(258 days)
No
The device description focuses on the physical properties and mechanical function of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench tests of physical characteristics.
No
The device is an intermediate catheter used to facilitate the insertion and guidance of other interventional devices, not to provide a therapeutic effect itself.
No
The device is an intermediate catheter used for facilitating the insertion and guidance of interventional devices, not for diagnosis.
No
The device description clearly outlines a physical catheter with various material components, a lumen, coatings, and accessories, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "facilitate the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lubricious inner lumen, variable stiffness, and a hydrophilic coating for manipulation within the vessel. This aligns with an interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The CEREGLIDE 92 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.
Product codes (comma separated list FDA assigned to the subject device)
QJP
Device Description
The CEREGLIDE™ 92 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE lined inner lumen to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets. These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.
The CEREGLIDE™ 92 Intermediate Catheter is packaged with a Tuohy Borst hemostasis valve (RHV) with a side port and two slit introducer accessories. The RHV with side port is used for flushing and insertion of catheters. The slit introducers are designed to introduce the CEREGLIDE™ 92 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 92 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular system, neuro vasculature
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™ 92 Intermediate Catheter to demonstrate that it is 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 design control procedures. The bench testing included visual inspection, catheter ID and OD, catheter working length and tip length, hub luer taper, system air and liquid leakage, burst pressure, hub pull testing, shaft tensile strength, particulate count, coating lubricity and durability, coating length, kink resistance (distal & proximal), delamination of PTFE liner, tip movement, tip linear stiffness, trackability, torque strength, introducer working length, introducer separation force. All samples met the established acceptance criteria.
In Vitro Usability Studies: The in vitro studies were conducted to evaluate usability parameters such as trackability, tip stability, durability, and (ancillary) device compatibility with tracking of the CEREGLIDE 92 Intermediate Catheter to target sites and delivery of a worst-case interventional device in the neurovascular model. Samples met the established acceptance criteria.
Performance Testing - Animal: No animal studies were required as appropriate verification and validation of the subject 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 and validation of the subject 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™ 92 Intermediate Catheter, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10-6 in accordance with ISO 11135. The CEREGLIDE™ 92 Intermediate Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 92 Intermediate Catheter and all accessories are for single use only.
Shelf-Life: The CEREGLIDE™ 92 Intermediate Catheter will have a shelf life of 6 months based on the successful completion of stability testing. Shelf-life testing was performed using standard test methods and acceptance criteria. Prior to aging, all samples were exposed to standard transportation conditioning. Results of testing on the subject device all met established acceptance criteria.
Biocompatibility Testing: The CEREGLIDE™ 92 Intermediate Catheter was assessed for biocompatibility in accordance with International Standard ISO 10993-1 and FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO-10993-1". The subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The following biocompatibility testing was completed: Cytotoxicity, Sensitization - Guinea Pig Maximization, Irritation - Rabbit Intracutaneous Reactivity, Acute Systemic Toxicity in Mice, Pyrogenicity - Materials Mediated Rabbit Pyrogen, ASTM Hemolysis Study - Direct and Extraction Methods, SC5b-9 Complement Activation Assay, ASTM Partial Thromboplastin Time (PTT), ASTM Heparinized Platelet and Leukocyte Count, Comparative Surface Assessment. All tests passed the acceptance criteria.
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.
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
November 29, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. Ariell Joiner, Ph.D. Manager, Regulatory Affairs 6303 Waterford District Drive, Suites 215 & 315 Miami, Florida 33126
Re: K230726
Trade/Device Name: CEREGLIDE 92 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: October 30, 2023 Received: October 31, 2023
Dear Ariell Joiner:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230726
Device Name CEREGLIDE 92 Intermediate Catheter
Indications for Use (Describe)
The CEREGLIDE 92 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Device Information
510(k) Summary K230726
Regulatory Classification
| I. Submitter | Cerenovus, Inc.
6303 Waterford District Drive
Suites 215 & 315
Miami, FL 33126 USA
Contact Person: Ariell Joiner
Tel: (908) 726-9577
Email: ajoiner@its.jnj.com | | | | | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| II. Date
Prepared | November 27, 2023 | | | | | | |
| III. Device
Information | Table 1. Device Information Device Proprietary Name CEREGLIDE 92 Intermediate Catheter Common or Usual name Catheter, Percutaneous, Neurovasculature Classification Name 21 CFR 870.1250 - Percutaneous Catheter | | | | | | |
II
| FDA Product Code | QJP | |
|---|---|---|
| IV. Predicate | ||
| and Reference | The predicate device is listed below in Table 2 and the reference devices are listed in | |
| Table 3 . |
| Table 2. Predicate Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K212224 | September 20, 2021 | Zoom 88 Large Distal | |
| Platform | Imperative Care, Inc. |
| Table 3. Reference Devices | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K191237 | November 8, 2019 | CERENOVUS Large Bore | |
| Catheter | Medos International | ||
| SARL* | |||
| K192804 | February 27, 2020 | CEREBASE DA Guide Sheath | Medos International |
| SARL |
The CEREGLIDE™ 92 Intermediate Catheter is a single lumen, variable stiffness V. Device Description catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE lined inner lumen to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets. These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.
