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 EndoWrist SP Instruments during urologic 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.

Endo Wrist SP Instruments:

Intuitive Surgical Endo Wrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, 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 surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign turnors 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.

Device Description

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 "simple prostatectomy" as a new representative, specific procedure in the Professional Instructions for Use. Simple prostatectomy is a "covered" procedure under radical prostatectomy as an "umbrella" procedure. This 510(k) also includes the addition of performance data (cadaver) for "transvesical prostatectomy" as validated approach for prostatectomy in the Performance Data section of the User Manual.

AI/ML Overview

The provided text is a 510(k) summary for the da Vinci SP Surgical System, Model SP1098. It primarily discusses a labeling modification to add "simple prostatectomy" as a representative procedure and the justification for this change. The document does not describe acceptance criteria for a device performance study in the typical sense of a new device validation with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence by comparing performance data from literature for different prostatectomy approaches.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Device Performance (as inferred from the provided text):

The "acceptance criteria" here are not explicitly stated numerical thresholds for performance. Instead, the inherent acceptance criterion is that the new procedure ("transvesical prostatectomy" for both simple and radical cases) performed with the da Vinci SP Surgical System demonstrates similar clinical outcomes to previously cleared prostatectomy approaches (extraperitoneal and transabdominal radical prostatectomy) performed with the same device. This demonstrates "substantial equivalence" and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	"Acceptance Criteria" (Implicit: Similar to cleared approaches)	Reported Device Performance for Transvesical Prostatectomy (TVP) using da Vinci SP System	Reported Performance for Extraperitoneal Radical Prostatectomy (EPRP) using da Vinci SP System (Predicate)	Reported Performance for Transabdominal Radical Prostatectomy (TARP) using da Vinci SP System (Predicate)
Operative Time (Avg)	Ranges should be similar.	Simple (TVSP): 153 - 232.43 minRadical (TVRP): 199 - 212 min	147 - 203.2 min	114 - 248.2 min
EBL (Avg)	Ranges should be similar.	Simple (TVSP): 100 - 227.13 mLRadical (TVRP): 100 - 1359 mL	50 - 197.2 mL	50 - 200 mL
Conversion Rate	Ranges should be similar and ideally low or 0%.	Simple (TVSP): 0%Radical (TVRP): 0%	0%	0%
Intraoperative Complication Rate	Ranges should be similar and ideally low.	Simple (TVSP): 0% - 2.4%Radical (TVRP): 0%	0% - 2.0%	0% - 2.7%
30-Day Postoperative Complication Rate	Ranges should be similar and ideally low.	Simple (TVSP): 0% - 12.5%Radical (TVRP): 5.0% - 12.8%	3.8% - 18.3%	0% - 15.2%
Major (C-D grade ≥ III) Complication Rate	Ranges should be similar and ideally low.	Simple (TVSP): 0% - 7.14%Radical (TVRP): 0% - 2.6%	0% - 11.7%	0% - 6.5%
Length of Stay	Ranges should be similar.	Simple (TVSP): <24 hrs - 2.5 daysRadical (TVRP): <24 hrs	<24 hrs - 2 days	<24 hrs - 7 days
30-Day Readmission Rate	Ranges should be similar and ideally low.	Simple (TVSP): 1.0%Radical (TVRP): 5.0% - 5.1%	2.0% - 8.6%	0% - 6.4%
Urinary Retention Rate	Ranges should be similar and ideally low.	Simple (TVSP): 0% - 4.4%Radical (TVRP): 5.1%	0.6% - 2.6%	1.3%
90-Day/3-Month Continence Rate	Ranges should be similar and ideally high.	Simple (TVSP): 90% - 100%Radical (TVRP): 96.6% - 97%	38.4% - 85%	62.5% - 78%
Urinary Catheterization Time (Avg)	Ranges should be similar.	Simple (TVSP): 1.9 - 10.5 daysRadical (TVRP): 3 - 49 days	7 days	5 days
Positive Surgical Margins	Ranges should be similar (for radical prostatectomy).	Simple (TVSP): NARadical (TVRP): 14.5% - 15.4%	17.3% - 29%	14% - 41.3%
Overall Mortality	Ranges should be similar and ideally low.	Simple (TVSP): 0% (at 30 days)Radical (TVRP): NR	NR	NR

