(226 days)
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Cardiac Stabilization and Positioning Devices, presented in the requested format:
Acceptance Criteria and Study Information (K070036)
This submission describes the reprocessing of existing cardiac stabilization and positioning devices. As such, the "device" being evaluated is the reprocessed version of already marketed devices. The performance evaluation focuses on demonstrating that the reprocessed devices are equivalent in safety and effectiveness to the original, brand-new devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material & Design Equivalence | The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. | Demonstrated: "The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices." "The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Functional Equivalence | The mechanism of action, performance specifications, and method of operation of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. Each individual reprocessed device is tested for appropriate function of its components. | Demonstrated: "The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components prior to packaging and labeling operations." "Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended." |
| Biocompatibility | The reprocessed devices must be biocompatible, ensuring no unacceptable biological response due to reprocessing. | Demonstrated: "Biocompatibility Validation of reprocessing" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Reprocessing Sterility | The reprocessing must render the devices sterile to an acceptable level (e.g., Sterility Assurance Level - SAL). | Demonstrated: "Sterilization Validation" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Packaging Integrity | The packaging for the reprocessed devices must maintain sterility and product integrity. | Demonstrated: "Packaging Validation" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Cleanliness / Decontamination | Reprocessing steps must include removal of adherent visible soil and decontamination. | Demonstrated: "Ascent Healthcare Solutions's reprocessing of Cardiac Stabilization and Positioning Devices includes removal of adherent visible soil and decontamination." |
| Overall Safety & Effectiveness | The reprocessed devices are safe, effective, and substantially equivalent to the predicate devices. | Demonstrated: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Cardiac Stabilization and Positioning Devices." "Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Cardiac Stabilization and Positioning Devices) are safe, effective, and substantially equivalent to the predicate devices as described herein." This conclusion implies that all individual criteria were met. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (Biocompatibility, Sterilization Validation, Function Test(s), Packaging Validation). The data provenance is described as "Bench and laboratory testing," implying internal testing conducted by Ascent Healthcare Solutions. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as this submission pertains to reprocessing, not a new clinical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for reprocessed medical devices, and the "ground truth" is primarily based on meeting engineering and performance specifications of the original device, rather than expert interpretation of medical images or conditions. The testing would be conducted by qualified laboratory personnel and engineers, but the document does not specify their number or qualifications.
4. Adjudication method for the test set
Not applicable. The "tests" described are bench and laboratory tests (biocompatibility, sterility, function, packaging). These tests typically involve objective measurements against predefined specifications, rather than a subjective adjudication process by multiple 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 submission is for reprocessed cardiac surgical instruments, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for reprocessed cardiac surgical instruments, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed device's performance is essentially the established performance and safety profile of the original, predicate device. The studies (bench and lab tests) aim to demonstrate that the reprocessed device performs identically to this established baseline. Specific types of ground truth used include:
- Engineering Specifications: For function tests, comparing reprocessed device performance against original design specifications.
- Validated Protocols: For biocompatibility and sterilization, adherence to recognized standards and validated protocols.
- Material Properties: Ensuring reprocessed materials maintain their original properties.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.