(107 days)
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The 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 React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The React™ 68 Catheter is designed with a hydrophilic coating.
This is a 510(k) premarket notification for the React™ 68 Catheter. The document focuses on demonstrating substantial equivalence to predicate devices through design comparisons and extensive bench testing. Animal and clinical studies were not deemed necessary for this submission.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes numerous functional, biocompatibility, and sterilization-related tests. The "Acceptance Criteria" for each test are implicitly that the device "met the acceptance criteria" or demonstrated results within acceptable limits for safe and effective use. The "Reported Device Performance" is the stated outcome of each test.
| Test Description | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (Elution Method) | No evidence of cell lysis/toxicity (grade < 2) | Grade of 0 (no reactivity), considered non-cytotoxic |
| Sensitization (Guinea Pig Maximization) | No evidence causing delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization |
| Irritation (Intracutaneous Reactivity) | Difference between test/control scores of 0 | Difference of 0.0 for NaCl and sesame oil extracts, considered non-irritant |
| Acute Systemic Toxicity (Systemic Toxicity) | No mortality or evidence of systemic toxicity | No mortality or evidence of systemic toxicity |
| Hemocompatibility (Hemolysis) | Hemolytic index within acceptable limits | Hemolytic index of 0.9% (direct), 0.0% (extract) |
| Hemocompatibility (Complement Activation) | Test article not statistically higher than controls | Test article not statistically higher than controls, not a potential activator of complement system |
| Hemocompatibility (Thrombogenicity) | Minimal thrombus formation | Minimal thrombus formation after 4 hours |
| Pyrogenicity (Material Mediated) | No animal temperature rise $\ge$ 0.5°C over baseline | No animal showed a temperature rise of 0.5°C or more |
| Performance Data – Bench (Microbial): | ||
| Ethylene Oxide Residual | Met ISO 10993-7 acceptance criteria | Met the acceptance criteria for ethylene oxide residual |
| Ethylene Chlorohydrin Residual | Met ISO 10993-7 acceptance criteria | Met the acceptance criteria for ethylene chlorohydrin residual |
| Bioburden | Met ISO 11737-1 acceptance criteria | Met the acceptance criteria for bioburden |
| Bacterial Endotoxin | Met ANSI/AAMI ST72 and USP <161> acceptance criteria | Met the acceptance criteria for bacterial endotoxin |
| Performance Data – Bench (Performance): | ||
| Visual Inspection | Met acceptance criteria | Met the acceptance criteria for visual inspection |
| Dimensional Measurements | Met acceptance criteria for all measured dimensions | 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 USP <788> acceptance criteria | 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 ISO 10555-1 Annex B acceptance criteria | Met the acceptance criteria for tensile strength at hub and shaft |
| Liquid Leak | Met ISO 10555-1 Annex C acceptance criteria | Met the acceptance criteria for liquid leak |
| Corrosion Resistance | Met ISO 10555-1 Annex A acceptance criteria | Met the acceptance criteria for corrosion resistance |
| Hub Aspiration Resistance | Met ISO 10555-1 Annex D acceptance criteria | Met the acceptance criteria for hub air aspiration |
| Compatibility | Met acceptance criteria for visual damage during use | Met the acceptance criteria for delivering and retrieving interventional devices |
| Radiopacity | Met acceptance criteria (markerband/wall thickness, fluoroscopy) | Met the acceptance criteria for radiopacity |
| Luer Standards | Met ISO 594-1 and ISO 80369-7 acceptance criteria | Met the acceptance criteria for luer standards |
| Torque Strength | Able to withstand typical clinical torsional forces | Able to withstand torsional forces typical of clinical use |
| Dynamic Pressure | Able to withstand typical clinical pressures | Able to withstand pressures typical of clinical use |
| Coating Integrity | Coating remained covered and lubricious | Remained coated and lubricous |
| Usability | Met acceptance criteria for maneuverability and flexibility | Met the acceptance criteria for usability |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each specific test within the bench testing. However, such tests would typically involve a statistically relevant number of units to ensure reliability. The data provenance is from bench testing conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The data is prospective as it was generated specifically for this submission. The country of origin of the data is not explicitly stated but can be inferred as the United States given the FDA submission and the company's address in Irvine, CA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a physical catheter, and its performance is evaluated through objective, standardized physical and chemical tests (e.g., ISO standards, USP, visual inspection, dimensional measurements). There is no "ground truth" derived from expert interpretation in the context of diagnostic performance testing of, for example, medical images.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for this type of device's performance is established through objective laboratory testing against predetermined specifications and international standards, not through adjudications of expert opinions.
