(167 days)
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter are 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 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
Both the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter (hereafter referred to as the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters) are variable stiffness, single lumen catheters designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainlesssteel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless-steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the catheter hub which can be used to attach accessories for flushing. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing and insertion of catheters. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.
This document describes the premarket notification (510(k)) for the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters, asserting their substantial equivalence to a predicate device based on non-clinical performance data.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Meet visual requirements described in ISO 10555-1 Section 4.4 | PASS: Samples met established acceptance criteria |
| Catheter ID | Internal diameters meet requirements | PASS: Samples met established acceptance criteria |
| Catheter OD | Outer diameters meet requirements | PASS: Samples met established acceptance criteria |
| Catheter Working Length | Lengths confirm to ISO 10555-1 Section 3.6 | PASS: Samples met established acceptance criteria |
| Catheter Tip Length | Tip length verifiable | PASS: Samples met established acceptance criteria |
| System Air Leakage | No air leak into the hub subassembly | PASS: Samples met established acceptance criteria |
| System Liquid Leakage | Catheter joint strength meets freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7 | PASS: Samples met established acceptance criteria |
| Delamination of PTFE Liner | PTFE appropriately adhered to inner lumen with braid reinforcement | PASS: Samples met established acceptance criteria |
| Kink | Catheter remains stable and does not kink during use | PASS: Samples met established acceptance criteria |
| Tip Movement | Meets tip column stiffness requirement | PASS: Samples met established acceptance criteria |
| Distal Tip Stiffness | Tip flexibility comparable to similar devices | PASS: Samples met established acceptance criteria |
| Peak Tensile Strength | Joint strength meets acceptance criteria of ISO 10555-1 Section 4.5 | PASS: Samples met established acceptance criteria |
| Particulate Count and Coating Integrity | Particulate size and counts under simulated use comparable to predicate, coating free of defects after simulated use | PASS: Samples met established acceptance criteria |
| Burst Pressure | Meets minimum static burst pressure specifications | PASS: Samples met established acceptance criteria |
| Torque Strength | Meets torque strength requirement | PASS: Samples met established acceptance criteria |
| Trackability | Meets trackability requirement | PASS: Samples met established acceptance criteria |
| In Vitro Usability Studies | Evaluate usability parameters (trackability, tip stability, durability, ancillary device compatibility) to target sites and delivery of stent-retriever in neurovascular model | PASS: Samples met established acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "All testing was conducted using sampling methods as required by internal procedure." However, specific sample sizes for each test are not provided. The data provenance is from bench testing and in-vitro usability studies conducted by the manufacturer, Cerenovus, Inc. The document does not specify a country of origin for the data beyond the manufacturer's location (Miami, FL, United States). These studies are considered prospective as they were conducted specifically for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document describes performance testing for medical devices based on engineering specifications and benchmark comparisons, not diagnostic or interpretive tasks requiring expert ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set:
This information is not applicable for the type of device performance testing described. Adjudication methods are typically used in clinical studies where multiple human readers or systems interpret data, and discrepancies need to be resolved. The tests here involve objective measurements against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
This information is not applicable. The device is an intermediate catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This information is not applicable. The device is a physical medical instrument, not a software algorithm. Standalone performance refers to the assessment of AI algorithms without human intervention, which is not relevant here.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests outlined is based on pre-defined engineering specifications, industry standards (e.g., ISO 10555-1), and comparative performance against a legally marketed predicate device. For example, "Catheter ID" uses internal diameter requirements as its ground truth, and "Peak Tensile Strength" uses ISO 10555-1 Section 4.5.
8. The Sample Size for the Training Set:
This information is not applicable. There is no mention of a "training set" as this device is a physical product and not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as above.
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October 16, 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Cerenovus, Inc. Cara Feely Regulatory Affairs Manager 6303 Waterford District Drive, Suites 215 & 315 Miami, Florida 33126
Re: K241244
Trade/Device Name: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP Dated: September 2, 2024 Received: September 13, 2024
Dear Cara Feely:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241244
Device Name CEREGLIDE 42 Intermediate Catheter CEREGLIDE 57 Intermediate Catheter
Indications for Use (Describe)
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter are 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 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
| 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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510(k) Summary - K241244
I. Submitter
Cerenovus, Inc. 6303 Waterford District Drive, Suites 215 & 315 Miami, FL 33126 United States
Contact Person: Cara Feely (Regulatory Affairs Manager) Tel: 00353863335253 Email: Cfeely@its.jnj.com
II. Date Prepared
October 14, 2024
III. Device Information
| Table 1. Device Information | |
|---|---|
| Device Proprietary Name | CEREGLIDE™ 42 Intermediate CatheterCEREGLIDE™ 57 Intermediate Catheter |
| Common or Usual name | Catheter, Percutaneous, Neurovasculature |
| Classification Name | 21 CFR 870.1250 - Catheter, Percutaneous |
| Regulatory Classification | II |
| FDA Product Code | QJP |
IV. Predicate Device Information
The primary predicate device is listed below in Table 2.
| Table 2. Primary Predicate Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K202752 | August 27, 2021 | AXS Vecta 46Intermediate Catheter | StrykerNeurovascular |
V. Device Description
Both the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter (hereafter referred to as the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters) are variable stiffness, single lumen catheters designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainlesssteel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless-steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the catheter hub which can be used to attach accessories for flushing. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing and insertion of catheters. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.
