Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Device Facts
| Record ID | K223530 |
|---|---|
| Device Name | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set |
| Applicant | Route 92 Medical, Inc. |
| Product Code | NRY · Cardiovascular |
| Decision Date | Apr 11, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated 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 failed IV t-PA therapy are candidates for treatment.
Device Story
System comprises Aspiration Catheter, Tenzing 7 Delivery Catheter, and Aspiration Tubing Set. Used by neurovascular-trained physicians in hospital settings for mechanical thrombectomy. Catheters are single-lumen, coil-reinforced, variable stiffness, and hydrophilically coated. Tubing set connects to a hospital-provided vacuum pump (constant vacuum -25 to -27.5 inHg) and collection canister. Physician navigates catheters to the occlusion site under fluoroscopic guidance; applies vacuum via tubing set to aspirate thrombus. Output is revascularization of occluded intracranial vessels. Benefits include restoration of blood flow in acute ischemic stroke patients.
Clinical Evidence
No human clinical data. Evidence consists of bench testing (simulated use, dimensional verification, tensile strength, kink/torsion resistance, burst testing, coating integrity) and two GLP chronic swine studies (3-day and 30-day) evaluating safety, clot retrieval performance, and downstream tissue assessment.
Technological Characteristics
Single-lumen, coil-reinforced, variable stiffness catheters; hydrophilic coating. Materials: polymers and metals (polyurethane, nylon, polycarbonate, PVC). Sterilization: 100% ethylene oxide (ISO 11135). Connectivity: manual connection to external vacuum pump. Standards: ISO 10993-1 (biocompatibility), ISO 80369-7 (Luer), ISO 10555-1 (catheter performance), ISO 11607-1 (packaging).
Indications for Use
Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include those ineligible for or failed IV t-PA therapy.
Regulatory Classification
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.
Predicate Devices
- Penumbra System ACE 68 Reperfusion Catheter (K161064)
Reference Devices
- Route 92 Medical Full Length 070 Access System (K222743)
Submission Summary (Full Text)
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April 11, 2023
Image /page/0/Picture/1 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Route 92 Medical, Inc. Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
#### Re: K223530
Trade/Device Name: Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 10, 2023 Received: March 10, 2023
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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS)
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 mediation-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 -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
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# Indications for Use
510(k) Number (if known) K223530
Device Name
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Indications for Use (Describe)
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute 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-PA therapy are candidates for treatment.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(K) SUMMARY K223530
| Sponsor: | Route 92 Medical, Inc.<br>155 Bovet Road, Suite 100<br>San Mateo, CA 94402<br>Phone: 650-581-1179 |
|-----------------------|---------------------------------------------------------------------------------------------------|
| Contact: | Kirsten Valley |
| Date Prepared: | April 7, 2023 |
| Device Name: | Route 92 Medical Full Length 070 Reperfusion System and<br>Aspiration Tubing Set |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Thrombus Retriever (Product Code NRY, 21<br>CFR 870.1250) |
| Device Classification | Class II |
| Predicate Device: | Penumbra System ACE 68 Reperfusion Catheter<br>K161064 |
| Reference Device: | Route 92 Medical Full Length 070 Access System,<br>K222743 |
#### Device Description
The Aspiration Catheter and Tenzing 7 Delivery Catheter comprise the Route 92 Medical Full Length 070 Reperfusion System. The Route 92 Medical Full Length 070 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.
The Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 7 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. 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, along with a legally marketed canister and accessories kit.
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#### Indications for Use
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated 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 failed IV t-PA therapy are candidates for treatment.
#### Comparison to the Predicate Device
The method of action, design, and materials of the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set are substantially equivalent to the predicate device as shown in the following table.
| Attribute | Predicate Device<br>Penumbra System ACE 68<br>Reperfusion Catheter, K161064 | Subject Device<br>Route 92 Medical Full Length 070<br>Reperfusion System and Aspiration<br>Tubing Set |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Penumbra System is intended for<br>use in the revascularization of patients<br>with acute ischemic stroke secondary<br>to intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral – M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset. | The Route 92 Medical Full Length<br>070 Reperfusion System and<br>Aspiration Tubing Set is indicated for<br>use in the revascularization of patients<br>with acute ischemic stroke secondary<br>to intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral – M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset. Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who failed IV t-<br>PA therapy are candidates for<br>treatment. |
| Device<br>Description | The Penumbra System ACE 68<br>Reperfusion Catheter includes an<br>aspiration catheter, a shaping<br>mandrel, a peel-away introducer<br>sheath, and an RHV. | The Route 92 Medical Full Length<br>070 Reperfusion System includes an<br>Aspiration Catheter and a Tenzing 7<br>Delivery Catheter and is used with the<br>Route 92 Medical Aspiration Tubing<br>Set. |
| User | Physicians trained in neurovascular<br>interventional techniques | Same |
| Anatomical<br>Sites | Neurovasculature only | Same |
| Attribute | Predicate Device<br>Penumbra System ACE 68<br>Reperfusion Catheter, K161064 | Subject Device<br>Route 92 Medical Full Length 070<br>Reperfusion System and Aspiration<br>Tubing Set |
| Materials | Polymers and metals commonly used<br>in the manufacture of medical devices | Same |
| Sterilization | 100% ethylene oxide | Same |
| Aspiration Catheter | | |
| Inner<br>Diameter | 0.068" | 0.070" |
| Outer<br>Diameter | 0.084" | 0.084" |
| Length | 115, 120, 125, 127, 132 cm | 132 cm |
| Delivery Catheter | | |
| Inner<br>Diameter | Not applicable | 0.019" |
| Outer<br>Diameter | Not applicable | 0.062" |
| Length | Not applicable | 151 cm |
| Compatibility:<br>Pump for<br>Aspiration | Penumbra Aspiration Pump is a<br>portable vacuum pump designed for<br>use in hospital settings which operates<br>on AC power at a frequency of 60 Hz.<br>The Penumbra Pump is provided non-<br>sterile and is used outside the sterile<br>field. | Commercially available vacuum<br>pump designed for use in hospital<br>settings that is compatible with the<br>Route 92 Medical Reperfusion<br>System and provides a constant<br>vacuum of -25 inHg to -27.5 inHg. |
| Aspiration Tubing | | |
| Inner<br>Diameter | 0.110" | 0.110" |
| Outer<br>Diameter | 0.188" | 0.188" |
| Length | 112" | 112" |
| Materials | Polyurethane, Nylon, Polycarbonate<br>and PVC | Polyurethane, Nylon, Polycarbonate<br>and PVC |
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# Non-Clinical Testing
Shelf Life and Sterility
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The 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. Aging studies for packaging integrity, seal strength, and device functionality were performed and met the acceptance criteria.
