(143 days)
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.
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.
The provided text describes information about the CEREGLIDE 92 Catheter System (K233982). However, it does not include details about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device (CEREGLIDE™ 92 Intermediate Catheter K230726) through non-clinical performance testing (bench, animal, and clinical were not required).
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only without human-in-the-loop performance) study results.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The "acceptance criteria" mentioned in the document refer to the success metrics for the bench testing conducted on the CEREGLIDE 92 Catheter System, primarily for individual physical and functional properties, not for an AI/ML-based diagnostic or prognostic task. The reported performance for these tests is simply "PASS: Samples met the established acceptance criteria."
Summary of what the document does provide regarding performance testing:
The device underwent non-clinical performance testing, primarily bench testing, to demonstrate substantial equivalence to the predicate device.
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Meet visual requirements described in ISO 10555-1 Section 4.4 | PASS: Samples met the established acceptance criteria |
| Catheter ID | Meet design requirements (internal diameters) | PASS: Samples met the established acceptance criteria |
| Catheter OD | Meet design requirements (outer diameters) | PASS: Samples met the established acceptance criteria |
| Catheter Working Length | Meet working length definition in ISO 10555-1 Section 3.6 | PASS: Samples met the established acceptance criteria |
| Catheter Tip Length | Meet design requirements (tip length and navigation length) | PASS: Samples met the established acceptance criteria |
| Hub Luer | Meet dimensional, interconnectability, and performance requirements defined in ISO 80369-7 | PASS: Samples met the established acceptance criteria |
| System Air Leak Resistance | No air leak | PASS: Samples met the established acceptance criteria |
| System Liquid Leak Resistance | Meet 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 | Meet acceptance criteria (hub to joint strength) | PASS: Samples met the established acceptance criteria |
| Shaft Tensile Strength | Meet acceptance criteria (joint strength) | PASS: Samples met the established acceptance criteria |
| Particulate Count | Comparison to predicate devices | PASS: Samples met the established acceptance criteria |
| Coating Durability and Friction | Meet design requirements (friction force and durability of hydrophilic coating) | PASS: Samples met the established acceptance criteria |
| Coating Length | Meet design requirements (hydrophilic coating length) | PASS: Samples met the established acceptance criteria |
| Coating Thickness | Meet design requirements (hydrophilic coating thickness) | PASS: Samples met the established acceptance criteria |
| Coating Integrity | Free of uncoated individual voids (Congo Red Dye Coverage Test) | PASS: Samples met the established acceptance criteria |
| Kink Resistance | Remain stable and not kink during use | PASS: Samples met the established acceptance criteria |
| Tip Flexibility | Relative to cleared devices of similar design | PASS: Samples met the established acceptance criteria |
| Torque Performance | Meet torque strength requirement | PASS: Samples met the established acceptance criteria |
| Trackability (Delivery and Withdrawal Force) | Meet design requirements | PASS: Samples met the established acceptance criteria |
| Burst Pressure | Meet minimum static burst pressure requirements | PASS: Samples met the established acceptance criteria |
| In Vitro Usability Studies | Evaluate compatibility, trackability, and durability in a neurovascular model | PASS: Samples met the established acceptance criteria |
Biocompatibility Testing:
| Test Method | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - MEM Elution | Grade ≤ 2 | PASS |
| Sensitization - Guinea Pig Maximization | Grade < 1 | PASS |
| Irritation - Rabbit Intracutaneous Reactivity | Difference of ≤ 1 from control mean score | PASS |
| Acute Systemic Toxicity in Mice | No biologically significant signs of systemic toxicity | PASS |
| Pyrogenicity - Materials Mediated Rabbit Pyrogen | Temperature change (△T) < 0.5°C | PASS |
| ASTM Hemolysis Study - Direct and Extraction Methods | Hemolytic Index < 2% | PASS |
| SC5b-9 Complement Activation Assay | Results evaluated based on comparison to negative controls | PASS |
| In Vivo Thromboresistance | Results evaluated based on comparison to negative controls | PASS |
2. Sample sized used for the test set and the data provenance:
"All testing was conducted using sampling methods as required by internal design control procedures." Specific sample sizes for each test are not provided. The data provenance is internal laboratory testing ("bench testing").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable; this device is not an AI/ML diagnostic. Performance was established through engineering tests.
