(168 days)
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter of a compatible aspiration pump and to allow the user to control the fluid flow.
Both the CEREGLIDE ™ 42 Intermediate Catheter and CEREGLIDE ™ 57 Intermediate Catheter are variable stiffness, single lumen catheters 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 to reduce friction during navigation in the vasculature. 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 Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories.
The RHV with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.
The CEREGLIDE ™ 42 Intermediate Catheter and the CEREGLIDE ™ 57 Intermediate Catheter are designed for use in the removal of thrombus from the neurovasculature using continuous aspiration from an external vacuum source. The CEREGLIDE ™ 42 Intermediate Catheter and CEREGLIDE ™ 57 Intermediate Catheter are intended to be used with a compatible aspiration pump as a vacuum source that provides a minimum vacuum pressure of -68 kPa [-20 inHg] and a maximum vacuum pressure of -95 kPa [-28 inHg], and minimum 17 L/min flow rate, with a collection canister of at least 1000 mL volume.
The CEREGLIDE ™ 42 Intermediate Catheter and the CEREGLIDE ™ 57 Intermediate Catheter are intended to be connected to the vacuum source using the Cerenovus Aspiration Tubing Set which is an externally manufactured tubing set with an internal diameter (ID) of 0.110" and overall length of 112", containing an integrated flow control switch.
This document is a 510(k) premarket notification for CEREGLIDE™ 42 Intermediate Catheter, CEREGLIDE™ 57 Intermediate Catheter, and Cerenovus Aspiration Tubing Set. It aims to demonstrate substantial equivalence to a legally marketed predicate device.
The entire submission focuses on non-clinical performance data (bench testing), sterilization, shelf-life, and biocompatibility testing. Crucially, there is no mention of a study involving human readers, AI assistance, ground truth establishment by experts, or any clinical performance data derived from patient studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of AI/human reader performance or clinical outcomes, because this information is not present in the provided text. The document explicitly states:
- "No animal studies were required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing."
- "Clinical studies were not required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing."
The "acceptance criteria" and "device performance" described in the document are limited to bench testing results for physical and mechanical properties, sterilization, shelf life, and biocompatibility.
Here's the information that can be extracted or inferred from the provided text regarding the closest equivalent to "acceptance criteria and device performance" for this specific device, which is based on bench testing:
Acceptance Criteria and Reported Device Performance (Bench Testing)
The "acceptance criteria" for this device, based on the provided document, are that the samples for each test "met the established acceptance criteria." The document does not provide the specific quantitative thresholds for these criteria. The "device performance" is simply reported as "PASS" for all tests.
| Test | Test Summary | Acceptance Criteria (Not Explicitly Quantified) | Reported Device Performance |
|---|---|---|---|
| Design Verification | |||
| Visual Inspection | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the visual requirement described in ISO 10555-1 Section 4.4. | Samples must meet ISO 10555-1 Section 4.4 visual requirements. | PASS |
| Catheter ID | Verify that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters' internal diameters meet the requirements. | Samples must meet specified internal diameter requirements. | PASS |
| Catheter OD | Verify that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters' outer diameters meet the requirements. | Samples must meet specified outer diameter requirements. | PASS |
| Catheter Working Length | Confirm the working lengths of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters as defined in ISO 10555-1 Section 3.6. | Samples must meet ISO 10555-1 Section 3.6 working length definition. | PASS |
| Catheter Tip Length | Verify the catheter tip length of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters. | Samples must meet specified tip length requirements. | PASS |
| System Air Leakage | Verify that there is no air leak into the hub subassembly. | No air leak into hub subassembly. | PASS |
| System Liquid Leakage | Verify that the catheter joint strength meets the freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7. | Samples must meet ISO 10555-1:2013, section 4.7 for liquid leakage. | PASS |
| Delamination of PTFE Liner | Verify that the PTFE has appropriately adhered to the inner lumen of the catheter with braid reinforcement. | PTFE must appropriately adhere to the inner lumen. | PASS |
| Kink | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the requirement for the catheter to remain stable and not kink during use. | Catheter must remain stable and not kink during use. | PASS |
| Tip Movement | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the tip column stiffness requirement. | Catheter must meet tip column stiffness requirements. | PASS |
