(28 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 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 vessels. One insertion kit is available for the arterial cannula (PIK 100) with a length of 100 cm and one for the venous cannula (PIK 150) with a length of 150 cm. Additionally as accessories to the percutaneous insertion kit, there are two sets with further dilatators available. One set with larger dual step dilatators (18 / 20, 20 / 22, 22 / 24 Fr) for a better vessel dilation in the cases where cannulae are used bigger than 23 Fr. One set contains a smaller dilatator (8 / 10 Fr), dedicated for the insertion of the smaller cannulae like 13 Fr. As further accessories are separately guidewire sets available. These guidewire sets consist of five separately packed quidewires (lengths 100 or 150 cm) which are the identic articles as used in the Percutaneous Insertion Kit itself.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Arterial HLS Cannula 13 Fr non-coated, with BIOLINE Coating and with SOFTLINE Coating (K131666)
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary for a Special 510(k), which focuses on demonstrating substantial equivalence to a previously cleared device (predicate). Therefore, it doesn't present a table of explicit, pre-defined acceptance criteria with numerical targets and the device's measured performance against those targets in the way a de novo or PMA submission might.
Instead, the "acceptance criteria" for this Special 510(k) are implied by the demonstration of substantial equivalence to the predicate devices. The study essentially aims to prove that the new device's performance is comparable or not inferior to the predicate device for relevant parameters.
Here's how we can infer the acceptance criteria and reported "performance":
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Chemically and biologically safe for its intended use. | Meets: Substantial equivalence testing performed and presented in the original HLS Cannula 510(k) (K102532) is applicable. This implies the 13 Fr cannula also meets these established biocompatibility standards. |
| Packaging: Maintains sterility and device integrity. | Meets: Substantial equivalence testing performed and presented in the original HLS Cannula 510(k) (K102532) is applicable. This implies the 13 Fr cannula's packaging meets these standards. |
| Sterility: Aseptically processed to be free from viable microorganisms. | Meets: Substantial equivalence testing performed and presented in the original HLS Cannula 510(k) (K102532) is applicable. This implies the 13 Fr cannula is also sterile. |
| Flow Rate: Provides adequate blood flow for its intended use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the flow rate is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
| Kink Resistance: Resists kinking during insertion and use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the kink resistance is acceptable and comparable. It also explicitly mentions "protected from kinking - to a greater or lesser extent - by wire reinforcement" similar to the predicate. Specific numerical acceptance criteria or performance values are not provided. |
| Pressure Resistance: Withstands the pressures encountered during use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the pressure resistance is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
| Integrity: Maintains structural integrity during use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the structural integrity is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
| Tensile Strength: Withstands tensile forces during use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the tensile strength is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each non-clinical test (Flow Rate, Kink resistance, Pressure resistance, Integrity, Tensile tests). The testing methodologies would typically involve a specific number of units for each test.
- Data Provenance: Not explicitly stated, but given the submitter is MAQUET Cardiopulmonary AG in Germany, it is highly likely the non-clinical testing was conducted in Europe (Germany or within the EU). The study is retrospective in the sense that it relies on previously conducted tests for the predicate devices and then applies additional tests specific to the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the studies are entirely non-clinical (bench testing). There is no "ground truth" derived from expert consensus on medical images or clinical outcomes in this context. The "truth" is established by direct physical measurements according to specified test standards or protocols.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are entirely non-clinical bench testing, not involving human interpretation or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates human reader performance, often in image interpretation, and is not relevant for the non-clinical bench testing described for this device.
Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable as the device is a physical medical device (cannula), not software or an AI algorithm. The performance described refers to the physical attributes and function of the cannula itself, not an algorithm's output.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is established by:
- Bench Testing Measurements: Direct physical measurements (e.g., flow rate in L/min, pressure in mmHg, force in N for tensile strength) under controlled laboratory conditions, following established test protocols and standards.
- Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is demonstrating that these measured characteristics are comparable or "essentially the same" as those demonstrated for the already cleared predicate devices.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of physical medical device bench testing or a 510(k) submission for a non-AI/software device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" or corresponding ground truth for this type of submission.
§ 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).