(41 days)
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)—a non-sterile, reusable device-used with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to a cryosurgical handpiece to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias.
Here's an analysis of the provided text regarding the AtriCure Cryo Module, focusing on the acceptance criteria and study details:
Analysis of Acceptance Criteria and Study Information for AtriCure Cryo Module (K111042)
Based on the provided 510(k) summary, the AtriCure Cryo Module is a Class II device intended for the cryosurgical treatment of cardiac arrhythmias. The submission primarily relies on demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Overall) | Device is substantially equivalent to predicate devices. | "The AtriCure Cryo Module is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products." |
| Conformance to Product Specifications | Device meets its defined product specifications. | "Appropriate product testing was conducted to evaluate conformance to product specification..." |
| Bench Comparison Testing | Performance comparable to predicate devices in bench tests. | "Bench comparison testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific metrics or thresholds for comparison are not provided in the summary.) |
| Transit Testing | Device withstands transportation stresses. | "Transit testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific tests or outcomes are not provided in the summary.) |
| Electromagnetic Compatibility (EMC) | Device meets EMC standards. | "Electromagnetic compatibility...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific standards or test results are not provided in the summary.) |
| Reliability | Device operates reliably over time. | "Reliability, reliability testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific reliability metrics, duration, or outcomes are not provided in the summary.) |
| Conformance to International Standards | Device adheres to relevant international standards. | "...in conformance international standards and device specifications." (Specific standards are not listed in the summary, but common ones for medical devices would include those related to electrical safety, quality management, etc.) |
| Materials Suitability | Materials are appropriate for intended use. | "All materials used in the manufacture of the AtriCure Cryo Module are suitable for their intended use and suitable for use with pressurized nitrous oxide." (This is a statement of suitability rather than a specific test outcome, implying internal material qualification presumably met prior established criteria.) |
| Safety (No Patient Contact) | Device has no direct patient contact. | "The AtriCure Cryo Module is not intended for patient contact." (This is a design characteristic that influences the level of safety testing required, rather than a test result. It implicitly means that acceptance criteria related to biocompatibility for direct patient contact were not applicable.) |
| Intended Use (Cryosurgical Treatment) | Device effectively performs cryosurgery. | "The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias." (The "substantially equivalent" assertion implies that its ability to perform cryosurgery is comparable to the predicate devices, which are already cleared for this purpose. No specific performance metrics for cryosurgery (e.g., lesion depth, temperature achieved) are provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in the context of clinical data or patient samples. The testing described ("bench comparison testing, transit testing, electromagnetic compatibility, reliability") appears to refer to engineering and functional verification/validation, rather than a clinical study with a patient test set.
- Data Provenance: Not applicable in the context of a clinical test set, as no clinical studies with patient data are described for the primary submission. The data provenance is from internal engineering and bench testing conducted by AtriCure, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the provided 510(k) summary does not describe a clinical study requiring expert-established ground truth for a test set (e.g., image interpretation, disease diagnosis). The testing performed is primarily focused on engineering and functional aspects of the device.
4. Adjudication Method for the Test Set:
- This question is not applicable as no clinical test set requiring adjudication (e.g., for diagnostic accuracy or outcome assessment) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on engineering and bench testing, not clinical comparative effectiveness with human readers or AI assistance. No mention of AI is made in the document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. The AtriCure Cryo Module is a physical medical device (cryosurgical system), not an algorithm or AI software. Therefore, "standalone" algorithm performance is not relevant to this submission.
7. The Type of Ground Truth Used:
- For the engineering and bench testing described, the "ground truth" would be defined by engineering specifications, industry standards, and the performance characteristics of the predicate devices. For example:
- For EMC, the ground truth would be conformance to specific electromagnetic compatibility standards.
- For reliability, the ground truth would be predetermined failure rates or operational lifespan targets.
- For bench comparison, the ground truth would be the established performance parameters of the predicate devices.
- For material suitability, the ground truth would be material specifications and safety data for use with nitrous oxide.
8. The Sample Size for the Training Set:
- This question is not applicable as there is no mention of an algorithm or AI model requiring a training set in this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no training set for an algorithm or AI model mentioned in this 510(k) submission.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.