter isconsidered non-pyrogenic. |
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The React™ 68 Catheter has been evaluated to meet requirements specified in ISO 10993-1.
Performance Data – Bench:
Non-clinical bench testing was conducted to evaluate the performance of the React™ 68 Catheter. The following non-clinical bench testing was conducted for the React™ 68 Catheter:
| Test | Test Method Summary | Results |
|---|---|---|
| Microbial | ||
| Ethylene Oxide Residual | The ReactTM 68 Catheter wasevaluated per ISO 10993-7. | The ReactTM 68 Catheter metthe acceptance criteria forethylene oxide residual. |
| Ethylene ChlorohydrinResidual | The ReactTM 68 Catheter wasevaluated per ISO 10993-7. | The ReactTM 68 Catheter metthe acceptance criteria forethylene chlorohydrin residual. |
| Bioburden | The ReactTM 68 Catheter wasevaluated per ISO 11737-1. | The ReactTM 68 Catheter metthe acceptance criteria forbioburden. |
| Bacterial Endotoxin | The ReactTM 68 Catheter wasevaluated per ANSI/AAMIST72 and USP <161>. | The ReactTM 68 Catheter metthe acceptance criteria forbacterial endotoxin. |
| Performance | ||
| Visual Inspection | The ReactTM 68 Catheter wasinspected under x2.5magnification. | The ReactTM 68 Catheter metthe acceptance criteria forvisual inspection. |
| Dimensional Measurements | The proximal ID, distal ID,proximal OD, distal OD, usablelength, total length, coatinglength, and distal tip length ofthe ReactTM 68 Catheter weremeasured. | The ReactTM 68 Catheter metthe acceptance criteria fordimensional measurements. |
| Tip Buckling | The ReactTM 68 Catheter wasevaluated for the maximumcompressive force. | The ReactTM 68 Catheter metthe acceptance criteria for tipbuckling |
| Test | Test Method Summary | Results |
| Kink Resistance | The ReactTM 68 Catheter was evaluated for the maximum kink diameter. | The ReactTM 68 Catheter met the acceptance criteria for kink resistance. |
| Particulate | The ReactTM 68 Catheter was evaluated per USP <788>. | The ReactTM 68 Catheter met the acceptance criteria for particulate evaluation. |
| Coating Lubricity | The ReactTM 68 Catheter was evaluated for the average friction forces. | The ReactTM 68 Catheter met the acceptance criteria for coating lubricity. |
| Tensile Strength | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex B. | The ReactTM 68 Catheter met the acceptance criteria for tensile strength at the hub and shaft. |
| Liquid Leak | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex C. | The ReactTM 68 Catheter met the acceptance criteria for liquid leak. |
| Corrosion Resistance | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex A. | The ReactTM 68 Catheter met the acceptance criteria for corrosion resistance. |
| Hub Aspiration Resistance | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex D. | The ReactTM 68 Catheter met the acceptance criteria for hub air aspiration. |
| Radiopacity | The markerband length and wall thickness of the ReactTM 68 Catheter were measured. In addition, radiopacity was confirmed via fluoroscopy. | The ReactTM 68 Catheter met the acceptance criteria for radiopacity. |
| Luer Standards | The ReactTM 68 Catheter was evaluated per ISO 594-1 and ISO 80369-7. | The ReactTM 68 Catheter met the acceptance criteria for luer standards. |
| Torque Strength | The ReactTM 68 Catheter was evaluated for transmission of proximal torque to the distal tip. | The ReactTM 68 Catheter was able to withstand torsional forces that are typical of clinical use. |
| Dynamic Pressure | The ReactTM 68 Catheter was evaluated for the amount of pressure it can withstand. | The ReactTM 68 Catheter was able to withstand pressures that are typical of clinical use. |
| Coating Integrity | The ReactTM 68 Catheter was evaluated for coating coverage and lubricity. | The ReactTM 68 Catheter remained coated and lubricous. |
| Test | Test Method Summary | Results |
| Recanalization | The Riptide™ AspirationSystem React™ 68 Catheterwas evaluated forrecanalization. | The Riptide™ AspirationSystem React™ 68 Cathetermet the acceptance criteria forrecanalization. |
| Vacuum Pressure | The Riptide™ AspirationSystem React™ 68 Catheterwas evaluated for vacuumpressure. | The Riptide™ AspirationSystem React™ 68 Cathetermet the acceptance criteria forvacuum pressure. |
| Suction Flow Rate | The Riptide™ AspirationSystem React™ 68 Catheterwas evaluated for suction flowrate. | The Riptide™ AspirationSystem React™ 68 Cathetermet the acceptance criteria forsuction flow rate. |
| Usability | The Riptide™ AspirationSystem React™ 68 Catheterand the Penumbra System®ACE 68 Reperfusion Catheterwere evaluated formaneuverability, flexibility, theability to engage and applyaspiration, and the ability tosafely retrieve clot. | The Riptide™ AspirationSystem React™ 68 Cathetermet the acceptance criteria forusability. |
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Note: Packaging for the React™ 68 Catheter was leveraged from the Riptide™ Aspiration Tubing.
In addition, the following non-clinical bench testing was conducted to evaluate the performance of the Riptide™ Aspiration System React™ 68 Catheter:
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Performance Data - Animal:
Non-clinical animal testing was conducted to evaluate the safety, efficacy, and usability of the Riptide™ Aspiration System React™ 68 Catheter in comparison to the Penumbra System® ACE 68 Reperfusion Catheter at acute and chronic time points in a porcine model, both in the presence and absence of simulated clot. Non-clinical animal testing was conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.
Performance Data - Clinical:
Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench and animal testing.
Conclusion:
The design modifications incorporated do not alter the fundamental scientific technology or intended use.
Non-clinical bench and animal testing supports a determination that the subject Riptide™ Aspiration System React™ 68 Catheter is substantially equivalent to the predicate Penumbra System® ACE 68 Reperfusion Catheter.
§ 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).