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
Not applicable. This is a physical medical device (catheter) and not an AI or imaging diagnostic device. Therefore, MRMC studies are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the React™ 68 Catheter's performance is defined by its compliance with:
- Industry Standards: Such as ISO 10993 (Biocompatibility), ISO 11737-1 (Bioburden), ANSI/AAMI ST72 (Bacterial Endotoxin), USP <161>/<788> (Bacterial Endotoxin/Particulate), ISO 10555-1 (Catheter testing), ISO 594-1/80369-7 (Luer standards).
- Predicate Device Performance: Demonstrating substantial equivalence to legally marketed predicate devices in terms of materials, dimensions, and functional characteristics.
- Engineering Specifications: Internal design requirements for dimensions, material properties, and functional performance (e.g., tip buckling, kink resistance, lubricity, tensile strength).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 4, 2018
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney Senior Regulatory Affairs Specialist 9775 Toledo Wav Irvine, California 92618
Re: K180715
Trade/Device Name: React 68 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY 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 medical devices and radiation-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,
Image /page/1/Picture/6 description: The image shows the name "Xiaolin Zheng" in a large, bold font, followed by a hyphen. Below the name, there is a large, stylized FDA logo in a light gray color. To the left of the logo, there is a large letter "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) K180715
Device Name React 68 Catheter
Indications for Use (Describe)
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K180715
| 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: | June 25, 2018 |
| Trade Name ofDevice: | React™ 68 Catheter |
| Common Name ofDevice: | Percutaneous Catheter |
| Review Panel: | Neurology |
| Product Code: | DQY |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Predicate Device(s): | AXS Catalyst™ Distal Access Catheter510(k)#: K151667ReFlex™ Guide Catheter510(k)#: K110055 |
Device Description:
The 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 React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The React™ 68 Catheter is designed with a hydrophilic coating.
Indications for Use:
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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| AXS Catalyst™ DistalAccess Catheter(K151667) | ReFlex™ GuideCatheter(K110055) | React™ 68 Catheter | |
|---|---|---|---|
| Indication for Use(IFU) Statement | The AXS Catalyst™Distal Access Catheteris indicated for theinsertion and guidanceof appropriately sizedinterventional devicesinto a selected bloodvessel in the peripheraland neurovascularsystems. The AXSCatalyst™ DistalAccess Catheter is alsoindicated for use as aconduit for retrievaldevices. | The ReFlex™ GuideCatheter is indicatedfor the introduction ofinterventional devicesinto the peripheral andneuro vasculature. | Same as K110055 |
| Materials | |||
| Hub | Nylon | Trogamid® | Same as K110055 |
| Strain Relief | Thermoplastic Rubber | Santoprene | DynaFlex® |
| Inner Layer | PTFE | Same | Same |
| Reinforcement | Stainless Steel withNitinol and PolymerFiber | Nitinol | Same as K110055 |
| Outer Jacket | Pebax® | Polymeric | Grilamid™Pebax® |
| Markerband | Platinum/Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Same |
| Coating | Hydrophilic | Same | Same |
| Dimensions | |||
| Working Length | 132 cm | 130 cm | Same as K151667 |
| Inner Diameter (ID) | 0.060" | 0.072" | 0.068" |
| Proximal OuterDiameter (OD) | 0.079" | 0.084" | 0.083" |
| Distal OuterDiameter (OD) | 0.071" | 0.084" | 0.083" |
| Packaged Accessories | |||
| Peelable Sheath | Yes | Same | Same |
| Rotating HemostasisValve | Yes | No | Same as K110055 |
| Packaging | |||
| Packaging Card | Polyethylene | Same | Same |
| Packaging Hoop | Polyethylene | Same | Same |
| AXS Catalyst™ DistalAccess Catheter(K151667) | ReFlex™ GuideCatheter(K110055) | React™ 68 Catheter | |
| Other | |||
| Sterilization | Ethylene Oxide (EO) | Same | 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 test article extract met therequirements of the test sincethe grade was less than a gradetwo (mild reactivity). | The ReactTM 68 Catheter isconsidered non-cytotoxic. |
| Sensitization(Guinea Pig Maximization Test) | The test article extractsshowed no evidence ofcausing delayed dermalcontact sensitization in theguinea pig. | 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 not | The control and test articlesamples are not considered to |
