(67 days)
Not Found
No
The document describes a labeling modification for an existing surgical system and explicitly states there are no changes to the technological characteristics. There is no mention of AI or ML in the device description or performance studies.
Yes
Justification: The device's intended use includes assisting in surgical procedures 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." These actions are direct interventions on tissue to treat a condition or disease, which defines a therapeutic device.
No
The device is described as an Endoscopic Instrument Control System intended to assist in the control of surgical instruments for various procedures, focusing on manipulation of tissue, not diagnosis.
No
The device description explicitly states that the da Vinci Xi and X Surgical Systems are "software-controlled, electro-mechanical systems" and consist of hardware components like a Surgeon Console, Patient Side Cart, and Vision Side Cart.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to assist surgeons in performing various surgical procedures. It involves the manipulation of tissue during surgery using instruments and visualization.
- Device Description: The device is described as a software-controlled, electro-mechanical system consisting of a console, cart, and instruments used for minimally invasive surgery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The performance study focuses on surgical outcomes (overall survival) rather than diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
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 revasoularization. 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.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
This premarket notification is for a labeling modification only, to revise the Precaution for Representative Uses statement so that it does not apply to radical prostatectomy performed using the subject devices. This labeling change is supported by real-world evidence (RWE). There are no changes to the technological characteristics or the indications for use 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric use
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)
Study Type: Retrospective cohort study using secondary administrative healthcare claims data.
Study Objective: Primary objective: Evaluate non-inferiority of robotic-assisted surgical device (RASD) radical prostatectomy (RP) as compared with non-RASD RP with respect to the difference in probability of 5-year overall survival (OS) among male patients at least 35 years of age with treatment-naive prostate cancer. Secondary objectives: Evaluate non-inferiority of RASD RP as compared with non-RASD RP with respect to the difference in 6-year, 7-year, 8-year, 9-year, and 10-year probability of OS among male patients at least 35 years of age with treatment-naive prostate cancer.
Sample Size: Primary analyses: N = 24,350 patients with an RP procedure between July 2007 and December 2014, restricting the last procedure date to occur 5 years prior to the start of COVID-19. Sensitivity analyses: N = 45,215 patients with an RP procedure between July 2007 and December 2020, utilizing all available data.
Data Source: Optum Clinformatics Data Mart (CDM) de-identified administrative healthcare claims data.
Key Results:
- Primary endpoint (5-year OS): Adjusted OS difference for RASD RP vs non-RASD RP was 0.20% (-0.46, 0.86). Non-inferiority p-value was
§ 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 24, 2024
Intuitive Surgical Emily Hovick Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K240723
Trade/Device Name: da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: March 15, 2024 Received: March 18, 2024
Dear Emily Hovick:
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 (the 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. 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 available 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.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.05.24
19:50:55 -04:00: Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Indications for Use (Describe)
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 revasoularization. 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
r-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (21 CFR § 807.92)
Submitter Information I.
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Emily Hovick
Senior Regulatory Affairs Specialist
Phone: 314-359-8534
Email: Emily.hovick@intusurg.com |
| Date Summary Prepared: | March 15, 2024 |
| II. Subject Device | |
| Trade Name: | da Vinci Xi Surgical System
da Vinci X Surgical System |
| Common Name: | System, surgical, computer-controlled instrument |
| Classification: | Class II |
| Regulation: | 21 CFR § 876.1500, Endoscope and Accessories |
| Product Code: | NAY |
| III. Predicate Device Information | |
| Predicate Devices: | da Vinci Xi Surgical System, K131861 |
| | da Vinci X Surgical System, K171294 |
IV. Device Description
This premarket notification is for a labeling modification only, to revise the Precaution for Representative Uses statement so that it does not apply to radical prostatectomy performed using the subject devices. This labeling change is supported by real-world evidence (RWE). There are no changes to the technological characteristics or the indications for use 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.
Image /page/3/Picture/8 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is simple and sans-serif. The word is centered in the image.
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V. Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: 134000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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.
Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence), except for radical prostatectomy which was evaluated for overall survival, or treatment of the patient's underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
VI. Technological Characteristics
This premarket notification is for a change to the labeling only. 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 softwarecontrolled, 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.
VII. Performance Data
There are no changes to the technological characteristic of the subject device in this premarket notification. Therefore, no bench or preclinical data were required.
