(103 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 React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricious, polytetrafluoroethylene and Engage liner is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the split y-introducer sheath.
The proximal end of the React™ 71 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is designed with a hydrophilic coating. The React™ 71 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.
Based on the provided text, the Riptide™ Aspiration System (React™ 71 Catheter) is a medical device. The acceptance criteria and the studies performed are detailed in the "510(k) Summary: K182101."
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists numerous tests with their acceptance criteria (implicitly, as the results consistently state "met the acceptance criteria") and the reported device performance. Due to the extensive list, a summarized table is provided below, grouping similar types of tests.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | No evidence of cell lysis/toxicity, Grade < 2 (Mild Reactivity) | Test article extract showed Grade 0 (No Reactivity); considered non-cytotoxic. |
| Sensitization | No evidence of delayed dermal contact sensitization | No evidence of delayed dermal contact sensitization; does not elicit a sensitization response. | |
| Irritation | Difference between test article and control extract mean score meets requirements | Difference between test article and control extract mean score was 0.0 and 0.2; considered a non-irritant. | |
| Acute Systemic Toxicity | No mortality or evidence of systemic toxicity | No mortality or evidence of systemic toxicity; does not indicate signs of toxicity. | |
| Hemolysis | Hemolytic index within acceptable limits (e.g., <5%) | Hemolytic index for direct contact was 0.8%, for extract was 0.0%; considered non-hemolytic. | |
| Complement Activation | Concentration of SC5b-9 not statistically higher than control | Concentration of SC5b-9 not statistically higher than control; not considered a potential activator of the complement system. | |
| Thrombogenicity (Canine Model) | Lower thrombogenic potential than predicate device | Mean score of 1.7 compared to predicate's 2.0; demonstrates lower thrombogenic potential. | |
| Pyrogenicity | No animal showed temperature rise ≥ 0.5°C | No animal showed a temperature rise ≥ 0.5°C; considered non-pyrogenic. | |
| Microbial | Ethylene Oxide Residual | Met ISO 10993-7 criteria | Met the acceptance criteria. |
| Ethylene Chlorohydrin Residual | Met ISO 10993-7 criteria | Met the acceptance criteria. | |
| Bioburden Recovery | Met ISO 11737-1 criteria | Met the acceptance criteria. | |
| Bacterial Endotoxin | Met ANSI/AAMI ST72 and USP <161> criteria | Met the acceptance criteria. | |
| Bioburden | Met ISO 11737-1 criteria | Met the acceptance criteria. | |
| Packaging | Visual Inspection | Met ASTM F1886 criteria | Met the acceptance criteria. |
| Bubble Leak | Met ASTM F2096 criteria | Met the acceptance criteria. | |
| Seal Strength | Met ASTM F88 criteria | Met the acceptance criteria. | |
| Performance (Bench) | Visual Inspection | Met criteria for x2.5 magnification | Met the acceptance criteria. |
| Dimensional Measurements | Met specified dimensions | Met the acceptance criteria. | |
| Tip Buckling | Withstand maximum compressive force | Met the acceptance criteria. | |
| Kink Resistance | Met maximum kink diameter | Met the acceptance criteria. | |
| Particulate | Met USP <788> criteria | Met the acceptance criteria. | |
| Coating Lubricity | Met average frictional forces criteria | Met the acceptance criteria. | |
| Tensile Strength | Met ISO 10555-1, Annex B criteria | Met the acceptance criteria at hub and shaft. | |
| Liquid Leak | Met ISO 10555-1, Annex C criteria | Met the acceptance criteria. | |
| Corrosion Resistance | Met ISO 10555-1, Annex A criteria | Met the acceptance criteria. | |
| Hub Aspiration Resistance | Met ISO 10555-1, Annex D criteria | Met the acceptance criteria. | |
| Radiopacity | Met criteria for markerband length, wall thickness, and fluoroscopy confirmation | Met the acceptance criteria. | |
| Luer Standards | Met ISO 594-1 and ISO 80369-7 criteria | Met the acceptance criteria. | |
| Torque to Failure | Withstand typical clinical torsional forces | Was able to withstand torsional forces typical of clinical use. | |
| Dynamic Pressure | Withstand typical clinical pressures | Was able to withstand pressures typical of clinical use. | |
| Coating Integrity | Remained coated and lubricious | Remained coated and lubricious. | |
| System Performance | Recanalization | Met specified criteria for recanalization | Met the acceptance criteria. |
| Vacuum Pressure | Met specified criteria for vacuum pressure | Met the acceptance criteria. | |
| Suction Flow Rate | Met specified criteria for suction flow rate | Met the acceptance criteria. | |
| Lumen Collapse | Remained patent | Remained patent. | |
| Usability | Met criteria for maneuverability, flexibility, aspiration, and clot retrieval | Met the acceptance criteria. |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state sample sizes for each bench or animal study. It mentions a "canine model" for the thrombogenicity test and a "porcine model" for the animal performance data. Specific numbers of animals or test articles used in these studies are not provided.
