(258 days)
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 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.
The provided document is a 510(k) Premarket Notification from the FDA regarding the "CEREGLIDE 92 Intermediate Catheter." It details various performance tests conducted on the device to demonstrate its substantial equivalence to a legally marketed predicate device.
However, it's crucial to understand that this document does NOT describe the acceptance criteria and study proving device performance for an AI/ML-driven medical device.
Instead, this document pertains to a traditional, physical medical device (a catheter). The "performance testing" described are typical bench testing (physical and mechanical properties) and biocompatibility testing for hardware, not algorithmic performance.
Therefore, many of the specific questions asked in the prompt, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," and "ground truth for the training set," are not applicable to the content of this document. These questions are relevant to the validation of AI/ML models in medical devices.
I will address the questions to the extent possible with the information provided, explicitly stating when information is not present or not applicable.
Acceptance Criteria and Device Performance for the CEREGLIDE 92 Intermediate Catheter
The CEREGLIDE 92 Intermediate Catheter is a physical medical device, not an AI/ML-driven one. Therefore, the "acceptance criteria" and "device performance" in this context refer to its physical, mechanical, and biological properties rather than algorithmic performance.
1. A table of acceptance criteria and the reported device performance
The document provides a summary of "Performance Testing - Bench" and "Biocompatibility Testing." For each test, the "Result" uniformly states "PASS: Samples met the established acceptance criteria" or simply "PASS." The specific numerical or quantitative acceptance criteria are generally not explicitly stated in the summary tables but are implied by the "PASS" result.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Design Verification | Visual Inspection | Meets visual requirements described in ISO 10555-1 Section 4.4 | PASS |
| Catheter ID | Meets specified internal diameter requirements | PASS | |
| Catheter OD | Meets specified outer diameter requirements | PASS | |
| Catheter Working Length | Confirms length as defined in ISO 10555-1 Section 3.6 | PASS | |
| Catheter Tip Length | Meets specified tip length requirements | PASS | |
| Hub Luer Taper | Fits standard Luer fittings | PASS | |
| System Air Leakage | No air leak into hub subassembly | PASS | |
| System Liquid Leakage | Freedom from leakage during pressurization (ISO 10555-1:2013, section 4.7) | PASS | |
| Burst Pressure | Withstands maximum hydrostatic pressure | PASS | |
| Hub Pull Testing | Hub-to-joint strength meets acceptance criteria | PASS | |
| Shaft Tensile Strength | Joint strength meets acceptance criteria | PASS | |
| Particulate Count | Meets particulate size and counts under simulated use | PASS | |
| Coating Lubricity and Durability | Lubriciousness and durability of hydrophilic coating | PASS | |
| Coating Length | Hydrophilic coating length meets design requirements | PASS | |
| Kink Resistance (Distal & Proximal) | Remains stable and does not kink during use | PASS | |
| Delamination of PTFE Liner | PTFE appropriately adhered to inner lumen | PASS | |
| Tip Movement | Meets tip column stiffness requirement | PASS | |
| Tip Linear Stiffness | Flexibility relative to other similar devices | PASS | |
| Trackability | Meets trackability requirement | PASS | |
| Torque Strength | Meets torque strength requirement | PASS | |
| Introducer Working Length | Confirms working length of introducer | PASS | |
| Introducer Separation Force | Confirms force required to separate introducer | PASS | |
| Design Validation | In Vitro Usability Studies | Evaluates usability parameters (trackability, tip stability, durability, device compatibility) | PASS |
| Biocompatibility | Cytotoxicity | 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 (ΔT) < 0.5°C | PASS | |
| ASTM Hemolysis Study - Direct and Extraction | Hemolytic Index < 2% | PASS | |
| SC5b-9 Complement Activation Assay | Results evaluated based on comparison to negative controls | PASS | |
| ASTM Partial Thromboplastin Time (PTT) | Average clotting time > 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 surface and geometric features | PASS |
2. Sample sized used for the test set and the data provenance
The document states: "All testing was conducted using sampling methods as required by internal design control procedures." However, the specific sample sizes for each test are not provided.
Data provenance: Given that these are bench tests for a physical device, the "data provenance" would refer to the testing conditions and lab environment, rather than patient data. The tests were conducted internally by the manufacturer. No country of origin for specific "data" (in the sense of patient data) is applicable. This was a non-clinical study involving bench testing and in-vitro/in-vivo animal tests for biocompatibility, not a clinical trial involving human patients or patient data.
