(85 days)
The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use du ring coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.
The design of the Octopus"" is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The "feet" design of the Octopus" is intended to position the anastomosis site between two "feet" for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.
This document is a 510(k) summary for a medical device (Octopus™ Tissue Stabilizer) and does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or AI/ML study would. It's a regulatory document demonstrating substantial equivalence to a predicate device.
Therefore, most of the requested information cannot be extracted from this text.
Here's how I can address the parts that are relevant to this type of document:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or report performance metrics in the way a clinical study would (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.
The "acceptance criteria" in this context are implicitly related to the regulatory requirements for showing that the new device is as safe and effective as the predicate device.
Reported Device Performance (Implicit from the document):
| Feature/Criterion | Reported Device Performance (Octopus™ Tissue Stabilizer) |
|---|---|
| Indications for Use | Same as CTS Thoracic Access Platform and Stabilizer. Intended for use during coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure. |
| Design | Similar to predicate products (DLP Cardiac Suction Tube and CTS Thoracic Access Platform and Stabilizer). Features plastic handle, vacuum tubing connection, malleable stainless steel arm, suction tip, and "feet" design to position anastomosis site between two "feet" for isolation and stabilization control. |
| Biocompatibility | Contact surface (plastic material) has been biocompatibility tested and deemed acceptable. |
| Safety and Efficacy | No differences in safety and efficacy compared to predicate products. |
The rest of the requested information (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, training set ground truth) is not applicable to this 510(k) summary document, as it describes a mechanical device for surgical use and not an AI/ML algorithm or a study involving human readers and a test set. This document relies on comparisons to predicate devices and biocompatibility testing, not on clinical performance metrics in the sense of accuracy, sensitivity, etc., that would require a ground truth or expert evaluation.
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.