(179 days)
No
The device description and specifications detail a mechanical medical device used for reperfusion, consisting of catheters, tubing, and a sheath system. There is no mention of any computational components, software, or data processing capabilities that would suggest the presence of an AI model.
Yes
The device is indicated for use in the revascularization of patients with acute ischemic stroke, which directly treats a medical condition.
No
Explanation: The device is a reperfusion system designed to treat acute ischemic stroke by removing large vessel occlusions. Its primary function is therapeutic (revascularization), not diagnostic.
No
The device is composed of physical components like catheters, tubing, and sheaths, designed for a physical medical procedure (revascularization of stroke patients). It is intended to be used with a compatible vacuum pump, further indicating it's a hardware system. There is no mention of software being the primary medical device, nor any computational or algorithmic components that would classify it as software-only.
No.
This device is an interventional medical device used for revascularization in acute ischemic stroke, which involves direct physical intervention within the body (intracorporeal) rather than testing samples from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment 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 Aspiration Catheter, Delivery Catheter, and Base Camp Sheath comprise the Route 92 Medical HiPoint Reperfusion System. The Route 92 Medical HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System.
The Aspiration Catheter has a single-lumen, coil-reinforced polymer distal shaft section connected to a proximal control wire. The Delivery Catheter is a single-lumen variable stiffness catheter. Both catheters have hydrophilic coating. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.
For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set.
The Route 92 Medical Base Camp Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8 French (F) or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
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 artery and middle cerebral artery M1 segment; Neurovasculature
Indicated Patient Age Range
Age >=18 years
Intended User / Care Setting
Physicians trained in neurovascular interventional techniques; hospital setting
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
Non-Clinical Testing:
- Shelf Life and Sterility: The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing were sterilized using an ethylene oxide sterilization cycle verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. Aging studies established that the device and packaging remain functional for the labeled expiration date.
- Biocompatibility Testing: Not required as patient-contacting materials were unchanged from reference devices K201518, K203043, K223530, K191717, and K240529.
- Performance Testing:
- Simulated Use Testing: Deliverability, clot retrieval, device integrity, kink and aspiration resistance, lumen patency, durability, and compatibility with accessory devices were evaluated in a neurovascular model. Results: All samples met predetermined acceptance criteria.
- Lumen Patency Testing: Test specimens were tested for lumen patency under vacuum. Results: All samples met predetermined acceptance criteria.
- Dimensional Verification: Device dimensions were measured to confirm conformance to specifications. Results: All samples met predetermined acceptance criteria.
- Luer Integrity: Tested per ISO 80369-7:2021. Results: All samples met predetermined acceptance criteria.
- Tensile Strength: The tensile strength of the catheter sections and bonds was tested. Results: All samples met predetermined acceptance criteria.
- Kink Resistance: Test specimen segments were formed into a defined bend diameter. Results: All samples met predetermined acceptance criteria.
- Torsion Resistance: Test specimens were rotated to evaluate integrity after rotation. Results: All samples met predetermined acceptance criteria.
- Tip Flexibility: Test specimens were tested for tip flexibility. Results: All samples met predetermined acceptance criteria.
- Air Leakage: Tested per ISO 10555-1:2013 Annex D. Results: All samples met predetermined acceptance criteria.
- Liquid Leakage: Tested per ISO 10555-1:2013 Annex C. Results: All samples met predetermined acceptance criteria.
- Static Burst: Tested per ISO 10555-1:2013 Annex F. Results: All samples met predetermined acceptance criteria.
- Dynamic Burst: Mechanical integrity was assessed under pressure. Results: All samples met predetermined acceptance criteria.
- Hydrophilic Coating Integrity: The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. Results: All samples met predetermined acceptance criteria.
- Aspiration Pressure: The vacuum pressure at the tip of the catheter was assessed during aspiration. Results: All samples met predetermined acceptance criteria.
- Particulate: The size and quantity of particulates generated during simulated use were evaluated. Results: All samples met predetermined acceptance criteria.
Animal Studies:
- Study Type: Chronic animal study conducted according to GLP in a swine model.
- Purpose: To demonstrate safety and performance and establish substantial equivalence to the predicate device.
- Protocol: Animals terminated at subacute (3-day) or chronic (30-day) time points. Devices evaluated under worst-case clinical conditions: soft and firm clot aspiration, wedge aspiration, downstream organ assessment, and in-life observations. Postmortem assessment of treated vessels performed.
- Key Results: Study findings for the subject device were comparable to the predicate device, demonstrating substantial equivalence.
Clinical Studies:
- Study Type: SUMMIT MAX, a prospective, multi-center, randomized, controlled, interventional, open-label clinical trial.
