(162 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a microcatheter for delivering therapeutic devices, with no mention of AI or ML capabilities.
No
The device is intended to deliver therapeutic devices, not to be a therapeutic device itself.
No
The device is described as being intended to "deliver therapeutic devices within the neurovasculature" and "deliver therapeutic devices through its inner lumen," indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines a physical microcatheter with various material and structural components, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver therapeutic devices within the neurovasculature." This describes a device used in vivo (within the body) for a therapeutic purpose (delivering other devices).
- Device Description: The description details a physical catheter designed for insertion into blood vessels and manipulation by a user. It focuses on its physical characteristics and function in delivering devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the CerusEndo Microcatheter (027) is a medical device used for interventional procedures within the neurovasculature, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CerusEndo Microcatheter (027) is intended to deliver therapeutic devices within the neurovasculature.
Product codes
QJP
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature, vascular anatomy, neurovascular locations
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital interventional neuroradiology suites
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Table 2 - Bench Testing Summary:
- Tensile Strength: This test measures the tensile strength of the catheter bonds using a tensile tester and are pulled to failure. Results: Device met acceptance criteria and has tensile strength similar to the predicate.
- Shaft Flexibility (stiffness): This test measures the bending stiffness of the distal and proximal catheter shaft segments. Results: Device met acceptance criteria and has a similar shaft flexibility as the predicate.
- Shape Retention: This test measures the ability of the catheter tip to form and retain a steam shape using conventional catheter lab shaping techniques. Results: Device met acceptance criteria and has a similar shape retention as the predicate.
- Kink Resistance: This test measures the distal and proximal catheter shaft resistance to kinking. Results: Device met acceptance criteria and has kink resistance similar to the predicate.
- Static Burst: This test measures the catheters resistance to burst failure by using a high pressure injector to pressurize the lumen while the distal tip is occluded. Results: Device met acceptance criteria and has static burst pressure similar to the predicate.
- Simulated Use: The device was used in accordance to the Instructions for Use. Results: Device met acceptance criteria.
- Particulate: This test assesses the coating integrity by measuring the quantity and size of particles generated during simulated use of the device in an anatomical model. Results: The number and size of particles were similar to the predicate device.
- Coating Friction and Durability: This test measures the lubricity of the coating and the durability after repeated abrasion cycles. Results: Device met acceptance criteria.
- Torque Testing: This test measures the torque strength of the catheter when turned to failure in a tortuous path model while the catheter tip is fixed. Results: Device met acceptance criteria and has torque strength similar to the predicate.
Table 3 - Biocompatibility Testing Summary:
- Cytotoxicity (MEM Elution): The test extract, a positive control, and a negative control were extracted at 37°C for 24 hours in MEM solution (5% serum supplemented cell culture medium) and exposed to mouse fibroblast cells. Results: Non-cytotoxic. The test article is considered non-cytotoxic to cells.
- Hemocompatibility (ISO In Vitro Hemocompatibility – Direct Contact): 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. Results: Non-hemolytic. There were no differences between the hemolytic index of the test article and the negative control.
- Hemocompatibility (Hemolysis – Indirect): 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. Results: Non-hemolytic. There were no significant differences between the test article extract/solid and negative control article results.
- Hemocompatibility (ISO Complement Activation C3 and SC5b-9 Test – Direct Contact): 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. Results: C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the negative control.
- Hemocompatibility (Thrombogenicity): Devices were placed in a canine carotid vessel. Results: Non-thrombogenic. No significant thrombus was observed on any of the subject catheters, and the device was determined to not show thrombogenic potential.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
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,
4
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 Device
CerusEndo Microcatheter (027)
(Cerus Endovascular) | Predicate Device K142449
Headway 27 Microcatheter
(MicroVention) | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Clinical Attributes | | | |
| Indications for
Use | The CerusEndo Microcatheter (027)
is intended to deliver therapeutic
devices within the
neurovasculature. | The Headway Microcatheter is intended
for general intravascular use, including
the peripheral, coronary and neuro
vasculature for the infusion of diagnostic
agents, such as contrast media, and
therapeutic agents, such as
occlusion coils. | Same |
| Environments of
Use | Hospital interventional
neuroradiology suites | Hospital interventional
neuroradiology suites | Identical |
| Patient
Population | Patients undergoing vascular
procedures | Patients undergoing vascular
procedures | Identical |
| Contraindications | No known contraindications | No known contraindications | Identical |
| Functions | To facilitate introduction of
therapeutic devices into the
vasculature | To facilitate introduction of diagnostic
and therapeutic devices into the
vasculature | Similar |
| Patient Access | Device access is gained using an
introducer sheath inserted into the
vasculature and is advanced over a
guidewire and through a guide
catheter | Device access is gained using an
introducer sheath inserted into the
vasculature and is advanced over a
guidewire and through a guide catheter | Identical |
| Table 1 - Comparison Table of Proposed Device and Predicate Device | ||
|---|---|---|
5
| Manufacturer | Subject Device
CerusEndo Microcatheter (027)
(Cerus Endovascular) | Predicate Device K142449
Headway 27 Microcatheter
(MicroVention) | Comparison |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intraoperative
Use | Yes | Yes | Identical |
| Technological Attributes | | | |
| General
Description | Percutaneous Catheter
Intravascular Catheter | Percutaneous Catheter Diagnostic
Intravascular Catheter | Same |
| Device
Configuration | Proximal Luer hub, hydrophilic
coating, radiopaque marker,
polymer tapered shaft construction,
stainless steel reinforced shaft, and
lined inner lumen | Proximal Luer hub, hydrophilic
coating, radiopaque marker,
polymer tapered shaft construction,
stainless steel reinforced shaft, and
lined inner lumen | Same |
| Catheter Body
Materials | Pebax outer layer, stainless steel
braid/coil, Pebax inner layer, PTFE
liner | Polyurethane outer layer, Pebax
inner layer, stainless steel
braid/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 CerusEndo
Microcatheter (027)
is not provided with
an 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 by
physician prior to use | Straight - Steam Shapeable by
physician prior to use | Identical |
| Guidewire
Compatibility | $\leq$ 0.018 in | 0.014 / 0.016 / 0.018 / 0.021 in | Similar |
| Accessories | Shaping mandrel | Shaping mandrel, introducer | The CerusEndo
Microcatheter (027) is
provided with a
shaping mandrel but is
not provided with an
introducer |
| 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.
