(312 days)
Not Found
No
The device description focuses on the physical characteristics and mechanical function of a microcatheter for delivering other devices. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is described as delivering therapeutic devices, not being a therapeutic device itself. Its function is to facilitate access and delivery of other devices.
No
The device description clearly states its purpose is to "deliver therapeutic devices" and "deliver other interventional or therapeutic devices through its inner lumen." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines a physical microcatheter with various hardware components (shaft, lumen, coating, marker, hub, etc.) and mentions bench testing for physical properties. There is no mention of software as the primary or sole component.
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 to the peripheral, coronary, and neurovasculature." This describes a device used within the body for a therapeutic purpose, not a device used outside the body to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a physical catheter designed for insertion into blood vessels to deliver other devices. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the CerusEndo Microcatheter is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The subject device is a microcatheter available in three versions: a 150 cm length microcatheter with a 15 cm length distal segment; a 150 cm length microcatheter with a 34 cm length distal segment; and a 160 cm length microcatheter with a 42 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 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 other interventional or therapeutic devices through its inner lumen. It is designed to be used in peripheral, coronary, and neurovascular locations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neurovasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed to demonstrate safety and substantial equivalence. Bench testing performed included: Tensile Strength, Shaft Flexibility (stiffness), Shape Retention, Kink Resistance, Static Burst, Simulated Use, Particulate, Coating Friction and Durability, Sterilization Validation. Biocompatibility testing performed included: Cytotoxicity (MEM Elution), Sensitization (ISO Kligman Guinea Pig Maximization Test), Irritation/ ISO Intracutaneous Toxicity in Rabbits, Systemic Toxicity (ISO Systemic Injection), Systemic Toxicity (Rabbit Material- Mediated Pyrogenicity), Hemocompatibility (ISO In Vitro Hemocompatibility - Direct Contact), Hemocompatibility (Hemolysis - Indirect), Hemocompatibility (ISO Complement Activation C3 and SC5b-9 Test – Direct Contact), Genotoxicity – Gene Mutation (Ames Assay, S-9 Activation), Genotoxicity – Micronucleus, Hemocompatibility (Thrombogenicity). All tests met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2019
Cerus Endovascular, Inc. Theresa Brandner Vice President of Regulatory 47757 Fremont Boulevard Fremont, California 94538
Re: K182487
Trade/Device Name: CerusEndo Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 11, 2019 Received: June 19, 2019
Dear Theresa Brandner:
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
1
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. 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) K182487
Device Name CerusEndo Microcatheter
Indications for Use (Describe)
The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature.
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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3
510(k) Summary K182487
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.
I. SUBMITTER
Submitter Name: Cerus Endovascular, Inc.
Address: 47757 Fremont Boulevard, Fremont, CA 94538
Phone Number: (510) 651-4000
Fax Number: (510) 405-8356
Contact Person: Theresa Brandner VP of Regulatory
Date Prepared: July 17, 2019
II. DEVICE
Name of Device: CerusEndo Microcatheter
Common Name: Catheter, Percutaneous
Classification Name: Percutaneous Catheter 21 CFR 870.1250
Regulatory Class: Class II
Product Code: DQY
III. PREDICATE DEVICE
K093160: Headway 21 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 three versions: a 150 cm length microcatheter with a 15 cm length distal segment; a 150 cm length microcatheter with a 34 cm length distal segment; and a 160 cm length microcatheter with a 42 cm length
4
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 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 other interventional or therapeutic devices through its inner lumen. It is designed to be used in peripheral, coronary, and neurovascular locations.