| Distal Tip Stiffness | Test the tip flexibility of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters, relative to other devices of similar design. | Tip flexibility must be acceptable relative to similar devices. | PASS |
| Peak Tensile Strength | Verify that the catheter joint strength meets the acceptance criteria of Section 4.5 of ISO 10555-1. | Joint strength must meet ISO 10555-1 Section 4.5. | PASS |
| Particulate Count & Coating Integrity | Verify the particulate size and counts of the CEREGLIDE™ 42 Intermediate Catheter under simulated use conditions with comparison to the predicate device. Coating integrity was visually inspected and verified to be free of coating defects after simulated use. | Particulate size/counts acceptable; coating free of defects after simulated use. | PASS |
| Burst Pressure | Verify the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet minimum static burst pressure specifications. | Must meet minimum static burst pressure specifications. | PASS |
| Torque Strength | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the torque strength requirement. | Catheter must meet torque strength requirements. | PASS |
| Trackability | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the trackability requirement. | Catheter must meet trackability requirements. | PASS |
| Design Validation | |||
| In Vitro Usability Studies | The in-vitro studies were conducted to demonstrate thrombus retrieval patency/durability, ancillary and accessory device compatibility, and to evaluate user requirements related to trackability and tip stability during thrombus removal. | Device must demonstrate acceptable thrombus retrieval patency/durability, accessory compatibility, trackability, and tip stability. | PASS |
Since the device is a catheter and tubing set for mechanical thrombectomy, and the submission is a 510(k) for substantial equivalence based primarily on bench testing, the requested information that typically applies to diagnostic AI algorithms or clinical trials with human outcomes is not applicable here.
Here's a breakdown of why the specific points of your request cannot be answered from the provided document:
- A table of acceptance criteria and the reported device performance: Provided above for bench testing. No clinical or human-reader performance criteria are given.
- Sample sized used for the test set and the data provenance: For bench testing, it states "All testing was conducted using sampling methods as required by internal procedure," but does not provide specific sample sizes. Data provenance is "bench testing," not from patient data or clinical studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for image interpretation or clinical outcomes was established by experts in this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation or adjudication described.
- 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 not an AI-enabled device and no MRMC study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the typical sense for image analysis. The "ground truth" for this device's performance is engineering specifications and compliance with ISO standards confirmed by bench testing.
- The sample size for the training set: Not applicable. No training set for an algorithm is described.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for an algorithm is described.
In summary, the provided FDA 510(k) clearance letter and summary for the CEREGLIDE™ catheters and tubing set demonstrate substantial equivalence through non-clinical bench performance testing, focusing on the physical and mechanical characteristics of the device. It does not involve AI, human readers, clinical trials, or the establishment of ground truth by medical experts in the context of diagnostic or interventional efficacy.
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October 16, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cerenovus, Inc. Cara Feely Regulatory Affairs Manager 6303 Waterford District Drive, Suites 215 & 315 Miami, Florida 33126
Re: K241221
Trade/Device Name: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: September 2, 2024 Received: September 13, 2024
Dear Cara Feely:
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241221
Device Name CEREGLIDE 42 Intermediate Catheter CEREGLIDE 57 Intermediate Catheter Cerenovus Aspiration Tubing Set
Indications for Use (Describe)
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter of a compatible aspiration pump and to allow the user to control the fluid flow.
| 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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510(k) Summary – K241221
I. Submitter
Cerenovus, Inc. 6303 Waterford District Drive, Suites 215 & 315 Miami, FL 33126 United States
Contact Person: Cara Feely (Regulatory Affairs Manager) Tel: 00353863335253 Email: Cfeely@its.jnj.com
II. Date Prepared
October 14, 2024
III. Device Information
| Table 1. Device Information | |
|---|---|
| Device Proprietary Name | CEREGLIDE™ 42 Intermediate CatheterCEREGLIDE™ 57 Intermediate CatheterCerenovus 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 |
IV. Predicate Device
The primary predicate device is listed below in Table 2.
