(188 days)
The EndoWrist Cobra Grasper 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 subject device is a remanufactured 420190 Cobra Grasper 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 and 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.
The provided FDA 510(k) clearance letter (K250417) is for a remanufactured medical device, specifically a "Remanufactured EndoWrist Cobra Grasper (420190)". This context is crucial because the acceptance criteria and study design for remanufactured devices often focus on demonstrating that the remanufactured device performs identically to the original equipment manufacturer (OEM) device and that the remanufacturing process does not introduce new safety or efficacy concerns.
The document does not describe a traditional AI/ML model's acceptance criteria or a comparative effectiveness study in the typical sense (e.g., human reader improvement with AI). Instead, the "acceptance criteria" here refer to demonstrating substantial equivalence for the remanufactured device to its predicate. The "study" mentioned is the set of tests performed to verify this equivalence.
Based on the provided text, here's a breakdown:
1. Acceptance Criteria and Reported Device Performance
For a remanufactured device, the acceptance criteria are generally met by demonstrating that the device's characteristics and performance are maintained or restored to be substantially equivalent to the original, legally marketed predicate device. The "reported device performance" is framed as the successful verification that no adverse changes were introduced by remanufacturing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Form, Fit, and Function Equivalence | Demonstrate identical design, material, chemical composition, principles of operation, energy source, and host system compatibility as the predicate OEM device. | "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." "The remanufactured Cobra Graspers 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." |
| Intended Use & Indications for Use | Maintain the exact same indications for use as the predicate OEM device. | "There are no changes to the claims, intended use, clinical applications, patient population, or method of operation." "The indications for use of the remanufactured Cobra Grasper is the same as the predicate OEM device." |
| Durability / Life Extension | Verify that the device can withstand additional controlled uses after remanufacturing. | "The use counter has been reset to permit an additional controlled set of uses." "Life testing to verify device performance and durability through additional uses" was performed. |
| Electrical Safety | Compliance with relevant electrical safety standards. | "Electrical safety evaluation (per IEC 60601-1)" was performed. |
| Biocompatibility | Demonstrate that remanufactured materials remain biocompatible. | "Biocompatibility testing (per ISO 10993-1)" was performed. |
| Reprocessing Validation | Validate that the device can be reprocessed according to OEM instructions. | "Reprocessing validation (per OEM instructions)" was performed. |
| Cybersecurity (if applicable) | Address potential cybersecurity risks introduced or affected by remanufacturing. | "Cybersecurity assessment (per FDA Guidance on Cybersecurity in Medical Devices)" was performed. |
| Safety and Efficacy Equivalence | Demonstrate that no different questions of safety or efficacy are raised compared to the predicate. | "Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured Cobra Grasper is demonstrated to be substantially equivalent to the predicate devices, with no different questions of safety or efficacy having been raised." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a quantitative "sample size" for the test set in terms of number of devices or tests. Instead, it describes types of tests performed.
- Test Set Description: The "test set" here refers to the actual remanufactured devices that were subjected to various verification and validation tests (life testing, electrical safety, biocompatibility, reprocessing validation, cybersecurity assessment).
- Data Provenance: The data provenance is from tests conducted on the remanufactured devices themselves. The document states a "remanufactured EndoWrist ProGrasp Forceps (model: 420093, K241872) was used as a reference for the testing methods," implying internal testing methods or protocols were applied. There's no indication of clinical study (retrospective/prospective) data or country of origin for such data, as this is a remanufactured physical device, not an AI/software.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept (experts establishing ground truth for a test set) is typically relevant for interpretative tasks, such as in diagnostic AI where radiologists label images.
For a remanufactured physical medical device, "ground truth" is established by adherence to engineering specifications, performance standards, material analysis, and functional testing. Thus, there is no mention of "experts" in the sense of clinical readers establishing ground truth. The "experts" would be the engineers, material scientists, and quality assurance personnel conducting the tests and verifying compliance. Their qualifications are assumed to be appropriate for performing these engineering and scientific tests.
4. Adjudication Method for the Test Set
As this is not a diagnostic interpretation task, "adjudication method" in the sense of clinician consensus (e.g., 2+1, 3+1) is not applicable. The "adjudication" for a remanufactured device involves engineering verification and validation, quality control inspections, and adherence to specified test protocols and acceptance criteria outlined in the Quality System (21 CFR Part 820).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not describe an MRMC study.
- Effect Size of Human Readers Improvement with AI: Not applicable, as this is a physical medical device and not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- Was a standalone study done? Not applicable in the context of an AI algorithm. The closest equivalent is the performance of the remanufactured device itself during various bench and functional tests, which are conducted "standalone" from a human operator in terms of assessing the device's inherent physical properties and functionalities.
7. Type of Ground Truth Used
The "ground truth" for this remanufactured device is engineering specifications, performance standards, and material properties of the original OEM device. The goal of the study is to confirm that the remanufactured device meets these pre-defined engineering and safety standards, proving it is substantially equivalent to the original. This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on physical and functional testing.
8. Sample Size for the Training Set
- Sample size: Not applicable. This is a remanufactured physical device, not an AI/ML model that requires a "training set." The remanufacturing process is based on reverse engineering, repair, and refurbishment adhering to the original design specifications, not on learning from a data set.
9. How the Ground Truth for the Training Set Was Established
- How established: Not applicable. As there is no training set for an AI/ML model, this question does not apply. The "ground truth" for the remanufacturing process itself is implicitly the design and performance specifications of the original OEM device, which are derived from engineering principles and validated through the original device's clearance.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.