- Purpose: Evaluating safety and effectiveness of the Route 92 Medical HiPoint Reperfusion System for removing occlusions in acute ischemic stroke patients as compared to a predicate device (AXS Vecta Aspiration System).
- Patient Population:
- Inclusion Criteria: Age ≥18 years; clinical signs consistent with acute ischemic stroke; baseline NIHSS score ≥ 6; pre-stroke mRS ≤ 2; baseline ASPECTS ≥ 6; endovascular treatment initiated within 8 hours from time last known well; angiographic confirmation of large vessel occlusion of M1 segment of MCA or distal ICA.
- Exclusion Criteria: Known pregnancy or breast feeding; known comorbidity complicating treatment or follow-up; terminal illness with 3.0; baseline platelet count 400 mg/dL; participation in another investigational device/drug study; clinical symptoms of bilateral stroke or stroke in multiple territories; CT/MRI evidence of recent/fresh cerebral hemorrhage (microbleeds allowed); intracranial tumor (except small meningioma ≤ 2 cm) or significant mass effect; presumed septic thrombus or bacterial endocarditis; inability to access cerebral vasculature; unlikely to be available for 90-day follow-up; arterial dissection in traversed vessel; high-grade stenosis or occlusion (tandem occlusion) in traversed vessel; known active/recent cocaine/methamphetamine abuse; known history/presence of aneurysm/AVM in target lesion territory; severe sustained hypertension; heparin within 48 hours with PTT > 2x normal or LMWH within 48 hours; renal failure with serum creatinine > 3.0 or GFR 3 passes considered failure):** Subject device: 76.4% (68/89), predicate device: 48.1% (37/77). Difference was 28.4% (95% CI: 14.1%, 42.6%), p 3 passes failure):**
- Route 92: 76.4% (68/89)
- Vecta: 48.1% (37/77)
- Incidence of symptomatic intracranial hemorrhage (sICH) within 24 hours:
- Route 92: 3.6% (3/84)
- Vecta: 2.7% (2/75)
- Successful arterial revascularization after use of assigned device (subsequent adjunctive therapy not failure):
- Route 92: 80.9% (72/89)
- Vecta: 70.1% (54/77)
- Device-related SAEs:
- Route 92: 5.6% (5/89)
- Vecta: 2.6% (2/77)
- Good clinical outcome (mRS ≤ 2) at 90-day follow-up:
- Route 92: 50.6% (44/87)
- Vecta: 53.3% (40/75)
- Incidence of all intracranial hemorrhages within 24 hours:
- Route 92: 42.7% (38/89)
- Vecta: 49.4% (38/77)
- Proportion of subjects with First Pass Effect (FPE) (mTICI ≥ 2b):
- Route 92: 60.5% (52/86)
- Vecta: 54.5% (36/66)
Predicate Device(s)
AXS Vecta Aspiration System, K191768
Reference Device(s)
Route 92 Medical 088 Access System, K201518, Route 92 Medical 070 Access System, K203043, Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, K223530, 8F Modified Sheath System (Route 92 Medical Base Camp Sheath System), K240529, Route 92 Medical Base Camp Sheath System, K191717
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).
FDA 510(k) Clearance Letter - Route 92 Medical HiPoint Reperfusion System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 19, 2025
Route 92 Medical, Inc.
Kirsten Valley
Chief Operating Officer
155 Bovet Road, Suite 100
San Mateo, California 94402
Re: K243601
Trade/Device Name: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: NRY
Dated: April 14, 2025
Received: April 15, 2025
Dear Kirsten Valley:
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.
Page 2
K243601 - Kirsten Valley Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243601 - Kirsten Valley Page 3
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243601
Device Name: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Indications for Use (Describe):
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(K) SUMMARY
Sponsor: Route 92 Medical, Inc.
155 Bovet Road, Suite 100
San Mateo, CA 94402
Phone: 650-581-1179
Contact: Kirsten Valley
Date Prepared: May 8, 2025
Device Name: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Common Name: Percutaneous Catheter
Classification Name: Catheter, Thrombus Retriever (21 CFR 870.1250)
Product Code: NRY
Device Classification: Class II
Predicate Device: AXS Vecta Aspiration System, K191768
Reference Devices:
- Route 92 Medical 088 Access System, K201518
- Route 92 Medical 070 Access System, K203043
- Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, K223530
- 8F Modified Sheath System (Route 92 Medical Base Camp Sheath System), K240529
- Route 92 Medical Base Camp Sheath System, K191717
Device Description
The Aspiration Catheter, Delivery Catheter, and Base Camp Sheath comprise the Route 92 Medical HiPoint Reperfusion System. The Route 92 Medical HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System.
