(440 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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, 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. 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.
This 510(k) is for a labeling modification only, to include "tracheobronchoplasty for symptomatic, severe tracheobronchomalacia" as an additional representative, specific procedure under the previously cleared "General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Procedures" Indications for Use for the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294).
There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
This FDA 510(k) clearance letter pertains to a labeling modification for the da Vinci Xi and X Surgical Systems, adding "tracheobronchoplasty for symptomatic, severe tracheobronchomalacia" as a specific procedure under the existing General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Indications for Use. Since this is a labeling modification and not a change to the technological characteristics of the device, the traditional acceptance criteria and study data typical for a new device clearance are not provided in the same way. The primary evidence presented is Real World Evidence (RWE) demonstrating substantial equivalence for this new indication.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of pre-defined numerical thresholds for a new device's performance. Instead, the study aims to demonstrate substantial equivalence for the robotic new indication (Robotic-assisted Tracheobronchoplasty, R-TBP) compared to the currently accepted method (Open Tracheobronchoplasty, O-TBP) based on a comparison of safety and effectiveness outcomes. The "reported device performance" are the R-TBP outcomes from the Premier Health Database (PHD) compared against O-TBP outcomes from a systematic literature review (SLR).
Table of Performance Outcomes (Implicit Acceptance Criteria and Reported Performance)
The implicit acceptance criteria are that the robotic-assisted procedure's outcomes should be comparable to or better than the open procedure's outcomes, without introducing new safety or effectiveness issues.
| Outcome Category | Specific Outcome | Robotic-assisted Tracheobronchoplasty (R-TBP) from PHD (N=124) | Open Tracheobronchoplasty (O-TBP) from SLR (N= varies) | Implicit Substantial Equivalence Evaluation (Based on data presented) |
|---|---|---|---|---|
| Effectiveness | Surgical Time (minutes) | 329.1 (61.7) | 388.2 (60.2) | R-TBP appears to have slightly shorter surgical time. |
| Hospital Length of Stay (days) | 4.4 (3.9) | 8.1 (3.7) | R-TBP appears to have significantly shorter hospital LOS. | |
| ICU Length of Stay (days) | 1.8 (2.3) | 3.7 (1.2) | R-TBP appears to have significantly shorter ICU LOS. | |
| Conversion to Open Surgery | 1 (0.8%) | Not Applicable (This is the comparator) | Very low conversion rate for R-TBP. | |
| Discharge Disposition: Home or Self Care | 70.2% | 37.3% | R-TBP has a significantly higher rate of discharge to home/self care. | |
| Discharge Disposition: Home with Assistance | 28.2% | 31.1% | Comparable/slightly lower for R-TBP. | |
| Discharge Disposition: Rehabilitation Facility | 1.6% | 30.4% | Significantly lower for R-TBP. | |
| Safety | Respiratory Failure | 7.3% | 17.4% | R-TBP appears to have lower rate of respiratory failure. |
| Mechanical Ventilation with Intubation | 0.0% | 17.6% | R-TBP appears to have significantly lower rate. | |
| Prolonged Air Leak | 2.4% | 0.6% | R-TBP appears to have slightly higher rate (CI overlap). | |
| Pneumothorax with Chest Tube | 6.5% | 2.3% | R-TBP appears to have higher rate (CI overlap may be present). | |
| Pleural Effusion | 1.6% | 3.0% | R-TBP appears to have lower rate. | |
| Chest Tube After Surgery | 3.2% | Not Reported | - | |
| Hemothorax | 0.8% | Not Reported | - | |
| Intraoperative Bleeding** | 0.0% (as identified by codes) | 200 (111.1) mL (reported as mL) | Difficult to directly compare due to different metrics. Robotic data used codes, open data used mL blood loss. | |
| Postprocedural Bleeding | 0.8% | 1.1% | R-TBP appears comparable/slightly lower. | |
| Venous Thromboembolism | 0.0% | 2.7% | R-TBP appears to have lower rate. | |
| Surgical Site Infection | 0.0% | 3.4% | R-TBP appears to have lower rate. | |
| Bronchitis | 4.0% | 1.9% | R-TBP appears to have higher rate (CI overlap). | |
| Pneumonia | 1.6% | 14.0% | R-TBP appears to have significantly lower rate. | |
| Atrial Arrhythmia | 3.2% | 6.4% | R-TBP appears to have lower rate. | |
| Acute Renal Failure | 2.4% | 11.4% | R-TBP appears to have significantly lower rate. | |
| Injury to Adjacent Organs | 0.8% | Not Reported | - | |
| Mortality Rate | 0.0% | 0.7% | R-TBP appears comparable/slightly lower. | |
| 30-Day Readmission Rate | 8.9% | 11.8% | R-TBP appears to have lower rate. | |
| 30-Day Reoperation Rate | 1.6% | 2.5% | R-TBP appears to have lower rate. |
Conclusion from Data: The presented data suggests that robotic-assisted tracheobronchoplasty generally shows comparable or improved safety and effectiveness outcomes across most metrics when compared to open tracheobronchoplasty, supporting the claim of substantial equivalence.
