(278 days)
The Scepter Mini Occlusion Balloon Catheter is intended:
For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.
For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
Scepter Mini Occlusion Balloon Catheter is a dual co-axial lumen balloon catheter. The catheter is designed to track over a steerable guidewire. The outer lumen is used for the inflation of the balloon independent of guidewire position. The inner lumen can be used to deliver diagnostic agents or liquid embolics to distal locations in tortuous anatomy. Radiopaque marker bands are located at each end of the balloon to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheter is packaged sterile for single use only.
The Scepter Mini has similar indications for use as the predicates, however, incorporates several minor design differences. The Scepter Mini has a slightly longer length and a slightly smaller diameter. The balloon of the Scepter Mini is slightly shorter. The distal tip of the Scepter Mini extends a shorter distance from the distal end of the balloon than that of the Scepter C and XC. For the Scepter Mini, the purge hole is covered by a semi-permeable membrane designed to allow air to escape while preventing liquids from passing. The predicate Scepter C and XC incorporate 3 radiopaque marker bands, while the design of the Scepter Mini allows for visualization under fluoroscopy with only 2 radiopaque marker bands (due to shorter distal tip segment). All Scepter catheters have a hydrophilic coating.
This document is a 510(k) Pre-market Notification for the Scepter Mini Occlusion Balloon Catheter, seeking to demonstrate its substantial equivalence to previously cleared predicate devices. The study detailed is a set of verification and validation tests, and a summary of an animal study, used to support this claim.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comprehensive table of "Verification Test Summary" where each test description implicitly defines the acceptance criteria by stating the desired outcome (e.g., "does not break," "does not leak," "pass") and then reports that the subject device "Pass"ed. For many tests, it explicitly states that the device "meets the same specification as predicates Scepter C/XC (K121785)."
| Test Description | Acceptance Criteria (Implied / Explicit) | Reported Device Performance |
|---|---|---|
| Sterility | Meets sterility assurance level (SAL 10-6) per ISO 11135-1. EtO and ECH residual levels are ≤ 0.2 mg per device per ISO 10993-7. Bacterial endotoxin test results . | Pass |
| Physical Attributes | Meets design specifications. | Pass |
| Force at break | Does not break during use and meets same specification as predicates Scepter C/XC (K121785). | Pass |
| Freedom from Leakage – Fluids (low pressure, long duration) | Does not leak fluids at low pressure/long duration and meets same specification as predicates Scepter C/XC (K121785). | Pass |
| Freedom from Leakage – Air | Air does not leak into subject device meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Freedom from Leakage - Liquid (high pressure, short time) | Does not leak fluids at high pressure/short duration and meets same specification as predicates Scepter C/XC (K121785). | Pass |
| Burst Pressure of Catheter | Does not burst statically below rated burst pressure meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Gauging Test | Catheter luer compatible to other standard luer fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design). | Pass |
| Separation Force | Catheter luer compatible to other standard luer fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design). | Pass |
| Unscrewing Torque | Catheter luer compatible to other standard luer fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design). | Pass |
| Ease of Assembly | Subject device luer mates together with other compatible fittings. | Pass |
| Resistance to Overriding | Catheter luer mates with other compatible fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design). | Pass |
| Stress Cracking | Catheter hub does not leak. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design). | Pass |
| Durability of Hydrophilic Coating | Hydrophilic coating does not flake off during use, is of the same material and meets same specification as predicates Scepter C/XC (K121785). | Pass |
| Lubricity of Hydrophilic Coating | Hydrophilic coating is lubricious, of the same material and meets same specification as predicates Scepter C/XC (K121785). | Pass |
| Simulated Use | Demonstrated equivalent performance during simulated use with similar ratings to predicates Scepter C/XC (K121785). | Pass |
| Compatibility with device/agents: Embolic material, contrast media, dimethyl sulfoxide (DMSO). | Subject device is compatible with embolic material, contrast media, and DMSO, meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Dynamic Burst Pressure | Does not burst dynamically below rated burst pressure and meets same specification as predicates Scepter C/XC (K121785). | Pass |
| Radio-Detectability | Radiopaque marker bands are visualized under fluoroscopy. | Pass |
| Kink resistance | Does not kink during normal use meeting same specification as predicates Scepter C/XC. | Pass |
| Non-pyrogenic | Bacterial endotoxins level is less than 2.15 EU/device. | Pass |
| Simulated Shipping and Packaging Testing | No defects that compromise integrity of package, meets seal strength, creep to burst, and dye penetration specification. | Pass |
| Catheter Flexural Fatigue | Meets same specification as predicates Scepter C/XC (K121785) for flexural fatigue, pressure integrity, and hoop stress. | Pass |
| In Vivo Testing (Histopathology evaluation) | No significant differences between the Scepter C balloon catheter and the control catheter in categories of performance and histopathologic evaluation. No denudation, perforation, dissection, or clinicant injury to the target vasculature. | Pass |
| Balloon Rated Burst Volume | Does not burst during use meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Balloon Compliance (rated volume) | Consistently inflates to the desired OD meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Balloon Inflation/Deflation Times | Inflates and deflates within an acceptable time range meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Balloon Fatigue Test | Does not burst before acceptable minimum cycle(s) meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Torque Test | Maintains acceptable torque during use meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Packaging and Shelf Life | Sterile barrier is maintained during shelf life of product. | Pass |
