(168 days)
Not Found
No
The description focuses on the mechanical and physical properties of the catheter and tubing set, with no mention of AI or ML for image processing, data analysis, or decision support.
Yes
The device is indicated for revascularization in patients with acute ischemic stroke, which is a therapeutic intervention. It is designed to remove thrombus (blood clots) from the neurovasculature, directly treating the disease condition.
No
The device, the CEREGLIDE 42/57 Intermediate Catheter, is indicated for revascularization and thrombus removal in acute ischemic stroke patients. It is a therapeutic device designed for intervention, not for diagnosing a condition.
No
The device description clearly details physical components like catheters, tubing sets, and accessories, indicating it is a hardware medical device, not software-only.
Based on the provided text, 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 ischemic stroke by removing thrombus from the neurovasculature. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device is a catheter designed to be introduced into the neurovasculature to physically remove a clot using aspiration. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat a condition by removing an obstruction, not to provide diagnostic information from a sample.
N/A
Intended Use / 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™ 71, 57 or 42 Intermediate Catheter of a compatible aspiration pump and to allow the user to control the fluid flow.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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.
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
Not Found
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)
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. All testing was conducted using sampling methods as required by internal procedure. Key results: All samples met the established acceptance criteria for all tests performed, including: Visual Inspection, Catheter ID, Catheter OD, Catheter Working Length, Catheter Tip Length, System Air Leakage, System Liquid Leakage, Delamination of PTFE Liner, Kink, Tip Movement, Distal Tip Stiffness, Peak Tensile Strength, Particulate Count and Coating Integrity, Burst Pressure, Torque Strength, Trackability.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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
2
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
3
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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4
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 Catheter |
| CEREGLIDE™ 57 Intermediate 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 |
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
5
| 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
6
| Table 3. Predicate and Subject Device Comparison | |||
|---|---|---|---|
| Description | Predicate Device: | ||
| Zenith Flex Aspiration | |||
| System (046 Zenith Flex | |||
| Catheter) (K190338) | Subject Device: | ||
| CEREGLIDE™ 42 | |||
| Intermediate Catheter; | |||
| Cerenovus Aspiration | |||
| Tubing Set | Subject Device: | ||
| CEREGLIDE™ 57 | |||
| Intermediate Catheter; | |||
| Cerenovus Aspiration | |||
| Tubing Set | |||
| Indications For | |||
| Use | The Zenith Flex Aspiration System, | ||
| including the 046 Zenith Flex Catheter, | |||
| Aspiration Tubing Set, and VC-701 | |||
| Cliq Aspirator Pump, is indicated 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. | 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 to the canister of a compatible aspiration | |||
| pump and to allow the user to control the fluid flow. | |||
| Product Code | NRY | Same as predicate | Same as predicate |
| Regulatory | |||
| Name | 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 lumen | ||
| catheter | Same as predicate | Same as predicate | |
| Length | 153 cm | ||
| 160 cm | 115 cm | ||
| 125 cm | |||
| 132 cm | |||
| 144 cm | |||
| 152 cm | |||
| 160 cm | 115 cm | ||
| 125 cm | |||
| 132 cm | |||
| 137 cm | |||
| Inner Diameter | |||
| (ID) | 0.046" | 0.042" | 0.057" |
| Distal Outer | |||
| Diameter (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 |
| Tip | |||
| Configuration | 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 |
| Introducer | |||
| Sheath | Peel-Away Introducer | Slit Introducer (2) | Slit Introducer (2) |
| Sterilization | |||
| Method | Ethylene Oxide | Same as predicate | Same as predicate |
| Sterility | |||
| Assurance Level | |||
| (SAL) | Not Specified | $10^{-6}$ | $10^{-6}$ |
| Packaging | Tyvek/Nylon Pouch, polyethylene | ||
| support tube, packaging card, SBS | |||
| carton | 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 Flex | |||
| Aspiration System (046 | |||
| Zenith Flex Catheter) | |||
| (K190338) | Subject Device: | ||
| CEREGLIDE™ 42 | |||
| Intermediate Catheter; | |||
| Cerenovus Aspiration Tubing | |||
| Set | Subject Device: | ||
| CEREGLIDE™ 57 | |||
| Intermediate Catheter; | |||
| Cerenovus Aspiration | |||
| Tubing Set | |||
| Required | |||
| Additional | |||
| Accessories | Vacuum Pump, | ||
| Aspiration Tubing | Cerenovus Aspiration Tubing Set | ||
| Compatible Aspiration Pump | |||
| Minimum | |||
| Aspiration | |||
| Pressure | -22 inHg | -20 inHg (-68 kPa) | |
| Maximum | |||
| Aspiration | |||
| Pressure | -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 Control | |||
| Mechanism | Not Specified | Flow Control Switch |
Continued on the next page
7
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 | ||
| Visual | ||
| Inspection | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57 | |
| Intermediate Catheters meet the visual requirement described in | ||
| ISO 10555-1 Section 4.4. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter ID | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57 | |
| Intermediate Catheters' internal diameters meet the | ||
| requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter OD | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57 | |
| Intermediate Catheters' outer diameters meet the requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter | ||
| Working | ||
| Length | Confirm the working lengths of the CEREGLIDETM 42 and | |
| CEREGLIDETM 57 Intermediate Catheters as defined in ISO | ||
| 10555-1 Section 3.6. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter Tip | ||
| Length | Verify the catheter tip length of the CEREGLIDETM 42 and | |
| CEREGLIDETM 57 Intermediate Catheters. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| System Air | ||
| Leakage | Verify that there is no air leak into the hub subassembly. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| 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. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Delamination of | ||
| PTFE Liner | Verify that the PTFE has appropriately adhered to the inner | |
| lumen of the catheter with braid reinforcement. | PASS: | |
| Samples met the established | ||
| acceptance criteria |
Continued on the next page
8
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™ 57 | |
| Intermediate Catheters meet the requirement for the catheter to | ||
| remain stable and not kink during use. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Tip Movement | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 | |
| Intermediate Catheters meet the tip column stiffness | ||
| requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Distal Tip | ||
| Stiffness | Test the tip flexibility of the CEREGLIDE™ 42 and | |
| CEREGLIDE™ 57 Intermediate Catheters, relative to other | ||
| devices of similar design. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Peak Tensile | ||
| Strength | Verify that the catheter joint strength meets the acceptance | |
| criteria of Section 4.5 of ISO 10555-1. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Particulate | ||
| Count and | ||
| 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. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Burst Pressure | Verify the CEREGLIDE™ 42 and CEREGLIDE™ 57 | |
| Intermediate Catheters meet minimum static burst pressure | ||
| specifications. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Torque Strength | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 | |
| Intermediate Catheters meet the torque strength requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Trackability | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 | |
| Intermediate Catheters meet the trackability requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| 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. | PASS: | |
| Samples met the established | ||
| acceptance 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 (