The Aspiration Catheter has a single-lumen, coil-reinforced polymer distal shaft section connected to a proximal control wire. The Delivery Catheter is a single-lumen variable stiffness catheter. Both catheters have hydrophilic coating. The devices are provided sterile and non-pyrogenic and are intended for single use only.
Page 6
The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.
For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set.
The Route 92 Medical Base Camp Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8 French (F) or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
Indications for Use
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Comparison to the Predicate Device
The method of action, design, and materials of the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set are substantially equivalent to the predicate device as shown in the following table.
| Attribute | Predicate Device K191768, AXS Vecta Aspiration System (Stryker Neurovascular) | Subject Device K243601, Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (Route 92 Medical) |
|---|---|---|
| Indications for Use | The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated 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 failed IV t- | The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who |
Page 7
| Attribute | Predicate Device K191768, AXS Vecta Aspiration System (Stryker Neurovascular) | Subject Device K243601, Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (Route 92 Medical) |
|---|---|---|
| PA therapy are candidates for treatment. | failed thrombolytic drug therapy are candidates for treatment. | |
| Device Description | The AXS Vecta Aspiration Catheter is a variable stiffness catheter with a continuous polymer shaft. A Scout Introducer to facilitate delivery is provided. | The Aspiration Catheter is a variable stiffness catheter with a distal polymer shaft section connected to a proximal control wire. A Delivery Catheter to facilitate delivery of the Aspiration Catheter is provided. The HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System. |
| User | Physicians trained in neurovascular interventional techniques | Same |
| Anatomical Sites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly used in the manufacture of medical devices | Same |
| Sterilization | Ethylene oxide | Same |
Aspiration Catheter
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| Inner Diameter (nominal) | 0.074" (Vecta 74), 0.071" (Vecta 71) | 0.088" (88 Aspiration Catheter), 0.070" (70 Aspiration Catheter) |
| Outer Diameter (nominal) | 0.083" distal / 0.087" proximal (Vecta 74), 0.082" distal / 0.085" proximal (Vecta 71) | 0.101" distal / 0.105" proximal (88 Aspiration Catheter), 0.082" distal / 0.087" proximal (70 Aspiration Catheter) |
| Length | 115, 125, 132 cm | 143 cm (88 Aspiration Catheter), 142 cm (70 Aspiration Catheter) |
Delivery Catheter
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| Inner Diameter | 0.044" | 0.019" |
| Outer Diameter | 0.058" | 0.080" distal /0.062" proximal (88 Delivery Catheter), 0.062" (70 Delivery Catheter) |
Page 8
| Attribute | Predicate Device K191768, AXS Vecta Aspiration System (Stryker Neurovascular) | Subject Device K243601, Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (Route 92 Medical) |
|---|---|---|
| Length | 133, 143, 150 cm | 151 cm |
| Compatibility: Pump for Aspiration | Medela Dominant Flex Pump or equivalent | Portable vacuum pump designed for use in the hospital setting that is capable of providing a constant vacuum of -25 inHg to -27.5 inHg. |
| Aspiration Tubing | AXS Universal Aspiration Tubing | Route 92 Medical Aspiration Tubing Set (K223530) |
Non-Clinical Testing
Shelf Life and Sterility
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing are sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. Aging studies established that the subject device and packaging remain functional for the labeled expiration date.
Biocompatibility Testing
The patient-contacting materials of the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set were unchanged compared to the reference devices K201518, K203043, K223530, K191717, and K240529; therefore, no additional biocompatibility testing was required.
Performance Testing
The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical HiPoint Reperfusion System is suitable for its intended use.