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5
Clinical Data Summary
Table 1: Study Summary
| Title | Use of Real-World Data to Demonstrate That Overall Survival Following Robotic-
Assisted Radical Prostatectomy is Non-Inferior to Non-Robotic Assisted Radical
Prostatectomy |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study Objective | Primary objective: Evaluate non-inferiority of robotic-assisted surgical device
(RASD) radical prostatectomy (RP) as compared with non-RASD RP with respect
to the difference in probability of 5-year overall survival (OS) among male patients
at least 35 years of age with treatment-naive prostate cancer. |
| | Secondary objectives: Evaluate non-inferiority of RASD RP as compared with
non-RASD RP with respect to the difference in 6-year, 7-year, 8-year, 9-year, and
10-year probability of OS among male patients at least 35 years of age with
treatment-naive prostate cancer. |
| Study Design | A retrospective cohort study using secondary administrative healthcare claims data
to evaluate OS following RP performed via RASD as compared to non-RASD
open surgical approaches among patients with treatment-naive prostate cancer in
the United States. |
| Study
Population | Male patients at least 35 years of age with treatment-naive prostate cancer
undergoing a RASD versus non-RASD RP procedure. |
| Number of
Patients / Time
Period | Primary analyses: N = 24,350 patients with an RP procedure between July 2007
and December 2014, restricting the last procedure date to occur 5 years prior to the
start of COVID-19.
Sensitivity analyses: N = 45,215 patients with an RP procedure between July 2007
and December 2020, utilizing all available data. |
| Data Source | Optum Clinformatics Data Mart (CDM) de-identified administrative healthcare
claims data |
| Study
Endpoints | Primary endpoint: The difference in the probability of OS at 5 years after the RP
procedure (i.e., the difference in the percent of patients who do not have a death
event), comparing RASD RP to non-RASD RP.
Secondary endpoints: The difference in the probability of OS at 6, 7, 8, 9, and 10
years after the RP procedure, comparing RASD RP to non-RASD RP. |
| Statistical
Methods | Propensity score (PS) method with stratification was applied on the outcome-free
design. The overall survival rate was estimated based on Average Treatment Effect
among the Treated population. |
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Table 2: Baseline characteristics of patients with treatment-naive prostate cancer undergoing radical prostatectomy procedure between 7/1/2007 and 12/31/2014, by surgical approach, before and after PS stratification. Note: subgroup analyses were not performed for any endpoint.
| Before PS Stratification | After PS stratification (weighted N, by strata) | ||||||
|---|---|---|---|---|---|---|---|
| RASD RP | |||||||
| N = 18,949 | Non-RASD RP | ||||||
| N = 5,401 | ASD | RASD RP | |||||
| Weighted N = | |||||||
| 3,850.31 | Non-RASD RP | ||||||
| Weighted N = 1,019.69 | ASD | ||||||
