(29 days)
No
The device description focuses on mechanical components (catheters, tubing, pump, canister) and their function (generating vacuum). There is no mention of software, algorithms, or data processing that would suggest AI/ML is involved. The performance studies are bench tests of physical attributes.
Yes
The device is described as an "Aspiration System" intended for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which directly involves treating a medical condition.
No
This device is designed for the revascularization of patients with acute ischemic stroke, which is a therapeutic intervention, not a diagnostic one.
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 IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a therapeutic intervention performed in vivo (within the body) to treat a medical condition.
- Device Description: The description details a system designed to generate vacuum and aspirate material from blood vessels. This is consistent with a medical device used for a therapeutic procedure, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The purpose is to remove blockages from blood vessels.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Riptide™ Aspiration System does not fit this description.
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 is composed of the following components:
-
- React™ Catheters
-
- Riptide™ Large Bore Aspiration Tubing
-
- Riptide™ Aspiration Pump
-
- RiptideTM Collection Canister with Intermediate Tubing
No changes were made to the catheters, tubing or collection canister with intermediate tubing cleared in the predicate system under K172448 and, most recently, under K183185.
The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide Aspiration System. The vacuum pressure of the Riptide Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel (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 performed for the Riptide™ Aspiration System:
- Functionality Test: The subject Riptide™ Aspiration System was tested to ensure the device meets the product specification for functionality testing. Results: The subject Riptide™ Aspiration System met the acceptance criteria for functional testing.
- Vacuum Pressure Test (Pump): The subject Riptide™ Aspiration System was tested to ensure the device meets the product specification for vacuum pressure. Results: The subject Riptide™ Aspiration System met the acceptance criteria for maximum vacuum pressure.
- Flow Rate Test (Pump): The subject Riptide™ Aspiration System was tested to ensure the device meets the product specification for volumetric flow rate. Results: The subject Riptide™ Aspiration System met the acceptance criteria for volumetric flow rate.
- Electrical Safety per IEC 60601-1: The subject Riptide™ Aspiration System was tested to demonstrate it conforms to AAMI/IEC 60601-1:2005 + AMD 1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Results: The subject Riptide™ Aspiration System met the acceptance criteria for demonstrating conformance to AAMI/IEC 60601-1:2005 + AMD 1:2012.
- Electromagnetic Compatibility per IEC 60601-1-2: The subject Riptide Aspiration System was tested to demonstrate compliance to IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests. Results: The subject Riptide™ Aspiration System met the acceptance criteria for demonstrating compliance to IEC 60601-1-2.
- Recanalization Test: The subject Riptide™ Aspiration System was tested to ensure it is able to aspirate a clot in the occluded vessel at recanalization rates similar to the predicate device. Results: The subject Riptide™ Aspiration System met the acceptance criteria for recanalization for the Riptide™ Aspiration System.
- Vacuum Pressure Test (Catheter Tip): The subject Riptide™ Aspiration System was tested to ensure it is capable of accurately translating vacuum pressure, generated by the pump, to the tip of the catheter. Results: The subject Riptide™ Aspiration System met the acceptance criteria for vacuum pressure.
- Volumetric Flow Rate Test (Catheter): The subject Riptide™ Aspiration System was tested to ensure it generates sufficient flow through the catheter to facilitate efficacious withdrawal of the clot from the vasculature. Results: The subject Riptide™ Aspiration System met the acceptance criteria for volumetric flow rate.
Non-clinical bench testing leveraged from the predicate Riptide™ System:
- Functionality, Post-Durability: Results: The subject Riptide™ Aspiration System met the acceptance criteria for functionality, post-durability.
- Tip-over Resistance / Degree of Tilt: Results: The subject Riptide™ Aspiration System met the acceptance criteria for tip-over resistance/degree of tilt.
- Usability: Results: The subject Riptide™ Aspiration System met the acceptance criteria for usability.
- Clot Engagement and Aspiration: Results: The subject Riptide™ Aspiration System met the acceptance criteria for clot engagement and aspiration.
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.
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
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July 21, 2020
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Kristy Ann Darling, RAC Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618
Re: K201689
Trade/Device Name: Riptide Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 19, 2020 Received: June 22, 2020
Dear Kristy Ann Darling:
We have reviewed vour 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/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 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 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-regulatoryassistance/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, Ph.D. Assistant Director (Acting) 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
2
Indications for Use
510(k) Number (if known) K201689
Device Name Riptide™ Aspiration System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | true |
|---|---|
| Over-The-Counter Use (21 CFR 807) | false |
|| | 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:
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration: 2029214 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristy Ann Darling
Senior Regulatory Affairs Specialist
Telephone: (949) 490-3819
Email: kristyann.d.darling@medtronic.com |
| Date Summary Prepared: | July 20, 2020 |
|---|---|
| Trade Name of Device: | Riptide™ Aspiration System |
| 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: | Riptide™ Aspiration System |
| 510(k): K172448 |
Device Description:
The Riptide™ Aspiration System is composed of the following components:
-
- React™ Catheters
-
- Riptide™ Large Bore Aspiration Tubing
-
- Riptide™ Aspiration Pump
-
- RiptideTM Collection Canister with Intermediate Tubing
No changes were made to the catheters, tubing or collection canister with intermediate tubing cleared in the predicate system under K172448 and, most recently, under K183185.