Information
| Table 2. Primary Predicate Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K190338 | August 2, 2019 | Zenith Flex Aspiration System(046 Zenith Flex Catheter) | InNeuroCo, Inc. |
Continued on the next page
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| V. Device Description | Both the CEREGLIDE TM 42 Intermediate Catheter and CEREGLIDE TM 57 Intermediate Catheter are variable stiffness, single lumen catheters 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 to reduce friction during navigation in the vasculature. 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 Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories. |
|---|---|
| The RHV with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter. | |
| The CEREGLIDE TM 42 Intermediate Catheter and the CEREGLIDE TM 57 Intermediate Catheter are designed for use in the removal of thrombus from the neurovasculature using continuous aspiration from an external vacuum source. The CEREGLIDE TM 42 Intermediate Catheter and CEREGLIDE TM 57 Intermediate Catheter are intended to be used with a compatible aspiration pump as a vacuum source that provides a minimum vacuum pressure of -68 kPa [-20 inHg] and a maximum vacuum pressure of -95 kPa [-28 inHg], and minimum 17 L/min flow rate, with a collection canister of at least 1000 mL volume. | |
| The CEREGLIDE TM 42 Intermediate Catheter and the CEREGLIDE TM 57 Intermediate Catheter are intended to be connected to the vacuum source using the Cerenovus Aspiration Tubing Set which is an externally manufactured tubing set with an internal diameter (ID) of 0.110" and overall length of 112", containing an integrated flow control switch. | |
| VI. Indications for Use | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE TM 71, 57 or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. |
| VII. Predicate Comparison | A comparison of the similarities and differences of product features between the CEREGLIDE TM 42 Intermediate Catheter, the CEREGLIDE TM 57 Intermediate Catheter, and the predicate device are presented in Table 3. |
Continued on the next page
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| Table 3. Predicate and Subject Device Comparison | |||
|---|---|---|---|
| Description | Predicate Device:Zenith Flex AspirationSystem (046 Zenith FlexCatheter) (K190338) | Subject Device:CEREGLIDE™ 42Intermediate Catheter;Cerenovus AspirationTubing Set | Subject Device:CEREGLIDE™ 57Intermediate Catheter;Cerenovus AspirationTubing Set |
| Indications ForUse | The Zenith Flex Aspiration System,including the 046 Zenith Flex Catheter,Aspiration Tubing Set, and VC-701Cliq Aspirator Pump, is indicated in therevascularization of patients with acuteischemic stroke secondary tointracranial 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. | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Setand a compatible aspiration pump, are indicated for use in therevascularization of patients with acute ischemic stroke secondaryto intracranial large vessel occlusive disease (within the internalcarotid, middle cerebral - M1 and M2 segments, basilar, andvertebral arteries) within 8 hours of symptom onset. Patients whoare ineligible for thrombolytic drug therapy or who failedthrombolytic drug therapy are candidates for treatment.The Cerenovus Aspiration Tubing Set is intended to connect theCerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42Intermediate Catheter to the canister of a compatible aspirationpump and to allow the user to control the fluid flow. | |
| Product Code | NRY | Same as predicate | Same as predicate |
| RegulatoryName | Percutaneous Catheter | Same as predicate | Same as predicate |
| Classification | Class II - 21 CFR 870.1250 | Same as predicate | Same as predicate |
| Basic Design | Variable stiffness single lumencatheter | Same as predicate | Same as predicate |
| Length | 153 cm160 cm | 115 cm125 cm132 cm144 cm152 cm160 cm | 115 cm125 cm132 cm137 cm |
| Inner Diameter(ID) | 0.046" | 0.042" | 0.057" |
| Distal OuterDiameter (OD) | 0.056" | 0.053"(1.35 mm) | 0.068"(1.73 mm) |
| Proximal OD | 0.058" | 0.0535"(1.36 mm) | 0.0685"(1.74 mm) |
| Catheter Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Coating Length | Not Specified | 55 cm | 55 cm |
| TipConfiguration | Not Specified | Non-shapeable tip | Non-shapeable tip |
| Marker Band | Platinum/ Iridium | Same as predicate | Same as predicate |
