(281 days)
For Adult Patients
AtriCure's Cryo2 cryo2 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.
The Cryo2 cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves.
For Adolescent Patients
The Cryo2 cryolCE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1 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.
For Adult Patients
AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use performed by freezing target tissues, creating an inflammatory response (cryonecrosis) for blocking pain by temporarily ablating peripheral nerves.
For Adolescent Patients
The cryolCE cryoSPHERE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1 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 cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac surgery; it is also intended for use in blocking pain by temporarily ablatinq peripheral nerves. The cryosurgical handpiece uilizes a high-pressure cryogen (nitrous oxide, N20) to freeze target tissues, creating an inflammatory response, and ultimately, cryonerosis. The cryosurgical handpiece provides below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitous oxide is supplied to the cryprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryolip, of the probe is malleable to allow access to varying anatomy and anatomical sites.
The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three infices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be cryotip into the desired form. The cryolip is attached to an insulated rigid shaft that allows the surgeon to adjust the exposed cryolip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).
The cryoICE PROBE is a sterile, single-use cryosurgical instrument.
The form tool facilitates bending of the malleable tip.
This PROBE was designed for treatment of cardieving controlled temperatures down to -50° to -70°C; it can also be used to temporarily block pain by ablating peripheral nerves in adolescent patients of at least 12 years of aqe.
The cryolCE cryoSPHERE cryoablation (CRYOS/CRYOS-L) probe is a single use cryablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe.
The PROBE is a single-use device offered in two configurations: standard length probe shaft (CRYOS), and extended length probe shaft (CRYOS-L). The probe shaft is malleable and supports forming by the supplied TOOL. The PROBE features a spherical 8mm cryoablation tip.
This document is a 510(k) summary for AtriCure CryoICE cryo-ablation probes (Cryo2, CryoS, CryoS-L). It focuses on the expanded indication for use in adolescent patients aged 12 and above for temporary pain unique to its use in intercostal nerves under direct visualization.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that clinical evidence demonstrated the use of the cryoablation probes in adolescent patients (≥ 12 years) for intercostal nerve ablation was "as safe and effective" as its use in adults. The evaluation was based on the following endpoints, implying these were the performance areas assessed:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (regarding intraoperative or post-operative complications) | Demonstrated to be as safe as adult use. |
| Effectiveness (regarding intraoperative or post-operative complications) | Demonstrated to be as effective as adult use. |
| Incidence of adverse events | Comparable to adult use. |
| Incidence of cryoablation associated numbness | Comparable to adult use. |
| Incidence of neuropathic pain | Comparable to adult use. |
| Incidence of chest wall numbness | Comparable to adult use. |
| Incidence of post-operative pneumothorax | Comparable to adult use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that AtriCure partnered with the UCSF Stanford Pediatric Device Consortium (PDC) to evaluate clinical evidence, which comprised clinical publications. The exact sample size from these publications is not specified in this summary. The data provenance (country of origin, retrospective/prospective nature) is also not explicitly stated in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. The evaluation relies on published clinical evidence rather than a dedicated expert panel for ground truth establishment within this specific submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary. Given that the evidence is based on clinical publications, any adjudication would have been part of the original studies, and details are not reiterated here.
5. 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a physical medical instrument (cryoablation probe) and not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical cryoablation probe and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the comparison of safety and effectiveness was based on outcomes data from the clinical publications. Specifically, it assessed "intraoperative or post-operative complications," "adverse events observed," and specific post-ablation conditions like "cryoablation associated numbness," "neuropathic pain," "chest wall numbness," and "post-operative pneumothorax." The comparison was against the known safety and effectiveness in adult patients.
8. The sample size for the training set
This document describes a premarket notification (510(k)) for a medical device and relies on existing clinical evidence. There is no "training set" in the context of machine learning for this type of device submission. The clinical evidence used for assessment is analogous to a validation set.
9. How the ground truth for the training set was established
As there is no "training set" in the context of machine learning for this device, this question is not applicable. The clinical evidence used for evaluation was derived from existing clinical publications, where the "ground truth" (e.g., presence of complications, pain levels) would have been established within those individual studies.
§ 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).