4
| V. Device
Description
(continued) | The CEREGLIDE™ 92 Intermediate Catheter is packaged with a Tuohy Borst
hemostasis valve (RHV) with a side port and two slit introducer accessories. The RHV
with side port is used for flushing and insertion of catheters. The slit introducers are
designed to introduce the CEREGLIDE™ 92 Intermediate Catheter into the base
catheter and protect the distal tip of the CEREGLIDE™ 92 Intermediate Catheter
during insertion into the hemostasis valve of the base catheter. |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VI. Indications
for Use | The CEREGLIDE 92 Intermediate Catheter is indicated for use in facilitating the
insertion and guidance of appropriately sized interventional devices into a selected
blood vessel in the neurovascular system. |
| VII. Predicate
Comparison | A comparison of indications for use and technological characteristics between the
CEREGLIDE™ 92 Intermediate Catheter and the predicate device is presented in
Table 4. |
| Table 4. Subject and Predicate Device Comparison Summary | ||
|---|---|---|
| Description | Subject Device: | |
| CEREGLIDE™ 92 Intermediate Catheter | Predicate Device: | |
| Zoom 88 Large Distal Platform (K212224) | ||
| Product Code | QJP | QJP, DQY |
| Regulatory Name | Percutaneous Catheter | Same |
| Classification | Class II - 21 CFR 870.1250 | Same |
| Basic Design | Variable stiffness, single lumen catheter | Same |
| Indications For | ||
| Use | The CEREGLIDE 92 Intermediate Catheter is indicated for | |
| use in facilitating the insertion and guidance of | ||
| appropriately sized interventional devices into a selected | ||
| blood vessel in the neurovascular system. | The Zoom 88 Large Distal Platform is indicated for the | |
| introduction of interventional devices into the peripheral, | ||
| coronary, and neuro vasculature. | ||
| Dimensions: | ||
| Length | 114 - 135 cm | 80 - 110 cm |
| ID | 0.092" (2.34 mm) | 0.088" |
| Distal OD | 0.102" (2.59 mm) | 0.106" |
| Proximal OD | 0.108" (2.74 mm) | 0.110" |
| Catheter Coating | Hydrophilic | Same |
| Materials | Commonly used medical grade plastics & metals with | |
| hydrophilic coating | Same | |
| Accessories Included: | ||
| Hemostasis Valve | Included: Tuohy Borst Hemostasis Valve with Side Port | |
| Extension Tubing | Rotating Hemostasis Valve (RHV) | |
| Introducer Sheath | Slit Introducer (2) | None |
| Sterilization | ||
| Method | Ethylene Oxide | Same |
| Sterility Assurance | ||
| Level (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, | |
| Carton | The catheters are placed in a protective polyethylene tube, | |
| mounted with accessory RHV onto a polyethylene | ||
| packaging card, placed into a pouch, sealed and labeled. | ||
| The sealed pouch and IFU are placed in a labeled shelf | ||
| carton box. | ||
| Shelf Life | 6 months | 1 year |
5
VIII. Non-Clinical Performance Testing
Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the CEREGLIDE™ 92 Intermediate Catheter to demonstrate that it is 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 design control procedures. The bench testing included the following tests:
| Table 5. Performance Testing Summary | |||||
|---|---|---|---|---|---|
| Test | Test Summary | Result | |||
| Design Verification | |||||
| Visual | |||||
| Inspection | Confirm that the CEREGLIDE 92 Intermediate Catheter meets | ||||
| the visual requirement described in ISO 10555-1 Section 4.4. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Catheter ID | Verify that the CEREGLIDE 92 Intermediate Catheter internal | ||||
| diameters meet the requirements. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Catheter OD | Verify that the CEREGLIDE 92 Intermediate Catheter outer | ||||
| diameters meet the requirements. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Catheter | |||||
| Working | |||||
| Length | Confirm the working length of the CEREGLIDE 92 | ||||
| Intermediate Catheter as defined in ISO 10555-1 Section 3.6. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Catheter Tip | |||||
| Length | Verify the tip length of the CEREGLIDE 92 Intermediate | ||||
| Catheter. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Hub Luer Taper | Verify that the catheter hub Luer taper fit standard Luer fittings | ||||
| using taper device. | 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 CEREGLIDE 92 Intermediate 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 | |||||
| Burst Pressure | Confirm the maximum hydrostatic pressure the CEREGLIDE | ||||
| 92 Intermediate Catheter can withstand using a Crescent | |||||
| Hydraulic Burst-leak Tester. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Hub Pull | |||||
| Testing | To verify the CEREGLIDE 92 Intermediate Catheter hub to | ||||
| joint strength meets acceptance criteria. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Shaft Tensile | |||||
| Strength | Verify that the CEREGLIDE 92 Intermediate Catheter joint | ||||
| strength meets the acceptance criteria. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Particulate | |||||
| Count | Verify the particulate size and counts of the CEREGLIDE 92 | ||||