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Description: The "test set" here is composed of peer-reviewed literature and a cadaver study.
- Literature Review: 11 primary publications for transvesical prostatectomy (8 for TVSP, 3 for TVRP) with a total of ~428 patients (247 for TVSP, 181 for TVRP).
- Comparison Literature: 10 publications for extraperitoneal radical prostatectomy (EPRP) with ~1,259 patients and 7 publications for transabdominal radical prostatectomy (TARP) with ~649 patients.
Data Provenance: Retrospective, collected from peer-reviewed scientific literature published between January 1, 2018, and January 7, 2023. The countries of origin are not specified, but peer-reviewed literature typically encompasses international data.
Cadaver Study: One male cadaver was used. This was a prospective study to confirm instrument access and motion.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Cadaver Study: The document states that "Design validation testing was performed... Evaluation of the ability to provide robotic and laparoscopic instrument access... was confirmed and an assessment of instrument motion... was performed." It doesn't explicitly state the number or qualifications of the experts performing this evaluation for the cadaver study, but it implies trained medical professionals (likely surgeons or surgical engineers) would conduct such validation.
Literature Review: The ground truth for the literature review is based on reported clinical outcomes from published studies. The "experts" in this context are the authors of the peer-reviewed articles, who are typically surgeons specializing in urology and robotic surgery. Their qualifications and number are variable across the 28 referenced publications.

4. Adjudication Method for the Test Set:

Literature Review: The method involved systematic searching of Scopus, Embase, and PubMed databases, followed by systematic literature screening. For comparative effectiveness, "all primary publications reporting relevant clinical outcomes for transvesical simple/radical prostatectomy performed using the da Vinci SP Surgical System were included." For the predicate approaches, publications with "50 or more patients in at least one study arm were included." This suggests a criteria-based inclusion/exclusion process for publications, but a formal "adjudication method" beyond standard systematic review practices (e.g., dual review and consensus) is not explicitly detailed.
Cadaver Study: No adjudication method is described beyond the inherent observation and confirmation by the performing team.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The study relies on comparing aggregated historical clinical outcomes from published literature and a single cadaver study, not on human readers interpreting cases with or without AI assistance. The device is a surgical system, not an AI diagnostic or assistive tool in the traditional sense of image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

The "da Vinci SP Surgical System" is a robotic surgical platform; it is a human-in-the-loop device by its very nature (a surgeon controls the system). Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms would not be applicable or relevant to this device.

7. The Type of Ground Truth Used:

Cadaver Study: Direct observation and confirmation of instrument access, motion, and robustness within a cadaveric model.
Literature Review: Clinical outcomes data reported in peer-reviewed publications. This includes various metrics collected by the original study authors, such as operative time, estimated blood loss (EBL), complication rates (intraoperative, 30-day postoperative, major), length of stay, readmission rate, urinary retention, continence rate, catheterization time, positive surgical margins, and mortality. These are patient outcomes, representing a form of "ground truth" for clinical performance.

8. The Sample Size for the Training Set:

The 510(k) summary does not describe any "training set" in the context of an AI/ML algorithm development. The device is a surgical system, not an AI algorithm that learns from data. The prior clinical experience with the da Vinci SP System and its predicate devices, as well as general surgical knowledge, would constitute the underlying "knowledge base" for its design and intended use, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no described AI training set.

Summary

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April 5, 2023

Intuitive Surgical Inc. Mike Yramategui Fellow Regulatory Engineer 1020 Kifer Rd. Sunnyvale, California 94086

Re: K230033

Trade/Device Name: Da Vinci SP Surgical System (SP1098) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NA Y Dated: January 3, 2023 Received: January 5, 2023

Dear Mike Yramategui:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

The OHT4: Office of Surgical and Infection Control Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling:

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The safety and effectiveness of this device for use in the performance of general laparoscopic surgerv procedures have not been established. This device is only intended to be used for single port urological procedures and for transoral otolaryngology surgical procedures in the oropharynx for benign tumors and malignant tumors classified as T1 and T2 with the da Vinci EndoWrist SP Instruments and the da Vinci SP Surgical System (SP1098).

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

David Krause -S

for Binita Ashar, M.D., M.B.A., F.A.C.S. Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230033

Device Name

da Vinci SP Surgical System, Model SP1098

Indications for Use (Describe)

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 EndoWrist SP Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant turnors 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.

Endo Wrist SP Instruments:

Type of Use (Select one or both, as applicable)	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary [21 CFR § 807.92(c)]

SUBMITTER INFORMATION I.

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Mike YramateguiFellow Regulatory EngineerPhone Number: 408-523-2145Fax Number: 408-523-8907Email: Mike.Yramategui@intusurg.com

Date Summary Prepared: April 4, 2023

SUBMITTER INFORMATION II.