The data provenance is non-clinical bench and animal testing. There is no mention of human subject data. Therefore, it is entirely retrospective or prospective non-clinical data performed in a laboratory/animal setting. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the studies were conducted to meet U.S. regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the studies are entirely non-clinical (bench and animal testing). The "ground truth" is based on the objective measurements and observations from the physical and biological tests conducted according to established standards (e.g., ISO, ASTM, USP).
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are entirely non-clinical. Adjudication typically refers to expert consensus or review in clinical studies.
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 information is not applicable. The device is a physical medical device (catheter), not an AI software. The studies described are non-clinical bench and animal tests, not an MRMC comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used:
The ground truth used for the non-clinical studies is based on:
- Objective Measurements: Such as dimensional measurements, pressure readings, flow rates, tensile strength, Luer standards, etc.
- Standardized Test Methods: Adherence to established international (ISO) and national (ASTM, USP, ANSI/AAMI) standards for evaluating materials, sterility, packaging, and performance.
- Biological Endpoints: In animal models, these include observations for systemic toxicity, sensitization, irritation, pyrogenicity, and direct measurement of thrombogenic potential.
- Visual Inspection and Functional Assessment: E.g., for coating integrity, recanalization, lumen patency, and usability by trained personnel.
8. The Sample Size for the Training Set:
This information is not applicable. This is a submission for a physical medical device. The concepts of "training set" and "testing set" are primarily relevant to machine learning and AI, which are not involved here. The non-clinical studies evaluate the device's inherent physical and biological properties.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as #8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 14, 2018
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Rvan Kennev Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K182101
Trade/Device Name: Riptide™ Aspiration System (React™ 71 Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: October 12, 2018 Received: October 15, 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. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
for
Xiaolin Zheng-S
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) K182101
Device Name RiptideTM Aspiration System (React™ 71 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: K182101
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No.: 2029214 |
|---|---|
| Contact Person: | Ryan KenneySenior Regulatory Affairs SpecialistTelephone: (949) 297-5489Email: ryan.j.kenney@medtronic.com |
| Date SummaryPrepared: | October 12, 2018 |
| Trade Name ofDevice: | Riptide™ Aspiration System (React™ 71 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: | Penumbra System® (ACE 68 Reperfusion Catheter)510(k)#: K161064 |
| Additional PredicateDevice: | Riptide™ Aspiration System (React™ 68 Catheter)510(k)#: K180705 |
Device Description:
The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricious, polytetrafluoroethylene and Engage liner is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the split y-introducer sheath.
The proximal end of the React™ 71 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is designed with a hydrophilic coating. The React™ 71 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.
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.