| Braid | Stainless Steel/Nitinol | Stainless Steel | Stainless Steel |
| Liner | PTFE Liner | Same as predicate | Same as predicate |
| Hub | Polycarbonate | Same as predicate | Same as predicate |
| Strain Relief | Polyolefin | Same as predicate | Same as predicate |
| Outer Jacket | Polyether Block Amide (Pebax),Urethane, Nylon | Same as predicate | Pebax, Urethane |
| Hemostasis Valve | Included | Same as predicate | Same as predicate |
| IntroducerSheath | Peel-Away Introducer | Slit Introducer (2) | Slit Introducer (2) |
| SterilizationMethod | Ethylene Oxide | Same as predicate | Same as predicate |
| SterilityAssurance Level(SAL) | Not Specified | $10^{-6}$ | $10^{-6}$ |
| Packaging | Tyvek/Nylon Pouch, polyethylenesupport tube, packaging card, SBScarton | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton |
| Shelf Life | Not Specified | 3 years | 3 years |
| Table 3. Predicate and Subject Device Comparison | |||
| Description | Predicate Device:Zenith FlexAspiration System (046Zenith Flex Catheter)(K190338) | Subject Device:CEREGLIDE™ 42Intermediate Catheter;Cerenovus Aspiration TubingSet | Subject Device:CEREGLIDE™ 57Intermediate Catheter;Cerenovus AspirationTubing Set |
| RequiredAdditionalAccessories | Vacuum Pump,Aspiration Tubing | Cerenovus Aspiration Tubing SetCompatible Aspiration Pump | |
| MinimumAspirationPressure | -22 inHg | -20 inHg (-68 kPa) | |
| MaximumAspirationPressure | -28 inHg | -28 inHg (-95 kPa) | |
| Flowrate (Air) | Not Specified | 0 to 60LPM | |
| Tubing ID | Not Specified | 0.110 in minimum | |
| Tubing Length | Not Specified | 112 in | |
| Flow ControlMechanism | Not Specified | Flow Control Switch |
Continued on the next page
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VIII. Non-Clinical Performance Data
Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter to demonstrate that they are substantially equivalent to the legally marketed predicate device. The following performance data are being provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by internal procedure. The bench testing included the following tests:
| Table 4. Performance Testing Summary | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification | ||
| VisualInspection | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters meet the visual requirement described inISO 10555-1 Section 4.4. | PASS:Samples met the establishedacceptance criteria |
| Catheter ID | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters' internal diameters meet therequirements. | PASS:Samples met the establishedacceptance criteria |
| Catheter OD | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters' outer diameters meet the requirements. | PASS:Samples met the establishedacceptance criteria |
| CatheterWorkingLength | Confirm the working lengths of the CEREGLIDETM 42 andCEREGLIDETM 57 Intermediate Catheters as defined in ISO10555-1 Section 3.6. | PASS:Samples met the establishedacceptance criteria |
| Catheter TipLength | Verify the catheter tip length of the CEREGLIDETM 42 andCEREGLIDETM 57 Intermediate Catheters. | PASS:Samples met the establishedacceptance criteria |
| System AirLeakage | Verify that there is no air leak into the hub subassembly. | PASS:Samples met the establishedacceptance criteria |
| System LiquidLeakage | Verify that the catheter joint strength meets the freedom fromleakage (liquid during pressurization) requirements of ISO10555-1:2013, section 4.7. | PASS:Samples met the establishedacceptance criteria |
| Delamination ofPTFE Liner | Verify that the PTFE has appropriately adhered to the innerlumen of the catheter with braid reinforcement. | PASS:Samples met the establishedacceptance criteria |
Continued on the next page
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VIII. Non-Clinical Performance Data, continued
| Table 4. Performance Testing Summary | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification | ||
| Kink | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57Intermediate Catheters meet the requirement for the catheter toremain stable and not kink during use. | PASS:Samples met the establishedacceptance criteria |
| Tip Movement | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57Intermediate Catheters meet the tip column stiffnessrequirement. | PASS:Samples met the establishedacceptance criteria |
