(119 days)
The Flow Switch is an angiographic accessory intended for use as an on-off device for angiography and other high pressure applications.
The Flow Switch is a device used to connect in line to liquid flow. This uses a Female Luer lock (inlet) and Male Luer lock (outlet) connection. Shut off is by means of a non-slip sliding handle that can be operated one-handed and gives an audible click into the OFF position. Flow directions are indicated by arrows on the handle.
Here's an analysis of the acceptance criteria and study information for the Merit Marquis® Flow Switch, based on the provided document:
Overall Assessment:
The provided document is a 510(k) summary for the "Merit Marquis® Flow Switch," which is essentially a regulatory submission to demonstrate substantial equivalence to a predicate device. This type of document primarily focuses on showing that the new device is as safe and effective as a previously cleared device, rather than providing a detailed clinical study demonstrating superiority or a specific effect size. Therefore, some of the requested information (like MRMC studies, specific effect sizes, or detailed clinical ground truth establishment for a training set) is not typically found in this type of submission for a Class II device like a flow switch.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes various tests performed to demonstrate that the device meets critical design specifications and clinical performance attributes. It does not explicitly lay out "acceptance criteria" in a quantitative table format but implies that successful completion of the listed tests against established standards (ISO, ASTM, USP) constitutes meeting the criteria.
| Test Category | Specific Test / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical/Mechanical Performance | Surface Inspection | Meets visual inspection standards for quality and integrity. | Succesfully completed. |
| Male and Female Luer Conical Fittings (6% Taper) | Conforms to ISO 594-1:1996 and ISO 594-2:1998 standards. | Succesfully completed (by implication of "conical fittings with a 6% (Luer)"). | |
| Pressure in OFF position | Withstands specified pressure without leakage or failure. | Succesfully completed. | |
| Pressure in ON position (Open) | Withstands specified pressure without leakage or failure. | Succesfully completed. | |
| Slider Handle Motion Test | Smooth, functional movement, indicating proper on-off operation. | Succesfully completed. | |
| Slider Force Test | Operable within appropriate force ranges. | Succesfully completed. | |
| Flow Test | Achieves specified flow rates without obstruction or impediment. | Succesfully completed. | |
| Biocompatibility | L929 MEM Elution (MEM extraction) | Non-cytotoxic. | Succesfully completed. |
| Kligman Maximization (Saline and cottonseed oil extractions) | Non-sensitizing. | Succesfully completed. | |
| Intracutaneous Injection (Saline and cottonseed oil extractions) | Non-irritating. | Succesfully completed. | |
| Systemic Injection (Saline and cottonseed oil extractions) | Non-toxic systemically. | Succesfully completed. | |
| Material Mediated Rabbit Pyrogen Test (Saline extraction) | Non-pyrogenic. | Succesfully completed. | |
| Hemocompatibility - In-Vitro Hemocompatibility - Indirect | Acceptable blood compatibility (e.g., minimal hemolysis, thrombosis). | Succesfully completed. | |
| Hemocompatibility - Hemolysis Indirect | Acceptable levels of hemolysis. | Succesfully completed. | |
| Hemocompatibility - Prothrombin Time Assay (PT) Indirect | No significant alteration of coagulation cascade. | Succesfully completed. | |
| Hemocompatibility - Unactivated Partial Thromboplastin Time Assay (UPTT) Indirect | No significant alteration of coagulation cascade. | Succesfully completed. | |
| Heavy Metals Content (USP ) | Within specified limits for heavy metal content. | Succesfully completed. | |
| Packaging Performance | Bubble Emission (after aging/shipping) | No gross leaks, passes ASTM F 2096-04. | Succesfully completed. |
| Dye Penetration (after aging/shipping) | No seal leaks, passes ASTM F 1929-98 (Reapproved 2004). | Succesfully completed. | |
| Seal Peel Tensile Strength (after aging/shipping) | Meets minimum seal strength, passes ASTM F 88-07. | Succesfully completed. | |
| Burst Strength (after aging/shipping) | Withstands internal pressure without bursting. | Succesfully completed. | |
| Visual Inspection (after aging/shipping) | Packaging maintains integrity and legibility. | Succesfully completed. | |
| Sterilization | Sterilization Process (Ethylene oxide) | Validated per ISO 11135:2007 to achieve sterility. | Succesfully completed (as indicated by reference to standard). |
Study Proving Acceptance Criteria:
The document states: "A battery of tests performed on the Merit Marquis® Flow Switch were designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use." The successful completion of all tests listed in the table above is the "study" that proves the device meets its acceptance criteria for substantial equivalence. These tests are based on recognized international and national standards (ISO 11070, ISO 594-1, ISO 594-2, ASTM F 2096-04, ASTM F 1929-98, ASTM F 88-07, ASTM D4169 – 09, ISO 11135:2007, ISO 10993-1: 2009, USP ).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual test. It refers to "a battery of tests." For device-specific physical and mechanical tests, industry practice and standard requirements often involve testing a representative sample (e.g., typically 3-10 units for destructive tests, or a larger batch for statistical process validation). For biocompatibility, specific numbers of animals or cell cultures would be used as per the mentioned ISO 10993 guidelines.
- Data Provenance: The tests were conducted by the manufacturer, Merit Medical Ireland Ltd., or their designated testing facilities. The tests are for a new device submission, implying the data is prospective as it was generated specifically for this premarket notification. The company (Merit Medical Ireland Ltd.) and its parent company (Merit Medical Systems, Inc.) are based in Ireland and the USA, respectively, implying the testing likely occurred in these regions or by accredited labs serving these regions.
3. Number of Experts Used and Qualifications for Ground Truth
- Not Applicable. This device is a mechanical accessory (flow switch). Its performance is evaluated by engineering and biological testing against established standards, not by expert interpretation of clinical images or data that would require a "ground truth" derived from human experts (e.g., radiologists, pathologists). The "ground truth" for this device's performance is objective measurements against specifications and standards.
4. Adjudication Method for the Test Set
- Not Applicable. As detailed in point 3, the evaluation of a mechanical device's function and biocompatibility relies on objective measurements and adherence to specified standards, not on subjective expert consensus or adjudication of clinical interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is typically used for diagnostic imaging devices or software where human readers interpret medical cases. The Merit Marquis® Flow Switch is an angiographic accessory, not a diagnostic imaging device or AI software, so an MRMC study is not relevant or applicable here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in essence. The entire battery of tests described (physical, mechanical, biocompatibility, packaging) represents a standalone evaluation of the device's intrinsic performance without human interaction in its evaluation process, beyond operating the test equipment. The device itself is a "human-in-the-loop" device by design as it requires a clinician to operate it. However, the performance assessment described in the submission focuses solely on the device's technical specifications and safety attributes independent of a user study.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is derived from established engineering specifications, international/national standards (ISO, ASTM, USP), and validated test methods. For example, a Luer fitting's ground truth is its conformance to ISO 594, and biocompatibility's ground truth is a pass/fail outcome against ISO 10993 criteria.
8. Sample Size for the Training Set
- Not Applicable. "Training set" refers to data used to train artificial intelligence or machine learning models. This device is a mechanical flow switch and does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As per point 8, there is no AI/ML model or "training set" for this device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).