(189 days)
The EndoWrist Long Tip 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 420048 Long Tip 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.
The provided FDA 510(k) clearance letter for the Remanufactured EndoWrist Long Tip Forceps (K250387) primarily focuses on establishing substantial equivalence to a predicate device. This type of submission often relies more on non-clinical performance data and a comparison to an existing device rather than a comprehensive de novo clinical study with pre-defined acceptance criteria for an AI/CADe device.
Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/CADe devices (items 1-9) does not directly apply to this remanufactured medical instrument. The "study" described in this document is a non-clinical performance evaluation aiming to demonstrate that the remanufactured device performs equivalently to the original and does not introduce new safety or efficacy concerns.
However, I can interpret the available information to best fit the prompt's structure, focusing on the concepts of "acceptance" and "proof" as presented in this 510(k).
Here's an analysis based on the provided text, rephrasing where necessary to align with the spirit of the prompt's questions, while acknowledging the inherent differences for a remanufactured mechanical device vs. a typical AI/CADe submission:
Understanding "Acceptance Criteria" for a Remanufactured Medical Device
For a remanufactured device like the EndoWrist Long Tip Forceps, "acceptance criteria" are not typically expressed as sensitivity/specificity thresholds for diagnostic accuracy (as would be the case for AI). Instead, they are related to functional equivalence, safety, and durability compared to the original device. The "study" proving acceptance is a set of non-clinical tests and assessments demonstrating that the remanufactured device meets these criteria and poses no new risks.
The "Study" Proving Acceptance
The submission describes a comprehensive non-clinical performance evaluation rather than a human-in-the-loop clinical trial or a standalone algorithm performance study. The core of the "proof" revolves around showing that the remanufactured device maintains the same performance, safety, and durability characteristics as the original, legally marketed predicate device.
Detailed Information Based on the Provided Document:
1. Table of "Acceptance Criteria" (Interpreted) and Reported Device Performance:
| Acceptance Criteria (Interpreted for Remanufactured Device) | Reported Device Performance (Summary from Text) |
|---|---|
| Functional Equivalence: Mechanism of action and principles of operation are identical to the predicate 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 Long Tip 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." |
| Durability / Life Extension: Ability to withstand additional controlled uses without performance degradation. | "Life testing to verify device performance and durability through additional uses" was performed. The "use counter has been reset to permit an additional controlled set of uses." (Implies successful completion of this testing). |
| Electrical Safety: Compliance with relevant electrical safety standards. | "Electrical safety evaluation (per IEC 60601-1)" was performed. (Implies compliance). |
| Biocompatibility: No adverse biological reactions. | "Biocompatibility testing (per ISO 10993-1)" was performed. (Implies compliance). |
| Reprocessing Validation: Ability to be reprocessed effectively per OEM instructions. | "Reprocessing validation (per OEM instructions)" was performed. (Implies successful validation). |
| Cybersecurity: Assessment of cybersecurity risks (if applicable to device control system). | "Cybersecurity assessment (per FDA Guidance on Cybersecurity in Medical Devices)" was performed. (Implies identified risks were addressed, though the forceps alone are unlikely to have complex cybersecurity needs, it's tied to the control system). |
| No New Safety/Efficacy Questions: Demonstration that remanufacturing does not introduce new concerns. | "Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured Long Tip Forceps 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:
- Sample Size: Not explicitly stated as a number of devices (e.g., N=X remanufactured forceps were tested). Instead, the submission describes types of tests (life testing, electrical safety, biocompatibility, reprocessing validation, cybersecurity assessment) applied to the remanufactured device. It's implied that sufficient samples were tested to gain confidence in the established equivalence.
- Data Provenance: The data are non-clinical engineering and laboratory test results generated by the manufacturer (Rebotix) and/or their testing partners. The country of origin of the data is not specified, but the applicant and correspondent are US-based. This is neither retrospective nor prospective in the clinical sense, but rather lab-based validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable in the traditional sense for a remanufactured mechanical instrument. "Ground truth" for an AI/CADe system is typically expert-labeled data.
- For this device, the "ground truth" for performance and safety is defined by the specifications and performance of the original, new predicate device. The "experts" involved would be the engineers, quality control personnel, and regulatory specialists who designed and executed the non-clinical tests and analyzed the results against established engineering standards and the predicate's performance. Their qualifications would be in engineering, materials science, electrical safety, biocompatibility, and quality assurance. Their exact number and specific qualifications are not detailed in this clearance letter.
4. Adjudication Method for the Test Set:
- Not applicable in the context of human reader consensus for AI performance.
- For mechanical testing, validation would involve comparison against predefined engineering specifications and performance benchmarks of the original device and relevant standards (e.g., IEC, ISO). Any deviations would likely be evaluated by a multidisciplinary team (engineering, quality, regulatory) within the manufacturer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was NOT done. This type of study is specifically designed to assess the impact of AI assistance on human reader performance, which is not relevant for a remanufactured surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was NOT done. This device is a mechanical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" is established through objective, measurable engineering parameters and performance characteristics of the predicate (original) device, as well as relevant international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety). It also includes adherence to the "Professional Instructions for Use" for the system it integrates with.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device. The remanufacturing process is a defined mechanical and chemical procedure, not an iterative learning process.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.