(149 days)
The CEREBASE DA Guide Sheath is indicated for the introduction of interventional devices into the neuro vasculature.
The CEREBASE DA Guide Sheath is a single lumen, stainless steel braided catheter of variable stiffness with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The guide sheath is a straight shaped catheter that comes in four lengths; 70 cm, 80 cm, 90 cm, and 95 cm. The lubricious PTFE-lined inner lumen is designed to facilitate delivery of the interventional devices. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The guide sheath has an outer hydrophilic coating at the distal end that reduces friction during use. A hemostasis valve and a dilator are provided with the CEREBASE DA Guide Sheath within its sterile packaging. The dilator is a single lumen radiopaque catheter with a tapered distal end and a luer hub at the proximal end. The dilator is compatible with the CEREBASE DA Guide Sheath and up to 0.038 inch diagnostic guidewires. The hemostasis valve with side port is an off the shelf component used for flushing and insertion of catheters.
The provided text describes the acceptance criteria and the study proving the device meets these criteria for the CEREBASE DA Guide Sheath. This is a medical device, and the study in question is a premarket notification for substantial equivalence to an existing predicate device, not a typical AI/ML performance study. Therefore, some of the requested information regarding AI/ML specific criteria (like human-in-the-loop, training set details, or multiple expert ground truth) is not applicable or not provided in this document.
Here's the breakdown of the acceptance criteria and performance as presented:
Acceptance Criteria and Device Performance for CEREBASE DA Guide Sheath
The acceptance criteria for the CEREBASE DA Guide Sheath are primarily based on non-clinical performance testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (Neuron MAX System).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were established through various tests designed to ensure the device meets predefined requirements (design inputs) and industry standards (e.g., ISO 10555-1, ISO 11070). The reported performance for all tests was "Pass," indicating that the samples met the established acceptance criteria.
| Test | Acceptance Criteria Summary | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Tests | ||
| Visual Inspection | Meets visual requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Catheter Internal Diameter (ID) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Catheter Outer Diameter (OD) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Catheter Working Length | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Distal Tip Length | Distance of distal marker band edge to tip meets requirements. | Pass. Samples passed established acceptance criteria. |
| Hub Luer Taper | Fits standard luer fittings using a taper device. | Pass. Samples passed established acceptance criteria. |
| Air Leak Test | No air leaks into the hub subassembly (no air bubbles). | Pass. Samples passed established acceptance criteria. |
| Liquid Leak Test | Joint strength meets freedom from leakage requirements (liquid during pressurization) of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Static Burst | Maximum hydrostatic pressure meets requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Hub Pull Testing | Strength of the catheter hub meets requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Shaft Tensile Strength | Strength of the catheter shaft meets requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Particulate Count | Quantifies particulate count generated by simulated use. | Pass. Samples passed established acceptance criteria. |
| Coating Lubricity | Measures lubricity; frictional force meets requirements. | Pass. Samples passed established acceptance criteria. |
| Coating Durability | Measures durability of lubricious coating layer. | Pass. Samples passed established acceptance criteria. |
| Coating Length | Hydrophilic coating length meets design requirement. | Pass. Samples passed established acceptance criteria. |
| Kink Resistance | Confirms catheter stability and no kinking during use. | Pass. Samples passed established acceptance criteria. |
| Delamination of PTFE Liner | PTFE appropriately adhered to inner lumen with braid reinforcement. | Pass. Samples passed established acceptance criteria. |
