(143 days)
Not Found
No
The device description focuses on the physical characteristics and mechanical performance of a catheter system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench and in vitro, evaluating physical properties and usability, not algorithmic performance.
No
Explanation: The device is indicated for facilitating the insertion and guidance of other interventional devices, rather than directly providing therapy itself.
No
The device is a catheter system designed to facilitate the insertion and guidance of interventional devices, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like catheters, delivery aids, valves, and introducers, and the performance testing includes physical properties and mechanical performance, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the insertion and guidance of interventional devices into blood vessels in the neurovascular system. This is a therapeutic or interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a catheter system designed for physical manipulation within the body (insertion, guidance). It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter (trackability, flexibility, strength, biocompatibility) and its ability to be used in a neurovascular model. There are no studies related to the accuracy or reliability of a diagnostic measurement or result.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used within the body to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The CEREGLIDE 92 Catheter System 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 Catheter System consists of the CEREGLIDE™ 92 Intermediate Catheter and associated accessories, including the INNERGLIDE™ 9 Delivery Aid, Rotating Hemostasis Valve (RHV), and Slit Introducers.
Intermediate Catheter
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 Catheter System is packaged with an INNERGLIDE™ 9 Delivery Aid, an RHV with a side port, and two Slit Introducer accessories. The INNERGLIDE™ 9 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 92 Catheter System to facilitate delivery of the CEREGLIDE™ 92 Intermediate Catheter to select blood vessels in the neurovasculature. 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
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:
Design Verification tests:
Visual Inspection: Samples met the established acceptance criteria.
Catheter ID: Samples met the established acceptance criteria.
Catheter OD: Samples met the established acceptance criteria.
Catheter Working Length: Samples met the established acceptance criteria.
Catheter Tip Length: Samples met the established acceptance criteria.
Hub Luer: Samples met the established acceptance criteria.
System Air Leak Resistance: Samples met the established acceptance criteria.
System Liquid Leak Resistance: Samples met the established acceptance criteria.
Hub Pull Testing: Samples met the established acceptance criteria.
Shaft Tensile Strength: Samples met the established acceptance criteria.
Particulate Count: Samples met the established acceptance criteria.
Coating Durability and Friction: Samples met the established acceptance criteria.
Coating Length: Samples met the established acceptance criteria.
Coating Thickness: Samples met the established acceptance criteria.
Coating Integrity: Samples met the established acceptance criteria.
Kink Resistance: Samples met the established acceptance criteria.
Tip Flexibility: Samples met the established acceptance criteria.
Torque Performance: Samples met the established acceptance criteria.
Trackability (Delivery and Withdrawal Force): Samples met the established acceptance criteria.
Burst Pressure: Samples met the established acceptance criteria.
Design Validation tests:
In Vitro Usability Studies: In vitro studies were conducted in a neurovascular model to evaluate compatibility, trackability, and durability of the INNERGLIDE 9 Delivery Aid and use for delivery of the CEREGLIDE 92 Intermediate Catheter. Samples met the established acceptance criteria.
Biocompatibility Testing for INNERGLIDE 9 Delivery Aid:
Cytotoxicity - MEM Elution: PASS
Sensitization - Guinea Pig Maximization: PASS
Irritation - Rabbit Intracutaneous Reactivity: PASS
Acute Systemic Toxicity in Mice: PASS
Pyrogenicity - Materials Mediated Rabbit Pyrogen: PASS
ASTM Hemolysis Study - Direct and Extraction Methods: PASS
SC5b-9 Complement Activation Assay: PASS
In Vivo Thromboresistance: PASS
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
May 9, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
Cerenovus, Inc. Niall Fox Director of Regulatory Affairs 6303 Waterford District Drive, Suites 215 & 315 Miami. Florida 33126
Re: K233982
Trade/Device Name: CEREGLIDE 92 Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: April 9, 2024 Received: April 9, 2024
Dear Niall Fox:
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 (OS) 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) K233982
Device Name CEREGLIDE 92 Catheter System
Indications for Use (Describe)
The CEREGLIDE 92 Catheter System 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K233982
| III. Device
| Information | Table 1. Device Information | |||
|---|---|---|---|---|
| Device Proprietary Name | CEREGLIDE 92 Catheter System | |||
| Common or Usual name | Catheter, Percutaneous, Neurovasculature | |||
| Classification Name | 21 CFR 870.1250 - Percutaneous Catheter | |||
| Regulatory Classification | II | |||
| FDA Product Code | QJP | |||
| IV. Predicate | ||||
| Device | ||||
| Information | Table 2. Predicate Device | |||
| 510(k) Number | Date Cleared | Name | Manufacturer | |
| K230726 | November 29, | CEREGLIDE™ 92 | Cerenovus, Inc. |
2023
V. Device Description
The CEREGLIDE™ 92 Catheter System consists of the CEREGLIDE™ 92 Intermediate Catheter and associated accessories, including the INNERGLIDE™ 9 Delivery Aid, Rotating Hemostasis Valve (RHV), and Slit Introducers.