Trade Name:	da Vinci SP® Surgical System, Model SP1098, EndoWrist SP® Instruments, and Accessories
Common Name:	System, Surgical, Computer Controlled Instrument
Classification Name:	Endoscope and Accessories (21 CFR §876.1500)
Regulatory Class:	Class II
Product Code:	NAY (System, Surgical, Computer Controlled Instrument
Submission Type:	Traditional 510(k)

III. PREDICATE DEVICE INFORMATION

Predicate Device:	da Vinci SP Surgical System, Model SP1098,EndoWrist SP Instruments, and Accessories (K202571)
-------------------	---------------------------------------------------------------------------------------------------

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IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

da Vinci SP Surgical System, Model SP1098:

EndoWrist SP Instruments:

Intuitive Surgical EndoWrist 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 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

COMPARISON OF INTENDED USE, INDICATIONS FOR USE AND VI. TECHNOLOGAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The da Vinci SP Surgical System, Model SP1098 and EndoWrist SP Instruments and Accessories are unchanged from the predicate device in terms of intended use, design, performance, and technological characteristics. The labeling has been changed to add "simple prostatectomy" as a new representative, specific procedure in the Professional Instructions for Use as a "covered" procedure under the existing clearance for radical prostatectomy as an "umbrella" procedure, and benign and radical transvesical prostatectomy as umbrella procedures.

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VII. PERFORMANCE DATA

This 510(k) is for a labeling modification only and there are no technological changes made to the subject device. Thus, previous bench testing related to electromagnetic compatibility, electrical safety, software, biocompatibility, sterilization, and shelf life were not impacted by this change.

Simple prostatectomy was added as a new representative, specific "covered" procedure in the Professional Instructions for Use under the cleared "umbrella" radical prostatectomy procedure. No performance testing was necessary to add simple prostatectomy as a representative, specific procedure.

Design validation testing was performed in a male cadaver to confirm the ability of the SP1098 for performing a transvesical prostatectomy. Evaluation of the ability to provide robotic and laparoscopic instrument access to the deep pelvis via an incision in the urinary bladder was confirmed and an assessment of instrument motion throughout the prostatectomy procedure was performed. Evaluation of SP Access Port Kit robustness as well as the ability of the SP Access Port Kit to provide adequate retraction for SP instrument access while remaining securely installed during use was also evaluated.

Real-World Evidence (RWE) supporting the substantial equivalence of transvesical prostatectomy to previously cleared extraperitoneal prostatectomy (EPRP) and transabdominal prostatectomy (TARP) was also provided. Peer-reviewed literature published between Jan 01, 2018 and January 7, 2023 on robotic-assisted surgery using the SP1098 were identified by systematically searching the Scopus. Embase, and PubMed databases. After systematic literature screening, 11 primary publications reporting relevant clinical outcomes for transvesical simple/radical prostatectomy performed using the da Vinci SP Surgical System were included for comparison. Publications for extraperitoneal and transperitoneal approaches to prostatectomy using the SP1098 were similarly screened, and all primary publications reporting relevant clinical outcomes with 50 or more patients in at least one study arm were included, resulting in 10 publications reporting EPRP data and 7 publications reporting TARP data. Table 1 includes the ranges of raw values extracted for each clinical outcome for comparison between approaches. The data in Table 1 demonstrate similar ranges of outcomes between the surgical approaches listed. Table 2 provides a listing of the publications.

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VII. CONCLUSION

The da Vinci SP Surgical System is unmodified from the predicate device, and there are no changes to the intended use or indications for use for these labeling changes. The addition of simple prostatectomy as a representative procedure does not represent a change or modification that requires clinical data to evaluate safety or effectiveness of the device. It does not introduce any different issues of safety or effectiveness as compared to the urological procedures previously cleared for the SP1098 system.

Design validation testing provided demonstrates the ability of the da Vinci SP Surgical System to perform transvesical prostatectomy. A review of the published literature (RWE) provides additional confirmation that a transvesical approach (TVSP / TVRP) is substantially equivalent to the cleared transabdominal approach (TARP) and extraperitoneal (EPRP) approaches for performing radical prostatectomy, and do not raise different questions of safety or effectiveness.

Thus, these labeling changes to the da Vinci SP Surgical System are substantially equivalent to the cleared predicate device.

