(29 days)
The AtriClip LAA Exclusion System is indicated for the exclusion 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 AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure exclusion of the left atrial appendage (LAA). Preclinical animal studies (Kamohara 2005,2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies.
The Clip is available in the following lengths to accommodate difference 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.
The provided document is a 510(k) premarket notification for the AtriClip LAA Exclusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria for a novel device.
The document does not contain acceptance criteria or performance data in the way typically expected for a new device's clinical or algorithmic performance. Instead, it aims to show that a modified version of an already cleared device (AtriClip LAA Exclusion System, K191413) is substantially equivalent to that predicate. This means the manufacturer did not conduct a new study to establish performance against acceptance criteria for a novel device.
Here's what can be inferred from the document regarding the information requested, with caveats:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated for this submission as it's a modification to an already cleared device. The "acceptance criteria" here are implicitly that the modified device's performance is equivalent to the predicate device and that the modifications do not introduce new safety or effectiveness concerns.
- Reported Device Performance: The document states that "verification and validation testing... Demonstrated equivalency in performance" to the predicate device. However, specific performance metrics or a table comparing them are not provided in this summary. The comparison table focuses on design and material characteristics, not performance data points.
2. Sample Size Used for the Test Set and Data Provenance:
- This is not a clinical study on a new device. The document mentions "preclinical animal studies (Kamohara 2005, 2006)" and a "human clinical study (Starck 2012)" to support the predicate device's description, confirming electrical isolation (acute and chronic for animal, acute for human). However, no new sample sizes or data provenance for a "test set" are provided for this specific 510(k) modification. The modification primarily concerns an alternate raw material supplier for titanium and minor proprietary name changes.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable to this 510(k) submission. This type of information would be relevant for studies establishing ground truth for diagnostic devices or software, not for demonstrating substantial equivalence of a modified implantable clip.
4. Adjudication Method:
- Not applicable for this type of submission.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done for this 510(k). This is an implantable clip, not an AI or imaging diagnostic device where MRMC studies are common.
6. Standalone Performance Study (Algorithm Only):
- No, this is an implantable medical device, not an algorithm.
7. Type of Ground Truth Used:
- For the predicate device, the "ground truth" for electrical isolation was established through "preclinical animal studies (Kamohara 2005, 2006)" (acute and chronic electrical isolation) and a "human clinical study (Starck 2012)" (acute electrical isolation). This implies physiological measurements and clinical observations.
- For this specific 510(k) submission, the "ground truth" for the modifications is demonstrating that the changes (e.g., alternate raw material supplier) do not alter the established performance and safety of the predicate device, likely through bench testing and material characterization, not patient-level "ground truth."
8. Sample Size for the Training Set:
- Not applicable. This is not a machine learning model.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
Summary of what the document focuses on instead:
The core of this 510(k) notification is a comparison of technological characteristics between the previously cleared AtriClip LAA Exclusion System (predicate) and the modified version. The comparison table (pages 4-5) highlights that almost all features (Proprietary Name, Device Classification, Regulatory Class, FDA Division, Performance Standards, Intended Use, Device Description, Software, Shelf Life, Biocompatibility, Sterilization, Sterility Assurance Level, Pyrogen, Suture Material, Preloaded Clip, Clip Opening) are "Same" between the predicate and the modified device. The only noted change regarding the clip itself is the addition of an "alternate raw material supplier of the titanium for the AOD1 clip."
The conclusion states that AtriCure "demonstrated that the modifications made to the AtriClip LAA Exclusion System are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared AtriClip LAA Exclusion System (K191413)." This equivalency was supported by "verification and validation testing" which "Demonstrated equivalency in performance," "Device biocompatibility remains unchanged," and "Did not raise any new issues of safety." However, the details of these tests and their specific results against quantitative acceptance criteria are not provided in this public summary.
§ 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.