Intermediate Catheter
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 Catheter System is packaged with an INNERGLIDE™ 9 Delivery Aid, an RHV with a side port, and two Slit Introducer accessories. The INNERGLIDE™ 9 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 92 Catheter System to facilitate delivery of the CEREGLIDE™ 92 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and
4
510(k) Summary (continued)
| V. Device
Description
(continued) | 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 Catheter System 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 Catheter System and the predicate device is presented in Table 3. |
| Table 3. Predicate and Subject Device Comparison Summary | |||
|---|---|---|---|
| Description | Predicate Device: | ||
| CEREGLIDE™ 92 Intermediate | |||
| Catheter | |||
| K230726 | Subject Device: | ||
| CEREGLIDE™ 92 Catheter System | |||
| K233982 | |||
| Product Code | QJP | Same | |
| Regulatory Name | Catheter, Percutaneous | 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 CEREGLIDE 92 Catheter System is | ||
| indicated for use in facilitating the insertion and | |||
| guidance of appropriately sized interventional | |||
| devices into a selected blood vessel in the | |||
| neurovascular system. | |||
| CEREGLIDE 92 Intermediate Catheter Dimensions: | |||
| Length | 114 - 135 cm | Same | |
| ID | 0.092" (2.34 mm) | Same | |
| Distal OD | 0.102" (2.59 mm) | Same | |
| Proximal OD | 0.108" (2.74 mm) | Same | |
| Catheter Coating | Hydrophilic | Same | |
| Coating Length | 50 cm | Same | |
| Materials: | |||
| Marker Band | Stainless Steel and Tungsten | Same | |
| Braid | Stainless Steel and Tungsten | Same | |
| Liner | PTFE Liner | Same | |
| Hub | Nylon | Same | |
| Strain Relief | Same | ||
| Outer Jacket | Pebax, Urethane, Nylon | Same | |
| Accessories Included: | |||
| Hemostasis valve | Tuohy Borst Hemostasis Valve with | ||
| Side Port Extension Tubing | RHV with Side Port | ||
| Introducer Sheath | Slit Introducer (2) | Same | |
| INNERGLIDE™ 9 | |||
| Delivery Aid | Dimensions: | ||
| Length | None | 165 cm | |
| ID | 0.030" (0.76 mm) | ||
| Distal OD | 0.042" (1.07 mm) | ||
| Proximal OD | 0.078" (1.98 mm) | ||
| Catheter Coating | Hydrophilic | ||
| Coating Length | 50 cm |
Continued the next page
5
510(k) Summary (continued)
| Materials: | |||
|---|---|---|---|
| INNERGLIDE™ | |||
| 9 Delivery Aid | Marker Band | Tungsten | |
| Liner | PTFE Liner | ||
| Hub | None | Makrolon | |
| Strain Relief | Pebax | ||
| Outer Jacket | Pebax, Vestamid | ||
| Sterilization Method | Ethylene Oxide | Same | |
| Sterility Assurance Level (SAL) | 10-6 | Same | |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek Pouch, Carton | Same | |
| Shelf Life | 6 months | Same |
VIII. Non-Clinical Performance Testing
Performance Testing - Bench
There are no changes to the CEREGLIDE 92 Intermediate Catheter (K230726). Appropriate testing was identified based on design, risk analyses, and the intended use of the INNERGLIDE 9 Delivery Aid to demonstrate that the CEREGLIDE 92 Catheter System 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.