Continued on the next page
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| VI. Indicationsfor Use | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter areindicated for use in facilitating the insertion and guidance of appropriately sized interventionaldevices into a selected blood vessel in the neurovascular system. The CEREGLIDE 57Intermediate Catheter is also indicated for use as a conduit for retrieval devices. |
|---|---|
| VII. PredicateComparison | A comparison of the similarities and differences of product features between theCEREGLIDE™ 42 Intermediate Catheter, the CEREGLIDE™ 57 Intermediate Catheter, andthe predicate device are presented in Table 3. |
| Table 3. Predicate and Subject Device Comparison | |||
|---|---|---|---|
| Description | Predicate Device:AXS Vecta 46 IntermediateCatheter (K202752) | Subject Device:CEREGLIDE™ 42Intermediate Catheter | Subject Device:CEREGLIDE™ 57Intermediate Catheter |
| Indications ForUse | The AXS Vecta IntermediateCatheter is indicated for use infacilitating the insertion andguidance of appropriately sizedinterventional devices into a selectedblood vessel in the neurovascularsystem. The AXS VectaIntermediate Catheter is alsoindicated for use as a conduit forretrieval devices. | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57Intermediate Catheter are indicated for use in facilitating the insertionand guidance of appropriately sized interventional devices into aselected blood vessel in the neurovascular system. The CEREGLIDE57 Intermediate Catheter is also indicated for use as a conduit forretrieval devices. | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57Intermediate Catheter are indicated for use in facilitating the insertionand guidance of appropriately sized interventional devices into aselected blood vessel in the neurovascular system. The CEREGLIDE57 Intermediate Catheter is also indicated for use as a conduit forretrieval devices. |
| Product Code | QJP | Same as predicate | Same as predicate |
| RegulatoryName | Catheter, Percutaneous | Same as predicate | |
| Classification | Class II - 21 CFR 870.1250 | Same as predicate | |
| Basic Design | Variable stiffness single lumencatheter | Same as predicate | |
| Length | 125 cm146 cm153 cm160 cm | 115 cm125 cm132 cm144 cm152 cm160 cm | 115 cm125 cm132 cm137 cm |
| Inner Diameter(ID) | 0.046" | 0.042" | 0.057" |
| Distal OuterDiameter (OD) | 0.056" | 0.053"(1.35 mm) | 0.068"(1.73 mm) |
| Proximal OD | 0.058" | 0.0535"(1.36 mm) | 0.0685"(1.74 mm) |
| Catheter Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Coating Length | Not Specified | 55 cm | 55 cm |
| TipConfiguration | Not Specified | Non-shapeable tip | Non-shapeable tip |
| Marker Band | Platinum/ Iridium | Same as predicate | Same as predicate |
| Braid | Stainless Steel/Nitinol | Stainless Steel | |
| Liner | PTFE Liner | Same as predicate | |
| Hub | Polycarbonate | Same as predicate | |
| Strain Relief | Polyolefin | Same as predicate | |
| Outer Jacket | Polyether Block Amide (Pebax),Urethane, Nylon | Pebax, Urethane | |
| Hemostasis Valve | Included | Same as predicate | Same as predicate |
| IntroducerSheath | Peel-Away Introducer | Slit Introducer (2) | Slit Introducer (2) |
Continued on the next page
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| Table 3. Predicate and Subject Device Comparison | |||
|---|---|---|---|
| Description | Predicate Device:AXS Vecta 46 IntermediateCatheter (K202752) | Subject Device:CEREGLIDE™ 42Intermediate Catheter | Subject Device:CEREGLIDE™ 57Intermediate Catheter |
| SterilizationMethod | Ethylene Oxide | Same as predicate | Same as predicate |
| Sterility AssuranceLevel (SAL) | Not Specified | 10-6 | 10-6 |
| Packaging | Tyvek/Nylon Pouch, polyethylenesupport tube, packaging card,SBS carton | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton |
| Shelf Life | Not Specified | 3 years | 3 years |
VIII. Non-Clinical Performance Data
Performance Testing – Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™57 Intermediate Catheter to demonstrate that they are substantially equivalent to the legally marketed predicate device. The following performance data are being provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by internal procedure. The bench testing included the following tests:
| Test | Test SummaryDesign Verification | Result |
|---|---|---|
| VisualInspection | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters meet the visual requirement described inISO 10555-1 Section 4.4. | PASS:Samples met the establishedacceptance criteria |
| Catheter ID | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters' internal diameters meet therequirements. | PASS:Samples met the establishedacceptance criteria |
| Catheter OD | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters' outer diameters meet the requirements. | PASS:Samples met the establishedacceptance criteria |
| CatheterWorkingLength | Confirm the working lengths of the catheters as defined in ISO10555-1 Section 3.6. | PASS:Samples met the establishedacceptance criteria |
| Catheter TipLength | Verify the catheter tip length of the CEREGLIDETM 42 andCEREGLIDETM 57 Intermediate Catheters. | 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 catheter joint strength meets the freedom fromleakage (liquid during pressurization) requirements of ISO10555-1:2013, section 4.7. | PASS:Samples met the establishedacceptance criteria |
