(312 days)
The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature.
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.
The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature. No specific acceptance criteria for "device performance" (e.g., accuracy, sensitivity, specificity) were provided. Instead, the document summarizes various bench tests and biocompatibility tests conducted to ensure the device's safety and substantial equivalence to a predicate device. The results consistently state "Device met acceptance criteria" or similar affirmations for each test, implying the device performed as expected by the manufacturer for the specific test.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list numerical acceptance criteria. Instead, it indicates that "Device met acceptance criteria" or similar positive outcomes for all tests. The table below summarizes the tests performed and the reported performance.
| Test Description | Reported Device Performance & Rationale |
|---|---|
| Bench Testing | |
| Tensile Strength | Device met acceptance criteria. (Measures tensile strength of catheter bonds). |
| Shaft Flexibility (stiffness) | Device met acceptance criteria. (Measures bending stiffness of distal and proximal catheter shaft segments). |
| Shape Retention | Device met acceptance criteria. (Measures ability of the catheter tip to form and retain a steam shape). |
| Kink Resistance | Device met acceptance criteria. (Measures distal and proximal catheter shaft resistance to kinking). |
| Static Burst | Device met acceptance criteria. (Measures resistance to burst failure by pressurizing the lumen with a high-pressure injector while the distal tip is occluded). |
| Simulated Use | Device met acceptance criteria. (Device used in accordance with Instructions for Use). |
| Particulate | Device met acceptance criteria. (Assesses coating integrity by measuring quantity and size of particles generated during simulated use in an anatomical model). |
| Coating Friction and Durability | Device met acceptance criteria. (Measures lubricity of the coating and durability after repeated abrasion cycles). |
| Sterilization Validation | Device met acceptance criteria. (Confirms minimum 6 log sterility assurance level, assesses ethylene oxide sterilant residual levels, and detects pyrogens). |
| Biocompatibility Testing | |
| Cytotoxicity (MEM Elution) | Non-cytotoxic. The test article is considered non-cytotoxic to cells. (Extracts exposed to mouse fibroblast cells). |
| Sensitization (ISO Kligman Guinea Pig Maximization Test) | Non-sensitizing. The test article did not elicit a sensitization response. (Samples extracted in saline and cotton seed oil). |
| Irritation/ISO Intracutaneous Toxicity in Rabbits | Non-irritant. No evidence of irritation. (Samples extracted in saline and cotton seed oil). |
| Systemic Toxicity (ISO Systemic Injection) | Non-cytotoxic. No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to mice. (Samples extracted in saline and cotton seed oil). |
| Systemic Toxicity (Rabbit Material-Mediated Pyrogenicity) | Non-pyrogenic. All individual rabbits for both the test article and negative control showed a total rise in temperature of < 0.5°C and were determined to be nonpyrogenic. (Samples extracted in saline and cotton seed oil). |
| Hemocompatibility (ISO In Vitro Hemocompatibility - Direct Contact) | Non-hemolytic. There were no differences between the hemolytic index of the test article and the negative control. (Test article added to aliquots of human blood and incubated). |
| Hemocompatibility (Hemolysis - Indirect) | Non-hemolytic. There were no significant differences between the test article extract/solid and negative control article results. (Extracts incubated with phosphate buffered saline). |
| Hemocompatibility (ISO Complement Activation C3 and SC5b-9 Test – Direct Contact) | C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the negative control. (Test article, predicate, negative control, and positive control added to serum from human blood samples). |
| Genotoxicity – Gene Mutation (Ames Assay, S-9 Activation) | Non-mutagenic. Based on the acceptance criteria, the test article extracts were both deemed non-mutagenic in all strains under both non-activated and activated conditions. (Samples extracted in saline and PEG 400). |
| Genotoxicity – Micronucleus | Not genotoxic. No significant increase of aberrations when compared to the negative controls. (Extracts placed on Chinese Hamster Ovary (CHO) cells with and without metabolic activations). |
| Hemocompatibility (Thrombogenicity) | Non-thrombogenic. No significant thrombus was observed on any of the subject catheters, and the device was determined to not show thrombogenic potential. (Devices placed in a canine carotid vessel). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size for any of the individual bench or biocompatibility tests.
- The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text. The tests are general non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable as the study described is a non-clinical, bench and biocompatibility testing study, not a clinical study involving ground truth established by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the study described is a non-clinical, bench and biocompatibility testing study, not a clinical study involving adjudication of human assessments.
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 performed. This is a non-clinical device clearance for a microcatheter, not an AI/software device.
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 performed. This is a non-clinical device clearance for a microcatheter, not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of "ground truth" as typically applied to clinical or AI studies is not directly relevant to this submission. For bench and biocompatibility tests, the "ground truth" or reference is established by the accepted scientific and regulatory standards/protocols for each specific test (e.g., ISO standards, ASTM standards, or internal validated methods). The results are compared against predefined acceptance criteria for those technical or biological endpoints (e.g., "non-cytotoxic," "non-hemolytic," "met acceptance criteria for tensile strength").
