(383 days)
The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.
A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator. BRMI will offer the cannula in the following ranges: Size: 16 - 24 Fr. Length: 12" - 20.5'
The provided text describes a 510(k) premarket notification for the BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel, high-risk device would.
However, based on the information provided, we can infer the acceptance criteria and the "study" (biocompatibility assessment and comparative analysis) that proves the device meets those criteria.
Here's an analysis structured according to your request, with "N/A" for information not present in the provided document:
Acceptance Criteria and Device Performance Study for BRMI Venous Flex II Cannulae
This submission focuses on demonstrating substantial equivalence to predicate devices. The acceptance criteria are primarily related to biocompatibility and comparative specifications, aiming to show that the new device is as safe and effective as the previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Absence of cytotoxicity | "Under conditions of the test . article is not cytotoxic." |
| Non-sensitizing | "The test group and negative control animals showed no signs of sensitization and therefore Passes Test as a grade I sensitizer (weak)." (Guinea Pig Maximization Study) | |
| Non-irritating (skin) | "Under conditions of the test, the test article Passes Test in accordance with requirements of CFR Title 16 Part 1500.41." (CFR Primary Skin Irritation Test) | |
| Absence of systemic toxicity | "Under conditions of the test, the test article Passes Test in accordance with requirements of the USP Systemic Injection Test." | |
| Minimal hemolysis (blood compatibility) | "The test article had 0.0% Hemolysis." | |
| Design Specifications | Size range (Fr.) comparable to predicate | Proposed: 16 - 24 Fr. |
| Predicate: 8 - 28 Fr. (Proposed within predicate range) | ||
| Length range comparable to predicate | Proposed: 12" - 20.5' | |
| Predicate: 6" - 20.5" (Proposed within predicate range) | ||
| Material Composition | Body material comparable to predicate | Proposed: Polyurethane |
| Predicate: Polyurethane | ||
| Vent Cap Body material comparable to predicate | Proposed: PVC | |
| Predicate: PVC | ||
| Connector material comparable to predicate | Proposed: PVC | |
| Predicate: PVC | ||
| Dilator material comparable to predicate | Proposed: Polyethylene | |
| Predicate: Polyethylene | ||
| Manufacturing/Inspection | SOP comparable to predicate processes | "Comparable to 70225" |
| IPQA comparable to predicate processes | "Comparable to 80160" | |
| Labeling | Generally comparable to predicate, with necessary additions | "Comparable to p/n 61227 Exception: additional statement 'care should be taken to avoid vessel perforation'. This statement will be added to IFU p/n 61227." (Indicates labeling addresses potential risks or expanded use cases, confirming safety measures). |
| Packaging | Packaging method comparable to predicate | "Individually packaged in a sealed Kwik Breathe pouch." (Same as predicate) |
| Sterilization | Sterilization method comparable to predicate | "EtO. Product is intended for single use only." (Same as predicate) |
| Intended Use | Comparable to predicate, with expanded access points | "Intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired." (Expanded use from femoral access only for the primary predicate, but within general venous return scope of combined predicates). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Biocompatibility Testing: The document refers to "whole product extract and/or tubesheet slices," "the test article," and "the test group and negative control animals." Specific numerical sample sizes (e.g., number of animals, number of samples per test) are not provided.
- Data Provenance: The biocompatibility testing was performed on a test article that is "substantially equivalent in design and materials" to the proposed device, specifically "The FEM II-xxx-A was used as the test article for this testing." This suggests internal company testing rather than external clinical data. The country of origin for the data is not specified. It appears to be retrospective in the sense that results from previous testing of a similar device (FEM II-xxx-A) are being used to support the current device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts for Biocompatibility Ground Truth: N/A. Biocompatibility testing relies on standardized laboratory procedures and protocols (e.g., ISO 10993, CFR Title 16 Part 1500.41, USP Systemic Injection Test). The "ground truth" is established by the pass/fail criteria defined within these international and national standards. No human experts are explicitly mentioned as establishing the "ground truth" for the test results themselves in the context of interpreting the raw test data against qualitative standards. The tests are objective.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. For these standardized, objective laboratory tests, there is no mention of a human adjudication process. The results are typically interpreted against predetermined thresholds or qualitative observations (e.g., presence/absence of cytotoxicity, signs of sensitization).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study (MRMC) is typically relevant for diagnostic imaging or screening devices where human readers interpret results, often with and without AI assistance. This submission is for a medical cannula, and as such, an MRMC study is not applicable and was not performed.
6. Standalone Performance Study
- Standalone Performance (Algorithm Only): No. This device is a physical medical instrument (a cannula), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" is not applicable. The "performance" is assessed through its material properties, design specifications, and biological compatibility.
7. Type of Ground Truth Used
- Ground Truth Type: For biocompatibility, the "ground truth" is based on established scientific and regulatory standards and objective laboratory measurements. These include:
- Cytotoxicity: Cell viability and growth observed under specific test conditions.
- Sensitization: Absence of allergic reactions in animal models.
- Irritation: Absence of inflammation or adverse reactions in animal models.
- Systemic Toxicity: Absence of systemic adverse effects in animal models.
- Hemolysis: Percentage of red blood cell lysis.
- For the comparative information (Table 1), the "ground truth" is the specifications and characteristics of the legally marketed predicate devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: N/A. This 510(k) submission does not describe a machine learning algorithm or AI model that would require a "training set." The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: N/A. As there is no training set for an AI model, this question is not applicable.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).