(113 days)
da Vinci SP Surgical System, Model SP1098:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult 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.
da Vinci SP Instruments:
Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult 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.
The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.
The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.
The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.
This 510(k) is for a labeling modification only, to add "colorectal surgical procedures" to the indications, and to add "Low anterior resection / total mesorectal excision (LAR/TME), Colectomy (Right, Left, Transverse, Total, Hemi), Sigmoidectomy, and Abdominoperineal Resection (APR)" as new representative, specific procedures in the Professional Instructions for Use.
The provided text describes a 510(k) premarket notification for a labeling modification to the da Vinci SP Surgical System. The modification adds "colorectal surgical procedures" to the indications for use. The document details the performance testing and clinical study conducted to support this change.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
For the Cadaver and Animal Performance Testing, the acceptance criteria was the successful completion of the specified surgical procedures, as rated by the participating surgeons. The study concluded that "Comparative animal and cadaver testing was conducted to demonstrate the equivalence of the SP1098 System to the multiport da Vinci Xi system, Model IS4000 for performing colorectal surgical procedures." The document states that surgeons completed questionnaires evaluating their ability to perform surgical tasks, implying successful performance.
For the Clinical Study, the acceptance criteria was demonstrating that the use of the da Vinci SP Surgical System in colorectal surgical procedures "does not raise different questions of safety or effectiveness" when compared to existing literature on multiport robotic-assisted colorectal surgery. This was assessed by comparing 95% confidence intervals (CI) of various clinical parameters from the SP study to those from published literature.
Table 1: Acceptance Criteria for Cadaver and Animal Testing (Excerpts)
| Surgical Procedure | Procedure Completion Acceptance Criteria (Key highlights) |
|---|---|
| Low Anterior Resection / Total Mesorectal Excision | Sufficient colon mobilization to ensure tension-free anastomosis; Complete mesorectal dissection (e.g., intact mesorectal fascial envelope, circumferential resection, distal dissection to levator ani); Critical anatomy identified; Appropriate vessel ligation; Anastomosis complete and deemed surgically acceptable upon visual inspection; Acceptable leak test. |
| Right Hemicolectomy | Sufficient colon mobilization to ensure tension-free anastomosis; Critical anatomy identified; Appropriate vessel ligation; Anastomosis complete and deemed surgically acceptable upon visual inspection; Acceptable leak test. |
| Low Anterior Resection / Total Mesorectal Excision (Porcine) | Sufficient colon mobilization to ensure tension-free anastomosis; Anastomosis complete and deemed surgically acceptable upon visual inspection; Acceptable leak test; Hemostasis maintained. |
Reported Device Performance (Clinical Study against Literature):
The conclusion for both LAR/TME and Right Colectomy studies states: "Comparison of the results from the da Vinci SP Surgical System to the published literature demonstrate that the 95% confidence intervals (CI) for all 12 clinical parameters in the SP study overlap the 95% CIs calculated from the published clinical literature on da Vinci Multiport systems for both LAR/TME and right colectomy. This comparison demonstrates that the da Vinci SP Surgical System is as safe and effective as the predicate device and does not raise different questions of safety or effectiveness."
Table 2: Clinical Study Performance (LAR/TME)
| Clinical Study Parameter | K242318 (SP1098) Performance (Mean ± SE or Proportion) | da Vinci Multi-port Literature (Mean ± SE or Proportion) | Overlapping 95% CI (Yes/No) |
|---|---|---|---|
| Operative time | 273.6 ± 14.84 min | 282.3 ± 12.38 min | Yes |
| Length of stay | 4.6 ± 0.69 days | 7.7 ± 0.79 days | Yes |
| Estimated blood loss | 75.2 ± 16.12 mL | 63.0 ± 14.66 mL | Yes |
| Intra-operative adverse event | 0% | 5.8% | Yes |
| Major adverse event complication rate | 10.3% | 8.1% | Yes |
| Anastomotic complication rate | 10.3% | 6.4% | Yes |
| Transfusion rate | 0% | 2.3% | Yes |
| Conversion rate | 0% | 6.2% | Yes |
| Mortality rate | 0% | 0.6% | Yes |
| Readmission rate | 14.3% | 7.1% | Yes |
| Reoperation rate | 0% | 5.5% | Yes |
| Positive surgical margin | 0% | Not reported in this table | N/A |
Table 3: Clinical Study Performance (Right Colectomy)
| Clinical Parameter | K242318 (SP1098) Performance (Mean ± SE or Proportion) | da Vinci Multi-port Literature (Mean ± SE or Proportion) | Overlapping 95% CI (Yes/No) |
|---|---|---|---|
| Operative time | 208.2 ± 11.43 min | 285.5 ± 26.92 min | Yes |
| Length of stay (days) | 3.5 ± 0.38 days | 5.1 ± 0.28 days | Yes |
| Estimated blood loss | 37.0 ± 8.40 mL | 98.7 ± 19.65 mL | Yes |
| Intra-operative adverse event rate | 3.6% | 2.8% | Yes |
| Major adverse event rate | 0% | 6.7% | Yes |
| Anastomotic complication rate | 0% | 4.2% | Yes |
| Transfusion rate | 0% | 7.3% | Yes |
| Conversion rate | 0% | 6.0% | Yes |
| Mortality rate | 0% | 0.6% | Yes |
| Readmission rate | 0% | 6.8% | Yes |
| Reoperation rate | 0% | 5.8% | Yes |
| Positive surgical margin | 0% | Not reported in this table | N/A |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Cadaver and Animal Performance Testing:
- Sample Size: Not explicitly stated as a number of distinct "test cases" in the traditional sense, but involved "three (3) independent practicing surgeons," each of whom performed "two (2) procedures in a cadaver model and one (1) procedure in a porcine model, for a total of 9 surgical procedures performed per system."