8. The sample size for the training set:
- This information is not applicable. This is a non-clinical device clearance for a microcatheter, not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set mentioned or implied in this non-clinical device submission.
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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
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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. 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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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
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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 isintended for general intravascularuse to deliver therapeutic devices tothe peripheral, coronary, andneurovasculature. | The Headway Microcatheter isintended for general intravascularuse, including the peripheral,coronary and neuro vasculature forthe infusion of diagnostic agents,such as contrast media, andtherapeutic agents, such asocclusion coils. | Same |
| Environments of Use | Hospital interventionalneuroradiology suites | Hospital interventionalneuroradiology suites | Identical |
| Patient Population | 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 ofdiagnostic and therapeuticdevices 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 MandrelProximal ID/OD | Stainless Steel0.0205 in min / 0.036 in | Stainless steel0.021 in min / 0.033 in (2.5 Fr) | SameSimilar |
| 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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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 strengthof the catheter bonds using a tensiletester and are pulled to failure. | Device met acceptancecriteria |
| Shaft Flexibility(stiffness) | This test measures the bending stiffnessof the distal and proximal catheter shaftsegments. | Device met acceptancecriteria |
| Shape Retention | This test measures the ability of thecatheter tip to form and retain a steamshape using conventional catheter labshaping techniques. | Device met acceptancecriteria |
| Kink Resistance | This test measures the distal andproximal catheter shaft resistance tokinking. | Device met acceptancecriteria |
| 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 |
| 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. | Device met acceptancecriteria |
| Coating Friction andDurability | This test measures the lubricity of thecoating and the durability after repeatedabrasion cycles. | Device met acceptancecriteria |
| SterilizationValidation | These tests confirms a minimum 6 logsterility assurance level, assessesethylene oxide sterilant residual levels,and detects pyrogens | Device met acceptancecriteria |
| 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-cytotoxicto cells. |
| Sensitization(ISO KligmanGuinea PigMaximization Test) | Test samples and control blanks wereextracted in normal saline and in cottonseed oil at 37°C for 72 hours. | Non-sensitizing.The test article did notelicit a sensitizationresponse. |
| Irritation/ISO IntracutaneousToxicity inRabbits | Test samples were extracted in normalsaline and in cotton seed oil at 37°C for72 hours. | Non-irritant.No evidence ofirritation. |
| Systemic Toxicity(ISO SystemicInjection) | Test samples and negative controlblanks were extracted and wereprepared in normal saline and in cottonseed oil at 37°C for 72 hours. | Non-cytotoxic.No weight loss,mortality, or evidence ofsystemic toxicity fromthe extract exposure tothe mice. |
| Systemic Toxicity(Rabbit Material-MediatedPyrogenicity) | Test samples were extracted andnegative control blanks were preparedin normal saline and in cotton seed oilat 37°C for 72 hours. | Non-pyrogenic.All individual rabbits forboth the test article andnegative control showeda total rise intemperature of < 0.5°Cand were determined tobe nonpyrogenic. |
| 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-hemolytic.There were nosignificant differencesbetween the test articleextract/solid andnegative control articleresults. |
| 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 thenegative control. |
| Genotoxicity – GeneMutation(Ames Assay,S-9 Activation) | Test samples and negative controlblanks were extracted in normal salineand PEG 400 at 37°C for 72 hours. | Non-mutagenic.Based on the acceptancecriteria under theexperimental conditionsutilized, the test articleextracts were bothdeemed non-mutagenicin all strains under bothnon-activated andactivated conditions. |
| Genotoxicity –Micronucleus | Test samples and negative controlblanks were extracted in polar (saline)and non-polar solvents at 37 °C for 72hours. The extracts are placed onChinese Hamster Ovary (CHO) cellswith and without metabolic activations(S-9). The cells are then incubated at37 °C, with 5% CO2, for 15 – 21 hours.The cells are harvested and thechromosomes stained and examined foraberrations. | Not genotoxic.No significant increaseof aberrations whencompared to thenegative controls |
| 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 showthrombogenic potential |
Table 2 - Bench Testing Summary
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Table 3 – Biocompatibility Testing Summary
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VIII. CONCLUSION
Differences between the subject device and the predicate device do not raise different questions of safety and effectiveness. After a comparison of the subject CerusEndo Microcatheter intended use, technological characteristics, and expected performance to the legally marketed predicate, the Headway 21 Microcatheter (K093160), Cerus Endovascular concludes that the CerusEndo Microcatheter performs as safely and effectively as the predicate device for the same intended use.
§ 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).