(29 days)
FOR ADULT PATIENTS
AtriCure's cryolCE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).
FOR ADOLESCENT PATIENTS
The cryolCE cryoSPHERE+ and cryoSPHERE MAX cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization* in adolescent patients of at least 12 years of age.
*Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.
The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are sterile, single use devices that achieve cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX device is offered in two probe length configurations: approximately 11" and 17" long. At the distal end, the ryoICE cryoSPHERE+ and cryoICE cryoSPHERE MAX probe features an 8mm or 10mm diameter ball tip shape for each length configuration. The flexible region of the probe is malleable and is capable of being bent by the end user using an included forming tool.
The provided text is an FDA 510(k) clearance letter for the AtriCure cryoICE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria. As such, information regarding many of the requested points (like sample size for test sets, number of experts for ground truth, MRMC studies, or training set details) is not present.
However, I can extract the available information regarding acceptance criteria and the type of study conducted to support the equivalence claim.
Acceptance Criteria and Reported Device Performance
The document states that the acceptance criteria were predetermined, and the device met these criteria, ensuring substantial equivalence. While specific numerical acceptance criteria are not detailed in the provided text, the criteria implicitly refer to demonstrating equivalence in performance, features, and safety compared to the predicate device.
| Feature / Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General Equivalence | Substantial equivalence to predicate device in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use/indication for use. | Demonstrated equivalence; no new safety or performance issues raised. |
| Reliability | Met predetermined reliability standards. | Met predetermined acceptance criteria. |
| Transit | Maintained integrity and function after transit simulations. | Met predetermined acceptance criteria. |
| Shelf-life | Maintained sterility and functionality throughout shelf-life. | Met predetermined acceptance criteria. |
| Cryogen Performance/Thermal Insulation | Similar thermal performance and insulation efficiency to predicate. | Met predetermined acceptance criteria. |
| Mechanical Integrity | Maintained structural and functional integrity under mechanical stress. | Met predetermined acceptance criteria. |
| Biocompatibility | Biocompatible patient-contacting materials. | Biocompatible patient-contacting materials (Same as predicate). |
| Sterility | Achieved and maintained sterility. | Sterile - single use, disposable device (Same as predicate); Gamma Irradiation (Same as predicate). |
| Electromagnetic Compatibility (EMC) | Compliant with EMC standards. | Met predetermined acceptance criteria. |
| Operating Temperature | Below -40°C. | Below -40°C (Same as predicate). |
| Intended Use / Indications for Use | Identical to predicate device. | Identical to predicate device. |
| Operating Principle | Joule-Thompson Effect. | Joule-Thompson Effect (Same as predicate). |
| Energy Used | Nitrous Oxide. | Nitrous Oxide (Same as predicate). |
| Human Factors | Hand-held device connected to a console, closed-loop system, activation by button or footswitch. | Same as predicate. |
| Ball Tip Material/Construction | Aluminum Alloy; smooth spherical ball. | Aluminum Alloy; smooth spherical ball (construction changed from welded to threaded with epoxy, but considered equivalent). |
| Ball Tip Diameter | 8mm. | 8mm (CRYOSP, CRYOSP-L) and 10mm (CRYOSMAX, CRYOSMAX-L) - modification allowing for differing body habitus and surgeon preference. |
| Shaft Material/Construction | Rigid Region: Makrolon Polycarbonate; Smooth. Flexible Region: Clear LDPE sheath with black braids; Smooth Aluminum. | Rigid Region: Double Wall Vacuum Insulated Stainless Steel with Shrink Tube; Smooth. Flexible Region: Double Wall Vacuum Insulated Stainless Steel with Shrink Tube; Corrugated Stainless Steel. |
| Exposed Shaft Length | Standard: 28cm (11"); Long: 46cm (18"). | Standard: 28cm (11"); Long: 43cm (17") (CRYOSP-L and CRYOSMAX-L). |
| Nose Cone | Overall Length: Less than 1 inch; Material: Polycarbonate Resin; Color: Translucent Blue. | Overall Length: Less than 2 inches; Material: Polycarbonate Resin; Color: Blue. |
| Device Flow Rate | Minimum flow rate value. | Specified flow rate range. |
| Probe Thermocouple | Material: Cu-Constantan w/Kapton; Location: Distal end of Rigid Shaft. | Material: Type t (cu-constantan); Location: Distal Cap, proximal to ball tip. |
Study Details Based on Provided Information:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only lists "Reliability Testing," "Transit," "Shelf-life," "Cryogen Performance/Thermal Insulation," "Mechanical testing," "Biocompatibility," "Sterility," and "EMC" as types of tests.
- Data Provenance: Not specified, but these are typically bench tests performed in a laboratory setting by the manufacturer. These are non-clinical bench testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical bench testing study, not a clinical study involving experts defining a medical ground truth for diagnostic accuracy.
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Adjudication method for the test set:
- Not applicable. This was a non-clinical bench testing study.
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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. This device is a cryoablation probe (surgical instrument), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical bench tests, the "ground truth" would be established engineering specifications, performance standards, material properties, and regulatory requirements (e.g., sterilization efficacy, biocompatibility standards).
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The sample size for the training set:
- Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. This information is not relevant to this device type.
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).