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 a physical catheter, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests refers to established engineering specifications, ISO standards, and biological safety limits.
4. Adjudication method for the test set
Not applicable. There is no "adjudication" in the sense of reconciling expert opinions on data. Adjudication methods like 2+1 or 3+1 are used for human-labeled datasets, typically for AI/ML models.
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. MRMC studies are performed to evaluate the diagnostic performance of AI-assisted human readers compared to human readers alone, typically in medical imaging or diagnostics. This document is about a physical interventional device, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
For the bench testing and biocompatibility assessments, the "ground truth" is based on:
- Established engineering specifications and design requirements for the catheter's physical dimensions, mechanical properties (tensile strength, burst pressure, kink resistance, trackability, etc.).
- International standards (e.g., ISO 10555-1) for catheter performance.
- Regulatory guidance and standards for biocompatibility (e.g., ISO 10993-1, ISO 11135 for sterilization, EN ISO 10993-7 for EO residuals).
- Comparison to predicate device characteristics to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI/ML model.
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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).
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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
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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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Device Information
510(k) Summary K230726
Regulatory Classification
| I. Submitter | Cerenovus, Inc.6303 Waterford District DriveSuites 215 & 315Miami, FL 33126 USAContact Person: Ariell JoinerTel: (908) 726-9577Email: ajoiner@its.jnj.com | ||||||
|---|---|---|---|---|---|---|---|
| II. DatePrepared | November 27, 2023 | ||||||
| III. DeviceInformation | 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. Predicateand Reference | The predicate device is listed below in Table 2 and the reference devices are listed inTable 3 . |
| Table 2. Predicate Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K212224 | September 20, 2021 | Zoom 88 Large DistalPlatform | Imperative Care, Inc. |
| Table 3. Reference Devices | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K191237 | November 8, 2019 | CERENOVUS Large BoreCatheter | Medos InternationalSARL* |
| K192804 | February 27, 2020 | CEREBASE DA Guide Sheath | Medos InternationalSARL |
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. DeviceDescription(continued) | The CEREGLIDE™ 92 Intermediate Catheter is packaged with a Tuohy Borsthemostasis valve (RHV) with a side port and two slit introducer accessories. The RHVwith side port is used for flushing and insertion of catheters. The slit introducers aredesigned to introduce the CEREGLIDE™ 92 Intermediate Catheter into the basecatheter and protect the distal tip of the CEREGLIDE™ 92 Intermediate Catheterduring insertion into the hemostasis valve of the base catheter. |
|---|---|
| VI. Indicationsfor Use | The CEREGLIDE 92 Intermediate Catheter is indicated for use in facilitating theinsertion and guidance of appropriately sized interventional devices into a selectedblood vessel in the neurovascular system. |
| VII. PredicateComparison | A comparison of indications for use and technological characteristics between theCEREGLIDE™ 92 Intermediate Catheter and the predicate device is presented inTable 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 ForUse | The CEREGLIDE 92 Intermediate Catheter is indicated foruse in facilitating the insertion and guidance ofappropriately sized interventional devices into a selectedblood vessel in the neurovascular system. | The Zoom 88 Large Distal Platform is indicated for theintroduction 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 withhydrophilic coating | Same |
| Accessories Included: | ||
| Hemostasis Valve | Included: Tuohy Borst Hemostasis Valve with Side PortExtension Tubing | Rotating Hemostasis Valve (RHV) |
| Introducer Sheath | Slit Introducer (2) | None |
| SterilizationMethod | Ethylene Oxide | Same |
| Sterility AssuranceLevel (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 polyethylenepackaging card, placed into a pouch, sealed and labeled.The sealed pouch and IFU are placed in a labeled shelfcarton box. |
| Shelf Life | 6 months | 1 year |
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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 | |||||
| VisualInspection | Confirm that the CEREGLIDE 92 Intermediate Catheter meetsthe visual requirement described in ISO 10555-1 Section 4.4. | PASS:Samples met the establishedacceptance criteria | |||
| Catheter ID | Verify that the CEREGLIDE 92 Intermediate Catheter internaldiameters meet the requirements. | PASS:Samples met the establishedacceptance criteria | |||