The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide Aspiration System. The vacuum pressure of the Riptide Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.
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
4
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.
5
Device Comparison:
| Attribute | Predicate Device:
Riptide™ Aspiration System
(K172448) | Subject Device:
Riptide™
Aspiration
System |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indication for
Use (IFU)
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. | Same |
| IEC 60601-1
Compliance | Yes | Same |
| IEC 60601-1-2
Compliance | Yes | Same |
| Voltage | 110-115 Vac | 220-240 Vac |
| Frequency | 60 Hz | 50/60 Hz |
| Sterilization | Non-sterile | Same |
The following non-clinical bench testing was performed for the Riptide™ Aspiration System:
6
| Test | Test Method Summary | Results |
|---|---|---|
| Functionality | The subject Riptide™ | |
| Aspiration System was | ||
| tested to ensure the device | ||
| meets the product | ||
| specification for | ||
| functionality testing. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| functional testing. | ||
| Vacuum Pressure | The subject Riptide™ | |
| Aspiration System was | ||
| tested to ensure the device | ||
| meets the product | ||
| specification for vacuum | ||
| pressure. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| maximum vacuum pressure. | ||
| Flow Rate | The subject Riptide™ | |
| Aspiration System was | ||
| tested to ensure the device | ||
| meets the product | ||
| specification for volumetric | ||
| flow rate. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| volumetric flow rate. | ||
| Electrical Safety per IEC | ||
| 60601-1 | The subject Riptide™ | |
| Aspiration System was tested | ||
| to demonstrate it conforms to | ||
| AAMI/IEC 60601-1:2005 + | ||
| AMD 1:2012 Medical | ||
| electrical equipment - Part 1: | ||
| General requirements for | ||
| basic safety and essential | ||
| performance. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| demonstrating conformance to | ||
| AAMI/IEC 60601-1:2005 + AMD | ||
| 1:2012. | ||
| Electromagnetic Compatibility | ||
| per IEC 60601-1-2 | The subject Riptide | |
| Aspiration System was | ||
| tested to demonstrate | ||
| compliance to IEC 60601-1- | ||
| 2: 2014 Medical electrical | ||
| equipment - Part 1-2: | ||
| General requirements for | ||
| basic safety and essential | ||
| performance -Collateral | ||
| Standard: Electromagnetic | ||
| disturbances - Requirements | ||
| and tests. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria. | ||
| for demonstrating compliance to IEC | ||
| 60601-1-2. | ||
| Test | Test Method Summary | Results |
| Recanalization | The subject Riptide™ | |
| Aspiration System was | ||
| tested to ensure it is able to | ||
| aspirate a clot in the | ||
| occluded vessel at | ||
| recanalization rates similar | ||
| to the predicate device. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| recanalization for the Riptide™ | ||
| Aspiration System. | ||
| Vacuum Pressure | The subject Riptide™ | |
| Aspiration System was | ||
| tested to ensure it is capable | ||
| of accurately translating | ||
| vacuum pressure, generated | ||
| by the pump, to the tip of the | ||
| catheter | The subject Riptide™ Aspiration | |
| System met the acceptance criteria | ||
| for vacuum pressure. | ||
| Volumetric Flow Rate | The subject Riptide™ | |
| Aspiration System was | ||
| tested to ensure it generates | ||
| sufficient flow through the | ||
| catheter to facilitate | ||
| efficacious withdrawal of the | ||
| clot from the vasculature. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| volumetric flow rate. |
The following non-clinical bench testing was also performed for the Riptide™ Aspiration System:
7
8
| Test | Test Method Summary | Results |
|---|---|---|
| Functionality, Post-Durability | Leveraged from predicate | |
| device. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| functionality, post-durability. | ||
| Tip-over Resistance / Degree | ||
| of Tilt | Leveraged from predicate | |
| device. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| tip-over resistance/degree of tilt. | ||
| Usability | Leveraged from predicate | |
| device. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| usability. | ||
| Clot Engagement and | ||
| Aspiration | Leveraged from predicate | |
| device. | The subject Riptide™ Aspiration | |
| System met the acceptance criteria for | ||
| clot engagement and aspiration. |
The following non-clinical bench testing was leveraged from the predicate Riptide™ System:
Performance Data - Animal:
There is no change to the Indication for Use (IFU) Statement of the subject Riptide™ Aspiration System in comparison to the legally marketed predicate device. The difference in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Performance Data - Clinical:
There is no change to the Indication for Use (IFU) Statement of the subject Riptide™ Aspiration System in comparison to the legally marketed predicate device. The difference in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Conclusion:
There is no change to the Indication for Use (IFU) Statement of the subject Riptide™ Aspiration System in comparison to the legally marketed predicate device. In addition, the subject Riptide™ System is equivalent in terms of fundamental scientific technology in comparison to the legally marketed predicate device. The difference in technological characteristics does not raise new questions on the safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods. Therefore, the subject Riptide™ Aspiration System does not raise new questions of safety or efficacy based on comparison to the legally marketed predicate device. In conclusion, the results of the nonclinical testing performed and leveraged for the subject device support a determination of substantial equivalence by demonstrating that the device is at least as safe and effective as the legally marketed predicate device.