Study Details
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Sample sizes used for the test set and the data provenance:
- Robotic-assisted Tracheobronchoplasty (R-TBP): 124 patients identified in the Premier Health Database (PHD) that underwent tracheobronchoplasty procedures.
- Open Tracheobronchoplasty (O-TBP): Approximately 278 patients, derived from a systematic literature review of 3 publications.
- Data Provenance (R-TBP): Retrospective, from the Premier Health Database (PHD) in the USA, covering data from 2013 to 2023, across 6 hospitals.
- Data Provenance (O-TBP): Retrospective, from published literature covering Massachusetts General Hospital (MGH) and Beth Israel Deaconess Medical Center (BIDMC) in the USA, from 2000 to 2023.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this RWE study. The "ground truth" (i.e., patient outcomes) is derived directly from medical records (PHD) and published study data (SLR). There wasn't an independent panel of experts establishing ground truth for individual cases.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not described, as the data collection relies on existing medical records and published literature. No explicit adjudication method for the test set is mentioned.
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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 is not an AI/software diagnostic device that involves human "readers." The device is a surgical system; the study compares surgical outcomes with and without the device's assistance in a specific procedure (R-TBP vs O-TBP). The comparison is between the robotic approach (device-assisted human surgeon) and the open approach (human surgeon without robotic assistance).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The da Vinci Surgical System is a tool used by a human surgeon ("human-in-the-loop"). The performance inherently involves the human surgeon's skill in operating the system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Outcomes data derived from retrospective medical records (for R-TBP) and published literature (for O-TBP). The outcomes reported include: operative time, length of stay, complication rates, mortality rates, readmission rates, reoperation rates, and discharge disposition.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm in the context of needing a "training set" for model development. The robotic surgical system itself is a mature technology; this submission is for a labeling expansion based on existing clinical use (RWE).
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm development.
Summary of Key Takeaways from the document relevant to the request:
- Device Type: Surgical Robotic System (da Vinci Xi/X)
- Submission Type: Labeling modification for an additional procedure (tracheobronchoplasty).
- Proof: Real-world evidence (RWE) from a database (Premier Health Database) for robotic procedures compared to a systematic literature review for open procedures.
- Primary Goal: Demonstrate substantial equivalence of the robotic-assisted procedure's outcomes to the established open procedure.
- Test Set (Robotic): 124 patients from US hospitals (retrospective, 2013-2023).
- Test Set (Open Comparator): ~278 patients from US hospitals (retrospective, 2000-2023) via literature review.
- Ground Truth: Patient outcomes data (safety and effectiveness metrics) extracted from clinical records/literature.
- No ML/AI Algorithm Validation: The study does not involve evaluating an AI model; thus, concepts like training sets, experts for ground truth, or MRMC studies for reader improvement with AI assistance are not applicable.
§ 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.