| Intermediate Catheter under simulated use conditions with | |||||
| comparison to the predicate and reference devices. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Coating | |||||
| Lubricity and | |||||
| Durability | Verify the lubriciousness and durability of the CEREGLIDE 92 | ||||
| Intermediate Catheter's hydrophilic coating. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Coating Length | Verify that the CEREGLIDE 92 Intermediate Catheter | ||||
| hydrophilic coating length meets the design requirements. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Kink Resistance | |||||
| (Distal & | |||||
| Proximal) | Confirm that the CEREGLIDE 92 Intermediate Catheter meets | ||||
| the requirement for the catheter to remain stable and not kink | |||||
| during use. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria | |||||
| Delamination of | |||||
| PTFE Liner | Verify that the PTFE has appropriately adhered to the inner | ||||
| lumen of the CEREGLIDE 92 Intermediate Catheter with braid | |||||
| reinforcement. | PASS: | ||||
| Samples met the established | |||||
| acceptance criteria |
6
| VIII. Non- |
|---|
| Clinical |
| Performance |
| Testing |
| (continued) |
| Table 5. Performance Testing Summary (continued) | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification (continued) | ||
| Tip Movement | Confirm that the CEREGLIDE 92 Intermediate Catheter | |
| meets the tip column stiffness requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Tip Linear Stiffness | Test the tip flexibility of the CEREGLIDE 92 Intermediate | |
| Catheter, relative to other devices of similar intended use | ||
| and design. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Trackability | Confirm that the CEREGLIDE 92 Intermediate Catheter | |
| meets the trackability requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Torque Strength | Confirm that the CEREGLIDE 92 Intermediate Catheter | |
| meets the torque strength requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Introducer Working | ||
| Length | Confirm the working length of the introducer. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Introducer | ||
| Separation Force | Confirm the force required to separate the introducer. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Design Validation | ||
| In Vitro Usability | ||
| Studies | The in vitro studies were conducted to evaluate usability | |
| parameters such as trackability, tip stability, durability, and | ||
| (ancillary) device compatibility with tracking of the | ||
| CEREGLIDE 92 Intermediate Catheter to target sites and | ||
| delivery of a worst-case interventional device in the | ||
| neurovascular model. | PASS: | |
| Samples met the established | ||
| acceptance criteria |
Performance Testing - Animal
No animal studies were required as appropriate verification and validation of the subject 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 and validation of the subject 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™ 92 Intermediate Catheter, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10° in accordance with ISO 11135. The CEREGLIDE™ 92 Intermediate Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 92 Intermediate Catheter and all accessories are for single use only.
Shelf-Life
The CEREGLIDE™ 92 Intermediate Catheter will have a shelf life of 6 months based on the successful completion of stability testing. Shelf-life testing was performed using standard test methods and acceptance criteria. Prior to aging, all samples were exposed to standard transportation conditioning. Results of testing on the subject device all met established acceptance criteria.
7
VIII. Non-Clinical Performance Testing (continued)
Biocompatibility Testing
The CEREGLIDE™ 92 Intermediate Catheter was assessed for biocompatibility in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," and FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process"," (Issued September 4, 2020). The subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The following biocompatibility testing was completed as part of this evaluation:
| Table 6. Biocompatibility Test Summary for CEREGLIDE™ 92 Intermediate
| Catheter and Introducer | ||
|---|---|---|
| Test Method | Acceptance Criteria | Result |
| Cytotoxicity | Grade ≤ 2 | PASS |
| Sensitization - Guinea Pig | ||
| Maximization | Grade 50% of the negative control | PASS |
| ASTM Heparinized Platelet | ||
| and Leukocyte Count | % platelet and leukocyte comparison to | |
| control article | PASS | |
| Comparative Surface | ||
| Assessment | 150x microscopic comparative evaluation of | |
| the surface and geometric features between | ||
| the subject device and reference device as | ||
| part of the thrombogenicity assessment. | PASS |
Based upon the intended use, design, materials, function, biocompatibility testing, and IX. Conclusion side-by-side in-vitro testing, it is concluded that the subject CEREGLIDE™ 92 Intermediate Catheter is substantially equivalent to the predicate Zoom 88 Large Distal Platform (K212224). The differences in materials and design 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.