| Backup Support | Measures stability while advancing other interventional devices; force at which catheter support failed meets requirements. | Pass. Samples passed established acceptance criteria. |
| Tip Linear Stiffness | Evaluates flexibility relative to other devices of similar design. | Pass. Samples passed established acceptance criteria. |
| Dilator Visual Inspection | Free of extraneous matter per ISO 11070. | Pass. Samples passed established acceptance criteria. |
| Dilator Inner Diameter (ID) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Dilator Hub Luer Taper | Fits standard luer fittings using a tapered device. | Pass. Samples passed established acceptance criteria. |
| Insertion Forces | Measures forces required to insert dilator and catheter into a simulated model. | Pass. Samples passed established acceptance criteria. |
| Dilator Outer Diameter (OD) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Dilator Working Length (WL) | Ensures compatibility with the catheter. | Pass. Samples passed established acceptance criteria. |
| Dilator Tensile Strength | Meets requirements of ISO 11070. | Pass. Samples passed established acceptance criteria. |
| Torque (Turns to Failure) | Counts number of turns catheter can withstand without separating. | Pass. Samples passed established acceptance criteria. |
| Trackability | Measures force required to advance catheter through a simulated vascular model. | Pass. Samples passed established acceptance criteria. |
| In Vitro Modeling and In Vivo Testing | Ensures design outputs meet customer requirements (conducted in a porcine model). | Pass. Samples passed established acceptance criteria. |
| Packaging Qualification | ||
| Visual Inspection (Packaging) | Meets visual criteria. | PASS |
| Dye Leak Penetration | No dye penetration. | PASS |
| Seal Strength | Meets strength requirements. | PASS |
| Shelf Life (Packaging) | Confirmed for at least one year through accelerated aging and package integrity testing per ISTA 3A:2018 and EN ISO 11607-1:2009. | PASS (1 year demonstrated). |
| Biocompatibility Testing | (Reference ISO 10993-1, FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993) | |
| Cytotoxicity - ISO Elution Method | No discrete intracytoplasmic granules, no cell lysis, no reduction of cell growth; reactivity grade = 0 per ISO 10993-5. | PASS: Non-cytotoxic |
| Sensitization - ISO Guinea Pig Maximization Sensitization | No abnormal dermal reactions and no sensitization observed. | PASS: Non-sensitizing |
| ISO Intracutaneous Reactivity Study | Injection sites appear normal; no difference in erythema and edema scores from control. | PASS: Non-irritating |
| ISO Acute Systemic Toxicity in Mice | Animals appear clinically normal; no deaths; no significant changes in body weight. | PASS: Non-toxic |
| USP Rabbit Material-Mediated Pyrogenicity | No single animal shows total temperature rise of ≥ 0.5 °C, within USP requirements. | PASS: Non-pyrogenic |
| ASTM Hemolysis | Hemolysis % not higher than control (direct contact or extracted samples). | PASS: Non-hemolytic |
| SC5b-9 Complement Activation Assay | SC5b-9 concentration of test article samples not statistically higher than negative control and activated normal human serum (NHS) controls. | PASS: Not a potential activator of the complement system |
| In Vivo Thromboresistance Study | Thrombus formation comparable to control article in similar animal vasculature. | PASS: Acceptable Thromboresistance |
| Sterilization | Sterility assurance level (SAL) of 10^-6 per ISO 11135-1:2014; EO residuals per EN ISO 10993-7:2009. The device and accessories are for single use only. | The device meets these requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document consistently states "Samples passed established acceptance criteria" for the performance tests. However, the specific number of samples tested for each criterion ("sample size") is not explicitly provided in the given text for the non-clinical tests. The document only mentions "test samples" or "samples."
For the In Vitro Modeling and In Vivo Testing, it states "In Vivo testing in a porcine model," indicating animal data.
For Biocompatibility, specific animal numbers are mentioned for certain tests:
- ISO Guinea Pig Maximization Sensitization (Guinea Pigs)
- ISO Acute Systemic Toxicity in Mice (Mice)
- USP Rabbit Material-Mediated Pyrogenicity (3 animals in Pyrogenicity test)
- In Vivo Thromboresistance Study (Implies animal model, potentially porcine as mentioned above for in vivo testing).
