(162 days)
The CerusEndo Microcatheter (027) is intended to deliver therapeutic devices within the neurovasculature.
The subject device is a microcatheter available in two versions: a 150 cm length microcatheter with a 34 cm length distal segment; and a 160 cm length microcatheter with a 34 cm length distal segment. The distal segment of the catheter is flexible to facilitate access into tortuous anatomy, and the distal tip of the catheter is formable, allowing the physician to shape it according to the needs of the procedure at the point of use. The CerusEndo Microcatheter (027) has a hydrophilic coating, radiopaque marker, Luer hub on the proximal end, polymer tapered shaft construction, stainless steel reinforced shaft, and Teflon lined inner lumen. The subject device is controlled by user manipulation to access discrete locations within the vascular anatomy. It is intended to deliver therapeutic devices through its inner lumen. It is designed to be used in neurovascular locations.
The CerusEndo Microcatheter (027) is intended to deliver therapeutic devices within the neurovasculature. The following information outlines the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Device must meet acceptance criteria and have tensile strength similar to the predicate. | Device met acceptance criteria and has tensile strength similar to the predicate. |
| Shaft Flexibility (stiffness) | Device must meet acceptance criteria and have similar shaft flexibility as the predicate. | Device met acceptance criteria and has a similar shaft flexibility as the predicate. |
| Shape Retention | Device must meet acceptance criteria and have similar shape retention as the predicate. | Device met acceptance criteria and has a similar shape retention as the predicate. |
| Kink Resistance | Device must meet acceptance criteria and have kink resistance similar to the predicate. | Device met acceptance criteria and has kink resistance similar to the predicate. |
| Static Burst | Device must meet acceptance criteria and have static burst pressure similar to the predicate. | Device met acceptance criteria and has static burst pressure similar to the predicate. |
| Simulated Use | Device must meet acceptance criteria. | Device met acceptance criteria (used in accordance with Instructions for Use). |
| Particulate | Number and size of particles must be similar to the predicate device. | The number and size of particles were similar to the predicate device. This test assesses coating integrity by measuring the quantity and size of particles generated during simulated use of the device in an anatomical model. |
| Coating Friction and Durability | Device must meet acceptance criteria. | Device met acceptance criteria. This test measures the lubricity of the coating and the durability after repeated abrasion cycles. |
| Torque Testing | Device must meet acceptance criteria and have torque strength similar to the predicate. | Device met acceptance criteria and has torque strength similar to the predicate. |
| Cytotoxicity (MEM Elution) | Non-cytotoxic. | Non-cytotoxic. The test article is considered non-cytotoxic to cells. The test extract, positive control, and negative control were extracted at 37°C for 24 hours in MEM solution and exposed to mouse fibroblast cells. |
| Hemocompatibility (ISO In Vitro – Direct Contact) | Non-hemolytic, no differences between hemolytic index of test article and negative control. | Non-hemolytic. There were no differences between the hemolytic index of the test article and the negative control. Blood samples from three human donors were pooled and diluted. The test article is added to aliquots of human blood and incubated at 37 °C for a minimum of 3 hours. |
| Hemocompatibility (Hemolysis – Indirect) | Non-hemolytic, no significant differences between test article extract/solid and negative control results. | Non-hemolytic. There were no significant differences between the test article extract/solid and negative control article results. Test samples were extracted in phosphate buffered saline at 37°C for 72 hours. The test article extract was incubated at 37°C for a minimum of 3 hours. |
| Hemocompatibility (ISO Complement Activation C3 and SC5b-9 Test – Direct Contact) | C3a and SC5b-9 complement proteins considered non-activated as compared to the negative control. | C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the negative control. The test article, predicate, negative control, and positive control (latex) were added to the serum pooled from three human blood samples. All were incubated at 37 °C for 30, 60, and 90 minutes. |
| Hemocompatibility (Thrombogenicity) | Non-thrombogenic. | Non-thrombogenic. No significant thrombus was observed on any of the subject catheters, and the device was determined to not show thrombogenic potential. Devices were placed in a canine carotid vessel. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific numerical sample sizes for each non-clinical test. It generally references "the device" or "test samples." However, it does provide some details regarding data provenance:
- Hemocompatibility (ISO In Vitro Hemocompatibility – Direct Contact): Blood samples from three human donors were pooled.