| Demographics [Day 0] | |||||||
| Age in years at index | 0.020 | 0.040 | |||||
| mean (SD) | 60.94 (7.29) | 61.06 (7.27) | 61.12 (3.28) | 61.12 (3.29) | |||
| median [IQR] | 61.00 [56.00, | ||||||
| 66.001 | 61.00 [56.00, 66.00] | 61.22 [56.00, 66.22] | 61.22 [55.81, 66.42] | ||||
| Age categories, years | |||||||
| 35 - 44 | 235 (1.24%) | 68 (1.26%) | 0.000 | 47.6 (1.24%) | 12.9 (1.23%) | 0.060 | |
| 45 - 54 | 3,522 (18.59%) | 996 (18.44%) | 0.000 | 716.3 (18.59%) | 187.7 (18.06%) | 0.030 | |
| 55 - 64 | 8,799 (46.44%) | 2,497 (46.23%) | 0.000 | 1,786.3 (46.43%) | 472.4 (46.97%) | 0.040 | |
| 65 - 74 | 6,000 (31.66%) | 1,734 (32.11%) | 0.010 | 1,220.2 (31.67%) | 325.7 (31.37%) | 0.030 | |
| >75 | 393 (2.07%) | 106 (1.96%) | 0.010 | 79.9 (2.08%) | 21.0 (2.37%) | 0.040 | |
| Race/Ethnicity; n (%) | |||||||
| Asian | 386 (2.04%) | 94 (1.74%) | 0.020 | 80.3 (2.04%) | 18.5 (2.01%) | 0.030 | |
| Black | 1,787 (9.43%) | 597 (11.05%) | 0.050 | 352.5 (9.43%) | 109.4 (9.78%) | 0.030 | |
| Hispanic | 1,061 (5.60%) | 338 (6.26%) | 0.030 | 211.1 (5.6%) | 61.8 (5.42%) | 0.040 | |
| White | 14,713 (77.65%) | 4,057 (75.12%) | 0.060 | 3,007.3 (77.64%) | 771.8 (77.51%) | 0.020 | |
| Unknown | 1,002 (5.29%) | 315 (5.83%) | 0.020 | 199.1 (5.29%) | 58.3 (5.28%) | 0.010 | |
| Region; n (%) | |||||||
| Midwest | 1,676 (8.84%) | 413 (7.65%) | 0.040 | 348.0 (8.85%) | 81.2 (9.11%) | 0.050 | |
| Northeast | 5,026 (26.52%) | 1,495 (27.68%) | 0.030 | 1,015.6 (26.52%) | 278.9 (26.41%) | 0.030 | |
| South | 8,349 (44.06%) | 2,248 (41.62%) | 0.050 | 1,711.5 (44.06%) | 430.2 (43.89%) | 0.030 | |
| West | 3,898 (20.57%) | 1,245 (23.05%) | 0.060 | 775.2 (20.57%) | 229.4 (20.59%) | 0.030 | |
| Insurance type; n (%) | |||||||
| Commercial | 14,052 (74.16%) | 4,111 (76.12%) | 0.050 | 2,838.4 (74.16%) | 771.0 (74.41%) | 0.030 | |
| Medicare | 4.897 (25.84%) | 1,290 (23.88%) | 0.050 | 1,011.9 (25.84%) | 248.7 (25.59%) | 0.030 | |
| Year of RP procedure; n (%) | |||||||
| 2007 | |||||||
| 2008 | 998 (5.27%) | ||||||
| 2,343 (12.36%) | 715 (13.24%) | ||||||
| 1,150 (21.29%) | 0.280 | ||||||
| 0.240 | 157.8 (5.27%) | ||||||
| 401.4 (12.37%) | 112.4 (5.98%) | ||||||
| 192.0 (11.96%) | 0.020 | ||||||
| 2009 | 2,702 (14.26%) | 955 (17.68%) | 0.090 | 517.0 (14.26%) | 177.4 (14.34%) | 0.040 | |
| 0.030 | |||||||
| 2010 | 2,584 (13.64%) | 805 (14.90%) | 0.040 | 509.3 (13.64%) | 155.2 (13.83%) | 0.030 | |
| 2011 | 2,968 (15.66%) | 672 (12.44%) | 0.090 | 624.8 (15.66%) | 139.1 (15.80%) | 0.020 | |
| 2012 | 2,506 (13.22%) | 431 (7.98%) | 0.170 | 550.5 (13.23%) | 93.6 (13.52%) | 0.050 | |
| 2013 | 2,546 (13.44%) | 376 (6.96%) | 0.220 | 569.5 (13.44%) | 83.4 (13.33%) | 0.020 | |
| 2014 | 2,302 (12.15%) | 297 (5.50%) | 0.240 | 520.2 (12.15%) | 66.5 (11.25%) | 0.040 | |
| Comorbidities and clinical characteristics [Day -180, | |||||||
| Day 0] | |||||||
| Evidence of smoking or smoking cessation; n (%) | 4,646 (24.52%) | 1,287 (23.83%) | 0.020 | 948.1 (24.52%) | 245.9 (24.98%) | 0.030 | |
| Alcohol related disorders; n (%) | 31 (0.16%) | 7 (0.13%) | 0.010 | 6.5 (0.16%) | 1.4 (0.17%) | 0.020 | |