#### Biocompatibility Testing
The patient-contacting materials of the Reperfusion System were unchanged compared to the K222743 Reference Device; therefore, no additional biocompatibility testing was required.
All patient-contacting components of the Aspiration Tubing were evaluated for biocompatibility in accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Per ISO 10993-1, the Route 92 Medical Aspiration Tubing Set is a device that has limited (≤24 hours) contact with intact skin. A summary of the biocompatibility testing is provided below.
| Aspiration Tubing Set | | | |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--|
| Test | Results | Conclusions | |
| Cytotoxicity - ISO<br>MEM Elution | The test article extract showed no evidence of<br>causing cell lysis or toxicity. The test article<br>extract met the requirements of the test as grade<br>was less than 2. | The test article is non-<br>cytotoxic. | |
| Sensitization - ISO<br>Guinea Pig<br>Maximization<br>Sensitization Test<br>(Normal Saline and<br>Sesame Oil) | The test article extracts showed no evidence of<br>causing delayed dermal contact sensitization in<br>the guinea pig. The test article was not considered<br>a sensitizer in the test. | The test article did not<br>elicit a sensitization<br>response. | |
| Irritation - ISO<br>Intracutaneous<br>Reactivity (Normal<br>Saline and Sesame Oil) | The test article met the requirements of the test<br>since the difference between each test article<br>extract overall mean score and corresponding<br>control extract overall mean score was 1.0 or less<br>for both sodium chloride and sesame oil test<br>article extracts. | Requirements of the<br>ISO intracutaneous<br>reactivity test have<br>been met for the test<br>article. | |
### Performance Testing
The successful completion of the performance testing listed in the following tables demonstrates that the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is suitable for its intended use.
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| Full Length 070 Reperfusion System | | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Test | Test Method | Results |
| Simulated Use<br>Testing | Deliverability, clot retrieval, device integrity, kink and<br>aspiration resistance, lumen patency, durability and<br>compatibility with accessory devices were evaluated in a<br>neurovascular model. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Lumen Patency<br>Testing | Test specimens were tested for lumen patency under<br>vacuum. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Dimensional<br>Verification | Device dimensions were measured to confirm<br>conformance to the specifications. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Luer Integrity | Tested per ISO 80369-7:2016. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Tensile<br>Strength | The tensile strength of the catheter sections and bonds<br>was tested. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Kink<br>Resistance | Test specimen segments were formed into a defined<br>bend diameter to evaluate kink resistance. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Torsion<br>Resistance | The test specimens were rotated to evaluate integrity<br>after rotation. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Full Length 070 Reperfusion System | | |
| Test | Test Method | Results |
| Liquid<br>Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Dynamic Burst | Mechanical integrity was maintained up to the specified<br>pressures. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
| Hydrophilic<br>Coating<br>Integrity | The integrity of the hydrophilic coating was evaluated<br>after multiple insertion and withdrawal cycles. | PASS<br>All samples met the pre-<br>determined acceptance<br>criteria |
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| Aspiration Tubing Set | | |
|-----------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Test | Test Method | Results |
| Dimensional<br>Verification | Device dimensions were measured<br>to confirm conformance to the<br>specifications. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Tensile Strength | Test specimens were tested for<br>tensile strength. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Lumen<br>Ovalization | Lumen patency under vacuum was<br>tested. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Joint Leaks | Leakage under vacuum was tested. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Lumen Patency | Test specimens were tested for<br>lumen patency under vacuum. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
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| Aspiration Tubing Set | | |
|------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Test | Test Method | Results |
| Simulated Use Testing | Use for clot retrieval was evaluated in a neurovascular model. | PASS<br>All samples met the pre-determined acceptance criteria |
| Packaging Integrity | Tested per ISO 11607-1 Part 1. | PASS<br>All samples met the pre-determined acceptance criteria |
| Canister Compatibility | Connection to collection canister under vacuum was tested. | PASS<br>All samples met the pre-determined acceptance criteria |
| Flow Switch | Ability to stop fluid flow under vacuum was tested. | PASS<br>All samples met the pre-determined acceptance criteria |
#### Animal Studies
Two chronic animal studies were conducted according to good laboratory practices (GLP) in a swine model to demonstrate the safety and performance of the Route 92 Medical Reperfusion System and 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, inlife observations, and postmortem assessment of relevant tissues (treated vessels, downstream vessels).
#### Substantial Equivalence
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set has the same intended use, similar technological characteristics, and same method of action as the predicate device. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness of the device. The successful completion of biocompatibility testing, bench performance testing, and animal testing demonstrates that the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is substantially equivalent to the predicate device.