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| Test Description | Results | Conclusions |
|---|---|---|
| statistically higher than theactivated normal human serumcontrol or the negative control. | be potential activators of thecomplement system. | |
| The concentration of SC5b-9in the test article sample wasnot statistically higher than theactivated normal human serumcontrol, the negative control orthe sponsor provided control. | ||
| Hemocompatibility(Thrombogenicity) | The thrombogenic potential ofthe control article wasevaluated in comparison to thetest article. Both the controland test articles weredetermined to have minimalthrombus formation after four(4) hours (±30 minutes)without anticoagulation. | The React™ 68 Catheterdemonstrates minimalthrombus formation. |
| 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. |
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 React™ 68 Catheter was evaluated per ISO 10993-7. | The React™ 68 Catheter met the acceptance criteria for ethylene oxide residual. |
| Ethylene Chlorohydrin Residual | The React™ 68 Catheter was evaluated per ISO 10993-7. | The React™ 68 Catheter met the acceptance criteria for ethylene chlorohydrin residual. |
| Bioburden | The React™ 68 Catheter was evaluated per ISO 11737-1. | The React™ 68 Catheter met the acceptance criteria for bioburden. |
| Test | Test Method Summary | Results |
| 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. |
| Kink Resistance | The ReactTM 68 Catheter wasevaluated for the maximumkink diameter. | The ReactTM 68 Catheter metthe acceptance criteria for kinkresistance. |
| Particulate | The ReactTM 68 Catheter wasevaluated per USP <788>. | The ReactTM 68 Catheter metthe acceptance criteria forparticulate evaluation. |
| Coating Lubricity | The ReactTM 68 Catheter wasevaluated for the averagefriction forces. | The ReactTM 68 Catheter metthe acceptance criteria forcoating lubricity. |
| Tensile Strength | The ReactTM 68 Catheter wasevaluated per ISO 10555-1.Annex B. | The ReactTM 68 Catheter metthe acceptance criteria fortensile strength at the hub andshaft. |
| Liquid Leak | The ReactTM 68 Catheter wasevaluated per ISO 10555-1.Annex C. | The ReactTM 68 Catheter metthe acceptance criteria forliquid leak. |
| Corrosion Resistance | The ReactTM 68 Catheter wasevaluated per ISO 10555-1.Annex A. | The ReactTM 68 Catheter metthe acceptance criteria forcorrosion resistance. |
| Hub Aspiration Resistance | The ReactTM 68 Catheter wasevaluated per ISO 10555-1.Annex D. | The ReactTM 68 Catheter metthe acceptance criteria for hubair aspiration. |
| Compatibility | The ReactTM 68 Catheter wasinspected for visual damage ofthe catheter when deliveringand retrieving interventionaldevices | The ReactTM 68 Catheter metthe acceptance criteria fordelivering and retrievinginterventional devices. |
| Test | Test Method Summary | Results |
| Radiopacity | The markerband length andwall thickness of the React™ 68 Catheter were measured. Inaddition, radiopacity wasconfirmed via fluoroscopy. | The React™ 68 Catheter metthe acceptance criteria forradiopacity. |
| Luer Standards | The React™ 68 Catheter wasevaluated per ISO 594-1 andISO 80369-7. | The React™ 68 Catheter metthe acceptance criteria for luerstandards. |
| Torque Strength | The React™ 68 Catheter wasevaluated for transmission ofproximal torque to the distaltip. | The React™ 68 Catheter wasable to withstand torsionalforces that are typical ofclinical use. |
| Dynamic Pressure | The React™ 68 Catheter wasevaluated for the amount ofpressure it can withstand. | The React™ 68 Catheter wasable to withstand pressures thatare typical of clinical use. |
| Coating Integrity | The React™ 68 Catheter wasevaluated for coating coverageand lubricity. | The React™ 68 Catheterremained coated and lubricous. |
| Usability | The React™ 68 Catheter andpredicate device were evaluatedfor maneuverability andflexibility. | The React™ 68 Catheter metthe acceptance criteria forusability. |
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Performance Data - Animal:
Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.
Performance Data - Clinical:
Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.
Conclusion:
The design modifications incorporated do not alter the intended use or fundamental scientific technology.
Non-clinical bench testing supports a determination that the subject React™ 68 Catheter is substantially equivalent to the predicate device.
§ 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).