(188 days)
The EndoWrist Cadiere Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.
The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The subject device is a remanufactured 420049 Cadiere Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during an endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.
This FDA 510(k) clearance letter pertains to a remanufactured medical device, the Remanufactured EndoWrist Cadiere Forceps. Unlike typical AI/software device clearance documents, this document focuses on demonstrating substantial equivalence for a physical device that has undergone a process to extend its lifespan and enable additional uses. Therefore, it does not contain the typical information related to acceptance criteria, test set, ground truth establishment, or AI model training as one would find for an AI/ML-based device.
Based on the provided text, here's what can be extracted regarding the device's acceptance criteria and the study proving it meets them:
Core Reason for Clearance: The manufacturer is demonstrating that the remanufactured device performs equivalently to the original (predicate) device, especially given that its "use counter has been reset to permit an additional controlled set of uses." The acceptance criteria are implicitly tied to ensuring the remanufactured device maintains the safety and efficacy of the original.
1. Table of Acceptance Criteria and the Reported Device Performance
Since this is a remanufactured physical device and not an AI/ML diagnostic tool, the "acceptance criteria" are not reported in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, they relate to the continued functional and safety performance of the remanufactured forceps.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance and Durability (after life extension/remanufacturing) | Life testing was performed to "verify device performance and durability through additional uses." The clearance implies these tests were successful in demonstrating continued performance consistent with the predicate. |
| Electrical Safety | An electrical safety evaluation was performed "per IEC 60601-1." This implies the remanufactured device met the electrical safety standards. |
| Biocompatibility (after reprocessing) | Biocompatibility testing was performed "per ISO 10993-1." This indicates the materials of the remanufactured device remain safe for patient contact after reprocessing. |
| Reprocessing Effectiveness | Reprocessing validation was performed "per OEM instructions." This confirms the device can be effectively cleaned and sterilized for re-use. |
| Cybersecurity (Host System Compatibility) | A cybersecurity assessment was performed "per FDA Guidance on Cybersecurity in Medical Devices," confirming continued compatibility and safety within the da Vinci Surgical System. |
| Maintenance of Original Design, Material, and Principle of Operation | The document explicitly states: "The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions." and "The remanufactured Cadiere Forceps have the same technological characteristics including design, material, chemical composition, principle of operation, energy source, performance, and host system compatibility as the predicate OEM device." This is a core part of demonstrating substantial equivalence. |
| No new questions of safety or efficacy | The conclusion states: "...with no different questions of safety or efficacy having been raised." This is the ultimate acceptance criterion for substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for "life testing," "electrical safety evaluation," "biocompatibility testing," "reprocessing validation," or "cybersecurity assessment." These types of tests typically involve a defined number of units or cycles to statistically demonstrate compliance with performance specifications. However, the specific numbers are not disclosed in this summary.
- Data Provenance: The data comes from internal testing and assessments conducted by Rebotix (the manufacturer) or their designated testing facilities. There is no mention of external data sources, clinical study sites, or patient data (retrospective or prospective). The reference to K241872 (remanufactured EndoWrist ProGrasp Forceps) as a reference for testing methods suggests a consistent internal methodology.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable for this type of device and submission. "Ground truth" in the context of AI/ML devices typically refers to the definitive determination of a condition (e.g., disease presence, lesion type) established by expert consensus or other definitive methods for labeling data. For a remanufactured physical device, "ground truth" is not established in this manner. Instead, performance is validated against established engineering and safety standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic decisions, typically in AI/ML performance studies. This is not relevant for the engineering and safety tests conducted for a remanufactured physical device.
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
This information is not applicable. An MRMC study is specific to evaluating the clinical performance of AI-assisted diagnostic tools and measuring the impact of AI on human reader performance. This submission is for a remanufactured surgical instrument, not an AI diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human interaction. This is not an AI/software device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance validation is primarily based on:
- Established engineering specifications and performance benchmarks for the original (predicate) device.
- Compliance with international safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
- Validation against Original Equipment Manufacturer (OEM) instructions for reprocessing.
- Demonstrating that the remanufactured device behaves mechanically and functionally identically to the predicate.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train an AI/ML model. This is a remanufactured physical device, not an AI/ML model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
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