| Catheter OD | Verify that the CEREGLIDE 92 Intermediate Catheter outerdiameters meet the requirements. | PASS:Samples met the establishedacceptance criteria | |||
| CatheterWorkingLength | Confirm the working length of the CEREGLIDE 92Intermediate Catheter as defined in ISO 10555-1 Section 3.6. | PASS:Samples met the establishedacceptance criteria | |||
| Catheter TipLength | Verify the tip length of the CEREGLIDE 92 IntermediateCatheter. | PASS:Samples met the establishedacceptance criteria | |||
| Hub Luer Taper | Verify that the catheter hub Luer taper fit standard Luer fittingsusing taper device. | PASS:Samples met the establishedacceptance criteria | |||
| System AirLeakage | Verify that there is no air leak into the hub subassembly. | PASS:Samples met the establishedacceptance criteria | |||
| System LiquidLeakage | Verify that the CEREGLIDE 92 Intermediate Catheter jointstrength meets the freedom from leakage (liquid duringpressurization) requirements of ISO 10555-1:2013, section 4.7. | PASS:Samples met the establishedacceptance criteria | |||
| Burst Pressure | Confirm the maximum hydrostatic pressure the CEREGLIDE92 Intermediate Catheter can withstand using a CrescentHydraulic Burst-leak Tester. | PASS:Samples met the establishedacceptance criteria | |||
| Hub PullTesting | To verify the CEREGLIDE 92 Intermediate Catheter hub tojoint strength meets acceptance criteria. | PASS:Samples met the establishedacceptance criteria | |||
| Shaft TensileStrength | Verify that the CEREGLIDE 92 Intermediate Catheter jointstrength meets the acceptance criteria. | PASS:Samples met the establishedacceptance criteria | |||
| ParticulateCount | Verify the particulate size and counts of the CEREGLIDE 92Intermediate Catheter under simulated use conditions withcomparison to the predicate and reference devices. | PASS:Samples met the establishedacceptance criteria | |||
| CoatingLubricity andDurability | Verify the lubriciousness and durability of the CEREGLIDE 92Intermediate Catheter's hydrophilic coating. | PASS:Samples met the establishedacceptance criteria | |||
| Coating Length | Verify that the CEREGLIDE 92 Intermediate Catheterhydrophilic coating length meets the design requirements. | PASS:Samples met the establishedacceptance criteria | |||
| Kink Resistance(Distal &Proximal) | Confirm that the CEREGLIDE 92 Intermediate Catheter meetsthe requirement for the catheter to remain stable and not kinkduring use. | PASS:Samples met the establishedacceptance criteria | |||
| Delamination ofPTFE Liner | Verify that the PTFE has appropriately adhered to the innerlumen of the CEREGLIDE 92 Intermediate Catheter with braidreinforcement. | PASS:Samples met the establishedacceptance criteria |
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| 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 Cathetermeets the tip column stiffness requirement. | PASS:Samples met the establishedacceptance criteria |
| Tip Linear Stiffness | Test the tip flexibility of the CEREGLIDE 92 IntermediateCatheter, relative to other devices of similar intended useand design. | PASS:Samples met the establishedacceptance criteria |
| Trackability | Confirm that the CEREGLIDE 92 Intermediate Cathetermeets the trackability requirement. | PASS:Samples met the establishedacceptance criteria |
| Torque Strength | Confirm that the CEREGLIDE 92 Intermediate Cathetermeets the torque strength requirement. | PASS:Samples met the establishedacceptance criteria |
| Introducer WorkingLength | Confirm the working length of the introducer. | PASS:Samples met the establishedacceptance criteria |
| IntroducerSeparation Force | Confirm the force required to separate the introducer. | PASS:Samples met the establishedacceptance criteria |
| Design Validation | ||
| In Vitro UsabilityStudies | The in vitro studies were conducted to evaluate usabilityparameters such as trackability, tip stability, durability, and(ancillary) device compatibility with tracking of theCEREGLIDE 92 Intermediate Catheter to target sites anddelivery of a worst-case interventional device in theneurovascular model. | 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 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.
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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 IntermediateCatheter and Introducer | ||
|---|---|---|
| Test Method | Acceptance Criteria | Result |
| Cytotoxicity | 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 (ΔT) < 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 |
| ASTM Partial ThromboplastinTime (PTT) | Average clotting time> 50% of the negative control | PASS |
| ASTM Heparinized Plateletand Leukocyte Count | % platelet and leukocyte comparison tocontrol article | PASS |
| Comparative SurfaceAssessment | 150x microscopic comparative evaluation ofthe surface and geometric features betweenthe subject device and reference device aspart 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.
§ 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).