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Outcome	Transvesical Prostatectomy (TVP)a		Extraperitoneal RadicalProstatectomy (EPRP)b(K202571)	Transabdominal RadicalProstatectomy (TARP)b(K173906)
	Simple (TVSP)for benign indications	Radical (TVRP)for prostate cancer
# Included Publications(Total Patient Count)	8 publications1-8,~247 patients	3 publications9-11,~181 patients	10 publications10,12-20,~1,259 patients	7 publications16,20-25,~649 patients
Operative Time (Avg)	$153^4$ - 232.43 min	1999 - 21211 min	14715 - 203.213 min	11425,24 - 248.216 min
EBL (Avg)	1001,2,4,8 - 227.13 mL	10010 - 1359 mL	5015 - 197.213 mL	5023-25 - 20021 mL
Conversion Rate	0%4,7	0%9	0%12,13,16,17,19	0%16,21
Intraoperative Complication Rate	0%2,4,5,7 - 2.4%6	0%9,11	0%12,13,17,19 - 2.0%15	0%23-25 - 2.7%20
30-Day Postoperative Complication Rate	0%5 - 12.5%4,c	5.0%9,d - 12.8%10	3.8%17 - 18.3%19	0%23,24 - 15.2%16
Major (C-D grade ≥ III) Complication Rate	0%4,6,8 - 7.14%3,e	0%9 - 2.6%10	0%15 - 11.7%19	0%23,24 - 6.5%16
Length of Stay	<24 hrs2,4,6-8 - 2.5 days3	<24 hrs9-11	<24 hrs10,12-14,16,19,20 - 2 days17	<24 hrs20,22,23 - 7 days21
30-Day Readmission Rate	1.0%8	5.0%9,d - 5.1%10	2.0%15 - 8.6%14	0%23-25 - 6.4%22
Urinary Retention Rate	0%2,4 - 4.4%8	5.1%10	0.6%17 - 2.6%10	1.3%20
90-Day/3-Month Continence Rate	90%5,f - 100%2	96.6%10 - 97%11	38.4%15 - 85%13	62.5%16 - 78%23
Urinary Catheterization Time (Avg)	1.95 - 10.53 days	310 - 49,11 days	7 days 10,14,15,20	5 days20,23,24,25
Positive Surgical Margins	NA	14.5%11 - 15.4%10	17.3%15 – 29%17	14%23 - 41.3%16,g
Overall Mortality	0 (0%) at 30 days3	NR	NR	NR

Table 1: Literature Summary Table: da Vinci SP Transvesical vs. Extraperitoneal and Transabdominal Prostatectomy*

«All primary publications from 01 Jan 2018 – 07 Jan 2023 included

6Primary publications from 01 Jan 2018 – 07 Jan 2023 with n ≥ 50 patients in at least one study arm included

Clow sample size (1/8 patients). Next highest postoperative complication rate reported for TVSP: 11% (10/91 patients)

4Low sample size (1/20 patients) representing a single minor (C-D grade I) complication

eNo other TVSP publication reported major (C-D grade ≥ III) complications

/Low sample size (9/10 patients). Next lowest continence rate reported for TVSP: 97% (41/42 patients)

816/19 had high risk features: n=15 patients with T3abN0-1, n=1 patient with T2N0 with GrGp4-5

Complication / Adverse Event, C-D : Estinated Blood Loss; EPRP : Extrapertoned Radical Prostectorny : 1QR: Interquarile Range; NA: Not Applicable;

NR: Not Reported; TARP: Transbominal Radical Prostatetomy; TVRP: Transvescal Radical Prostatectomy; TVSP: Transvescal Simple Prostatetony

Literature summary table provides data as extracted from publications and were not statistically analyzed

