(332 days)
The Cardica® C-Port® xA Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
The Cardica® C-Port® Anastomosis System is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in the conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device and the device positioned against the target vessel, the anastomosis is created by pushing the actuation button.
This submission concerns a medical device, the Cardica® C-Port® xA Anastomosis System, and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable.
The submission is a 510(k) Pre-market Notification for a device intended for surgical anastomosis. The primary method of demonstrating acceptance criteria is by claiming substantial equivalence to a previously cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Indications for Use: Must be substantially equivalent to the predicate device. | The Cardica® C-Port® xA Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. This is stated to be substantially equivalent to the predicate device (K040832). |
| Device Characteristics: Must be substantially equivalent in design, materials, and function to the predicate device. | The device is described as a sterile, single-use device for end-to-side anastomosis between a conduit and a small vessel using stainless steel clips. It consists of accessories for conduit loading and a device to complete anastomosis. Claimed substantially equivalent in device characteristics, method of use, and materials to K040832. |
| Method of Use: Must be substantially equivalent to the predicate device. | The operation involves loading the conduit, positioning the device against the target vessel, and pushing an actuation button to create the anastomosis. Claimed substantially equivalent in method of use to K040832. |
| Labeling: Must be substantially equivalent to the predicate device. | Claimed substantially equivalent in labeling to K040832. |
| Safety and Effectiveness: Demonstrated through non-clinical testing to ensure equivalence. | "All necessary in vitro and in vivo testing has been performed on the C-Port® xA Anastomosis System and packaging to ensure substantial equivalence to the predicate device and to ensure the safety and effectiveness of the device." Further details of specific test results are not provided in this summary. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a substantial equivalence determination based on a comparison to the predicate device (Cardica® C-Port® Anastomosis System, K040832). This is a non-clinical study typically involving engineering analysis, bench testing (in vitro), and potentially animal studies (in vivo) to demonstrate that the new device performs as intended and is as safe and effective as the predicate device.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in this summary. For a non-clinical 510(k) submission based on substantial equivalence, the "test set" would refer to the samples and conditions used in the in vitro and in vivo studies. The summary only broadly states "All necessary in vitro and in vivo testing has been performed."
- Data provenance: Not explicitly stated. Such testing is typically conducted internally by the manufacturer or by contract research organizations (CROs) in a controlled environment. It is not patient or country-specific data as would be the case for clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to clinical data evaluation, which is not the primary basis of this 510(k) submission. The "ground truth" here is the performance and safety established for the predicate device, against which the new device is compared through non-clinical testing.
4. Adjudication method for the test set:
- Not applicable. This applies to clinical study endpoints and data interpretation by multiple readers/experts.
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:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for this substantial equivalence submission is the established safety and effectiveness profile of the predicate device (Cardica® C-Port® Anastomosis System, K040832). The new device's performance, as measured through in vitro and in vivo testing, is then compared to this established profile to demonstrate equivalent safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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.