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| Penumbra System®(ACE 68 Reperfusion Catheter)(K161064) | Riptide™ Aspiration System(React™ 68 Catheter)(K180705) | Riptide™ Aspiration System(React™ 71 Catheter)(K182101) | |
|---|---|---|---|
| Indication for Use (IFU)Statement | The Penumbra System® isintended for use in therevascularization of patients withacute ischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours ofsymptom onset. | The Riptide™ AspirationSystem is intended for use inthe revascularization ofpatients with acute ischemicstroke secondary tointracranial large vesselocclusive disease (within theinternal carotid, middlecerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment. | Same as K180705 |
| Materials | |||
| Proximal Hub | Grilamid™ | Trogamid® | Same as K180705 |
| Strain Relief(Hub Sleeve) | Grilamid™ | DynaFlex® | Same as K180705 |
| Strain Relief | 304 Stainless Steel | N/A | Same as K180705 |
| Inner Diameter Band | Polyolefin, PET Yellow(Black Ink) | N/A | Same as K180705 |
| Liner | PTFE | Same as K161064 | Polyolefin,PTFE |
| Braid Reinforcement | N/A | Nitinol | Same as K180705 |
| Coil Reinforcement | 304V Stainless SteelNickel (55%)/Titanium (45%) | Nitinol | Same as K180705 |
| Penumbra System®(ACE 68 Reperfusion Catheter)(K161064) | Riptide™ Aspiration System(React™ 68 Catheter)(K180705) | Riptide™ Aspiration System(React™ 71 Catheter)(K182101) | |
| Proximal Extrusions | Vestamid®Pebax® 72D | Grilamid™Pebax® 45DPebax® 55DPebax® 63DPebax® 72D | PolyamidePolyolefinPolyurethane |
| Distal Extrusions | Pebax® 35DPebax® 40DPebax® 55DPebax® 63DPellathane® 80ATecoflex® 80A | Pebax® 25DPebax® 35D | |
| Extrusion Colorants | Clear/Natural or Purple | Clear/Natural or Green | Same as K180705 |
| Marker Band | Platinum (90% )/Iridium (10%) | Same | Same |
| Coating | SRDX Harmony | Surmodics Serene® | Same as K180705 |
| Dimensions | |||
| Working Length | 132 cm | Same | Same |
| Proximal Inner Diameter(ID) | 0.068" (Min.) | 0.068" (Min.) | 0.071" |
| Proximal Outer Diameter(OD) | 0.084" (Max.) | 0.083" (Max.) | 0.0855" (Max.) |
| Distal ID | 0.068" (Min.) | 0.068" (Min.) | 0.071" |
| Distal OD | 0.084" (Max.) | 0.083" (Max.) | 0.0855" (Max.) |
| Coating Length | 30cm | 40cm | Same as K180705 |
| Tip Shape | Straight | Same | Same |
| Accessories | |||
| Peelable Sheath | PTFE | Same | Same |
| Penumbra System®(ACE 68 Reperfusion Catheter)(K161064) | Riptide™ Aspiration System(React™ 68 Catheter)(K180705) | Riptide™ Aspiration System(React™ 71 Catheter)(K182101) | |
| Rotating HemostasisValve | Polycarbonate Silicone O-Ring | N/A | Same as K180705 |
| Shaping Mandrel | 0.038" OD Stainless Steel | Same as K180705 | |
| Packaging | |||
| Carton | SBS Paperboard | Same as K180705 | |
| Packaging Card | Polyethylene | Same | Same as K180705 |
| Packaging Hoop | Polyethylene | Same | Same as K180705 |
| Packaging Tray | PolyethyleneTerephthalatePolystrene | N/A | Same as K180705 |
| Pouch | PolyesterPolyethyleneTyvek® | NylonTyvek® | Same as K180705 |
| Other | |||
| Shelf Life | 8 Months | 3 Months | Same as K180705 |
| Sterilization | Ethylene Oxide (EO) | Same | Same |
| Use | Single Use, Disposable | Same | Same |
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Biocompatibility:
Biocompatibility was conducted for the React™ 71 Catheter. The React™ 71 Catheter is categorized as a limited exposure (< 24 hours), external communicating circulating blood. The following biocompatibility was conducted for the React™ 71 Catheter:
| Test Description | Results | Conclusions |
|---|---|---|
| Cytotoxicity(Elution Method) | The test article extract showedno evidence of causing celllysis or toxicity and had aGrade 0 (No Reactivity). Thetest article extract met therequirements of the test sincethe grade was < Grade 2(Mild Reactivity). | The ReactTM 71 Catheter isconsidered non-cytotoxic. |
| Sensitization(Guinea Pig Maximization Test) | The test article extractsshowed no evidence ofcausing delayed dermalcontact sensitization in theguinea pig. | The ReactTM 71 Catheter doesnot elicit a sensitizationresponse. |
