(29 days)
Not Found
No
The summary describes a mechanical aspiration system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the revascularization of patients with acute ischemic stroke, which directly addresses a medical condition and has a therapeutic effect.
No.
The device is intended for revascularization and restoring blood flow, which are therapeutic interventions, not diagnostic functions.
No
The device description explicitly lists multiple hardware components including catheters, tubing, a pump, and a collection canister.
Based on the provided information, the Riptide™ Aspiration System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to physically remove blood clots from large intracranial vessels in patients experiencing acute ischemic stroke. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The components listed (catheters, tubing, pump, collection canister) are all designed for mechanical aspiration and fluid management within the body.
- Lack of In Vitro Testing: The performance studies described are non-clinical bench tests evaluating electrical safety, electromagnetic compatibility, and mechanical performance (suction, navigation). There is no mention of testing biological samples or analyzing substances from the body outside of it.
- Anatomical Site: The device is used within the patient's intracranial arteries.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Riptide™ Aspiration System does not perform this function. It is a medical device used for a therapeutic procedure.
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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Product codes
NRY
Device Description
The Riptide™ Aspiration System is designed to restore blood flow in 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, using continuous aspiration. The Riptide™ Aspiration System is composed of the following components and illustrated in Figure 1:
-
- React™ 68 Catheter (REACT-68), React™ 71 Catheter (REACT-71, REACT-71-115, REACT-71-125)
-
- Riptide™ Large Bore Aspiration Tubing (MAT-110-110)
-
- Riptide™ Aspiration Pump (MAP-1000)
-
- Riptide™ Collection Canister with Intermediate Tubing (MAC-1200)
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)
The following non-clinical bench tests were conducted for the Riptide™ Aspiration System:
- Riptide™ Aspiration Pump Electrical Safety (IEC 60601-1): Electrical safety testing conducted per IEC 60601-1 Edition 3.2 2020-08. Results: Pass.
- Riptide™ Aspiration Pump Electromagnetic Compatibility (IEC 60601-1-2): Electromagnetic compatibility (EMC) testing conducted per IEC 60601-1-2 Edition 4.1 2020-09. Results: Pass.
- Riptide™ Aspiration Pump and Riptide™ Collection Canister with Intermediate Tubing Medical Suction Equipment (ISO 10079-1/10079-4): Medical suction equipment testing conducted per ISO 10079-1 Fourth Edition 2022-03 and ISO 10079-4 First Edition 2021-08. Results: Pass.
- React™ 71 Catheter Design Validation (The length of the subject device shall be compatible with minimum length 136 cm guide catheter): The subject device was evaluated per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff" (February 2016) and per FDA recognized consensus standards ISO 14971 (Third Edition 2019-12) and IEC 62366-1 (Edition 1.1 2020-06 CONSOLIDATED VERSION). Results: Pass.
- React™ 71 Catheter Design Validation (The subject device should be able to navigate to the distal M1 segment of the MCA over a microcatheter): The subject device was evaluated per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff" (February 2016) and per FDA recognized consensus standards ISO 14971 (Third Edition 2019-12) and IEC 62366-1 (Edition 1.1 2020-06 CONSOLIDATED VERSION). Results: Pass.
The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Riptide™ Aspiration System (K201689)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
October 29, 2024
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Tony Rizzardi Principal Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K243080
Trade/Device Name: Riptide Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: September 27, 2024 Received: September 30, 2024
Dear Tony Rizzardi:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243080
Device Name Riptide™ Aspiration System
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 thrombolytic drug therapy or who failed thrombolytic drug 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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4
510(k) Summary - K243080
| 510(k) Owner | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618, USA
Establishment Registration: 2029214 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tony Rizzardi
Principal Regulatory Affairs Specialist
Telephone: (763) 505-3017
Email: tony.rizzardi@medtronic.com |
| Date Summary Prepared | 29 October 2024 |
|---|---|
| Trade Name of Device | Riptide™ Aspiration System |
| Common Name of Device | Catheter, Thrombus Retriever |
| Review Panel | Neurology |
| Medical Specialty | Cardiovascular |
| Product Code | NRY |
| Regulation Number | 21 CFR 870.1250 |
| Regulation Name | Percutaneous Catheter |
| Device Classification | Class II |
| Predicate Device | Riptide™ Aspiration System (K201689) |
Device Description
The Riptide™ Aspiration System is designed to restore blood flow in 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, using continuous aspiration. The Riptide™ Aspiration System is composed of the following components and illustrated in Figure 1:
-
- React™ 68 Catheter (REACT-68), React™ 71 Catheter (REACT-71, REACT-71-115, REACT-71-125)
-
- Riptide™ Large Bore Aspiration Tubing (MAT-110-110)
-
- Riptide™ Aspiration Pump (MAP-1000)
-
- Riptide™ Collection Canister with Intermediate Tubing (MAC-1200)
Image /page/4/Figure/9 description: The image shows a medical device with four labeled parts. Part 1 is a thin, coiled tube. Part 2 is a connector between two tubes. Part 3 is the main unit of the device, which includes a knob and a pressure gauge. Part 4 is a container with measurement markings.