| Distal TipStiffness | Test the tip flexibility of the CEREGLIDE™ 42 andCEREGLIDE™ 57 Intermediate Catheters, relative to otherdevices of similar design. | PASS:Samples met the establishedacceptance criteria |
| Peak TensileStrength | Verify that the catheter joint strength meets the acceptancecriteria of Section 4.5 of ISO 10555-1. | PASS:Samples met the establishedacceptance criteria |
| ParticulateCount andCoatingIntegrity | Verify the particulate size and counts of the CEREGLIDE™ 42Intermediate Catheter under simulated use conditions withcomparison to the predicate device. Coating integrity wasvisually inspected and verified to be free of coating defectsafter simulated use. | PASS:Samples met the establishedacceptance criteria |
| Burst Pressure | Verify the CEREGLIDE™ 42 and CEREGLIDE™ 57Intermediate Catheters meet minimum static burst pressurespecifications. | PASS:Samples met the establishedacceptance criteria |
| Torque Strength | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57Intermediate Catheters meet the torque strength requirement. | PASS:Samples met the establishedacceptance criteria |
| Trackability | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57Intermediate Catheters meet the trackability requirement. | PASS:Samples met the establishedacceptance criteria |
| Design Validation | ||
| In VitroUsabilityStudies | The in-vitro studies were conducted to demonstrate thrombusretrieval patency/durability, ancillary and accessory devicecompatibility, and to evaluate user requirements related totrackability and tip stability during thrombus removal. | PASS:Samples met the establishedacceptance criteria |
Performance Testing - Animal
No animal studies were required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing.
Performance Testing - Clinical
Clinical studies were not required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing.
Sterilization
The CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter are packaged with included accessories and sterilized using a validated 100% Ethylene Oxide (EO) sterilization process to ensure sterility assurance level (SAL) of 10th in accordance with ISO 11135. The CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter, and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter, and all accessories are for single use only.
{9}------------------------------------------------
VIII. Non-Clinical Performance Data, continued
Shelf-Life
The CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter will have a shelf life of three years. Shelf-life testing was adopted from CEREGLIDE™ 71 Intermediate Catheter (K221934) that shares the same materials, design features, and manufacturing processes as the subject devices. Prior to aging, all samples were exposed to standard transportation conditioning. Results of shelf-life performance testing all met established acceptance criteria.
Biocompatibility Testing
A biological safety evaluation was conducted for the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter in accordance with the FDA biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" (issued September 2023), considering differences from the CEREGLIDE™ 71 Intermediate Catheter (K221934).
biocompatibility testing conducted on the CEREGLIDE™ 71 Additionally、 Intermediate Catheter (K221934), per ISO 10993-1 and applicable regulatory requirements, adequately evaluates the biocompatibility profile of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters for endpoints recommended by the FDA biocompatibility guidance for an externally communicating device with limited (<24 hours) duration of contact with circulating blood. The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters have met the requirements of biocompatibility assessments.
IX. Conclusion
Based upon the intended use, design, materials, function, and side-by-side in-vitro testing, it is concluded that the subject devices, the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™57 Intermediate Catheter, are substantially equivalent to the predicate device, Zenith Flex Aspiration System (046 Zenith Flex Catheter) (K190338). The differences in materials and design do not raise new questions regarding the safety and effectiveness of the devices. The subject devices, as designed, manufactured, packaged, and sterilized, are substantially equivalent to the primary predicate device currently marketed under the Federal Food, Drug and Cosmetic Act.
End of document
§ 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).