- Hemocompatibility (ISO Complement Activation C3 and SC5b-9 Test – Direct Contact): Serum pooled from three human blood samples was used.
- Hemocompatibility (Thrombogenicity): Devices were placed in a canine carotid vessel, indicating an in vivo animal model study.
The tests described are non-clinical (bench and in vitro/animal) and therefore do not involve retrospective or prospective human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The studies are non-clinical engineering and biocompatibility tests whose acceptance criteria are based on established standards and comparisons to a predicate device, rather than expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable. The tests performed are objective, measurable non-clinical tests (e.g., tensile strength, burst pressure, chemical analysis) that do not require an adjudication method among human reviewers to establish ground truth.
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:
No, an MRMC comparative effectiveness study was not done. This device is a microcatheter, a physical medical instrument, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm-only performance study was not done. As stated above, this device is a physical medical instrument.
7. The Type of Ground Truth Used:
The ground truth for most of these non-clinical tests is established through:
- Physical measurements and objective criteria: For tests like tensile strength, shaft flexibility, kink resistance, static burst, coating friction, and torque testing, the "ground truth" is the measured physical property compared against pre-defined engineering specifications or performance relative to the predicate device.
- Biological/Chemical assay results: For biocompatibility tests (cytotoxicity, hemocompatibility), the "ground truth" is determined by the results of established in vitro or in vivo biological assays, indicating the device's interaction with biological systems within acceptable limits.
- Comparison to predicate device: A significant aspect of the "ground truth" establishment is demonstrating that the subject device's performance is "similar to" or "does not raise new questions of safety and effectiveness" compared to the legally marketed predicate device (K142449: Headway 27 Microcatheter).
8. The Sample Size for the Training Set:
This information is not applicable. This is a medical device clearance based on non-clinical performance and substantial equivalence to a predicate device, not an AI/machine learning study that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as above.
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March 15, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Cerus Endovascular, Inc. Lori E. Adels, Ph.D. Chief Compliance Officer 47757 Fremont Boulevard Fremont, California 94538
Re: K213314
Trade/Device Name: CerusEndo Microcatheter (027) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: February 11, 2022 Received: February 14, 2022
Dear Lori Adels:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
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) K213314
Device Name CerusEndo Microcatheter (027)
Indications for Use (Describe)
The CerusEndo Microcatheter (027) is intended to deliver therapeutic devices within the neurovasculature.
| 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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510(k) Summary K213314
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.
I. SUBMITTER
Submitter Name: Cerus Endovascular, Inc.
-
47757 Fremont Boulevard, Address: Fremont, CA 94538
Phone Number: (510) 651-4000 -
Fax Number: (510) 405-8356
-
Contact Person: Lori Adels, PhD Chief Compliance Officer
Date Prepared: March 15, 2022
II. DEVICE
Name of Device: CerusEndo Microcatheter (027)
Common Name: Catheter, Percutaneous, Neurovasculature
Classification Name: Percutaneous Catheter 21 CFR 870.1250
Regulatory Class: Class II
Product Code: QJP
III. PREDICATE DEVICE
K142449: Headway 27 Microcatheter manufactured by MicroVention Inc.
The predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The subject device is a microcatheter available in two versions: a 150 cm length microcatheter with a 34 cm length distal segment; and a 160 cm length microcatheter with a 34 cm length distal segment. The distal segment of the catheter is flexible to facilitate access into tortuous anatomy, and the distal tip of the catheter is formable,
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allowing the physician to shape it according to the needs of the procedure at the point of use. The CerusEndo Microcatheter (027) has a hydrophilic coating, radiopaque marker, Luer hub on the proximal end, polymer tapered shaft construction, stainless steel reinforced shaft, and Teflon lined inner lumen. The subject device is controlled by user manipulation to access discrete locations within the vascular anatomy. It is intended to deliver therapeutic devices through its inner lumen. It is designed to be used in neurovascular locations.