| Test | Test Method | Results |
|---|---|---|
| Simulated Use Testing | Deliverability, clot retrieval, device integrity, kink and aspiration resistance, lumen patency, durability and compatibility with accessory devices were evaluated in a neurovascular model. | PASS - All samples met the predetermined acceptance criteria |
| Lumen Patency Testing | Test specimens were tested for lumen patency under vacuum. | PASS - All samples met the predetermined acceptance criteria |
| Dimensional Verification | Device dimensions were measured to confirm conformance to the specifications. | PASS - All samples met the predetermined acceptance criteria |
Page 9
| Test | Test Method | Results |
|---|---|---|
| Luer Integrity | Tested per ISO 80369-7:2021. | PASS - All samples met the predetermined acceptance criteria |
| Tensile Strength | The tensile strength of the catheter sections and bonds was tested. | PASS - All samples met the predetermined acceptance criteria |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | PASS - All samples met the predetermined acceptance criteria |
| Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation. | PASS - All samples met the predetermined acceptance criteria |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASS - All samples met the predetermined acceptance criteria |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS - All samples met the predetermined acceptance criteria |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS - All samples met the predetermined acceptance criteria |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | PASS - All samples met the predetermined acceptance criteria |
| Dynamic Burst | Mechanical integrity was assessed under pressure. | PASS - All samples met the predetermined acceptance criteria |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. | PASS - All samples met the predetermined acceptance criteria |
| Aspiration Pressure | The vacuum pressure at the tip of the catheter was assessed during aspiration. | PASS - All samples met the predetermined acceptance criteria |
| Particulate | The size and quantity of particulates generated during simulated use were evaluated. | PASS - All samples met the predetermined acceptance criteria |
Page 10
Animal Studies
A chronic animal study was conducted according to good laboratory practices (GLP) in a swine model to demonstrate the safety and performance of the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set to establish substantial equivalence to the predicate device. Study animals were terminated at either subacute (3-day) or chronic (30-day) time points. Devices were evaluated under worst-case clinical conditions, including soft and firm clot aspiration, wedge aspiration, downstream organ assessment, and in-life observations. Postmortem assessment of treated vessels was performed. The study findings for the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set were comparable to the predicate device demonstrating substantial equivalence.
Clinical Studies
Summary
SUMMIT MAX was a prospective, multi-center, randomized, controlled, interventional, open-label clinical trial evaluating safety and effectiveness of the Route 92 Medical HiPoint Reperfusion System for removing occlusions in acute ischemic stroke patients as compared to a predicate device (AXS Vecta Aspiration System).
Patient Population
Key inclusion criteria were as follows: age 18 and older, baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6, pre-stroke modified Rankin Scale (mRS) of 2 or less, baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6, and endovascular treatment initiated within 8 hours of symptom onset. Angiographic confirmation of a middle cerebral artery (MCA) M1 segment or internal carotid artery (ICA) occlusion was required. Intravenous thrombolysis was allowed. Complete inclusion and exclusion criteria are listed below.
Inclusion Criteria
- The consent process has been completed and documented according to applicable country regulations and as approved by the IRB / Ethics Committee.
- Age ≥18 years.
- Patient presenting with clinical signs consistent with an acute ischemic stroke.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6.
- Pre-stroke modified Rankin Score (mRS) ≤ 2.
- Baseline ASPECTS ≥ 6.
- Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well.
- If indicated, thrombolytic therapy shall be initiated per clinical guidelines. If eligible for thrombolytic therapy, subjects should be treated as soon as possible, and lytic use should not be delayed regardless of potential eligibility for mechanical neurothrombectomy.
- The patient was indicated for aspiration neurothrombectomy with the Route 92 Medical Reperfusion System as determined by the Investigator.
Angiographic Inclusion Criteria
- Angiographic confirmation of a large vessel occlusion of the M1 segment of the middle cerebral artery or distal internal carotid artery (patency of the cervical ICA to the origin
Page 11
of the ophthalmic artery).
Exclusion Criteria
- Known pregnancy or breast feeding.
- In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up.
- Known serious, advanced, or terminal illness with anticipated life expectancy 3.0.
- Known baseline platelet count 400 mg/dL.
- Known to be participating in another study involving an investigational device or drug.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/fresh cerebral hemorrhage (the presence of microbleeds was allowed).
- Baseline CT or MRI showing intracranial tumor (except small meningioma ≤ 2 cm) or significant mass effect with midline shift due to the tumor.
- Presumed septic thrombus, or suspicion of bacterial endocarditis.
- Inability to access the cerebral vasculature in the opinion of the neurointerventional team.
- Unlikely to be available for a 90-day follow-up (e.g., no fixed home address).
- Evidence of arterial dissection in a vessel that must be traversed.
- Evidence of high-grade stenosis or occlusion (i.e., tandem occlusion) in a vessel that must be traversed.
- Known active or recent history of cocaine or methamphetamine abuse (within last 6 months).
- Known history or presence of aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion.
- For all patients, severe sustained (15 minutes or more) hypertension with SBP > 200 and/or DBP >120; for patients treated with a lytic, sustained hypertension despite treatment with SBP >185 and/or DBP >110.
- Treatment with heparin within 48 hours with a partial thromboplastic time more than two times the laboratory normal or treatment with any low molecular weight heparin (LMWH) within 48 hours.
- Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) 3 passes considered a failure, % (n/N) | 76.4% (68/89) | 48.1% (37/77) | 28.4% (14.1%, 42.6%) |