(216 days)
AtriCure's cryoICE cryoFORM cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
AtriCure's cryolCE cryoFORM cryoablation probe (CRYOF) is a sterile, single use, cryosurgical device to be used in coniunction with the AtriCure Crvo Module [K111042. K11207. K140058, K142203) to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The probe is comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube.
The provided text describes the AtriCure® cryoICE™ cryoFORM cryoablation probe (CRYOF) and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Cardiac Tissue Ablation Performance | Ability to successfully ablate cardiac tissue and block electrical pathways. | Successfully tested on an animal model to confirm modifications do not affect this ability. Lesions assessed via histopathology and morphometric measurements demonstrated statistical equivalence via two one-sided tests (TOST) for lesion width and depth compared to the predicate device. |
| Biocompatibility | Compliance with ISO 10993-1 for biological evaluation; no cytotoxicity, sensitization, irritation, systemic toxicity, or material-mediated pyrogenicity. | Biocompatibility evaluation conducted per ISO 10993-1, including tests for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Material-Mediated Pyrogenicity. The device is considered an "External Communicating Device" for "Tissue/Bone" contact "under 24 hours." |
| Design Controls & Specifications | Conformance to design controls and product specifications as per 21 CFR 820.30 and AtriCure's Quality System. | Performance determined to conform to design controls and product specifications. |
| Mechanical Integrity | Performance related to mechanical aspects of the device. | Mechanical Testing performed as part of non-clinical bench testing. |
| Reliability | Performance related to the consistent operation of the device. | Reliability Testing performed as part of non-clinical bench testing. |
| Cryogen Performance | Effective and safe handling/delivery of the cryogen (Nitrous Oxide). | Cryogen Performance Testing performed as part of non-clinical bench testing. |
| Sterilization | Effective sterilization and maintenance of sterility. | Sterilization Validation performed, using Gamma Irradiation. |
| Packaging & Stability | Maintenance of device integrity and sterility over time and during transit. | Accelerated Aging Testing and Transit Testing performed. |
| LAL Testing | Absence of bacterial endotoxins. | LAL Testing performed. |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The "Thigh Prep Study Testing" used an unspecified number of "live porcine thigh tissue models." The text does not provide a specific number of animals or lesions, but it implies multiple lesions were created and assessed for statistical equivalence.
- Data Provenance: The data is from a prospective GLP (Good Laboratory Practice) animal study conducted on porcine (swine) models. The country of origin of the data is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The text states, "Lesions were assessed using histopathology and morphometric measurements." It does not specify the number or qualifications of experts (e.g., pathologists, veterinarians) who performed these assessments.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text does not describe any adjudication method for establishing ground truth from multiple readers/assessors. It simply mentions that lesions were "assessed."
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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:
- No, an MRMC comparative effectiveness study was not done. The device in question is a cryoablation probe (a surgical tool), not an AI diagnostic or assistance system. The study focused on the physical performance of the device in tissue ablation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical instrument and does not involve an algorithm for standalone performance in the context of what is typically considered "standalone AI performance." The performance reported is that of the physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for evaluating lesion success was primarily established through histopathology and morphometric measurements of the ablated tissue in a porcine model. This falls under a form of pathological assessment.
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The sample size for the training set:
- Not applicable. This submission describes a physical medical device (cryoablation probe) and its performance through animal and bench testing, not an AI/machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, this question is irrelevant to the provided document.
§ 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.