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Author(s)	Title
1. Ganesan V, Steinberg RL,Garbens A, et al.	Single-port robotic-assisted simple prostatectomy is associated withdecreased post-operative narcotic use in a propensity score matchedanalysis. Journal of Robotic Surgery. 2021.
2. Kaouk J, Sawczyn G,Wilson C, et al.	Single-Port Percutaneous Transvesical Simple Prostatectomy Using theSP® Robotic System: Initial Clinical Experience. Urology. 2020.
3. Khalil MI, Chase A,Joseph JV, Ghazi A.	Standard Multi-Port versus Single-Port Robot-Assisted SimpleProstatectomy: A Single Center Initial Experience. Journal ofendourology. 2022.
4. Sawczyn G, AminsharifiA, Garisto J, Valero R,Kaouk J.	Single-port transvesical robotic simple prostatectomy using the novel SPsurgical system: Technical aspects. Urology Video Journal. 2020;5.
5. Steinberg RL, Passoni N,Garbens A, Johnson BA,Gahan JC.	Initial experience with extraperitoneal robotic-assisted simpleprostatectomy using the da Vinci SP surgical system. Journal of roboticsurgery. 2019.
6. Zeinab AM, Kaviani A,Ferguson E, et al.	Single-port transvesical versus open simple prostatectomy: a perioperativecomparative study. Prostate Cancer Prostatic Dis. 2022.
7. Zeinab AM, Kaviani A,Ferguson E, Beksac T,Eltemamy M, Kaouk J.	A Transition Towards A Faster Recovery in Single-Port TransvesicalSimple Prostatectomy. J Endourol. 2022.
8. Zeinab MA, Beksac AT,Corse T, et al.	The Multi-Institutional Experience in Single-Port Robotic TransvesicalSimple Prostatectomy for BPH Management. J Urol.2022:101097ju0000000000002692.
9. Kaouk J, Beksac AT,Zeinab MA, Duncan A,Schwen ZR, EltemamyM.	Single Port Transvesical Robotic Radical Prostatectomy: Initial ClinicalExperience and Description of Technique. Urology. 2021.
10. Zeinab AM, Beksac AT,Ferguson E, Kaviani A,Kaouk J.	Transvesical versus extraperitoneal single-port robotic radicalprostatectomy: a matched-pair analysis. World J Urol. 2022;40(8):2001-2008.
11. Zeinab AM, Kaviani A,Ferguson E, Beksac AT,Kaouk J.	Single-port transvesical robotic radical prostatectomy: Description oftechnique. Urology Video Journal. 2022;15.
12. Aminsharifi A, Hemal S,Aram P, Abou Zeinab M,Beksac T, Kaouk J.	The performance and optimum cutoff value for pelvic cavity index as apredictor of early continence after extraperitoneal single-port roboticradical prostatectomy: Role of pelvic anatomical characteristics. JEndourol. 2022.
13. Aminsharifi A, WilsonCA, Sawczyn G, Kim S,Lenfant L, Kaouk J.	Predictors associated with a prolonged hospital stay after single-portextraperitoneal robotic radical prostatectomy: A comparative analysis ofoutpatient versus inpatient care. J Endourol. 2020.
14. Beksac AT, Zeinab MA,Ferguson E, Kaviani A,Kaouk J.	Single-Port Extraperitoneal Robot Assisted Radical Prostatectomy -Description of Technique. Urology Video Journal. 2022;15.
15. Harrison R, StifelmanM, Billah M, et al.	Propensity-Score Matched Analysis Between Extraperitoneal Single Portand Intraperitoneal Multiport Radical Prostatectomy: A Single-Institutional Experience. Urology. 2022.
16. Kaouk J, Aminsharifi A,Wilson CA, et al.	Extraperitoneal versus Transabdominal Single-Port Robotic RadicalProstatectomy: A Comparative Analysis of Perioperative Outcomes. TheJournal of urology. 2019:101097JU0000000000000700.
17. Kim J, Kaldany A,Lichtbroun B, et al.	Single Port Robotic Radical Prostatectomy: Short-term Outcomes andLearning Curve. J Endourol. 2022.
Author(s)	Title
18. Lenfant L, Corrigan D,Beksac AT, Schwen Z,Kaouk J.	Learning curve analysis of single-port robot-assisted extraperitonealprostatectomy using the cumulative sum (CUSUM) method. BJU Int.2021.
19. Wilson CA, AminsharifiA, Sawczyn G, et al.	Outpatient Extraperitoneal Single-port Robotic Radical Prostatectomy.Urology. 2020.
20. Zeinab AM, Beksac AT,Ferguson E, et al.	Single-port Extraperitoneal and Transabdominal Radical Prostatectomy: AMulti-Institutional Propensity-Score Matched Study. Urology. 2022.
21. Kim KH, Ahn HK, KimM, Yoon H.	Technique and perioperative outcomes of single-port robotic surgery usingthe da Vinci SP platform in urology. Asian J Surg. 2022.
22. Lenfant L, Sawczyn G,Kim S, Aminsharifi A,Kaouk J.	Single-institution Cost Comparison: Single-port Versus Multiport RoboticProstatectomy. European Urology Focus. 2020.
23. Moschovas CM, BhatKRS, Onol F, Rogers T,Patel V.	Early outcomes of Single Port Robotic Radical Prostatectomy.LessonsLearned from The learning curve experience. BJU Int. 2020.
24. Moschovas CM, BhatKRS, Sandri M, et al.	Comparing the Approach to Radical Prostatectomy Using the Multiport daVinci Xi and da Vinci SP Robots: A Propensity Score Analysis ofPerioperative Outcomes. Eur Urol. 2020.
25. Moschovas CM, Kind S,Bhat S, et al.	Implementing the da Vinci SP Without Increasing Positive SurgicalMargins: Experience and Pathologic Outcomes of a Prostate CancerReferral Center. Journal of Endourology. 2022;36(4):493-498

Table 2: List of Publications Reviewed

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Regulation Number and Section

§ 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.