| Irritation(Intracutaneous Reactivity) | The test article met therequirements of the test sincethe difference between eachtest article extract overallmean score and correspondingcontrol extract overall meanscore was 0.0 and 0.2 for theSodium Chloride and SesameOil test article extracts,respectively. | The ReactTM 71 Catheter isconsidered a non-irritant. |
| Acute Systemic Toxicity(Systemic Toxicity) | There was no mortality orevidence of systemic toxicityfrom the extracts injected intomice. | The ReactTM 71 Catheter doesnot indicate signs of toxicity. |
| Hemocompatibility(Hemolysis) | The hemolytic index for thetest article in direct contactwith blood was 0.8%, and thehemolytic index for the testarticle extract was 0.0%. | The ReactTM 71 Catheter isconsidered non-hemolytic. |
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| Test Description | Results | Conclusions |
|---|---|---|
| Hemocompatibility(Complement Activation) | The concentration of SC5b-9in the test article was notstatistically higher than theactivated normal human serumcontrol or the negative control.The test article wasstatistically lower than thesponsor provided controlarticle. | The ReactTM 71 Catheter is notconsidered to be potentialactivator of the complementsystem. |
| Hemocompatibility(Thrombogenicity – CanineModel) | The control article wasevaluated and determined tohave a mean score of 2.0. Thetest article was evaluated anddetermined to have a meanscore of 1.7 after four (4)hours (±30 minutes) withoutsystemic anticoagulation. | The ReactTM 71 Catheterdemonstrates lowerthrombogenic potential inarterial vessels compared tothe ACE 68 ReperfusionCatheter. |
| Pyrogenicity(Material Mediated) | Not a single animal showed atemperature rise of 0.5°C ormore above its baselinetemperature. The total rise ofthe rabbits' temperature duringthe three (3) hours was 0.0°C. | The ReactTM 71 Catheter isconsidered non-pyrogenic. |
The React™ 71 Catheter has been evaluated to meet requirements specified in ISO 10993-1.
Performance Data – Bench:
Non-clinical bench testing was leveraged and conducted to evaluate the performance of the React™ 71 Catheter.
The following non-clinical bench testing was leveraged for the React™ 71 Catheter:
| Test | Test Method Summary | Results |
|---|---|---|
| Microbial | ||
| Ethylene Oxide Residual | The ReactTM 71 Catheter was evaluated per ISO 10993-7. | The ReactTM 71 Catheter met the acceptance criteria for ethylene oxide residual. |
| Ethylene Chlorohydrin Residual | The ReactTM 71 Catheter was evaluated per ISO 10993-7. | The ReactTM 71 Catheter met the acceptance criteria for ethylene chlorohydrin residual. |
| Bioburden Recovery | The ReactTM 71 Catheter was evaluated per ISO 11737-1. | The ReactTM 71 Catheter met the acceptance criteria for bioburden recovery. |
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| Test | Test Method Summary | Results |
|---|---|---|
| Bacterial Endotoxin | The React™ 71 Catheter wasevaluated per ANSI/AAMIST72 and USP <161>. | The React™ 71 Catheter metthe acceptance criteria forbacterial endotoxin. |
| Packaging | ||
| Visual Inspection | The React™ 71 Catheter wasevaluated per ASTM F1886. | The React™ 71 Catheter metthe acceptance criteria forvisual inspection. |
| Bubble Leak | The React™ 71 Catheter wasevaluated per ASTM F2096. | The React™ 71 Catheter metthe acceptance criteria forbubble leak. |
| Seal Strength | The React™ 71 Catheter wasevaluated per ASTM F88. | The React™ 71 Catheter metthe acceptance criteria for sealstrength. |
The following non-clinical bench testing was conducted for the React™ 71 Catheter:
| Test | Test Method Summary | Results |
|---|---|---|
| MicrobialBioburden | The React™ 71 Catheter wasevaluated per ISO 11737-1. | The React™ 71 Catheter metthe acceptance criteria forbioburden. |
| PerformanceVisual Inspection | The React™ 71 Catheter wasinspected under x2.5magnification. | The React™ 71 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 React™ 71 Catheter weremeasured. | The React™ 71 Catheter metthe acceptance criteria fordimensional measurements. |
