(30 days)
The Cerenovus Large Bore Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration 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, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.
The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
The provided text does not describe an acceptance criteria study for an AI/ML-enabled device but rather a 510(k) submission for a physical medical device (Cerenovus Large Bore Catheter and Aspiration Tubing Set). Therefore, much of the requested information regarding AI/ML device performance (like expert consensus, adjudication methods, MRMC studies, training/test set details) is not applicable or present in the document.
However, I can extract the relevant acceptance criteria and performance data for the mechanical device as found in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (implicit from "PASS" result) | Reported Device Performance |
|---|---|---|
| Static Flow Rate | Samples meet the established acceptance criteria | PASS |
| Aspiration Flow Rate | Samples meet the established acceptance criteria | PASS |
Explanation of "Acceptance Criteria" for this context:
For physical medical devices, "acceptance criteria" for performance testing typically refer to specific measurable thresholds or ranges that the device must demonstrate to confirm its functionality and safety. While the exact numerical values for these criteria are not explicitly stated in this summary, the document indicates that pre-established criteria exist and were met ("Samples met the established acceptance criteria").
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in the summary. The document mentions "samples" in the plural form were tested for each performance test.
- Data provenance: Not explicitly stated. The testing ("Performance Testing - Bench") was conducted by Cerenovus, Inc. as part of their 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This pertains to AI/ML device evaluations. For a mechanical device, performance is typically measured against engineering specifications and industry standards, not expert-established ground truth in the same manner as image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to AI/ML device evaluations.
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:
- No. This pertains to AI/ML device evaluations. The device mentioned is a physical catheter and aspiration set, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML device evaluations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing / Engineering Specifications: For this mechanical device, the "ground truth" or reference for performance is established by engineering specifications, validated test methods, and potentially industry standards (e.g., ISO, ASTM for material properties, fluid dynamics). The specific parameters measured (flow rate) are compared against pre-defined acceptable ranges.
8. The sample size for the training set:
- Not applicable. This pertains to AI/ML device evaluations. This device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- Not applicable. This pertains to AI/ML device evaluations.
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January 17, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cerenovus, Inc. Ryan Rivera Senior Regulatory Affairs Project Lead 6303 Waterford District Drive, Suites 215 & 315 Miami. Florida 33216
Re: K233988
Trade/Device Name: Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 15, 2023 Received: December 18, 2023
Dear Ryan Rivera:
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
Enclosure
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Indications for Use
510(k) Number (if known) K233988
Device Name
Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
Indications for Use (Describe)
The Cerenovus Large Bore Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration 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, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K233988
| Submitter | Cerenovus, Inc.6303 Waterford District DriveSuites 215 & 315Miami, FL 33126 USA | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contact | Ryan RiveraTel: (714) 876-5048Email: rriver82@its.jnj.com | ||||||||||||
| Date Prepared | January 12, 2024 | ||||||||||||
| Device Tradeor ProprietaryName | Cerenovus Large Bore CatheterCerenovus Aspiration Tubing Set | ||||||||||||
| DeviceInformation | Table 1. Device InformationDevice Proprietary NameCerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCommon or Usual nameCatheter, Thrombus RetrieverClassification Name21 CFR 870.1250 - Catheter, PercutaneousRegulatory ClassificationIIFDA Product CodeNRY | Table 1. Device Information | Device Proprietary Name | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Common or Usual name | Catheter, Thrombus Retriever | Classification Name | 21 CFR 870.1250 - Catheter, Percutaneous | Regulatory Classification | II | FDA Product Code | NRY | |
| Table 1. Device Information | |||||||||||||
| Device Proprietary Name | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | ||||||||||||
| Common or Usual name | Catheter, Thrombus Retriever | ||||||||||||
| Classification Name | 21 CFR 870.1250 - Catheter, Percutaneous | ||||||||||||
| Regulatory Classification | II | ||||||||||||
| FDA Product Code | NRY | ||||||||||||
| Predicate |
Device
| 510(k)Number | Date Cleared | Device Name | Manufacturer |
|---|---|---|---|
| K193380 | Jul 20, 2020 | CERENOVUS Large BoreCatheter; CERENOVUSAspiration Tubing Set | Cerenovus, Inc*. |
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| DeviceDescription | The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheterdesigned to be introduced over a steerable guide wire or microcatheter into the neurovasculature. The catheter shaft is composed of a stainless steel variable pitch braid witha PTFE inner liner to facilitate movement of guide wires and other devices. Theexterior of the catheter shaft is covered with polymer materials, which encapsulate thestainless steel braid construction. The catheter has a stiff proximal shaft whichtransitions into the flexible distal shaft to facilitate the advancement of the catheter inthe anatomy. The distal end of the catheter has a radiopaque marker band to facilitatefluoroscopic visualization and has a hydrophilic coating to provide lubricity fornavigation of vessels. The proximal end of the catheter has a luer fitting located on theend of the catheter hub which can be used to attach accessories for flushing andaspiration. An ID band is placed at the distal end of the hub over a strain relief. Thecatheter is packaged with a hemostasis valve with a side port and two peel-awayintroducers as accessories. The hemostasis valve with side port is used for flushing,insertion of catheters, and connection to an external aspiration system. The peel awayintroducer sheaths are designed to protect the distal tip of the catheter during insertioninto the hemostasis valve.The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pumpusing the Cerenovus Aspiration Tubing Set. |