| Table 4. Performance Testing Summary | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification | ||
| Visual | ||
| Inspection | Confirm that the INNERGLIDE 9 Delivery Aid meets the | |
| visual requirements described in ISO 10555-1 Section 4.4. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter ID | Verify that the INNERGLIDE 9 Delivery Aid internal | |
| diameters meet the design requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter OD | Verify that the INNERGLIDE 9 Delivery Aid outer diameters | |
| meet the design requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter | ||
| Working | ||
| Length | Confirm the working length of the INNERGLIDE 9 Delivery | |
| Aid as defined in ISO 10555-1 Section 3.6. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter Tip | ||
| Length | Verify that the tip length and navigation length of the | |
| INNERGLIDE 9 Delivery Aid meet the design requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Hub Luer | Verify that the hub luer on the INNERGLIDE 9 Delivery Aid | |
| meets dimensional, interconnectability, and performance | ||
| requirements defined in ISO 80369-7. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| System Air | ||
| Leak Resistance | Verify that the INNERGLIDE 9 Delivery Aid has no air leak. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| System Liquid | ||
| Leak Resistance | Verify that the INNERGLIDE 9 Delivery Aid 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 | ||
| Hub Pull | ||
| Testing | Verify that the INNERGLIDE 9 Delivery Aid and | |
| CEREGLIDE 92 Intermediate Catheter hub to joint strength | ||
| meets acceptance criteria. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Shaft Tensile | ||
| Strength | Verify that the INNERGLIDE 9 Delivery Aid and | |
| 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 | |
| Catheter System under simulated use conditions with | ||
| comparison to the predicate devices. | PASS: | |
| Samples met the established | ||
| acceptance criteria |
6
VIII. Non-Clinical Performance Testing (continued)
| Table 4. Performance Testing Summary (continued) | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification (continued) | ||
| Coating | ||
| Durability and | ||
| Friction | Verify that the friction force and durability of the hydrophilic | |
| coating on the INNERGLIDE 9 Delivery Aid meet the design | ||
| requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Coating Length | Verify that the INNERGLIDE 9 Delivery Aid hydrophilic | |
| coating length meets the design requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Coating | ||
| Thickness | Verify that the INNERGLIDE 9 Delivery Aid hydrophilic | |
| coating thickness meets the design requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Coating | ||
| Integrity | Verify that the coating on the INNERGLIDE 9 Delivery Aid is | |
| free of uncoated individual voids when evaluated with Congo | ||
| Red Dye Coverage Test. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Kink Resistance | Confirm that the INNERGLIDE 9 Delivery Aid meets the | |
| requirement to remain stable and not kink during use. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Tip Flexibility | Test the tip flexibility of the INNERGLIDE 9 Delivery Aid, | |
| relative to cleared devices of similar design. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Torque | ||
| Performance | Confirm that the INNERGLIDE 9 Delivery Aid meets the | |
| torque strength requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Trackability | ||
| (Delivery and | ||
| Withdrawal | ||
| Force) | Confirm that the INNERGLIDE 9 Delivery Aid trackability | |
| meets the design requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Burst Pressure | Verify the CEREGLIDE 92 Intermediate Catheter continues to | |
| meet minimum static burst pressure requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Design Validation | ||
| In Vitro | ||
| Usability | ||
| Studies | In vitro studies were conducted in a neurovascular model to | |
| evaluate compatibility, trackability, and durability of the | ||
| INNERGLIDE 9 Delivery Aid and use for delivery of the | ||
| CEREGLIDE 92 Intermediate Catheter. | 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 Catheter System, 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 Catheter System and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 92 Catheter System and all accessories are for single use only.
Shelf-Life
The CEREGLIDE™ 92 Catheter System 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
510(k) Summary (continued)
| VIII. Non- |
|---|
| Clinical |
| Performance |
| Testing |
| (continued) |
Biocompatibility Testing
The INNERGLIDE 9 Delivery Aid 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 5. Biocompatibility Test Summary for the INNERGLIDE 9 Delivery Aid | |||
|---|---|---|---|
| Test Method | Acceptance Criteria | Result | |
| Cytotoxicity - MEM Elution | Grade ≤ 2 | PASS | |
| Sensitization - Guinea Pig | |||
| Maximization | Grade |