V. INDICATIONS FOR USE
The CerusEndo Microcatheter (027) is intended to deliver therapeutic devices within the neurovasculature.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subiect device has similar design, dimensions, materials, intended use, and technological characteristics to the legally marketed predicate cleared under K142449. Non-clinical testing has been performed to demonstrate that any differences in technological characteristics do not raise new questions of safety and effectiveness. A table comparing the intended use and technical characteristics of the proposed device and the legally marketed predicate is provided in Table 1.
| Manufacturer | Subject DeviceCerusEndo Microcatheter (027)(Cerus Endovascular) | Predicate Device K142449Headway 27 Microcatheter(MicroVention) | Comparison |
|---|---|---|---|
| Clinical Attributes | |||
| Indications forUse | The CerusEndo Microcatheter (027)is intended to deliver therapeuticdevices within theneurovasculature. | The Headway Microcatheter is intendedfor general intravascular use, includingthe peripheral, coronary and neurovasculature for the infusion of diagnosticagents, such as contrast media, andtherapeutic agents, such asocclusion coils. | Same |
| Environments ofUse | Hospital interventionalneuroradiology suites | Hospital interventionalneuroradiology suites | Identical |
| PatientPopulation | Patients undergoing vascularprocedures | Patients undergoing vascularprocedures | Identical |
| Contraindications | No known contraindications | No known contraindications | Identical |
| Functions | To facilitate introduction oftherapeutic devices into thevasculature | To facilitate introduction of diagnosticand therapeutic devices into thevasculature | Similar |
| Patient Access | Device access is gained using anintroducer sheath inserted into thevasculature and is advanced over aguidewire and through a guidecatheter | Device access is gained using anintroducer sheath inserted into thevasculature and is advanced over aguidewire and through a guide catheter | Identical |
| Table 1 - Comparison Table of Proposed Device and Predicate Device | ||
|---|---|---|
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| Manufacturer | Subject DeviceCerusEndo Microcatheter (027)(Cerus Endovascular) | Predicate Device K142449Headway 27 Microcatheter(MicroVention) | Comparison |
|---|---|---|---|
| IntraoperativeUse | Yes | Yes | Identical |
| Technological Attributes | |||
| GeneralDescription | Percutaneous CatheterIntravascular Catheter | Percutaneous Catheter DiagnosticIntravascular Catheter | Same |
| DeviceConfiguration | Proximal Luer hub, hydrophiliccoating, radiopaque marker,polymer tapered shaft construction,stainless steel reinforced shaft, andlined inner lumen | Proximal Luer hub, hydrophiliccoating, radiopaque marker,polymer tapered shaft construction,stainless steel reinforced shaft, andlined inner lumen | Same |
| Catheter BodyMaterials | Pebax outer layer, stainless steelbraid/coil, Pebax inner layer, PTFEliner | Polyurethane outer layer, Pebaxinner layer, stainless steelbraid/coil, PTFE/polyolefin liner | Similar |
| Marker | Platinum/iridium | Platinum/iridium | Identical |
| Hub | Nylon | Nylon | Identical |
| Strain Relief | Pebax | Pebax | Identical |
| Introducer | Not applicable | Pebax | The CerusEndoMicrocatheter (027)is not provided withan introducer |
| Shaping Mandrel | Stainless Steel | Stainless steel | Identical |
| Proximal ID/OD | 0.027 in min / 0.040 in | 0.0278 in min / 0.040 in | Similar |
| Distal ID/OD | 0.027 in min / 0.036 in | 0.027 in min / 0.035 in | Similar |
| Effective Length | 150 cm, 160 cm | 150 cm, 156 cm | Similar |
| Coating | Hydrophilic coating | Hydrophilic coating | Same |
| Tip Configuration | Straight - Steam Shapeable byphysician prior to use | Straight - Steam Shapeable byphysician prior to use | Identical |
| GuidewireCompatibility | $\leq$ 0.018 in | 0.014 / 0.016 / 0.018 / 0.021 in | Similar |
| Accessories | Shaping mandrel | Shaping mandrel, introducer | The CerusEndoMicrocatheter (027) isprovided with ashaping mandrel but isnot provided with anintroducer |
| Method of Supply | Sterile, single use | Sterile, single use | Identical |
| Sterilization | Ethylene oxide,single patient use | Ethylene oxide,single patient use | Identical |
| Biocompatibility | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 | Identical |
There are no significant technological differences between the subject device and predicate device.