The data provenance is from non-clinical testing (bench testing, in vitro, and in vivo animal studies) and laboratory evaluations. The location/country of these studies is not specified, but the submission is from Medos International SARL in Switzerland to the U.S. FDA. The data is prospective as it was collected for the purpose of demonstrating device performance for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for a medical device's performance in a 510(k) submission is established by meeting predefined engineering specifications, adherence to international standards (e.g., ISO), and successful outcomes in validated physical, chemical, and biological tests. There are no human "experts" in the sense of clinicians establishing ground truth from patient data, as this is not an AI/ML diagnostic or prognostic device study.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human-read interpretations of clinical data, typically in studies involving multiple human readers or AI algorithms. The testing here is objective, based on physical and chemical measurements and biological responses.
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 submission is for a percutaneous catheter, not an AI/ML-driven diagnostic or assistive device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or more accurately, the demonstration of acceptable performance) is based on:
- Engineering specifications and design inputs: The device was tested against its own design requirements.
- International standards: Adherence to established standards like ISO 10555-1, ISO 11070, ISO 10993 series, ISO 11135-1, EN ISO 11607-1, and USP requirements.
- Bench testing results: Objective measurements of physical properties (e.g., diameters, lengths, strengths, leaks, lubricity, kinking, torque, trackability).
- In Vitro modeling results: Performance in simulated environments.
- In Vivo animal testing results: Performance in a porcine model to meet customer requirements.
- Biocompatibility test results: Demonstrating no adverse biological reactions based on standard tests (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, thromboresistance).
The comparison is also made against the technological characteristics of a legally marketed predicate device (Neuron MAX System). The conclusion of "substantial equivalence" is the ultimate "ground truth" for regulatory clearance in this context.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm that requires a training set.
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February 27, 2020
Medos International SARL Michael Liao Senior Regulatory Affairs Program Lead Chemin-Blanc 38 Le Locle, 2400, Switzerland
Re: K192804
Trade/Device Name: CEREBASE DA Guide Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: January 29, 2020 Received: January 30, 2020
Dear Michael Liao:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Xiaolin Zheng, Ph.D., M.S. 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) K192804
Device Name CEREBASE DA Guide Sheath
Indications for Use (Describe)
The CEREBASE DA Guide Sheath is indicated for the introduction of interventional devices into the neuro vasculature.
| 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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Medos International, SARL I. Submitter Chemin-Blanc 38 2400 Le Locle, Switzerland
Tel: (510) 770-5376
Contact Person: Michael Liao Email of Contact Person: mliao7(@jts.jnj.com Date Prepared: January 28, 2020
II. Device
| Table 1. Device | |
|---|---|
| Device Proprietary Name | CEREBASE DA Guide Sheath |
| Common or Usual Name | Catheter, Percutaneous, Neurovasculature |
| Classification Name | Catheter, Percutaneous, Class II, 21 C.F.R. 870.1250 |
| Regulatory Classification | II |
| Product Code | QJP |
III. Predicate Device
IV. Device
Description
The predicate device is listed below in Table 2.
| =10/1-) |
|---|
| Table 2. Prior 510(k) Clearance | |||
|---|---|---|---|
| 510(k)Number | Date Cleared | Name | Manufacturer |
| K111380 | 07/19/2011 | Neuron MAX System | Penumbra, Inc. |
| K140080 | 04/24/2014 | ENVOY DA Guiding Catheter | Medos InternationalSARL |
| K140307 | 04/21/2014 | ENVOY Guiding Catheter | Codman & Shurtleff,Inc. |
The CEREBASE DA Guide Sheath is a single lumen, stainless steel braided catheter of variable stiffness with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The guide sheath is a straight shaped catheter that comes in four lengths; 70 cm, 80 cm, 90 cm, and 95 cm. The lubricious PTFE-lined inner lumen is designed to facilitate delivery of the interventional devices. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The guide sheath has an outer hydrophilic coating at the distal end that reduces friction during use. A hemostasis valve and a dilator are provided with the CEREBASE DA Guide Sheath within its sterile packaging. The dilator is a single lumen radiopaque catheter with a tapered distal end and a luer hub at the proximal end. The dilator is compatible with the CEREBASE DA Guide Sheath and up to 0.038 inch diagnostic guidewires. The hemostasis valve with side port is an off the shelf component used for flushing and insertion of catheters.
