(207 days)
The Route 92 Medical Full Length 054 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.
The 054 Aspiration Catheter and Tenzing 5 Delivery Catheter comprise the Route 92 Medical Full Length 054 Reperfusion System. The Route 92 Medical Full Length 054 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.
The 054 Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 5 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.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria based on clinical outcomes or expert-adjudicated ground truth.
Therefore, many of the requested elements for describing an acceptance criteria study, especially those related to AI algorithm performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of regulatory submission. This document describes non-clinical testing to ensure the device's functional performance, safety, and compatibility.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria values for each test, but rather generally states "All samples met the pre-determined acceptance criteria." The performance is reported as "PASS" for all tests.
| Test | Test Method | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Shelf Life and Sterility | Ethylene oxide sterilization cycle verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. Aging studies established functional integrity for labeled expiration date. | Sterility assurance level of 1 x 10⁻⁶; functional for 6 months. | PASS |
| Biocompatibility Testing | Not performed again as materials were unchanged from reference device K223530. | None (re-use of prior assessment) | Not applicable |
| Simulated Use Testing | Deliverability, clot retrieval, device integrity, kink and aspiration resistance, lumen patency, durability and compatibility with accessory devices evaluated in a neurovascular model. | Meet pre-determined functional criteria in a neurovascular model. | PASS |
| Lumen Patency Testing | Test specimens tested for lumen patency under vacuum. | Meet pre-determined lumen patency criteria under vacuum. | PASS |
| Dimensional Verification | Device dimensions measured to confirm conformance to specifications. | Conformance to specifications. | PASS |
| Luer Integrity | Tested per ISO 80369-7:2021. | Conformance to ISO 80369-7:2021. | PASS |
| Tensile Strength | Tensile strength of catheter sections and bonds tested. | Meet pre-determined tensile strength criteria. | PASS |
| Kink Resistance | Test specimen segments formed into a defined bend diameter to evaluate kink resistance. | Meet pre-determined kink resistance criteria. | PASS |
| Torsion Resistance | Test specimens rotated to evaluate integrity after rotation. | Maintain integrity after rotation. | PASS |
| Tip Flexibility | Test specimens tested for tip flexibility. | Meet pre-determined tip flexibility criteria. | PASS |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | Conformance to ISO 10555-1:2013 Annex D. | PASS |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | Conformance to ISO 10555-1:2013 Annex C. | PASS |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | Conformance to ISO 10555-1:2013 Annex F. | PASS |
| Dynamic Burst | Mechanical integrity assessed under pressure. | Maintain mechanical integrity under pressure. | PASS |
| Hydrophilic Coating Integrity | Integrity of the hydrophilic coating evaluated after multiple insertion and withdrawal cycles. | Maintain coating integrity after multiple cycles. | PASS |
| Aspiration Pressure | Vacuum pressure at the tip of the catheter assessed during aspiration. | Meet pre-determined aspiration pressure criteria. | PASS |
| Particulate | Size and quantity of particulates generated during simulated use evaluated. | Meet pre-determined particulate limits. | PASS |
2. Sample size used for the test set and the data provenance
The document states "All samples met the pre-determined acceptance criteria" for each test but does not specify the numerical sample sizes (N) for each test set. The data provenance is described as "Non-Clinical Testing" which implies in-vitro or laboratory testing, not human-derived data like images or patient records. Therefore, information like country of origin or retrospective/prospective is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests are non-clinical, mechanical, and performance-based (e.g., tensile strength, lumen patency). The "ground truth" is based on engineering specifications and adherence to international standards (like ISO) rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. No expert adjudication was involved as the tests are objective, non-clinical measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for revascularization, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:
- Engineering specifications: Device dimensions, tensile strength, etc.
- International standards: ISO 11135 for sterility, ISO 80369-7:2021 for Luer integrity, ISO 10555-1:2013 for air/liquid leakage and burst strength.
- Functional performance criteria: In a simulated neurovascular model for deliverability, clot retrieval, etc.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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April 23, 2024
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Route 92 Medical, Inc. Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
Re: K233329
Trade/Device Name: Route 92 Medical Full Length 054 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 24, 2024 Received: March 25, 2024
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.
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).
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2
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.
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 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
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Indications for Use
510(k) Number (if known) K233329
Device Name
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
Indications for Use (Describe)
The Route 92 Medical Full Length 054 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K233329 510(K) SUMMARY
| Sponsor: | Route 92 Medical, Inc.155 Bovet Road, Suite 100San Mateo, CA 94402Phone: 650-581-1179 |
|---|---|
| Contact: | Kirsten Valley |
| Date Prepared: | April 21, 2024 |
| Device Name: | Route 92 Medical Full Length 054 Reperfusion System andAspiration Tubing Set |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Thrombus Retriever (Product Code NRY, 21CFR 870.1250) |
| Device Classification | Class II |
| Predicate Device: | Penumbra Reperfusion Catheter 054 and PenumbraSeparator 054, K090752 |
| Reference Devices: | Route 92 Medical Full Length 054 Access System,K231583Route 92 Medical Full Length 070 Reperfusion System andAspiration Tubing Set, K223530 |
Device Description
The 054 Aspiration Catheter and Tenzing 5 Delivery Catheter comprise the Route 92 Medical Full Length 054 Reperfusion System. The Route 92 Medical Full Length 054 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.