- Data Provenance: The location (country) of these studies is not specified in the document. The study was prospective in nature, as it involved actively conducting procedures for testing.
-
Clinical Study:
- Sample Size: 60 subjects (40 subjects in the United States and 20 subjects in South Korea).
- LAR/TME cohort: 29 subjects (19 U.S., 10 South Korea)
- Right Colectomy cohort: 28 subjects (18 U.S., 10 South Korea)
- Other colorectal procedures: 3 subjects (Sigmoid Colectomy (N=2), Transverse Colectomy (N=1))
- Data Provenance: Prospective, multicenter, single-arm clinical study. Data originated from the United States and South Korea.
- Sample Size: 60 subjects (40 subjects in the United States and 20 subjects in South Korea).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
-
Cadaver and Animal Performance Testing:
- Number of experts: Three (3) independent practicing surgeons.
- Qualifications of experts: Described as "independent practicing surgeons." Specific experience or years of practice are not detailed.
-
Clinical Study:
- The "ground truth" here is the clinical outcomes and parameters observed in the subjects undergoing the procedures. These were assessed by the participating clinical sites and reported. The ground truth for comparison was established via "systematic literature searches... conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods" of "recently published clinical literature between 2010 and March 2024 on multiport robotic systems." The clinicians performing the literature review would be the "experts" in this context, but their number and specific qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cadaver and Animal Performance Testing: Not explicitly stated. The document mentions surgeons "completed questionnaires that evaluated their ability to perform surgical tasks." It's implied that the surgeons themselves assessed the criteria, but a formal adjudication method for discrepancies (if any) is not described.
- Clinical Study: Not explicitly stated. Clinical outcomes data are collected and analyzed, but a specific independent adjudication committee or method for confirming every data point is not detailed in this summary. The comparison to literature would involve independent researchers analyzing published data.
5. 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a surgical system ("da Vinci SP Surgical System") and its instruments, not an AI or imaging diagnostic tool that relies on human readers interpreting results with or without AI assistance. The "comparison" was between the SP Surgical System's outcomes and those reported in literature for multiport robotic systems, not human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a surgical system that inherently requires a human surgeon "in-the-loop" for its operation. It is not an algorithm-only device. The clinical study and cadaver/animal testing evaluated the system's performance when operated by surgeons.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cadaver and Animal Performance Testing: Expert assessment of procedural completion and surgical outcomes by participating surgeons based on defined criteria (e.g., tension-free anastomosis, intact fascial envelope, acceptable leak test).
- Clinical Study: Clinical outcomes data (e.g., operative time, blood loss, length of stay, adverse event rates, conversion rates, mortality rates, readmission rates, reoperation rates, positive surgical margin rates) collected prospectively from patients undergoing actual surgical procedures. This data serves as the ground truth for evaluating safety and effectiveness against an existing standard of care (represented by multiport robotic surgery literature).
8. The sample size for the training set
This information is not provided in the given document. The document describes premarket notification for a labeling modification for an existing surgical system (da Vinci SP). It is unlikely that a "training set" in the context of machine learning (where this term is most commonly used) would be applicable to this submission, as the device is a physical surgical system, not an AI or algorithm that requires a training set for model development. The focus is on verification and validation of the physical system for an expanded indication.
9. How the ground truth for the training set was established
Since no training set for an AI/algorithm is mentioned or implied, this question is not applicable. The device is a surgical system.
§ 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.