| Tip Buckling | The React™ 71 Catheter wasevaluated for the maximumcompressive force it canwithstand. | The React™ 71 Catheter metthe acceptance criteria for tipbuckling. |
| Kink Resistance | The React™ 71 Catheter wasevaluated for the maximumkink diameter. | The React™ 71 Catheter metthe acceptance criteria for kinkresistance. |
| Particulate | The React™ 71 Catheter wasevaluated per USP <788>. | The React™ 71 Catheter metthe acceptance criteria forparticulate. |
| Coating Lubricity | The React™ 71 Catheter wasevaluated for the averagefrictional forces. | The React™ 71 Catheter metthe acceptance criteria forcoating lubricity. |
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| Test | Test Method Summary | Results |
|---|---|---|
| Tensile Strength | The ReactTM 71 Catheter was evaluated per ISO 10555-1. Annex B. | The ReactTM 71 Catheter met the acceptance criteria for tensile strength at the hub and shaft. |
| Liquid Leak | The ReactTM 71 Catheter was evaluated per ISO 10555-1. Annex C. | The ReactTM 71 Catheter met the acceptance criteria for liquid leak. |
| Corrosion Resistance | The ReactTM 71 Catheter was evaluated per ISO 10555-1. Annex A. | The ReactTM 71 Catheter met the acceptance criteria for corrosion resistance. |
| Hub Aspiration Resistance | The ReactTM 71 Catheter was evaluated per ISO 10555-1. Annex D. | The ReactTM 71 Catheter met the acceptance criteria for hub air aspiration. |
| Radiopacity | The markerband length and wall thickness of the ReactTM 71 Catheter were measured. In addition, radiopacity was confirmed via fluoroscopy. | The ReactTM 71 Catheter met the acceptance criteria for radiopacity. |
| Luer Standards | The ReactTM 71 Catheter was evaluated per ISO 594-1 and ISO 80369-7. | The ReactTM 71 Catheter met the acceptance criteria for luer standards. |
| Torque to Failure | The ReactTM 71 Catheter was evaluated for transmission of proximal torque to the distal tip. | The ReactTM 71 Catheter was able to withstand torsional forces that are typical of clinical use. |
| Dynamic Pressure | The ReactTM 71 Catheter was evaluated for the amount of pressure it can withstand. | The ReactTM 71 Catheter was able to withstand pressures that are typical of clinical use. |
| Coating Integrity | The ReactTM 71 Catheter was evaluated for coating coverage and lubricity. | The ReactTM 71 Catheter remained coated and lubricious. |
In addition, the following non-clinical bench testing was conducted to evaluate the performance of the Riptide™ Aspiration System (React™ 71 Catheter):
| Test | Test Method Summary | Results |
|---|---|---|
| Recanalization | The Riptide™ AspirationSystem (React™ 71 Catheter)was evaluated forrecanalization. | The Riptide™ AspirationSystem (React™ 71 Catheter)met the acceptance criteria forrecanalization. |
| Vacuum Pressure | The Riptide™ AspirationSystem (React™ 71 Catheter)was evaluated for vacuumpressure. | The Riptide™ AspirationSystem (React™ 71 Catheter)met the acceptance criteria forvacuum pressure. |
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| Test | Test Method Summary | Results |
|---|---|---|
| Suction Flow Rate | The Riptide™ AspirationSystem (React™ 71 Catheter)was evaluated for suction flowrate. | The Riptide™ AspirationSystem (React™ 71 Catheter)met the acceptance criteria forsuction flow rate. |
| Lumen Collapse | The Riptide™ AspirationSystem (React™ 71 Catheter)was evaluated for lumencollapse. | The Riptide™ AspirationSystem (React™ 71 Catheter)remained patent. |
| Usability | The Riptide™ AspirationSystem (React™ 71 Catheter)and the Penumbra System®(ACE 68 Reperfusion Catheter)were evaluated formaneuverability, flexibility, theability to engage and applyaspiration, and the ability tosafely retrieve clot. | The Riptide™ AspirationSystem (React™ 71 Catheter)met the acceptance criteria forusability. |
Performance Data - Animal:
Non-clinical animal testing was conducted to evaluate the safety, efficacy, and usability of the Riptide™ Aspiration System (React™ 71 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 nonclinical 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™ 71 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).