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| IV. DeviceDescription,Continued | The CEREBASE DA Guide Sheath's lumen must be flushed and outer body wet withheparinized saline solution prior to use. If using as a primary access sheath with thedilator, the dilator must be soaked and flushed with heparinized saline solution as wellprior to use. After being flushed with heparinized saline solution the dilator can thenbe inserted and advanced until the tapered distal tip is beyond the distal end of theCEREBASE DA Guide Sheath. Then the hemostasis valve is closed around the dilatorand primary access can be gained to the vasculature using a standard technique ofchoice. |
|---|---|
| V. Indicationsfor Use | The CEREBASE DA Guide Sheath is indicated for the introduction ofinterventional devices into the neuro vasculature. |
VI.
Comparison of Technological Characteristics with Predicate Device
Table 3 below provides comparison of technological characteristics with the predicate device. Based on design verification and validation testing, the minor differences in characteristics do not raise different questions of safety and effectiveness.
| Table 3. Technological Characteristic Comparison | ||
|---|---|---|
| Description | CEREBASE DA Guide Sheath - SubjectDevice | Neuron MAX(K111380) |
| Indications | The CEREBASE DA Guide Sheath is indicatedfor the introduction of interventional devicesinto the neuro vasculature. | The Neuron MAXX System isindicated for the introduction ofinterventional devices into theperipheral, coronary, and neurovasculature |
| Lengths | 70 cm80 cm90 cm95cm | 80 cm90 cm-- |
| Shapes | Straight | Straight, MP |
| Outside Diameter | 8F | 8F |
| Inside Diameter | 0.090" | 0.088" |
| Tip Length | 1 mm | 2mm |
| Hub Material | Polycarbonate (yellow) | Nylon, Polyurethane |
| Shaft Material | Nylon Segment(s)Pebax (nylon blend) Segment(s)Polyurethane Segment(s) | Nylon, Polyurethane |
| Inner Lining | PTFE | PTFE |
| Outer Coating | Hydrophilic Coating | Hydrophilic Coating |
| Shaft Braid | 304 Stainless Steel | Stainless Steel |
| Outer JacketMaterial Segment | 11 outer jacket material segments of differentdurometer | 5 outer jacket material segments ofdifferent durometer |
| Distal TipRadiopaque Marker | Metal Marker Band | Radiopaque Filler and Metal Markerband |
| Hemostasis Valve | Yes | Yes |
| Dilator | Yes | Yes |
| Dilator Material | Polyethylene | Polyethylene |
| Packaging | PET/ LDPE Tyvek PouchPolypropylene TubingSBS Mounting CardSBS Carton | PET/PE/ Tyvek PouchHPDE TubingMounting CardCarton |
| Sterilization Method | EtO | EtO |
| Shelf Life | 1 year | 3 years |
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VII. Non-Clinical Data Performance
The design verification and validation testing activities were conducted on the CEREBASE DA Guide Sheath to ensure that design outputs met design inputs. Table 4 below provides a description and result of each of these performance tests.