Figure 1. Riptide™ Aspiration System
5
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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
| Attribute | Predicate Device: | Subject Device: |
|---|---|---|
| Riptide™ Aspiration System (K201689) | Riptide™ Aspiration System (K243080) | |
| General | ||
| Indication for | ||
| Use Statement | 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. | 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 | ||
| thrombolytic drug therapy or who failed | ||
| thrombolytic drug therapy are | ||
| candidates for treatment. | ||
| Devices | ||
| Comprising the | ||
| System | • React™ 68 Catheter (REACT-68) | |
| • React™ 71 Catheter (REACT-71) | ||
| • Riptide™ Large Bore Aspiration | ||
| Tubing (MAT-110-110) | ||
| • Riptide™ Aspiration Pump | ||
| (MAP- 1000) | ||
| • Riptide™ Collection Canister with | ||
| Intermediate Tubing (MAC-1200) | • React™ 68 Catheter (REACT-68) | |
| • React™ 71 Catheter (REACT-71, | ||
| REACT-71-115, REACT-71-125) | ||
| • Riptide™ Large Bore Aspiration | ||
| Tubing (MAT-110-110) | ||
| • Riptide™ Aspiration Pump | ||
| (MAP- 1000) | ||
| • Riptide™ Collection Canister with | ||
| Intermediate Tubing (MAC-1200) | ||
| React™ 68 Catheter | ||
| Materials of | ||
| Construction | Commonly used medical grade plastics | |
| and metals with hydrophilic coating | Same as K201689 | |
| Inner Diameter | 0.068" | Same as K201689 |
| Outer Diameter | 0.083" | Same as K201689 |
| Usable Length | 132 cm | Same as K201689 |
| Accessory | Peelable split-y introducer sheath | Same as K201689 |
| Packaging | Polyethylene hoop/backing card, nylon- | |
| Tyvek™ pouch, SBS carton | Same as K201689 | |
| Sterilization | Ethylene oxide, SAL 10-6 | Same as K201689 |
| Shelf Life | 2 years | Same as K201689 |
| React™ 71 Catheter | ||
| Attribute | Predicate Device: | |
| Riptide™ Aspiration System (K201689) | Subject Device: | |
| Riptide™ Aspiration System (K243080) | ||
| Materials of | ||
| Construction | Commonly used medical grade plastics | |
| and metals with hydrophilic coating | Same as K201689 | |
| Inner Diameter | 0.071" | Same as K201689 |
| Outer Diameter | 0.0855" (Max) | Same as K201689 |
| Usable Length | 132 cm | 115, 125, and 132 cm |
| Accessory | Peelable split-y introducer sheath | Same as K201689 |
| Packaging | Polyethylene hoop/backing card, nylon- | |
| Tyvek™ pouch, SBS carton | Same as K201689 | |
| Sterilization | Ethylene oxide, SAL 10-6 | Same as K201689 |
| Shelf Life | 2 years | Same as K201689 |
| Riptide™ Large Bore Aspiration Tubing | ||
| Materials of | ||
| Construction | Commonly used medical grade | |
| plastics | Same as K201689 | |
| Inner Diameter | 0.110" | Same as K201689 |
| Outer Diameter | 0.188" | Same as K201689 |
| Usable Length | 112.0" | Same as K201689 |
| Packaging | Nylon-Tyvek™ pouch, SBS carton | Same as K201689 |
| Sterilization | Ethylene oxide, SAL 10-6 | Same as K201689 |
| Shelf Life | 3 years | Same as K201689 |
| Riptide™ Aspiration Pump | ||
| Vacuum Range | 0-29 inHg (0-98.2 kPa) | Same as K201689 |
| Flow Rate | MAP-1000 (60 Hz): 0-0.8 SCFM (0-23 | |
| LPM) | Same as K201689 | |
| Voltage | MAP-1000: 110-115 Vac (US) | Same as K201689 |
| Frequency | 60 Hz | Same as K201689 |
| Duty Cycle | Non-continuous | |
| 97% (58.2 minutes on, 1.8 minutes off) | Same as K201689 | |
| Applied Part | ||
| Classification | Type BF | Type CF |
| IEC 60601-1 | ||
| and | ||
| IEC 60601-1-2 | ||
| Compliance | Yes: | |
| IEC 60601-1 (Edition 3.1) and | ||
| IEC 60601-1-2 (Edition 4.0) | Yes: | |
| IEC 60601-1 (Edition 3.2 2020-08) | ||
| IEC 60601-1-2 (Edition 4.1 2020-09) | ||
| ISO 10079-1 | ||
| and | ||
| ISO 10079-4 | ||
| Compliance | No | Yes: |
| ISO 10079-1 (Fourth edition 2022-03) | ||
| ISO 10079-4 (First edition 2021-08) | ||
| Physical | ||
| Dimensions | Length: 16.1" | |
| Depth: 13.2" | ||
| Height: 12.3" | Same as K201689 | |
| Weight | MAP-1000: Approximately 24 lbs (11 kg) | Same as K201689 |
| Noise | 60.5 dBa |