6
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 strength | |
| of the catheter bonds using a tensile | ||
| tester and are pulled to failure. | Device met acceptance | |
| criteria and has tensile | ||
| strength similar to the | ||
| predicate. | ||
| Shaft Flexibility | ||
| (stiffness) | This test measures the bending stiffness | |
| of the distal and proximal catheter shaft | ||
| segments. | Device met acceptance | |
| criteria and has a similar | ||
| shaft flexibility as the | ||
| predicate. | ||
| Shape Retention | This test measures the ability of the | |
| catheter tip to form and retain a steam | ||
| shape using conventional catheter lab | ||
| shaping techniques. | Device met acceptance | |
| criteria and has a similar | ||
| shape retention as the | ||
| predicate. | ||
| Kink Resistance | This test measures the distal and | |
| proximal catheter shaft resistance to | ||
| kinking. | Device met acceptance | |
| criteria and has kink | ||
| resistance similar to the | ||
| predicate. | ||
| Static Burst | This test measures the catheters | |
| resistance to burst failure by using a | ||
| high pressure injector to pressurize the | ||
| lumen while the distal tip is occluded. | Device met acceptance | |
| criteria and has | ||
| static burst | ||
| pressure similar | ||
| to the predicate. | ||
| Simulated Use | The device was used in accordance to | |
| the Instructions for Use. | Device met acceptance | |
| criteria. | ||
| Particulate | This test assesses the coating integrity | |
| by measuring the quantity and size of | ||
| particles generated during simulated | ||
| use of the device in an anatomical | ||
| model. | The number and size | |
| of particles were | ||
| similar to the predicate | ||
| device. | ||
| Coating Friction and | ||
| Durability | This test measures the lubricity of the | |
| coating and the durability after repeated | ||
| abrasion cycles. | Device met acceptance | |
| criteria. | ||
| Torque Testing | This test measures the torque strength of | |
| the catheter when turned to failure in a | ||
| tortuous path model while the catheter | ||
| tip is fixed. | Device met acceptance | |
| criteria and has torque | ||
| strength similar to the | ||
| predicate. |
7
| Test | Extract/Test System | Results |
|---|---|---|
| Cytotoxicity (MEM | ||
| Elution) | The test extract, a positive control, and | |
| a negative control were extracted at | ||
| 37°C for 24 hours in MEM solution | ||
| (5% serum supplemented cell culture | ||
| medium) and exposed to mouse | ||
| fibroblast cells. | Non-cytotoxic. | |
| The test article is | ||
| considered non- | ||
| cytotoxic to cells. | ||
| Hemocompatibility | ||
| (ISO In Vitro | ||
| Hemocompatibility | ||
| – Direct Contact) | 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. | Non-hemolytic. There | |
| were no differences | ||
| between the hemolytic | ||
| index of the test article | ||
| and the negative control. | ||
| Hemocompatibility | ||
| (Hemolysis – | ||
| Indirect) | 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. | Non-hemolytic | |
| There were no | ||
| significant | ||
| differences between the | ||
| test article extract/solid | ||
| and negative control | ||
| article results. | ||
| Hemocompatibility | ||
| (ISO Complement | ||
| Activation C3 and | ||
| SC5b-9 Test – | ||
| Direct Contact) | 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. | C3a and SC5b-9 | |
| complement proteins | ||
| were considered to be | ||
| non-activated as | ||
| compared to the | ||
| negative | ||
| control. | ||
| Hemocompatibility | ||
| (Thrombogenicity) | Devices were placed in a canine carotid | |
| vessel. | Non-thrombogenic. No | |
| significant thrombus | ||
| was observed on any of | ||
| the subject catheters, | ||
| and the device was | ||
| determined to not show | ||
| thrombogenic | ||
| potential |
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.