(207 days)
No
The 510(k) summary describes a mechanical aspiration system for treating stroke and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for use in the revascularization of patients with acute intracranial large vessel occlusive disease, which treats a medical condition.
No
Explanation: The device is described as a "Reperfusion System" used for revascularization in patients with acute intracranial large vessel occlusive disease, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components like catheters, tubing, and connectors, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the revascularization of patients with acute intracranial large vessel occlusive disease. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device consists of catheters and tubing designed for aspiration and delivery within blood vessels. These are physical tools used in a medical procedure.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly intended for use in vivo (within the living body) for a therapeutic purpose, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained in neurovascular interventional techniques
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 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^-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 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 demonstrates that the Route 92 Medical Full Length 054 Reperfusion System is suitable for its intended use.
- 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 the pre-determined acceptance criteria (PASS).
- Lumen Patency Testing: Test specimens were tested for lumen patency under vacuum. Results: All samples met the pre-determined acceptance criteria (PASS).
- Dimensional Verification: Device dimensions were measured to confirm conformance to the specifications. Results: All samples met the pre-determined acceptance criteria (PASS).
- Luer Integrity: Tested per ISO 80369-7:2021. Results: All samples met the pre-determined acceptance criteria (PASS).
- Tensile Strength: The tensile strength of the catheter sections and bonds was tested. Results: All samples met the pre-determined acceptance criteria (PASS).
- Kink Resistance: Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. Results: All samples met the pre-determined acceptance criteria (PASS).
- Torsion Resistance: The test specimens were rotated to evaluate integrity after rotation. Results: All samples met the pre-determined acceptance criteria (PASS).
- Tip Flexibility: Test specimens were tested for tip flexibility. Results: All samples met the pre-determined acceptance criteria (PASS).
- Air Leakage: Tested per ISO 10555-1:2013 Annex D. Results: All samples met the pre-determined acceptance criteria (PASS).
- Liquid Leakage: Tested per ISO 10555-1:2013 Annex C. Results: All samples met the pre-determined acceptance criteria (PASS).
- Static Burst: Tested per ISO 10555-1:2013 Annex F. Results: All samples met the pre-determined acceptance criteria (PASS).
- Dynamic Burst: Mechanical integrity was assessed under pressure. Results: All samples met the pre-determined acceptance criteria (PASS).
- Hydrophilic Coating Integrity: The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. Results: All samples met the pre-determined acceptance criteria (PASS).
- Aspiration Pressure: The vacuum pressure at the tip of the catheter was assessed during aspiration. Results: All samples met the pre-determined acceptance criteria (PASS).
- Particulate: The size and quantity of particulates generated during simulated use were evaluated. Results: All samples met the pre-determined acceptance criteria (PASS).
Animal Studies: No animal study was deemed necessary to demonstrate substantial equivalence to the predicate device.
Clinical Studies: No clinical study was deemed necessary to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Penumbra Reperfusion Catheter 054 and Penumbra Separator 054, K090752
Reference Device(s)
Route 92 Medical Full Length 054 Access System, K231583, Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, K223530
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
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).
1
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
2
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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3
K233329 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: | April 21, 2024 |
| Device Name: | Route 92 Medical Full Length 054 Reperfusion System and
Aspiration Tubing Set |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Thrombus Retriever (Product Code NRY, 21
CFR 870.1250) |
| Device Classification | Class II |
| Predicate Device: | Penumbra Reperfusion Catheter 054 and Penumbra
Separator 054, K090752 |
| Reference Devices: | Route 92 Medical Full Length 054 Access System,
K231583
Route 92 Medical Full Length 070 Reperfusion System and
Aspiration 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.
4
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 Device
Penumbra Reperfusion Catheter 054
and Penumbra Separator 054
(K090752) | Subject Device
Route 92 Medical Full Length 054
Reperfusion System and Aspiration
Tubing Set (K233329) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Penumbra 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. | 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. |
| Device
Description | The Penumbra System consists of
three devices that work as a system to
remove thrombus including the
Penumbra Reperfusion Catheter,
Penumbra Separator and Aspiration
Tubing. The Penumbra System is
used with the Penumbra Aspiration
Pump. | The Route 92 Medical Full Length
054 Reperfusion System includes the
054 Aspiration Catheter and Tenzing
5 Delivery Catheter and is used with
the Route 92 Medical Aspiration
Tubing Set. The devices are sterile,
non-pyrogenic, and intended for
single use only. |
| User | Physicians trained in neurovascular
interventional techniques | Same |
| Attribute | Predicate Device
Penumbra Reperfusion Catheter 054
and Penumbra Separator 054
(K090752) | Subject Device
Route 92 Medical Full Length 054
Reperfusion System and Aspiration
Tubing Set (K233329) |
| Anatomical
Sites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly used
in the manufacture of medical devices | Same |
| Sterilization | Ethylene oxide | Same |
| Shelf-life | 3 years | 6 months |
| Aspiration Catheter | | |
| Inner
Diameter
(nominal) | 0.054" | 0.054" |
| Outer
Diameter
(nominal) | 0.064" | 0.066" |
| Length | 135 cm | 125 cm and 148 cm |
| Delivery Catheter | | |
| Inner
Diameter | Not applicable | 0.019" proximal
0.015" distal |
| Outer
Diameter | Not applicable | 0.048" |
| Length | Not applicable | 167 cm |
| Compatibility:
Pump for
Aspiration | Penumbra Pump MAX | Commercially available vacuum
pump designed for use in hospital
settings that is compatible with the
Route 92 Medical Reperfusion
System and provides a constant
vacuum of -25 inHg to -27.5 inHg. |
| Aspiration Tubing | | |
| Inner
Diameter | 0.71"-0.110" | 0.110" |
| Outer
Diameter | Not available | 0.188" |
| Length | 112" | 112" |
| Attribute | Predicate Device
Penumbra Reperfusion Catheter 054
and Penumbra Separator 054
(K090752) | Subject Device
Route 92 Medical Full Length 054
Reperfusion System and Aspiration
Tubing Set (K233329) |
| Materials | Biocompatible materials, commonly
utilized for interventional devices | Same |
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6
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 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 pre- | |||
| determined acceptance criteria | |||
| Lumen Patency | |||
| Testing | Test specimens were tested for lumen patency under | ||
| vacuum. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Dimensional | |||
| Verification | Device dimensions were measured to confirm | ||
| conformance to the specifications. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Luer Integrity | Tested per ISO 80369-7:2021. | PASS | |
| All 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 bonds | ||
| was tested. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Kink Resistance | Test specimen segments were formed into a defined | ||
| bend diameter to evaluate kink resistance. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Torsion | |||
| Resistance | The test specimens were rotated to evaluate integrity | ||
| after rotation. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASS | |
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS | |
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS | |
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | PASS | |
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Dynamic Burst | Mechanical integrity was assessed under pressure. | PASS | |
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Hydrophilic | |||
| Coating Integrity | The integrity of the hydrophilic coating was evaluated | ||
| after multiple insertion and withdrawal cycles. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Aspiration | |||
| Pressure | The vacuum pressure at the tip of the catheter was | ||
| assessed during aspiration. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria | |||
| Particulate | The size and quantity of particulates generated during | ||
| simulated use were evaluated. | PASS | ||
| All samples met the pre- | |||
| determined acceptance criteria |
7
Animal Studies:
No animal study was deemed necessary to demonstrate substantial equivalence to the predicate device.
8
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.