(85 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 Exclusion System contains a clip for exclusion of the heart's 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 pre-loaded on a disposable Clip applier. The AtriClip Exclusion System does not contain natural rubber latex components.
The provided text describes the 510(k) premarket notification for the AtriClip LAA Exclusion System. It focuses on demonstrating substantial equivalence to a predicate device (K181474), primarily based on labeling changes (indications for use and device description in the instructions for use) rather than a new design or device performance study.
Therefore, many of the requested criteria related to a study proving device performance against acceptance criteria (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are explicitly stated as not applicable or not performed because the submission is not for a new device design or a change in its intended use or function.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not detail specific quantitative acceptance criteria or performance metrics for the AtriClip LAA Exclusion System itself, as it's a 510(k) for a modified labeling of an existing, already cleared device. The "performance data" section explicitly states: "The proposed changes do not include any change to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System."
Instead, the "acceptance criteria" here are implicitly about demonstrating that the labeling changes do not negate the device's substantial equivalence to its predicate. The "performance" is therefore the assertion that the device continues to meet the established performance parameters of its predicate.
| Feature | Predicate (K181474) AtriClip™ LAA Exclusion System (Original Labeling) | Subject AtriClip™ LAA Exclusion System (Modified Labeling) | Equivalence Comparison (Acceptance) |
|---|---|---|---|
| Proprietary Name | AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip/V-Clip | AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip/V-Clip | n/a (same) |
| Model Numbers | LAA, ACH, PRO, ACHV, PROV series | LAA, ACH, PRO, ACHV, PROV series | n/a (same) |
| Indications for Use | Occlusion of LAA, under direct visualization, in conjunction with other cardiac surgical procedures. | Exclusion of LAA, under direct visualization, in conjunction with other cardiac surgical procedures. | Similar. AtriClip devices have the same intended use. (The term "occlusion" was changed to "exclusion," but the core meaning and clinical application are deemed equivalent.) |
| Device Description in IFU | Describes the Clip for occlusion of LAA; pre-loaded on applier; no natural rubber latex. | Describes Clip for exclusion of LAA; adds reference to preclinical animal studies (Kamohara 2005, 2006) demonstrating acute and chronic electrical isolation, and human clinical study (Starck 2012) showing acute electrical isolation (with statement that chronic electrical isolation not evaluated in human studies); pre-loaded on applier; no natural rubber latex. | Different, but AtriClip devices have the same intended use. (The added descriptive text is considered an update to the IFU, not a change in fundamental device function or safety/effectiveness for the stated intended use.) |
| Preloaded Clip | Gillinov-Cosgrove Clip / V-Clip | Gillinov-Cosgrove Clip / V-Clip | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | Passed. ISO 10993 assessed. | Passed. ISO 10993 assessed. | Same |
| Sterilization | Gamma Irradiation. | Gamma Irradiation. | Same |
| Sterility Assurance Level | 10^-6 SAL | 10^-6 SAL | Same |
Study Proving Device Meets Acceptance Criteria:
The "study" referenced in this submission is the 510(k) premarket notification process itself, which argues for substantial equivalence based on the updated labeling. The core argument is that the device's fundamental design, operating principles, and function have not changed. Therefore, previously submitted preclinical and clinical data from the predicate device (K181474) and referenced literature (Kamohara 2005, 2006; Starck 2012) are considered sufficient to support the device with its updated labeling.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: No new "test set" in the context of device performance testing was used for this 510(k) submission, as it relates to labeling changes only.
- Data Provenance for Referenced Studies (Kamohara, Starck): The document does not specify the country of origin or whether these were retrospective or prospective studies. Kamohara (2005, 2006) are referred to as "preclinical animal studies," and Starck (2012) as a "human clinical study."
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This was not a study requiring expert ground truth for performance evaluation of a new or modified device. The "ground truth" here is regulatory compliance and a determination of substantial equivalence by the FDA.
4. Adjudication Method for the Test Set
- Not applicable. No new test set for device performance was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size
- Not applicable. No MRMC study was performed or required for this labeling update.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a mechanical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission's approval is the established regulatory framework for 510(k) clearances, specifically demonstrating substantial equivalence to a predicate device. This is based on comparisons of design, materials, manufacturing, indications for use, and a demonstration that any changes (in this case, primarily labeling) do not raise new questions of safety or effectiveness. The supporting data for the claims made in the updated labeling (e.g., electrical isolation) come from previously published preclinical and clinical studies (Kamohara 2005/2006, Starck 2012).
8. The Sample Size for the Training Set
- Not applicable. This submission is not for an AI/ML algorithm or a device requiring a training set in that context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.