(103 days)
Not Found
No
The provided text describes a mechanical aspiration system and catheter, focusing on its physical properties, materials, and intended use for clot removal. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as an "Aspiration System" intended for "revascularization of patients with acute iscoke secondary to intracranial large vessel occlusive disease," which involves directly treating a medical condition.
No
The device is described as an "Aspiration System" and a "Catheter" intended for "revascularization of patients with acute iscoke secondary to intracranial large vessel occlusive disease," which is a treatment rather than a diagnostic function. While it uses fluoroscopy for visualization, this is for guidance during the interventional procedure, not for diagnosis.
No
The device description clearly details a physical catheter with specific material properties, a markerband for visualization under fluoroscopy, and a hub. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for revascularization of patients with acute ischemic stroke by physically removing blood clots from large intracranial vessels. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The device description details a catheter designed to be introduced into the vasculature and navigated to the site of occlusion. This is consistent with an interventional medical device used directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside of the body on biological samples to provide diagnostic or other information. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing was leveraged and conducted to evaluate the performance of the React™ 71 Catheter.
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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3
510(k) Summary: K182101
| 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 Summary
Prepared: | October 12, 2018 |
| Trade Name of
Device: | Riptide™ Aspiration System (React™ 71 Catheter) |
| Common Name of
Device: | 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 Predicate
Device: | 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.
4
| | 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® 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. | 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. | 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 Steel
Nickel (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® 45D
Pebax® 55D
Pebax® 63D
Pebax® 72D | Polyamide
Polyolefin
Polyurethane |
| Distal Extrusions | Pebax® 35D
Pebax® 40D
Pebax® 55D
Pebax® 63D
Pellathane® 80A
Tecoflex® 80A | Pebax® 25D
Pebax® 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 Hemostasis
Valve | 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 | Polyethylene
Terephthalate
Polystrene | N/A | Same as K180705 |
| Pouch | Polyester
Polyethylene
Tyvek® | Nylon
Tyvek® | 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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6
7
Biocompatibility:
Biocompatibility was conducted for the React™ 71 Catheter. The React™ 71 Catheter is categorized as a limited exposure (. | The React™ 71 Catheter met
the acceptance criteria for
bacterial endotoxin. |
| Packaging | | |
| Visual Inspection | The React™ 71 Catheter was
evaluated per ASTM F1886. | The React™ 71 Catheter met
the acceptance criteria for
visual inspection. |
| Bubble Leak | The React™ 71 Catheter was
evaluated per ASTM F2096. | The React™ 71 Catheter met
the acceptance criteria for
bubble leak. |
| Seal Strength | The React™ 71 Catheter was
evaluated per ASTM F88. | The React™ 71 Catheter met
the acceptance criteria for seal
strength. |
The following non-clinical bench testing was conducted for the React™ 71 Catheter:
| Test | Test Method Summary | Results |
|---|---|---|
| Microbial | ||
| Bioburden | The React™ 71 Catheter was | |
| evaluated per ISO 11737-1. | The React™ 71 Catheter met | |
| the acceptance criteria for | ||
| bioburden. | ||
| Performance | ||
| Visual Inspection | The React™ 71 Catheter was | |
| inspected under x2.5 | ||
| magnification. | The React™ 71 Catheter met | |
| the acceptance criteria for | ||
| visual inspection. | ||
| Dimensional Measurements | The proximal ID, distal, ID, | |
| proximal OD, distal OD, usable | ||
| length, total length, coating | ||
| length, and distal tip length of | ||
| the React™ 71 Catheter were | ||
| measured. | The React™ 71 Catheter met | |
| the acceptance criteria for | ||
| dimensional measurements. | ||
| Tip Buckling | The React™ 71 Catheter was | |
| evaluated for the maximum | ||
| compressive force it can | ||
| withstand. | The React™ 71 Catheter met | |
| the acceptance criteria for tip | ||
| buckling. | ||
| Kink Resistance | The React™ 71 Catheter was | |
| evaluated for the maximum | ||
| kink diameter. | The React™ 71 Catheter met | |
| the acceptance criteria for kink | ||
| resistance. | ||
| Particulate | The React™ 71 Catheter was | |
| evaluated per USP . | The React™ 71 Catheter met | |
| the acceptance criteria for | ||
| particulate. | ||
| Coating Lubricity | The React™ 71 Catheter was | |
| evaluated for the average | ||
| frictional forces. | The React™ 71 Catheter met | |
| the acceptance criteria for | ||
| coating lubricity. |
10
| 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™ Aspiration | |
| System (React™ 71 Catheter) | ||
| was evaluated for | ||
| recanalization. | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| met the acceptance criteria for | ||
| recanalization. | ||
| Vacuum Pressure | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| was evaluated for vacuum | ||
| pressure. | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| met the acceptance criteria for | ||
| vacuum pressure. |
11
| Test | Test Method Summary | Results |
|---|---|---|
| Suction Flow Rate | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| was evaluated for suction flow | ||
| rate. | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| met the acceptance criteria for | ||
| suction flow rate. | ||
| Lumen Collapse | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| was evaluated for lumen | ||
| collapse. | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| remained patent. | ||
| Usability | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| and the Penumbra System® | ||
| (ACE 68 Reperfusion Catheter) | ||
| were evaluated for | ||
| maneuverability, flexibility, the | ||
| ability to engage and apply | ||
| aspiration, and the ability to | ||
| safely retrieve clot. | The Riptide™ Aspiration | |
| System (React™ 71 Catheter) | ||
| met the acceptance criteria for | ||
| usability. |
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).