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510(k) Data Aggregation
(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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(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 |
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