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VII. PERFORMANCE DATA
Non- clinical tests were performed to demonstrate safety and substantial equivalence. Bench testing performed is summarized in Table 2. Biocompatibility testing performed is summarized in Table 3.
| Test | Test Method Summary | Results |
|---|---|---|
| Tensile Strength | This test measures the tensile strengthof the catheter bonds using a tensiletester and are pulled to failure. | Device met acceptancecriteria and has tensilestrength similar to thepredicate. |
| Shaft Flexibility(stiffness) | This test measures the bending stiffnessof the distal and proximal catheter shaftsegments. | Device met acceptancecriteria and has a similarshaft flexibility as thepredicate. |
| Shape Retention | This test measures the ability of thecatheter tip to form and retain a steamshape using conventional catheter labshaping techniques. | Device met acceptancecriteria and has a similarshape retention as thepredicate. |
| Kink Resistance | This test measures the distal andproximal catheter shaft resistance tokinking. | Device met acceptancecriteria and has kinkresistance similar to thepredicate. |
| Static Burst | This test measures the cathetersresistance to burst failure by using ahigh pressure injector to pressurize thelumen while the distal tip is occluded. | Device met acceptancecriteria and hasstatic burstpressure similarto the predicate. |
| Simulated Use | The device was used in accordance tothe Instructions for Use. | Device met acceptancecriteria. |
| Particulate | This test assesses the coating integrityby measuring the quantity and size ofparticles generated during simulateduse of the device in an anatomicalmodel. | The number and sizeof particles weresimilar to the predicatedevice. |
| Coating Friction andDurability | This test measures the lubricity of thecoating and the durability after repeatedabrasion cycles. | Device met acceptancecriteria. |
| Torque Testing | This test measures the torque strength ofthe catheter when turned to failure in atortuous path model while the cathetertip is fixed. | Device met acceptancecriteria and has torquestrength similar to thepredicate. |
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| Test | Extract/Test System | Results |
|---|---|---|
| Cytotoxicity (MEMElution) | The test extract, a positive control, anda negative control were extracted at37°C for 24 hours in MEM solution(5% serum supplemented cell culturemedium) and exposed to mousefibroblast cells. | Non-cytotoxic.The test article isconsidered non-cytotoxic to cells. |
| Hemocompatibility(ISO In VitroHemocompatibility– Direct Contact) | Blood samples from three humandonors were pooled and diluted. Thetest article is added to aliquots ofhuman blood and incubated at 37 °Cfor a minimum of 3 hours. | Non-hemolytic. Therewere no differencesbetween the hemolyticindex of the test articleand the negative control. |
| Hemocompatibility(Hemolysis –Indirect) | Test samples were extracted inphosphate buffered saline at 37°C for72 hours. The test article extract wasincubated at 37°C for a minimum of 3hours. | Non-hemolyticThere were nosignificantdifferences between thetest article extract/solidand negative controlarticle results. |
| Hemocompatibility(ISO ComplementActivation C3 andSC5b-9 Test –Direct Contact) | The test article, predicate, negativecontrol, and positive control (latex)were added to the serum pooled fromthree human blood samples. All wereincubated at 37 °C for 30, 60, and 90minutes. | C3a and SC5b-9complement proteinswere considered to benon-activated ascompared to thenegativecontrol. |
| Hemocompatibility(Thrombogenicity) | Devices were placed in a canine carotidvessel. | Non-thrombogenic. Nosignificant thrombuswas observed on any ofthe subject catheters,and the device wasdetermined to not showthrombogenicpotential |
Table 3 - Biocompatibility Testing Summary
VIII. CONCLUSION
After a comparison of the subject CerusEndo Microcatheter (027) intended use, technological characteristics, and expected performance to the legally marketed predicate, the Headway 27 Microcatheter (K142449), Cerus Endovascular concludes that the CerusEndo Microcatheter (027) is substantially equivalent to the legally marketed predicate device. The differences between the subject device and the predicate do not raise different questions of safety and effectiveness.
§ 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).