| Insertion tool performance: Ease to enter RHV. | Ease to enter RHV rated 3 or higher in tested category meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Decay Test | Balloon maintains rated burst OD for a minimum of 30 min meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Surface Contamination | No Contamination (no uncured coating, particulate greater than 0.02 mm², sharp edges, and embedded particulate). | Pass |
| Corrosion Resistance | Metallic components show no signs of corrosion. (Data leveraged from reference device Headway 17 (K083343)). | Pass |
| Catheter Particle Testing | Less than 25 particles greater than 10 microns and less than 3 particles greater than 25 microns per 1mL meeting same specification as predicates Scepter C/XC (K121785). | Pass |
| Cytotoxicity - Medium Eluate Method | Non-cytotoxic (between no cell lysis (grade 0) to slight reactivity (grade 1)). | Non-cytotoxic |
| Sensitization: Maximization Test in Guinea Pigs | Non-sensitizer (no irritation present on test or negative control guinea pigs). | Non-sensitizer |
| Intracutaneous Reactivity | Non-irritating (no evidence of irritation (score 0.0)). | Non-irritating |
| Systemic Injection Test in Mice | Systemically non-toxic (no weight loss, mortality, or evidence of systemic toxicity). | Systemically non-toxic |
| Rabbit Pyrogen Test | Nonpyrogenic (rise of rabbit temperatures during three hours of observation did not exceed 0.5 ℃). | Nonpyrogenic |
| ASTM Blood Compatibility - Direct and Indirect Contact Hemolysis | Non-hemolytic (0.59% hemolysis in direct contact and 1.25% hemolysis in indirect contact). | Non-hemolytic |
| Unactivated Partial Thromboplastin Time Test | No effect on clotting (average clotting time of the test article showed no significant difference from the control). | No effect on clotting |
| Complement Activation | Non-activated (plasma exposed to test article for 90 minutes exhibited no statistically significant increase in SC5b-9). | Non-activated |
| In Vitro Hemocompatibility Test - Human Blood, Direct Contact | No effect on hematological parameters (concentration of White Blood Cells (WBC) and Platelets in human blood exposed to the test article was not statistically significantly decreased). | No effect on hematological parameters |
| Salmonella thvpimurium and Escherichia coli Reverse Mutation Assay | Non-mutagenic (test article extracts did not induce a statistically significant increase in the number of revertant colonies). | Non-mutagenic |
| Mouse Lymphoma Mutagenesis Assay | Non-mutagenic (increased mutant frequency (IMF) of the cells exposed to the test article extracts was less than the Global Evaluation Factor (GEF) 126 x 10^-6). | Non-mutagenic |
| Rodent Blood Micronucleus Assay | No clastogenic effect (test article did not result in a statistically significant increase in the percentage of reticulocytes containing micronuclei). | No clastogenic effect |
2. Sample Size Used for the Test Set and the Data Provenance:
- Verification Tests: The document doesn't explicitly state the sample sizes for each individual mechanical or physical verification test. However, it indicates these tests were performed on the "subject device" (Scepter Mini Occlusion Balloon Catheter). The provenance of this data is MicroVention, Inc.'s internal testing/laboratories. This data is likely prospective, generated specifically for this submission.
- Animal Study (In Vivo Testing): The animal study used for the "In Vivo Testing" was performed using the predicate device Scepter C in an "acute swine animal model." The exact number of swine used is not explicitly stated in this summary, but it implies multiple animals ("compared with a commercially equivalent device"). The data provenance is from this predicate device study. This would be prospective data for the predicate, but retrospective in its application to the subject device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- The document does not mention expert involvement in establishing ground truth for the mechanical, physical, or biocompatibility tests. These are objective, quantitative tests with defined pass/fail criteria.
- For the animal study, the "histopathologic evaluation" implies assessment by a qualified pathologist. However, the exact number of experts or their specific qualifications (e.g., "veterinary pathologist with X years of experience") are not specified in this summary.
4. Adjudication Method for the Test Set:
- For the technical verification tests, the results are objective (numerical values meeting specifications, or physical observations like "no leak," "no break"). An adjudication method is not applicable in the sense of expert consensus on ambiguous findings, as the tests produce clear pass/fail outcomes against predefined criteria.
- For the animal study's histopathologic evaluation, it's not specified if multiple pathologists reviewed slides or if an adjudication method was used for discrepancies.
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 MRMC study was performed. This submission is for a physical medical device (balloon catheter), not an artificial intelligence (AI) or software as a medical device (SaMD) that typically relies on human reader performance. Therefore, there is no AI component, and no effect size regarding human reader improvement with AI assistance is relevant or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Does not apply. This is a physical medical device; there is no AI algorithm to evaluate.
7. The Type of Ground Truth Used:
- Verification Tests (Mechanical, Physical, Chemical): The ground truth for these tests is based on engineering specifications, industry standards (e.g., ISO), and regulatory requirements (e.g., USP). These are objective, measurable outcomes.
- Biocompatibility Tests: Ground truth is established based on pre-defined biological responses (e.g., lack of cytotoxicity, non-irritating, non-pyrogenic) as per ISO 10993-1:2009 and FDA guidelines.
- Animal Study (In Vivo Testing): The ground truth for the efficacy and safety during the in-vivo performance characteristics and histopathology evaluation is based on direct observation in the animal model and subsequent pathological examination of tissues for injury or adverse events. This could be considered pathology and in-vivo observational data.
8. The Sample Size for the Training Set:
- Does not apply. This is a physical medical device, not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Does not apply. There is no training set for this type of device submission.
§ 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).