(29 days)
The AcQCross™ Qx Integrated Transseptal DilatorNeedle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.
AcQCross™ Qx combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). AcQCross™ Ox consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Qx is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of AcQCross™ QX. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a spring-tensioned actuator in the handle of AcQCross™ QX that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector that allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. AcQCross™ Qx is for single-use only and is provided sterile.
This document is a 510(k) summary for the AcQCross™ Qx Integrated Transseptal Dilator/Needle, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, several of the requested sections cannot be fully populated as this type of information is generally not included in a 510(k) summary that relies on demonstrating equivalence to a previously cleared device.
However, I can extract the relevant information regarding performance testing and how substantial equivalence was established.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the device performance tests. Instead, it relies on demonstrating that the AcQCross™ Qx performs "as intended" and that "minor differences do not potentially impact the safety and effectiveness" compared to the predicate device. The performance tests were conducted in accordance with ISO standards and additional bench testing was performed on the modified standalone device.
| Test Category | Relevant Standard(s) / Description of Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. | "The results demonstrate that AcQCross™ Qx meets the requirements of ISO 10993-1 and is biocompatible." (Leveraged from K170373 and K171081. Additional cytotoxicity and hemolysis testing due to a new shaft supplier was performed.) |
| Sterilization | ISO 11135: 2014 - Sterilization of health-care products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. | "AcQCross™ Qx is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device... to meet a sterility assurance level (SAL) of 10-6." (Leveraged from K170373 and K171081. Minor packaging change adopted per AAMI TIR28, requiring no further process validation.) |
| Electrical Safety and EMC | ANSI/AAMI IEC 60601-1:2005, IEC 60601-1-2, IEC 60601-2-2. | Testing leveraged from K170373, K171081, and K193509. (No specific performance data detailed in this summary, but implies compliance with standards.) |
| Bench Testing (General) | ISO 11070: 2014 --- Sterile single-use intravascular introducers, dilators and guidewires. | |
| ISO 10555-1: 2013 --- Sterile, single-use intravascular catheters --- Part 1: General Requirements. | "AcQCross™ Qx performs as intended." (Leveraged from K170373, K171081, and K193509.) | |
| Bench Testing (Specific to modified standalone AcQCross™ Qx) | Curve retention | (No specific quantitative results are provided in the summary, but the conclusion states "The non-clinical tests demonstrated that the device is as safe and effective as the predicate device.") |
| Pushability | ||
| Needle Actuation | ||
| Electrical Continuity | ||
| Shaft to handle tensile | ||
| Bench Testing (with compatible sheaths) | Needle Actuation | "AcQCross™ performs as intended, and the addition of compatible sheath configurations do not potentially impact the safety or effectiveness of the device as compared to the predicate device." |
| Visual inspection | ||
| Aspiration/Flushing | ||
| Electrical Continuity |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document is a 510(k) summary for a medical device that relies on substantial equivalence. It does not contain information about the sample sizes used for the performance tests. The data provenance (country of origin, retrospective/prospective) is also not specified, which is typical for this type of regulatory submission focusing on engineering and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of testing described in this document. The performance tests are engineering-based (biocompatibility, sterilization, electrical safety, bench testing) and do not involve "ground truth" derived from expert medical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the case for the engineering performance tests described.
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 device (transseptal dilator/needle) is a mechanical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical instrument, not an algorithm. The phrase "standalone device" in the document refers to the AcQCross™ Qx being cleared for use by itself (with compatible sheaths) rather than only as part of specific introducer sets.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth, in the context of clinical or diagnostic studies, is not applicable here. The "truth" for the performance tests (e.g., biocompatibility showing no toxicity, sterilization achieving SAL, mechanical forces meeting specifications) is established through standardized laboratory testing and engineering validation.
8. The sample size for the training set
This information is not applicable. The device is a mechanical tool; it does not involve training data sets or machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of medical device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).