4. Adjudication method for the test set:
Not applicable; this device is not an AI/ML diagnostic.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable; this device is not an AI-assisted diagnostic.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable; this device does not involve an algorithm.
7. The type of ground truth used:
For the non-clinical performance testing, the "ground truth" was established by predefined engineering specifications, industry standards (e.g., ISO 10555-1, ISO 80369-7, ISO 11135, EN ISO 10993-7, ISO 10993-1), and internal design requirements.
8. The sample size for the training set:
Not applicable; this device is not an AI/ML device and does not have a training set.
9. How the ground truth for the training set was established:
Not applicable.
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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).
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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. DeviceInformation | 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. PredicateDeviceInformation | 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. DeviceDescription(continued) | insertion of catheters. The Slit Introducers are designed to introduce theCEREGLIDE™ 92 Intermediate Catheter into the base catheter and protect the distaltip of the CEREGLIDE™ 92 Intermediate Catheter during insertion into thehemostasis valve of the base catheter. |
|---|---|
| VI. Indicationsfor Use | The CEREGLIDE 92 Catheter System is indicated for use in facilitating the insertionand guidance of appropriately sized interventional devices into a selected blood vesselin the neurovascular system. |
| VII. PredicateComparison | A comparison of indications for use and technological characteristics between theCEREGLIDE™ 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 IntermediateCatheterK230726 | Subject Device:CEREGLIDE™ 92 Catheter SystemK233982 | |
| 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 IntermediateCatheter is indicated for use infacilitating the insertion and guidanceof appropriately sized interventionaldevices into a selected blood vessel inthe neurovascular system. | The CEREGLIDE 92 Catheter System isindicated for use in facilitating the insertion andguidance of appropriately sized interventionaldevices into a selected blood vessel in theneurovascular 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 withSide Port Extension Tubing | RHV with Side Port | |
| Introducer Sheath | Slit Introducer (2) | Same | |
| INNERGLIDE™ 9Delivery 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 | ||
| VisualInspection | Confirm that the INNERGLIDE 9 Delivery Aid meets thevisual requirements described in ISO 10555-1 Section 4.4. | PASS:Samples met the establishedacceptance criteria |
| Catheter ID | Verify that the INNERGLIDE 9 Delivery Aid internaldiameters meet the design requirements. | PASS:Samples met the establishedacceptance criteria |
| Catheter OD | Verify that the INNERGLIDE 9 Delivery Aid outer diametersmeet the design requirements. | PASS:Samples met the establishedacceptance criteria |
| CatheterWorkingLength | Confirm the working length of the INNERGLIDE 9 DeliveryAid as defined in ISO 10555-1 Section 3.6. | PASS:Samples met the establishedacceptance criteria |
| Catheter TipLength | Verify that the tip length and navigation length of theINNERGLIDE 9 Delivery Aid meet the design requirements. | PASS:Samples met the establishedacceptance criteria |
| Hub Luer | Verify that the hub luer on the INNERGLIDE 9 Delivery Aidmeets dimensional, interconnectability, and performancerequirements defined in ISO 80369-7. | PASS:Samples met the establishedacceptance criteria |
| System AirLeak Resistance | Verify that the INNERGLIDE 9 Delivery Aid has no air leak. | PASS:Samples met the establishedacceptance criteria |
| System LiquidLeak Resistance | Verify that the INNERGLIDE 9 Delivery Aid joint strengthmeets the freedom from leakage (liquid during pressurization)requirements of ISO 10555-1:2013, section 4.7. | PASS:Samples met the establishedacceptance criteria |
