(90 days)
No
The document describes a robotic surgical system controlled by a physician and mentions image processing, but there is no mention of AI or ML being used for decision-making, image analysis beyond basic processing, or autonomous control. The focus is on physician control and instrument manipulation.
No.
The da Vinci SP Surgical System is a surgical assist robotic system, not a therapeutic device. It assists surgeons in performing procedures but does not directly deliver therapy itself.
No
The da Vinci SP Surgical System is intended to assist in the accurate control of surgical instruments during surgical procedures. Its function is to facilitate surgery, not to diagnose medical conditions or diseases. While it uses a camera for visualization, this is for guiding the surgical procedure, not for generating diagnostic information.
No
The device description clearly outlines hardware components including a Surgeon Console, Vision Cart, and Patient Cart, in addition to instruments and accessories. While software is undoubtedly involved in controlling these components and processing images, the device is fundamentally a system of interconnected hardware and software, not software alone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the system is for assisting in the accurate control of surgical instruments during urologic and transoral otolaryngology surgical procedures. This involves direct manipulation of tissue within the body.
- Device Description: The description details a surgical system with a surgeon console, vision cart, and patient cart, used with instruments and a camera for performing surgery.
- Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination of specimens outside the body. It is a surgical tool used within the body.
While the device uses a camera and image processing, this is for visualizing the surgical field during the procedure, not for analyzing biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
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 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.
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
Product codes (comma separated list FDA assigned to the subject device)
NA Y
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 User Manual.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic surgical procedures, transoral otolaryngology surgical procedures in the oropharynx, prostatectomy
Indicated Patient Age Range
adult
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Outcome | Transvesical Prostatectomy (TVP) Simple (TVSP) for benign indications | Transvesical Prostatectomy (TVP) Radical (TVRP) for prostate cancer | Extraperitoneal Radical Prostatectomy (EPRP) (K202571) | Transabdominal Radical Prostatectomy (TARP) (K173906) |
|---|---|---|---|---|
| # Included Publications (Total Patient Count) | 8 publications, ~247 patients | 3 publications, ~181 patients | 10 publications, ~1,259 patients | 7 publications, ~649 patients |
| Operative Time (Avg) | 153 - 232.43 min | 199 - 212 min | 147 - 203.2 min | 114 - 248.2 min |
| EBL (Avg) | 100 - 227.1 mL | 100 - 135 mL | 50 - 197.2 mL | 50 - 200 mL |
| Conversion Rate | 0% | 0% | 0% | 0% |
| Intraoperative Complication Rate | 0% - 2.4% | 0% | 0% - 2.0% | 0% - 2.7% |
| 30-Day Postoperative Complication Rate | 0% - 12.5% | 5.0% - 12.8% | 3.8% - 18.3% | 0% - 15.2% |
| Major (C-D grade $\ge$ III) Complication Rate | 0% - 7.14% | 0% - 2.6% | 0% - 11.7% | 0% - 6.5% |
| Length of Stay |
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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:
1
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).
2
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
3
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:
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
60
4
510(k) Summary [21 CFR § 807.92(c)]
SUBMITTER INFORMATION I.
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mike Yramategui
Fellow Regulatory Engineer
Phone Number: 408-523-2145
Fax Number: 408-523-8907
Email: 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) |
| ------------------- | --------------------------------------------------------------------------------------------------- |
|---|
5
IV. 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.
6
V. INDICATIONS FOR USE
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 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.
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.
7
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.
8
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.
9
| Outcome | Transvesical Prostatectomy (TVP)a | | Extraperitoneal Radical
Prostatectomy (EPRP)b
(K202571) | Transabdominal Radical
Prostatectomy (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 |