(175 days)
The HLS Cannula from MAQUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.
The HLS Cannula from MAQUET is a wire-reinforced, thin-wall cannula made of polyurethane. The transparent proximal section has no reinforcement and can be clamped. Each cannula is supplied with a pre-mounted 3/8" connector and an introducer that allows a guide wire up to 0.038" to be inserted. The cannula is available with an optional percutaneous insertion kit for the Seldinger technique and an optional BIOLINE or SOFTLINE Coating. The HLS Cannula comes in a range of sizes and lengths. The HLS Cannula is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The insertion kit from MAQUET comprises various components which permit access to the vessel. One insertion kit is available for the arterial cannula (PIK 100) and one for the venous cannula (PIK 150).
This document describes the premarket notification (510(k)) for the HLS Cannula, which is a medical device used for circulatory perfusion during extracorporeal circulation. The study outlined is a non-clinical performance test comparing the HLS Cannula to predicate devices to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow Rate / Pressure Drop | Substantially equivalent to predicate devices. | The performance data of MAQUET cannulae as compared to the MEDTRONIC predicate cannulae are substantially equivalent for relevant flow of 0-6 liters/minute. |
| Kink Resistance | Wire-reinforced cannula shafts will not kink. | Test performed to verify that the wire re-inforced cannulae shafts will not kink. (Implied acceptance met by satisfactory test.) |
| Tensile Strength (Cannula-Connector) | Bonding stability between cannula and connector is verified. | Test performed to verify the bonding stability between cannulae and connector. (Implied acceptance met by satisfactory test.) |
| Tensile Strength (Introducer Grip) | Bonding of introducer and grip is verified. | Verification of bonding of introducer and grip. (Implied acceptance met by satisfactory test.) |
| Six Hours Pressure Resistance | Durability of all connections for 6 hours at 1.5 bar. | Test performed to verify the durability of all connections of HLS arterial and venous Cannulae for a period of 6 hours at 1.5 bar. (Implied acceptance met by satisfactory test.) |
| Air Tightness | All connections are air-tight at a specified vacuum. | Test performed to verify that all connections of the cannulae are air-tight if put to a specified vacuum. (Implied acceptance met by satisfactory test.) |
| Corrosion | No corrosion. | Test performed to evaluate if cannulae corrode. (Implied acceptance met by satisfactory test.) |
| Printed Depth-Markings Adhesion | Adhesion of printing is sufficient. | Test performed to verify that the adhesion of the printing is sufficient. (Implied acceptance met by satisfactory test.) |
| Biologic Evaluation | Compliance to ISO 10993-1. | Products met these requirements. |
| Intravascular Catheter Standards | Compliance to ISO 10555-1. | Products met these requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of units or samples used for each test. It generally refers to "HLS Cannulae" in the plural, suggesting multiple units were tested.
- Data Provenance: The studies were non-clinical performance tests conducted by Maquet Cardiopulmonary AG. The data provenance is internal testing performed by the manufacturer to support the 510(k) submission. There is no information regarding country of origin of data beyond the manufacturer's location (Germany) for the submission. The studies are prospective in the sense that they were designed and executed to evaluate the performance of the HLS Cannula prior to market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described tests are non-clinical performance and material characteristic evaluations (e.g., flow rate, tensile strength, kink resistance, biocompatibility standard compliance). These tests rely on established scientific methods and engineering standards, not on expert consensus or human interpretation of outcomes in a clinical setting to establish "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable for the non-clinical performance and material characteristic tests described. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes where discrepancies might arise.
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
This information is not applicable. The document describes the premarket notification for a medical device (cannula) and its non-clinical performance testing. It does not involve AI, image interpretation, or human reader performance studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is derived from engineering specifications, material science standards (e.g., ISO 10993-1, ISO 10555-1), and established predicate device performance. For example, the "ground truth" for flow rate is the measured flow rate and pressure drop of the predicate device. For kink resistance, it's the physical property of the cannula not kinking under test conditions.
8. The sample size for the training set
This information is not applicable. This document describes the testing of a physical medical device, not a machine learning model 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.
§ 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).