(107 days)
No
The summary describes a mechanical aspiration system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset, which is a therapeutic intervention.
No
This device is an aspiration system intended for revascularization in patients with acute ischemic stroke, which is a therapeutic rather than a diagnostic function. While it mentions visualization under fluoroscopy, this is for guidance during the interventional procedure, not for diagnosing the condition itself.
No
The device description explicitly details a physical catheter with specific material properties, a radiopaque markerband, and a hydrophilic coating, indicating it is a hardware 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 device used in vivo (within the body) for a therapeutic procedure (revascularization of intracranial large vessels). IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter designed to be introduced into the vasculature, which is an in vivo application.
- Anatomical Site: The specified anatomical site is within the human body.
- Input Imaging Modality: Fluoroscopy is an in vivo imaging technique.
The Riptide™ Aspiration System is a medical device used for a therapeutic intervention within the patient's body, not for testing biological samples in vitro.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Biocompatibility:
- Study Type: Cytotoxicity (Elution Method)
- Results: The test article extract showed no evidence of causing cell lysis or toxicity and had a grade of zero (no reactivity).
- Conclusions: The ReactTM 68 Catheter is considered non-cytotoxic.
- Study Type: Sensitization (Guinea Pig Maximization Test)
- Results: The test article extract met the requirements of the test since the grade was less than a grade two (mild reactivity).
- Conclusions: The ReactTM 68 Catheter does not elicit a sensitization response.
- Study Type: Irritation (Intracutaneous Reactivity)
- Results: The difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.0 for the sodium chloride and sesame oil test article extracts, respectively.
- Conclusions: The ReactTM 68 Catheter is considered a non-irritant.
- Study Type: Acute Systemic Toxicity (Systemic Toxicity)
- Results: There was no mortality or evidence of systemic toxicity from the extracts injected. All animals were clinically normal throughout the study.
- Conclusions: The ReactTM 68 Catheter does not indicate signs of toxicity.
- Study Type: Hemocompatibility (Hemolysis)
- Results: The hemolytic index for the test article in direct contact with blood was 0.9%, and the hemolytic index for the test article extract was 0.0%.
- Conclusions: The ReactTM 68 Catheter is considered non-hemolytic.
- Study Type: Hemocompatibility (Complement Activation)
- Results: The concentration of SC5b-9 in the sponsor provided control sample was not statistically higher than the activated normal human serum control or the negative control. The concentration of SC5b-9 in the test article sample was not statistically higher than the activated normal human serum control, the negative control or the sponsor provided control.
- Conclusions: The control and test article samples are not considered to be potential activators of the complement system.
- Study Type: Hemocompatibility (Thrombogenicity)
- Results: The thrombogenic potential of the control article was evaluated in comparison to the test article. Both the control and test articles were determined to have minimal thrombus formation after four (4) hours (±30 minutes) without anticoagulation.
- Conclusions: The ReactTM 68 Catheter demonstrates minimal thrombus formation.
- Study Type: Pyrogenicity (Material Mediated)
- Results: Not a single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the temperature during three (3) hours was 0.0°C.
- Conclusions: The React™ 68 Catheter is considered non-pyrogenic.
Performance Data – Bench:
- Ethylene Oxide Residual: Met acceptance criteria.
- Ethylene Chlorohydrin Residual: Met acceptance criteria.
- Bioburden: Met acceptance criteria.
- Bacterial Endotoxin: Met acceptance criteria.
- Visual Inspection: Met acceptance criteria.
- Dimensional Measurements: Met acceptance criteria.
- Tip Buckling: Met acceptance criteria.
- Kink Resistance: Met acceptance criteria.
- Particulate: Met acceptance criteria.
- Coating Lubricity: Met acceptance criteria.
- Tensile Strength: Met acceptance criteria.
- Liquid Leak: Met acceptance criteria.
- Corrosion Resistance: Met acceptance criteria.
- Hub Aspiration Resistance: Met acceptance criteria.
