Search Results
Found 1 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
Page 1 of 1