| Delamination ofPTFE Liner | Verify that the PTFE has appropriately adhered to the innerlumen of the catheter with braid reinforcement. | PASS:Samples met the establishedacceptance criteria |
| Kink | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters meet the requirement for the catheter toremain stable and not kink during use. | PASS:Samples met the establishedacceptance criteria |
| Tip Movement | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters meet the tip column stiffnessrequirement. | PASS:Samples met the establishedacceptance criteria |
| Distal TipStiffness | Test the tip flexibility of the CEREGLIDETM 42 andCEREGLIDETM 57 Intermediate Catheters, relative to otherdevices of similar design. | PASS:Samples met the establishedacceptance criteria |
| Peak TensileStrength | Verify that the CEREGLIDETM 42 Intermediate Catheter jointstrength meets the acceptance criteria of Section 4.5 of ISO10555-1. | PASS:Samples met the establishedacceptance criteria |
| ParticulateCount andCoatingIntegrity | Verify the particulate size and counts of the CEREGLIDETM 42Intermediate Catheter under simulated use conditions withcomparison to the predicate device. Coating integrity wasvisually inspected and verified to be free of coating defectsafter simulated use. | PASS:Samples met the establishedacceptance criteria |
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VIII. Non-Clinical Performance Data, continued
| Table 4. Performance Testing Summary | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification | ||
| Burst Pressure | Verify that the CEREGLIDETM 42 and 57 IntermediateCatheters meet minimum static burst pressure specifications. | PASS:Samples met the establishedacceptance criteria |
| Torque Strength | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters meet the torque strength requirement. | PASS:Samples met the establishedacceptance criteria |
| Trackability | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57Intermediate Catheters meet the trackability requirement. | PASS: Samples met theestablished acceptance criteria |
| Design Validation | ||
| In VitroUsabilityStudies | The in-vitro studies were conducted to evaluate usabilityparameters such as trackability, tip stability, durability, and(ancillary) device compatibility with tracking of theCEREGLIDETM 42 and CEREGLIDETM 57 IntermediateCatheters to target sites and delivery of a stent-retriever in theneurovascular model. | PASS:Samples met the establishedacceptance criteria |
Performance Testing - Animal
No animal studies were required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing.
Performance Testing - Clinical
Clinical studies were not required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing.
Sterilization
The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters are packaged with included accessories and sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 106 in accordance with ISO 11135. The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters and all accessories are for single use only.
Shelf-Life
The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters will have a shelf life of three years. Shelf-life testing was adopted from CEREGLIDE™ 71 Intermediate Catheter (K221930) that shares the same materials, design features, and manufacturing processes as the subject devices. Prior to aging, all samples were exposed to standard transportation conditioning. Results of shelf-life performance testing all met established acceptance criteria.
Biocompatibility Testing
A biological safety evaluation was conducted for the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters in accordance with the FDA biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" (issued September 2023). Additionally, biocompatibility testing conducted on the CEREGLIDE™ 71 Intermediate Catheter (K221930), per ISO 10993-1 and applicable regulatory requirements, adequately evaluates the biocompatibility profile of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters for endpoints recommended by the FDA biocompatibility guidance for an externally communicating device with limited (≤24 hours) duration of contact with circulating blood. The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters have met the requirements of biocompatibility assessments, for their intended use.
Continued on the next page
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IX. Conclusion Based upon the intended use, design, materials, function, and side-by-side in-vitro testing, it is concluded that the subject devices, the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters, are substantially equivalent to the predicate device, AXS Vecta 46 Intermediate Catheter (K202752). The differences in materials and design do not raise new questions regarding the safety and effectiveness of the devices. The subject devices, as designed, manufactured, packaged, and sterilized, are substantially equivalent to the primary predicate device currently marketed under the Federal Food, Drug and Cosmetic Act.
End of document
§ 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).