The 054 Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 5 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 054 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 054 Reperfusion System and Aspiration Tubing Set are substantially equivalent to the predicate device as shown in the following table.
| Attribute | Predicate DevicePenumbra Reperfusion Catheter 054and Penumbra Separator 054(K090752) | Subject DeviceRoute 92 Medical Full Length 054Reperfusion System and AspirationTubing Set (K233329) |
|---|---|---|
| Indicationsfor Use | The Penumbra System is intended foruse in the revascularization of patientswith acute ischemic stroke secondaryto intracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. | The Route 92 Medical Full Length054 Reperfusion System andAspiration Tubing Set is indicated foruse in the revascularization of patientswith acute ischemic stroke secondaryto intracranial large vessel occlusivedisease (within the internal carotid,middle cerebral - M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who failed IV t-PA therapy are candidates fortreatment. |
| DeviceDescription | The Penumbra System consists ofthree devices that work as a system toremove thrombus including thePenumbra Reperfusion Catheter,Penumbra Separator and AspirationTubing. The Penumbra System isused with the Penumbra AspirationPump. | The Route 92 Medical Full Length054 Reperfusion System includes the054 Aspiration Catheter and Tenzing5 Delivery Catheter and is used withthe Route 92 Medical AspirationTubing Set. The devices are sterile,non-pyrogenic, and intended forsingle use only. |
| User | Physicians trained in neurovascularinterventional techniques | Same |
| Attribute | Predicate DevicePenumbra Reperfusion Catheter 054and Penumbra Separator 054(K090752) | Subject DeviceRoute 92 Medical Full Length 054Reperfusion System and AspirationTubing Set (K233329) |
| AnatomicalSites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly usedin the manufacture of medical devices | Same |
| Sterilization | Ethylene oxide | Same |
| Shelf-life | 3 years | 6 months |
| Aspiration Catheter | ||
| InnerDiameter(nominal) | 0.054" | 0.054" |
| OuterDiameter(nominal) | 0.064" | 0.066" |
| Length | 135 cm | 125 cm and 148 cm |
| Delivery Catheter | ||
| InnerDiameter | Not applicable | 0.019" proximal0.015" distal |
| OuterDiameter | Not applicable | 0.048" |
| Length | Not applicable | 167 cm |
| Compatibility:Pump forAspiration | Penumbra Pump MAX | Commercially available vacuumpump designed for use in hospitalsettings that is compatible with theRoute 92 Medical ReperfusionSystem and provides a constantvacuum of -25 inHg to -27.5 inHg. |
| Aspiration Tubing | ||
| InnerDiameter | 0.71"-0.110" | 0.110" |
| OuterDiameter | Not available | 0.188" |
| Length | 112" | 112" |
| Attribute | Predicate DevicePenumbra Reperfusion Catheter 054and Penumbra Separator 054(K090752) | Subject DeviceRoute 92 Medical Full Length 054Reperfusion System and AspirationTubing Set (K233329) |
| Materials | Biocompatible materials, commonlyutilized for interventional devices | Same |
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Non-Clinical Testing
Shelf Life and Sterility
The Route 92 Medical Full Length 054 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° 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 Full Length 054 Reperfusion System and Aspiration Tubing Set were unchanged compared to the reference device K223530; therefore, no additional biocompatibility testing was required.
Performance Testing
The successful completion of the performance testing listed in the following tables demonstrates that the Route 92 Medical Full Length 054 Reperfusion System is suitable for its intended use.
| Full Length 054 Reperfusion System | |||
|---|---|---|---|
| Test | Test Method | Results | |
| Simulated UseTesting | Deliverability, clot retrieval, device integrity, kinkand aspiration resistance, lumen patency, durabilityand compatibility with accessory devices wereevaluated in a neurovascular model. | PASSAll samples met the pre-determined acceptance criteria | |
| Lumen PatencyTesting | Test specimens were tested for lumen patency undervacuum. | PASSAll samples met the pre-determined acceptance criteria | |
| DimensionalVerification | Device dimensions were measured to confirmconformance to the specifications. | PASSAll samples met the pre-determined acceptance criteria | |
| Luer Integrity | Tested per ISO 80369-7:2021. | PASSAll samples met the pre-determined acceptance criteria | |
| Full Length 054 Reperfusion System | |||
| Test | Test Method | Results | |
| Tensile Strength | The tensile strength of the catheter sections and bondswas tested. | PASSAll samples met the pre-determined acceptance criteria | |
| Kink Resistance | Test specimen segments were formed into a definedbend diameter to evaluate kink resistance. | PASSAll samples met the pre-determined acceptance criteria | |
| TorsionResistance | The test specimens were rotated to evaluate integrityafter rotation. | PASSAll samples met the pre-determined acceptance criteria | |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASSAll samples met the pre-determined acceptance criteria | |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASSAll samples met the pre-determined acceptance criteria | |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASSAll samples met the pre-determined acceptance criteria | |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | PASSAll samples met the pre-determined acceptance criteria | |
| Dynamic Burst | Mechanical integrity was assessed under pressure. | PASSAll samples met the pre-determined acceptance criteria | |
| HydrophilicCoating Integrity | The integrity of the hydrophilic coating was evaluatedafter multiple insertion and withdrawal cycles. | PASSAll samples met the pre-determined acceptance criteria | |
| AspirationPressure | The vacuum pressure at the tip of the catheter wasassessed during aspiration. | PASSAll samples met the pre-determined acceptance criteria | |
| Particulate | The size and quantity of particulates generated duringsimulated use were evaluated. | PASSAll samples met the pre-determined acceptance criteria |
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Animal Studies:
No animal study was deemed necessary to demonstrate substantial equivalence to the predicate device.
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Clinical Studies:
No clinical study was deemed necessary to demonstrate substantial equivalence to the predicate device. Conclusion
The Route 92 Medical Full Length 054 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 performance testing demonstrates that the Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is substantially equivalent to the predicate device.
§ 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).