(24 days)
The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.
The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection quide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.
The Clip Appliers are disposable device with a handle, shaft, suture anchors, articulation controls, and deployment loop which contains the Clip. This Special 510(k) contains an alternate to the PET suture supply sourcing used within the AtriClip implant and Clip Appliers of the LAA Exclusion system.
This is a 510(k) premarket notification for the AtriClip LAA Exclusion System, a medical device designed for occluding the heart's left atrial appendage during cardiac surgical procedures. This submission is for modifications to an already cleared device (K180010).
The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. The submission asserts that the modifications made do not change the intended use, operating principles, or function of the device, and therefore, the prior approval and equivalence still hold.
However, based on the information provided, we can infer and construct some of the requested details:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are not presented as numerical targets for performance metrics like sensitivity or specificity. Instead, they are based on demonstrating that the modified device is as safe and effective as the predicate device and that the changes do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Inferred from Substantial Equivalence Determination) | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device. | "The devices have the same intended use." |
| Operating Principle: No changes from predicate device. | "No changes were made in operating principle." |
| Specifications of Performance: No changes from predicate device. | "No changes were made in... specifications of performance." |
| Contraindications, Warnings, and Precautions: Remain the same as predicate device. | "The contraindications, warnings, and precautions remain the same." |
| Equivalency in Performance (Bench Testing): Demonstrated for design and performance elements. | "Demonstrated equivalency in performance." Specifically, conducted: Tensile Testing (Strength, Knotted Strength), Suture Elongation, Friction Comparison Testing. |
| Biocompatibility: Remains unchanged and meets ISO 10993-1. | "Device biocompatibility remains unchanged." Tested for: Material Mediated Pyrogen, Genotoxicity, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity. |
| Safety Issues: No new issues raised. | "Did not raise any new issues of safety." |
Study Information (Based on Substantial Equivalence Submission)
Since this is a 510(k) for modifications to an already cleared device, the "study" proving acceptance is primarily a demonstration of equivalence through bench testing and biocompatibility assessment of the modified components, rather than a clinical trial with patient outcomes.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size (Test Set): Not explicitly stated as "sample size" in the context of a clinical test set. The "test set" here refers to the materials and components of the modified device that underwent bench testing and biocompatibility evaluation. The quantity of items tested for Tensile, Elongation, Friction, and Biocompatibility (e.g., number of clips, appliers, or material samples) is not specified.
- Data Provenance: Not explicitly stated. Given that these are bench tests and biocompatibility tests, the data would originate from the manufacturer's internal testing facilities or contract labs. The country of origin is not mentioned. The data is prospective in the sense that the tests were conducted specifically for this submission on the modified materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not directly applicable to a 510(k) based on bench testing and biocompatibility. There is no concept of "ground truth" derived from expert consensus on images or clinical cases in this submission. The "ground truth" in this context is the objective measurement from the specified engineering and biological tests demonstrating that the modified material performs equivalently and is biocompatible. The experts would be the engineers and toxicologists who designed, performed, and interpreted these tests, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. There is no ambiguous data or expert disagreement requiring an adjudication method for the physical and chemical properties tested. The results are objective measurements from the tests performed.
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
Not applicable. This device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating equivalence is based on:
- Engineering Specifications: Testing the physical properties (tensile strength, elongation, friction) of the modified components against established engineering specifications and comparing them to the predicate device's performance.
- Biological Standards: Testing biocompatibility according to recognized international standards (ISO 10993-1) using established biological assays (Material Mediated Pyrogen, Genotoxicity, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of AI or machine learning for this physical device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.