|---|---|
| Indications forUse | The Cerenovus Large Bore Catheter, with the Cerenovus Aspiration Tubing Set and acompatible aspiration pump, is indicated for use in the revascularization of patientswith acute ischemic stroke secondary to intracranial large vessel occlusive disease(within the internal carotid, middle cerebral - M1 and M2 segments, basilar, andvertebral arteries) within 8 hours of symptom onset. Patients who are ineligible forintravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy arecandidates for treatment.The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large BoreCatheter or the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatibleaspiration pump and to allow the user to control the fluid flow. |
| PredicateComparison | A comparison of the similarities and differences of product features between theCerenovus Large Bore Catheter and the predicate device is presented in Table 3. |
| Table 3. Subject and Predicate Device Comparison Summary | ||
|---|---|---|
| Predicate Device (K193380): | Subject Device (K233988): | |
| Description | CERENOVUS Large Bore Catheter;CERENOVUS Aspiration Tubing Set | Cerenovus Large Bore Catheter;Cerenovus Aspiration Tubing Set |
| Product Code | NRY | Same |
| Regulatory Name | Catheter, Percutaneous | Same |
| Classification | Class II - 21 CFR 870.1250 | Same |
| Basic Design | Variable stiffness single lumen catheter | Same |
| Table 3. Subject and Predicate Device Comparison Summary | ||
| Description | Predicate Device:CERENOVUS Large Bore Catheter(K193380) | Subject Device (K233988):Cerenovus Large Bore Catheter;Cerenovus Aspiration Tubing Set |
| Indications For Use | The CERENOVUS Large Bore Catheter, with theCERENOVUS® Aspiration Tubing Set andNOUVAG Vacuson 60 aspiration pump (or equivalentaspiration pump), is indicated for use in therevascularization of patients with acute ischemicstroke secondary to intracranial large vessel occlusivedisease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries)within 8 hours of symptom onset. Patients who areineligible for intravenous tissue plasminogen activator(IV t-PA) or who failed IV t-PA are candidates fortreatment.The CERENOVUS® Aspiration Tubing Set isintended to connect the CERENOVUS Large BoreCatheter to the canister of the NOUVAG Vacuson 60Aspiration Pump (or equivalent vacuum pump) and toallow the user to control the fluid flow. | The Cerenovus Large Bore Catheter, with theCerenovus Aspiration Tubing Set and acompatible aspiration pump, is indicated for usein the revascularization of patients with acuteischemic stroke secondary to intracranial largevessel occlusive disease (within the internalcarotid, middle cerebral - M1 and M2 segments,basilar, and vertebral arteries) within 8 hours ofsymptom onset. Patients who are ineligible forintravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidatesfor treatment.The Cerenovus Aspiration Tubing Set is intendedto connect the Cerenovus Large Bore Catheter orthe CEREGLIDE™ 71 Intermediate Catheter tothe canister of a compatible aspirationpump and to allow the user to control the fluid flow. |
| Length | 125 - 135 cm | Same |
| ID | 0.071 inch | Same |
| Distal OD | 0.081 inch | Same |
| Proximal OD | 0.0825 inch | Same |
| Catheter Coating | Hydrophilic | Same |
| Coating Length | 30 cm | Same |
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Same |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Same |
| Strain Relief | Pebax, Urethane, Nylon | Same |
| Outer Jacket | Same | |
| Tip Configuration | Non-shapeable tip | Same |
| Hemostasis Valve | Hemostasis Valve with Side Port Extension Tubing | Same |
| Introducer Sheath | Peel-Away Sheath Introducer (2) | Same |
| SterilizationMethod | Ethylene Oxide | Same |
| Sterility AssuranceLevel (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Pouch,Carton | Same |
| Shelf Life | 1 year | Same |
| RequiredAdditionalAccessories | CERENOVUS Aspiration Tubing SetNOUVAG Vacuson 60 Pump | Cerenovus Aspiration Tubing SetCompatible Aspiration Pump |
| Aspiration Pump Requirements: | ||
| MinimumAspiration Pressure | -20 inHg (-68 kPa) | Same |
| MaximumAspiration Pressure | -29 inHg (-98 kPa) | Same |
| Flowrate (Air) | 0 to 60 LPM | Same |
| Aspiration Tubing Requirements: | ||
| Tubing ID | 0.110 in minimum | Same |
| Tubing Length | 112 in | Same |
| Flow Control | Flow Control Switch | Same |
| Mechanism |
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Non-Clinical Testing Summary
Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the Cerenovus Large Bore Catheter to support the proposed change and demonstrate that the subject device is substantially equivalent to the legally marketed predicate device. This testing was previously completed and submitted in K193380.
| Table 4. Performance Testing Summary | ||
|---|---|---|
| Test | Test Summary | Result |
| Static Flow Rate | Determine the flow rate through thecatheter. | PASS:Samples met the establishedacceptance criteria |
| Aspiration FlowRate | Determine the aspiration flow ratethrough the catheter when the catheter isconnected to a constant vacuum source. | PASS:Samples met the establishedacceptance criteria |
Animal Testing
N/A - No animal studies were deemed necessary as appropriate verification and validation of the modifications were achieved based on the results of the previously completed bench testing, considering the similarities of the subject and predicate devices.
Shelf-Life Testing
N/A – Changes do not impact the shelf-life of the product.
Biocompatibility Testing
N/A - Changes do not impact biocompatibility.
Sterilization
N/A - Changes do not impact sterilization.
Conclusion Based upon the intended use, design, materials, and function, it is concluded that the subject device, Cerenovus Large Bore Catheter is substantially equivalent to the predicate device, CERENOVUS Large Bore Catheter (K193380). The differences in wording of the Indications for Use statement do not raise any new questions regarding the safety and effectiveness of the device. The subject device, as designed, manufactured, packaged and sterilized, is substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act.
§ 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).