(54 days)
The Intuitive Surgical 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/pickups, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular 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. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
This SPECIAL 510(k) is being submitted for a design modification to the Intuitive Surgical EndoWrist Instruments to incorporate the functionality (vacuum stabilization, irrigation) of the Medtronic Octopus TE Tissue Stabilizer (class I, cardiovascular surgical instrument, Product Codes DWS and MWS, under CFR Section 870.4500) on an EndoWrist Instrument known as the EndoWrist Stabilizer. This modification affects the instrument only, and there are no changes to the da Vinci Surgical System associated with this pre-market notification.
The Intuitive Surgical EndoWrist Stabilizer is a multiple use instrument similar to existing EndoWrist instruments and has the following key features:
- The EndoWrist Stabilizer incorporates collapsible "pods" as grips that provide suction based tissue stabilization. The collapsible feature allows the instrument to be used through a 12mm thoracic port.
- A disposable, pre-packaged sterilized tubing assembly known as "ClearField" tubing is used to connect the instrument to pressurized irrigation fluid to irrigate the surgical site reducing the amount of blood on the stabilized tissue.
- A disposable, pre-packaged sterilized tubing assembly known as "CardioVac" tubing provides vacuum suction to the stabilizer pods from the Vacuum Source tubing described below.
- A disposable, pre-packaged sterilized tubing assembly known as "Vacuum Source" tubing that connects the CardioVac tubing to a canister with a four-meter vacuum hose, and also includes a two-meter vacuum hose (with filter) to connect to a regulated vacuum source.
The Intuitive Surgical Endowrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vincis S™ Surgical System. The surgeon sits at a Surgeon Console and controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon "locks" the stabilizer in position by switching MTM control away from the arm holding the tabilizer instrument by tapping a foot pedal on the Surgeon Console.
The provided text describes a 510(k) Special submission for a design modification to the Intuitive Surgical EndoWrist Instruments, incorporating vacuum stabilization and irrigation functionality. This is a medical device submission, and as such, the concept of "acceptance criteria" is typically met through demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit numerical performance targets like those found in AI/ML performance studies.
Therefore, the "acceptance criteria" here refer to proving that the modified device is as safe and effective as the predicate devices, and that the design output meets the design input requirements without raising new safety or effectiveness concerns.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Safety and effectiveness are comparable to legally marketed predicate devices.
- No new issues of safety or effectiveness are introduced. | - "Design Analysis and comparison, as well as bench testing, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited..."
- "...results of the design control process confirm that the design input meets the design output requirements, and that there are no new issues of safety or effectiveness." |
| Functional Equivalence (Vacuum Stabilization and Irrigation): - The incorporated vacuum stabilization and irrigation features perform comparably to the predicate Class I tissue stabilizer. | - "The vacuum stabilization and irrigation features are identical to the Medtronic Octopus TE Tissue Stabilizer and accessories cleared by FDA under K041338."
- "...the stabilizer end effector and irrigation is the same as the Octopus TE Stabilizer (Medtronic)." |
| Compatibility with da Vinci Surgical System: - No changes in design, technology, materials, manufacturing, performance, specifications, or method of use for the da Vinci Surgical System. | - "This modification affects the instrument only, and there are no changes to the da Vinci Surgical System associated with this pre-market notification."
- "The Intuitive Surgical Endowrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vincis S™ Surgical System." |
| Controlled Delivery and Use: - Instrument operation is consistent with other EndoWrist Instruments, allowing the surgeon to "lock" the stabilizer in position. | - "The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon 'locks' the stabilizer in position by switching MTM control away from the arm holding the tabilizer instrument by tapping a foot pedal on the Surgeon Console." |
| Material and Technological Characteristics: - Materials and technological characteristics are consistent with predicate devices for the robotic operation and architecture. | - "The technological characteristics of the subject device are the same as for the predicate device(s). The robotic operation and architecture are the same as existing Intuitive Surgical EndoWrist Instruments..." |
Study Details
The provided document describes a 510(k) Special submission, which generally focuses on demonstrating substantial equivalence for a modification to a previously cleared device. It is not a clinical trial or performance study akin to those for AI/ML devices with specific numerical performance metrics.
-
Sample size used for the test set and the data provenance:
- The document mentions "bench testing" but does not specify a sample size for any test set (e.g., number of instruments tested or specific conditions).
- Data provenance is not explicitly stated but would typically be internal testing conducted by the manufacturer, Intuitive Surgical, Inc. This is not a clinical study with patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of submission. "Ground truth" established by experts is relevant for diagnostic or AI/ML-driven devices where accuracy against a known standard is measured. Here, the focus is on functional verification against design requirements and comparison to predicate devices. The "ground truth" is primarily engineering specifications and functional performance.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not the nature of this submission. The "adjudication" is essentially the manufacturer's internal quality and design review process, and ultimately the FDA's regulatory review.
-
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of an AI assistance tool on human performance (e.g., radiologists reading images with and without AI). The Intuitive Surgical EndoWrist Stabilizer is a surgical instrument, not an AI diagnostic or assistance tool.
-
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No, this is a physical surgical instrument modification, not an algorithm. Therefore, a standalone algorithm-only performance study is not relevant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this regulatory submission is primarily based on engineering specifications, functional requirements, and direct comparison to the physical and functional characteristics of legally marketed predicate devices. This includes:
- Demonstrating that the vacuum stabilization and irrigation capabilities are "identical" to the Medtronic Octopus TE Tissue Stabilizer.
- Ensuring the instrument's mechanical and operational characteristics are "the same as" existing Intuitive Surgical EndoWrist Instruments.
- Confirmation through "Design Analysis and comparison, as well as bench testing" that functional characteristics are met.
- The "ground truth" for this regulatory submission is primarily based on engineering specifications, functional requirements, and direct comparison to the physical and functional characteristics of legally marketed predicate devices. This includes:
-
The sample size for the training set:
- This concept is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This submission is for a physical surgical instrument.
-
How the ground truth for the training set was established:
- This concept is not applicable. There is no training set for a physical surgical instrument.
§ 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.