(85 days)
The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vinci Surgical System to transect soft tissues during endoscopic surgical procedures.
The Intuitive Surgical® Bipolar Forceps is an endoscopic instrument with a grasping end effector to be used in conjunction with the Intuitive Surgical® Endoscopic Instrument Control System and a standard external electrosurgical generator unit (ESU). It is a resposable instrument connected to the ESU via a bipolar electrosurgical cable. The ESU, which is activated by a foot pedal on the generator itself, controls the coagulation current. The surgeon controls the grasping end effector (or grips) of the device. A coagulation current passes from the ESU between the two closely spaced grip electrodes then back to the generator, allowing for precise tissue coagulation. The device is similar in size and function to other Intuitive Surgical® Endowrist™ Endoscopic Instruments.
This document is a 510(k) premarket notification for the Intuitive Surgical Endowrist™ Bipolar Forceps. However, it does not contain the detailed information required to fill out a table of acceptance criteria, reported device performance, or details about specific studies like sample sizes, expert qualifications, or ground truth establishment.
Here's why and what information can be extracted:
Missing Information:
The document primarily focuses on establishing substantial equivalence to a predicate device (Dexide Bipolar Forceps II, K991859 and da Vinci Surgical System, K990144). It states that the device is "essentially identical in terms of size, function, and materials."
Crucially, this type of 510(k) submission (especially for a device like this from 2001) often relies on design analysis and comparison and in vitro testing to demonstrate substantial equivalence, rather than extensive clinical studies with specified acceptance criteria and measured performance in humans.
Specifically, the document does not provide:
- A table of explicit acceptance criteria (e.g., specific force measurements, coagulation times, tissue effects, or clinical outcomes).
- Reported device performance against such criteria.
- Details about sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Information about MRMC comparative effectiveness studies or standalone algorithm performance, as this is a surgical instrument, not an AI/software device.
- Explicit descriptions of the ground truth used for any testing (beyond general statements about "functional characteristics").
- Sample size for training sets, or how ground truth for training was established, as this is not an AI/ML device.
Information that can be extracted or inferred:
| Category | Information from Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly states that "in vitro testing confirm that basic functional characteristics and safety are substantially equivalent to the predicate device cited." |
| Reported Performance: Similarly, no specific performance metrics are reported. The conclusion is that the device is "substantially equivalent." | |
| 2. Sample size (test set) & Data Provenance | Not provided. The term "in vitro testing" is used, implying laboratory-based tests rather than human subject data. |
| 3. Number & Qualifications of Experts | Not provided. |
| 4. Adjudication method | Not applicable/Not provided. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. This is a surgical instrument, not an AI/software product requiring MRMC studies for reader improvement. |
| 6. Standalone Algorithm Performance | Not applicable. This is a surgical instrument, not an AI/software algorithm. |
| 7. Type of Ground Truth used | Implied: For the "in vitro testing", the ground truth would likely be established physical and electrical properties, and functional characteristics (e.g., cutting, coagulation efficiency) compared to the known performance of the predicate device. This would not involve expert consensus, pathology, or outcomes data in the sense of clinical trials. |
| 8. Sample size (training set) | Not applicable. This is a physical medical device, not a machine learning model. |
| 9. Ground truth for training set | Not applicable. This is a physical medical device. |
Summary of what the document suggests:
The Intuitive Surgical Endowrist™ Bipolar Forceps demonstrated its safety and effectiveness by showing "substantial equivalence" to existing, legally marketed predicate devices. This equivalence was established through:
- Design analysis and comparison: Primarily focusing on the device's size, function, and materials.
- In vitro testing: Laboratory tests to confirm basic functional characteristics and safety.
The 510(k) process in this context primarily aims to demonstrate that the new device is as safe and effective as a legally marketed predicate, rather than meeting specific quantifiable performance criteria through large-scale clinical trials, especially for a device of this nature and submission date.
§ 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.