| Table 4. Performance Testing | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Visual Inspection | The purpose of this test was to verify that the test samples meet the visual requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Catheter Internal Diameter (ID) | The purpose of this test was to verify that the catheter internal diameter meets requirements. The inner diameter of each sample was measured. | Pass. Samples passed established acceptance criteria. |
| Catheter Outer Diameter (OD) | The purpose of this test was to verify that the catheter outer diameter meets requirements. The outer diameter of each sample was measured. | Pass. Samples passed established acceptance criteria. |
| Catheter Working Length | The purpose of this test was to ensure the working length meets requirements. The length of the catheter was measured. | Pass. Samples passed established acceptance criteria. |
| Distal Tip Length | The purpose of this test was to ensure the distance of the distal edge of the marker band to the tip of the catheter meets requirements. | Pass. Samples passed established acceptance criteria. |
| Hub Luer Taper | The purpose of this test was to verify that the catheter hub luer taper fits standard luer fittings using a taper device. | Pass. Samples passed established acceptance criteria. |
| Air Leak Test | The purpose of this test was to verify that there are no air leaks into the hub subassembly. The samples were inspected to ensure no air bubbles that may indicate a hub air leak. | Pass. Samples passed established acceptance criteria. |
| Liquid Leak Test | The purpose of this test was to ensure that the catheter joint strength meets the freedom from leakage requirements (liquid during pressurization) requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Static Burst | The purpose of this test was to verify the maximum hydrostatic pressure meets requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Hub Pull Testing | The purpose of this test was to verify that the strength of the catheter hub meets the requirements of ISO 10555-1. A tensile tester measured the tensile strength of the joint. | Pass. Samples passed established acceptance criteria. |
| Shaft Tensile Strength | The purpose of this test was to verify that the strength of the catheter shaft meets the requirements of ISO 10555-1. A tensile tester measured the tensile strength of the distal section of the catheter shaft. | Pass. Samples passed established acceptance criteria. |
| Particulate Count | The purpose of this test was to quantify the particulate count generated by simulated use of the test samples. | Pass. Samples passed established acceptance criteria. |
| Coating Lubricity | The purpose of this test was to measure the lubricity of the coating. The test samples were put through a lubricity tester to measure frictional force. | Pass. Samples passed established acceptance criteria. |
| Coating Durability | The purpose of this test was to measure the durability of the lubricious coating layer. | Pass. Samples passed established acceptance criteria. |
| Coating Length | The purpose of this test was to verify that the catheter hydrophilic coating length meets the design requirement. | Pass. Samples passed established acceptance criteria. |
| Kink Resistance | The purpose of this test was to confirm the catheter met requirement for stability and did not kink during use. | Pass. Samples passed established acceptance criteria. |
| Delamination of PTFE Liner | The purpose of this test was to verify that the PTFE is appropriately adhered to the inner lumen of the catheter with braid reinforcement. | Pass. Samples passed established acceptance criteria. |
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| VII. Non- |
|---|
| Clinical Data |
| Performance, |
| Continued |
| Table 4. Performance Testing, Continued | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Backup Support | The purpose of this test was to measure the stability of the test sample while advancing other interventional devices through its lumen.A wire was pushed through the lumen of each test sample and the force at which catheter support failed was measured. | Pass. Samples passed established acceptance criteria. |
| Tip Linear Stiffness | The purpose of this test was to evaluate the flexibility of the catheter relative to other devices of similar design. | Pass. Samples passed established acceptance criteria. |
| Dilator Visual Inspection | The purpose of this test was to verify that the dilator was free of extraneous matter per ISO 11070. | Pass. Samples passed established acceptance criteria. |
| Dilator Inner Diameter (ID) | The purpose of this test was to verify that the dilator internal diameter meets requirements. | Pass. Samples passed established acceptance criteria. |
| Dilator Hub Luer Taper | The purpose of this test was to verify that the dilator fits standard luer fittings using a tapered device. | Pass. Samples passed established acceptance criteria. |
| Insertion Forces | The purpose of this test was to measure the forces required to insert the dilator and catheter into a simulated model. | Pass. Samples passed established acceptance criteria. |
| Dilator Outer Diameter (OD) | The purpose of this test was to verify that the dilator outer diameter meets requirements. | Pass. Samples passed established acceptance criteria. |
| Dilator Working Length (WL) | The purpose of this test is to verify the working length of the dilator to ensure compatibility with the catheter. | Pass. Samples passed established acceptance criteria. |
| Dilator Tensile Strength | The purpose of this test was to verify that the dilator joint strength meets the requirements of ISO 11070. | Pass. Samples passed established acceptance criteria. |
| Torque (Turns to Failure) | The purpose of this test is to count the number of turns the catheter can withstand without separating. | Pass. Samples passed established acceptance criteria. |
| Trackability | The purpose of this test is the measure of the force required to advance the catheter through a simulated vascular model. | Pass. Samples passed established acceptance criteria. |
| In Vitro Modeling and In Vivo Testing | The purpose of In Vitro modeling and In Vivo testing in a porcine model were to ensure that design outputs meet the customer requirements. | Pass. Samples passed established acceptance criteria. |
VII. Non-Clinical Data Performance, Continued
One year accelerated aging was successfully performed on the CEREBASE DA Guide Sheath. Additionally, through review of package integrity testing and previous testing with a sterile pouch made of the same material combination, the sterile pouch is confirmed to have a shelf life of at least one year. The shelf life of the CEREBASE DA Guide Sheath is established as one year.