- Radiopacity: Met acceptance criteria.
- Luer Standards: Met acceptance criteria.
- Torque Strength: Able to withstand torsional forces typical of clinical use.
- Dynamic Pressure: Able to withstand pressures typical of clinical use.
- Coating Integrity: Remained coated and lubricous.
- Recanalization: Met acceptance criteria.
- Vacuum Pressure: Met acceptance criteria.
- Suction Flow Rate: Met acceptance criteria.
- Usability: Met acceptance criteria.
Performance Data - Animal:
- Study Type: Non-clinical animal testing
- Methods: Evaluated safety, efficacy, and usability 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. Conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.
- Key Results: Not explicitly detailed, but stated as successful completion supporting substantial equivalence.
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.
Penumbra System® ACE 68 Reperfusion Catheter 510(k)#: K161064
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.
RiptideTM Aspiration System 510(k)#: K172448, ArcTM Intracranial Support Catheter 510(k)#: K150107
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 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);
1
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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3
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 Summary | |
| Prepared: | June 25, 2018 |
| Trade Name of | |
| Device: | RiptideTM Aspiration System (React 68 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(s): | Penumbra System® ACE 68 Reperfusion Catheter |
| 510(k)#: K161064 | |
| Reference Device(s): | RiptideTM Aspiration System |
| 510(k)#: K172448 | |
| ArcTM Intracranial Support Catheter | |
| 510(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.
4
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 68
Reperfusion Catheter | React™ 68 Catheter |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| 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 Steel
Nickel (55%)/Titanium (45%) | Nitinol |
| Proximal Extrusions | Vestamid®
Pebax® 72D | Grilamid™
Pebax® 45D
Pebax® 55D
Pebax® 63D
Pebax® 72D |
| Distal Extrusions | Pebax® 35D
Pebax® 40D
Pebax® 55D
Pebax® 63D
Pellathane® 80A
Tecoflex® 80A | Pebax® 25D
Pebax® 35D |
| | Penumbra System® ACE 68
Reperfusion 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 | Polyethylene
Terephthalate
Polystrene | N/A |
| Pouch | Polyester
Polyethylene
Tyvek® | Nylon
Tyvek® |
| Other | | |
| Shelf Life | 8 Months | 3 Months |
| Sterilization | Ethylene Oxide (EO) | Same |
| Use | Single Use, Disposable | Same |
Device Comparison:
5
Biocompatibility:
Biocompatibility was conducted for the React™ 68 Catheter. The React™ 68 Catheter is categorized as a limited exposure (. | The ReactTM 68 Catheter met
the acceptance criteria for
bacterial endotoxin. |
| Performance | | |
| Visual Inspection | The ReactTM 68 Catheter was
inspected under x2.5
magnification. | The ReactTM 68 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 ReactTM 68 Catheter were
measured. | The ReactTM 68 Catheter met
the acceptance criteria for
dimensional measurements. |
| Tip Buckling | The ReactTM 68 Catheter was
evaluated for the maximum
compressive force. | The ReactTM 68 Catheter met
the acceptance criteria for tip
buckling |
| 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 . | 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™ Aspiration
System React™ 68 Catheter
was evaluated for
recanalization. | The Riptide™ Aspiration
System React™ 68 Catheter
met the acceptance criteria for
recanalization. |
| Vacuum Pressure | The Riptide™ Aspiration
System React™ 68 Catheter
was evaluated for vacuum
pressure. | The Riptide™ Aspiration
System React™ 68 Catheter
met the acceptance criteria for
vacuum pressure. |
| Suction Flow Rate | The Riptide™ Aspiration
System React™ 68 Catheter
was evaluated for suction flow
rate. | The Riptide™ Aspiration
System React™ 68 Catheter
met the acceptance criteria for
suction flow rate. |
| Usability | The Riptide™ Aspiration
System React™ 68 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™ 68 Catheter
met the acceptance criteria for
usability. |
8
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:
9
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.