| Hub PullTesting | Verify that the INNERGLIDE 9 Delivery Aid andCEREGLIDE 92 Intermediate Catheter hub to joint strengthmeets acceptance criteria. | PASS:Samples met the establishedacceptance criteria |
| Shaft TensileStrength | Verify that the INNERGLIDE 9 Delivery Aid andCEREGLIDE 92 Intermediate Catheter joint strength meets theacceptance criteria. | PASS:Samples met the establishedacceptance criteria |
| ParticulateCount | Verify the particulate size and counts of the CEREGLIDE 92Catheter System under simulated use conditions withcomparison to the predicate devices. | PASS:Samples met the establishedacceptance criteria |
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VIII. Non-Clinical Performance Testing (continued)
| Table 4. Performance Testing Summary (continued) | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification (continued) | ||
| CoatingDurability andFriction | Verify that the friction force and durability of the hydrophiliccoating on the INNERGLIDE 9 Delivery Aid meet the designrequirements. | PASS:Samples met the establishedacceptance criteria |
| Coating Length | Verify that the INNERGLIDE 9 Delivery Aid hydrophiliccoating length meets the design requirements. | PASS:Samples met the establishedacceptance criteria |
| CoatingThickness | Verify that the INNERGLIDE 9 Delivery Aid hydrophiliccoating thickness meets the design requirements. | PASS:Samples met the establishedacceptance criteria |
| CoatingIntegrity | Verify that the coating on the INNERGLIDE 9 Delivery Aid isfree of uncoated individual voids when evaluated with CongoRed Dye Coverage Test. | PASS:Samples met the establishedacceptance criteria |
| Kink Resistance | Confirm that the INNERGLIDE 9 Delivery Aid meets therequirement to remain stable and not kink during use. | PASS:Samples met the establishedacceptance criteria |
| Tip Flexibility | Test the tip flexibility of the INNERGLIDE 9 Delivery Aid,relative to cleared devices of similar design. | PASS:Samples met the establishedacceptance criteria |
| TorquePerformance | Confirm that the INNERGLIDE 9 Delivery Aid meets thetorque strength requirement. | PASS:Samples met the establishedacceptance criteria |
| Trackability(Delivery andWithdrawalForce) | Confirm that the INNERGLIDE 9 Delivery Aid trackabilitymeets the design requirements. | PASS:Samples met the establishedacceptance criteria |
| Burst Pressure | Verify the CEREGLIDE 92 Intermediate Catheter continues tomeet minimum static burst pressure requirements. | PASS:Samples met the establishedacceptance criteria |
| Design Validation | ||
| In VitroUsabilityStudies | In vitro studies were conducted in a neurovascular model toevaluate compatibility, trackability, and durability of theINNERGLIDE 9 Delivery Aid and use for delivery of theCEREGLIDE 92 Intermediate Catheter. | PASS:Samples met the establishedacceptance 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.
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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 PigMaximization | Grade < 1 | PASS | |
| Irritation - RabbitIntracutaneous Reactivity | Difference of ≤ 1 from control mean score | PASS | |
| Acute Systemic Toxicityin Mice | No biologically significant signs of systemictoxicity | PASS | |
| Pyrogenicity - MaterialsMediated Rabbit Pyrogen | Temperature change (△T) < 0.5°C | PASS | |
| ASTM Hemolysis Study -Direct and Extraction Methods | Hemolytic Index < 2% | PASS | |
| SC5b-9 ComplementActivation Assay | Results evaluated based on comparison tonegative controls | PASS | |
| In Vivo Thromboresistance | Results evaluated based on comparison tonegative controls | PASS |
Based upon the intended use, design, materials, function, performance testing and IX. Conclusion biocompatibility testing, it is concluded that the subject device, CEREGLIDE™ 92 Catheter System (K233982) is substantially equivalent to the predicate CEREGLIDE™ 92 Intermediate Catheter (K230726). The addition of the INNERGLIDE™ 9 Delivery Aid did not raise any new questions regarding the safety and effectiveness of the device. The CEREGLIDE™ 92 Catheter System, as designed, manufactured, packaged, and sterilized, is substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).