Packaging Qualification
Shelf Life
The CEREBASE DA Guide Sheath was sterilized, packaged and subjected to conditioning and simulation testing for worst case conditions per ISTA 3A: 2018, Packaged-Products for parcel Delivery System Shipment 70Kg (150 lb) or less. The samples were used to validate the package integrity of the CEREBASE DA Guide Sheath per EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.
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VII. Non-Clinical Data Performance, Continued
The following packaging qualification testing was completed as part of this evaluation:
| Table 5. Packaging Qualification | |
|---|---|
| Test | Result |
| Visual Inspection | PASS |
| Dye Leak Penetration | PASS |
| Seal Strength | PASS |
| Shelf Life | PASS |
| Biocompatibility | PASS |
Performance Testing - Clinical
No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Biocompatibility Testing
The CEREBASE DA Guide Sheath was assessed for biocompatibility in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation of Testing within a Risk Management Process." and FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Issued June 16, 2016). 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:
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VII. Non-Clinical Data Performance, Continued
| Table 6. Biocompatibility Test Results | |||
|---|---|---|---|
| Test | Test Summary | Conclusion | |
| CEREBASE DA Guide Sheath | |||
| Cytotoxicity - ISO ElutionMethod | Test articles exhibited no discrete intracytoplasmicgranules, no cell lysis, no reduction of cell growth,resulting in a reactivity grade = 0 per ISO 10993-5. | PASS: Non-cytotoxic | |
| Sensitization - ISO Guinea PigMaximization Sensitization | No abnormal dermal reactions and no sensitizationwas observed. | PASS: Non-sensitizing | |
| ISO Intracutaneous ReactivityStudy | Injection sites appeared normal and no difference inerythema and edema scores from control. | PASS: Non-irritating | |
| ISO Acute Systemic Toxicity inMice | Animals appeared clinically normal throughout thestudy upon observation. No deaths and no significantchanges in body weight. | PASS: Non-toxic | |
| USP Rabbit Material-MediatedPyrogenicity | Out of 3 animals, no single animal showed atotal temperature rise of ≥ 0.5 °C, within USPrequirements. | PASS: Non-pyrogenic | |
| Hemocompatibility | ASTM Hemolysis | Hemolysis % was not higher than control in sampleseither in direct contact with the catheter or insamples extracted after contact with the catheter. | PASS: Non-hemolytic |
| SC5b-9 ComplementActivation Assay | SC5b-9 concentration of test article samples werenot statistically higher than both negative control andactivated normal human serum (NHS) controls. | PASS: Not apotential activatorof the complementsystem | |
| In Vivo ThromboresistanceStudy | Thrombus formation on the catheter was comparableto that on control article in similar animalvasculature. | PASS: AcceptableThromboresistance | |
| Hemostatic Valve | |||
| Cytotoxicity - ISO ElutionMethod | Test articles exhibited no discrete intracytoplasmicgranules, no cell lysis, no reduction of cell growth,resulting in a reactivity grade = 0 per ISO 10993-5. | PASS: Non-cytotoxic | |
| Sensitization - ISO Guinea PigMaximization Sensitization | No abnormal dermal reactions and no sensitizationwas observed. | PASS: Non-sensitizing | |
| Irritation or IntracutaneousReactivity | Injection sites appeared normal. Mean erythema andedema scores of test articles had differences of <1from control. | PASS: Non-irritating | |
| ISO Acute Systemic Toxicity inMice | Animals appeared clinically normal throughout thestudy upon observation. No deaths and no significantchanges in body weight. | PASS: Non-toxic | |
| USP Rabbit Material-MediatedPyrogenicity | Out of 3 animals, no single animal showed atotal temperature rise of ≥ 0.5 °C, within USPrequirements. | PASS: Non-pyrogenic | |