V. INDICATIONS FOR USE
The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device has similar design, dimensions, materials, intended use, and technological characteristics to the legally marketed predicate cleared under K093160. 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.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Manufacturer | CerusEndo Microcatheter | ||
| (Cerus Endovascular) | Headway Microcatheter | ||
| (MicroVention) | Comparison | ||
| Clinical Attributes | |||
| Indications for Use | The CerusEndo Microcatheter is | ||
| intended for general intravascular | |||
| use to deliver therapeutic devices to | |||
| the peripheral, coronary, and | |||
| 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 | Same | ||
| Subject Device | Predicate Device | ||
| Manufacturer | CerusEndo Microcatheter | Headway Microcatheter | Comparison |
| (Cerus Endovascular) | (MicroVention) | ||
| Patient Access | Device access is gained using an | Device access is gained using an | Identical |
| introducer sheath inserted into | introducer sheath inserted into | ||
| the vasculature and is advanced | the vasculature and is advanced | ||
| over a guidewire and through a | over a guidewire and through a | ||
| guide catheter | guide catheter | ||
| Intraoperative | Yes | Yes | Identical |
| Use | |||
| Technological Attributes | |||
| General | Percutaneous Catheter | Percutaneous Catheter | Same |
| Description | Intravascular Catheter | Diagnostic Intravascular Catheter | |
| Device | Proximal Luer hub, hydrophilic | Proximal Luer hub, hydrophilic | Same |
| Configuration | coating, radiopaque marker, | coating, radiopaque marker, | |
| polymer tapered shaft | polymer tapered shaft | ||
| construction, stainless steel | construction, stainless steel | ||
| reinforced shaft, and lined inner | reinforced shaft, and lined inner | ||
| lumen | lumen | ||
| Catheter Body | Polyether outer layer, stainless steel | Polyurethane outer layer, | Similar |
| Materials | polyether inner layer, braid/coil, | polyether/polyamide inner layer, | |
| PTFE/polyether liner | stainless steel braid/coil, | ||
| PTFE/polyolefin liner | |||
| Marker | Platinum/iridium | Platinum/iridium | Same |
| Hub | Nylon | Nylon | Same |
| Strain Relief | Pebax | Pebax | Same |
| Introducer | Not applicable | Pebax | The CerusEndo |
| Microcatheter is not | |||
| provided with an | |||
| introducer | |||
| Shaping Mandrel | |||
| Proximal ID/OD | Stainless Steel | ||
| 0.0205 in min / 0.036 in | Stainless steel | ||
| 0.021 in min / 0.033 in (2.5 Fr) | Same | ||
| Similar | |||
| Distal ID/OD | 0.0205 in min / 0.031 in | 0.021 in min / 0.026 in (2.0 Fr) | Similar |
| Effective Length | 150 cm, 160 cm | 150 cm, 156 cm | Similar |
| Coating | Hydrophilic coating | Hydrophilic coating | Similar |
| Tip Configuration | Straight - Steam Shapeable by | Straight - Steam Shapeable by | Same |
| Guidewire | physician prior to use | ||
| ≤ 0.018 in | physician prior to use | ||
| ≤ 0.018 in | Same | ||
| Compatibility | |||
| Accessories | Shaping mandrel | Shaping mandrel, introducer | The CerusEndo |
| Microcatheter is | |||
| provided with a | |||
| shaping mandrel but is | |||
| not provided with an | |||
| introducer | |||
| Method of Supply | Sterile, single use | Sterile, single use | Same |
| Sterilization | Ethylene oxide, | ||
| single patient use | Ethylene oxide, | ||
| single patient use | Same | ||
| Biocompatibility | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 | Same |
Table 1 - Comparison Table of Proposed Device and Predicate Device
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6
There are no significant technological differences between the subject device and predicate device. The technological differences between the subject and predicate device are indicated in the table above.
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 | ||
| Shaft Flexibility | ||
| (stiffness) | This test measures the bending stiffness | |
| of the distal and proximal catheter shaft | ||
| segments. | Device met acceptance | |
| criteria | ||
| 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 | ||
| Kink Resistance | This test measures the distal and | |
| proximal catheter shaft resistance to | ||
| kinking. | Device met acceptance | |
| criteria | ||
| 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 | ||
| 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. | Device met acceptance | |
| criteria | ||
| Coating Friction and | ||
| Durability | This test measures the lubricity of the | |
| coating and the durability after repeated | ||
| abrasion cycles. | Device met acceptance | |
| criteria | ||
| Sterilization | ||
| Validation | These tests confirms a minimum 6 log | |
| sterility assurance level, assesses | ||
| ethylene oxide sterilant residual levels, | ||
| and detects pyrogens | Device met acceptance | |
| criteria | ||
| 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. | ||
| Sensitization | ||
| (ISO Kligman | ||
| Guinea Pig | ||
| Maximization Test) | Test samples and control blanks were | |
| extracted in normal saline and in cotton | ||
| seed oil at 37°C for 72 hours. | Non-sensitizing. | |
| The test article did not | ||
| elicit a sensitization | ||
| response. | ||
| Irritation/ | ||
| ISO Intracutaneous | ||
| Toxicity in | ||
| Rabbits | Test samples were extracted in normal | |
| saline and in cotton seed oil at 37°C for | ||
| 72 hours. | Non-irritant. | |
| No evidence of | ||
| irritation. | ||
| Systemic Toxicity | ||
| (ISO Systemic | ||
| Injection) | Test samples and negative control | |
| blanks were extracted and were | ||
| prepared in normal saline and in cotton | ||
| seed oil at 37°C for 72 hours. | Non-cytotoxic. | |
| No weight loss, | ||
| mortality, or evidence of | ||
| systemic toxicity from | ||
| the extract exposure to | ||
| the mice. | ||
| Systemic Toxicity | ||
| (Rabbit Material- | ||
| Mediated | ||
| Pyrogenicity) | Test samples were extracted and | |
| negative control blanks were prepared | ||
| in normal saline and in cotton seed oil | ||
| at 37°C for 72 hours. | Non-pyrogenic. | |
| All individual rabbits for | ||
| both the test article and | ||
| negative control showed | ||
| a total rise in | ||
| temperature of |