(252 days)
The CTS FloCoil Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.
The CTS FloCoil Shunt consists of coil reinforced polymer shaft with a polymer seal on each end and tapered polymer tips. The polymer seals on each end contact the vessel wall and cause occlusion of the artery proximal and distal to the arteriotomy . The FloCoil Shunt is selected according to the outer diameter of the polymer seals and is available in various sizes for various vessel diameters. There is a hole in both tapered tip ends of the FloCoil Shunt to allow for the perfusion of blood through the shunt's inner lumen and beyond the arteriotomy. A polyester thread (tether) is attached to the FloCoil Shunt in the middle of the shaft. Attached to the tether is a radiopaque tab which is used to aid insertion and removal of the FloCoil Shunt.
The provided 510(k) summary for the CTS FloCoil™ Shunt (K970638) is for a medical device that helps reduce blood in the operative field during surgery and provides temporary blood flow. This submission is from 1997, and the information provided is characteristic of 510(k) summaries from that era, which often contained less detailed study information compared to current FDA submission requirements.
Based on the provided text, the specific details regarding the robustness of the studies (such as sample sizes, expert qualifications, and detailed statistical methodologies for acceptance criteria) are very limited. The submission focuses on functional performance testing, biocompatibility, and substantial equivalence to predicate devices rather than a rigorous performance study against quantitative acceptance criteria with specific metrics like sensitivity and specificity.
Here's an attempt to extract and describe the information based on your request, along with highlighting what is not present in the document.
Acceptance Criteria and Reported Device Performance
The document does not present a formal table of specific quantitative acceptance criteria with a corresponding "reported device performance" in terms of metrics like sensitivity, specificity, accuracy, or AUC that would be typical for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the successful completion of functional performance testing and biocompatibility evaluation, and the "reported device performance" is a general statement of success.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: The Shunt would function according to its intended use instructions (i.e., help reduce blood in the operative field by temporary occlusion of the artery and provide blood flow distal to the arteriotomy). | "All testing conducted confirmed the acceptability of the CTS FloCoil Shunt to perform as intended to help reduce blood in the operative field by temporary occlusion of the artery while providing blood flow distal to the arteriotomy." |
| Biocompatibility: The device and its materials are safe for use in the human body as directed. | "The CTS FloCoil Shunt and Shunt materials passed the necessary biocompatibility tests." |
| Substantial Equivalence: The device is as safe and effective as existing predicate devices. | "The CTS FloCoil Shunt is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method." and "All necessary testing was performed on the CTS FloCoil Shunt to ensure the product is substantially equivalent to the predicate devices and to ensure that the CTS FloCoil Shunt does not have any differences which have a significant effect on safety and effectiveness." |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the "test set" in terms of human subjects or distinct cases. The "Functional Performance Testing" and "Biocompatibility Evaluation" refer to testing conducted on the device itself and its materials, not on a human population in a clinical trial.
- Data provenance (country of origin, retrospective/prospective) is not applicable or specified, as no clinical study in human subjects is described. The testing appears to be lab-based or bench-top.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this device would be its physical and chemical properties and functional performance under laboratory conditions, as observed by engineers or technicians, not an expert medical consensus from a test set of medical outcomes.
-
Adjudication method for the test set:
- Not applicable, as no expert review or clinical case adjudication is described.
-
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 MRMC study was conducted or is applicable. This device is a physical surgical shunt, not an AI or imaging diagnostic tool that would involve human readers interpreting results.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional performance, the ground truth would be established through engineering specifications and bench testing parameters. For biocompatibility, it would be standardized laboratory tests to assess material interaction with biological systems (e.g., cytotoxicity, irritation, sensitization).
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. The concept of a "training set" doesn't apply.
-
How the ground truth for the training set was established:
- Not applicable.
Conclusion for this specific device (K970638):
The 510(k) summary for the CTS FloCoil™ Shunt (K970638) describes a physical medical device. The "acceptance criteria" and "study" are focused on demonstrating functional capability, material biocompatibility, and substantial equivalence to legally marketed predicate devices through bench testing and material characterization, rather than clinical performance metrics or AI algorithm validation. The questions regarding AI, expert consensus, and specific clinical study designs are not applicable to the information provided in this 1997 submission for this type of device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).