| Hemocompatibility:ASTM Hemolysis | Hemolysis % was not higher than control in sampleseither in direct contact with the catheter or insamples extracted after contact with the valve. | PASS: Non-hemolytic | |
| (Table continued on next page) |
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VII. Non-Clinical Data Performance, Continued
| Table 6. Biocompatibility Test Results, Continued | |||
|---|---|---|---|
| Test | Test Summary | Conclusion | |
| Dilator | |||
| Cytotoxicity - ISO ElutionMethod | Test articles exhibited no discrete intracytoplasmicgranules, no cell lysis, no reduction of cell growth,resulting in a reactivity grade = 0 per ISO 10993-5. | PASS: Non-cytotoxic | |
| Sensitization - ISO Guinea PigMaximization Sensitization | No abnormal dermal reactions and no sensitizationwas observed. | PASS: Non-sensitizing | |
| ISO Intracutaneous ReactivityStudy | Injection sites appeared normal. Mean erythema andedema scores of test articles had differences of <1from control. | PASS: Non-irritating | |
| ISO Acute Systemic Toxicity inMice | Animals appeared clinically normal throughout thestudy upon observation. No deaths and no significantchanges in body weight. | PASS: Non-toxic | |
| USP Rabbit Material-MediatedPyrogenicity | Out of 3 animals, no single animal showed atotal temperature rise of ≥ 0.5 °C, within USPrequirements. | PASS: Non-pyrogenic | |
| Hemocompatibility | ASTM Hemolysis | Hemolysis % was not higher than control in sampleseither in direct contact with the dilator or in samplesextracted after contact with the dilator. | PASS: Non-hemolytic |
| SC5b-9 ComplementActivation Assay | SC5b-9 concentration of test article samples werenot statistically higher than both negative control andactivated normal human serum (NHS) controls. | PASS: Not apotential activatorof the complementsystem | |
| In Vivo ThromboresistanceStudy | Thrombus formation on the dilator was comparableto that on control article in similar animalvasculature. | PASS: AcceptableThromboresistance | |
| Packaging | |||
| Cytotoxicity - ISO ElutionMethod | Test articles exhibited no discrete intracytoplasmicgranules, no cell lysis, no reduction of cell growth,resulting in a reactivity grade = 0 per ISO 10993-5 | PASS: Non-cytotoxic |
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single use only.
| VII. Non-Clinical DataPerformance, Continued | SterilizationThe CEREBASE DA Guide Sheath, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10-6 in accordance with ISO 11135-1: 2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices. The CEREBASE DA Guide Sheath and all accessories meet EO residuals per EN ISO 10993-7: 2009 Biological evaluation of medical devices. Ethylene oxide sterilization residuals for a limited contact delivery system – externally communicating. The CEREBASE DA Guide Sheath and all accessories are for |
|---|---|
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- VIII. Conclusion Based upon the intended use, design, materials, function, side-by-side in-vitro testing and animal testing, and passing biocompatibility test results, it is concluded that the subject device, CEREBASE DA Guide Sheath is substantially equivalent to the predicate device, Neuron MAX System (K111380, cleared 19 July 2011). The fundamental scientific technology is the same as the predicate device. The differences in verbiage in the Indications for Use statement only limits the locations that the subject device can be used and do not raise any questions regarding the safety and effectiveness of the device. Risk assessment of the CEREBASE DA and verification/validation testing confirmed the device is as safe and effective as the predicate device.
§ 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).