| Obesity; n (%) | 1,940 (10.24%) | 504 (9.33%) | 0.030 | 401.4 (10.24%) | 97.3 (10.28%) | 0.020 | |
| Cancers other than prostate cancer; n (%) | 1,575 (8.31%) | 577 (10.68%) | 0.080 | 306.1 (8.31%) | 104.0 (8.82%) | 0.030 | |
| Benign prostatic hyperplasia; n (%) | 637 (3.36%) | 187 (3.46%) | 0.010 | 129.3 (3.36%) | 35.1 (3.22%) | 0.040 | |
| Lower urinary tract conditions; n (%) | 7,206 (38.03%) | 2,248 (41.62%) | 0.070 | 1,441.4 (38.03%) | 417.2 (39.03%) | 0.040 | |
| Hypertension; n (%) | 11,671 (61.59%) | 3,412 (63.17%) | 0.030 | 2,361.3 (61.59%) | 641.3 (62.13%) | 0.020 | |
| Diabetes mellitus; n (%) | 3,168 (16.72%) | 932 (17.26%) | 0.010 | 640.5 (16.72%) | 175.6 (17.24%) | 0.030 | |
| Kidney disease; n (%) | 1,468 (7.75%) | 465 (8.61%) | 0.030 | 293.8 (7.75%) | 85.6 (7.77%) | 0.030 | |
| Gagne Comorbidity Index | 0.120 | 0.030 | |||||
| mean (SD) | 1.21 (1.45) | 1.39 (1.64) | 1.23 (0.63) | 1.23 (0.64) | |||
| median [IQR] | 1.00 [0.00, 1.00] | 1.00 [0.00, 2.00] | 1.00 [0.00, 1.55] | 1.00 [0.00, 1.77] | |||
| Frailty score | 0.110 | 0.040 | |||||
| mean (SD) | 0.10 (0.03) | 0.10 (0.03) | 0.10 (0.01) | 0.10 (0.01) | |||
| median [IQR] | 0.10 [0.08, 0.12] | 0.10 [0.08, 0.12] | 0.10 [0.08, 0.12] | 0.10 [0.08, 0.12] | |||
| Medications and treatments [Day -180, Day -1] | |||||||
| Pelvic or abdominal surgery; n (%) | 17,736 (93.60%) | 5,118 (94.76%) | 0.050 | 3,595.5 (93.6%) | 964.7 (93.97%) | 0.030 | |
| Transurethral prostate surgery; n (%) | 70 (0.37%) | 41 (0.76%) | 0.050 | 12.6 (0.37%) | 6.7 (0.4%) | 0.030 | |
| Urethral or bladder neck surgery; n (%) | 2,805 (14.80%) | 819 (15.16%) | 0.010 | 567.3 (14.8%) | 153.9 (15.01%) | 0.020 | |
| Treatment for other cancers: | |||||||
| Radiotherapy; n (%) | 13 (0.07%) | 7 (0.13%) | 0.020 | 2.2 (0.07%) | 1.2 (0.08%) | 0.020 | |
| Chemotherapy; n (%) | 8 (0.04%) | 5 (0.09%) | 0.020 | 1.4 (0.04%) | 0.8 (0.05%) | 0.000 | |
| Immunotherapy; n (%) | 0 (0.00%) | 0 (0.00%) | 0.000 | 0.0 (0%) | 0.0 (0%) | 0.000 | |
| Hormonal therapy; n (%) | |||||||
| Anticoagulants; n (%) | 11 (0.06%) | ||||||
| 462 (2.44%) | 3 (0.06%) | ||||||
| 86 (1.59%) | 0.000 | 2.3 (0.06%) | |||||
| 100.3 (2.44%) | 0.6 (0.05%) | ||||||
| 17.7 (2.32%) | 0.030 | ||||||
| Antiplatelets (including aspirin); n (%) | 650 (3.43%) | 167 (3.09%) | 0.060 | ||||
| 0.020 | 134.3 (3.43%) | 32.5 (3.5%) | 0.020 | ||||
| 0.020 | |||||||
| NSAIDs; n (%) | 2,679 (14.14%) | 745 (13.79%) | 0.010 | 546.5 (14.14%) | 141.3 (14.11%) | 0.020 | |
| Laboratory results [Day -180, Day -1] | |||||||
| Before PS Stratification | After PS stratification (weighted N, by strata) | ||||||
| RASD RP | |||||||
| N = 18,949 | Non-RASD RP | ||||||
| N = 5,401 | ASD | RASD RP | |||||
| Weighted N = | |||||||
| 3,850.31 | Non-RASD RP | ||||||
| Weighted N = 1,019.69 | ASD | ||||||
| Preoperative PSA, ng/mL (last value observed, among | |||||||
| those with ≥1 value) | 0.120 | 0.130 | |||||
| mean (SD) | 6.74 (6.43) | 7.84 (10.79) | 7.90 (2.87) | 7.90 (5.31) | |||
| median [IQR] | 5.24 [4.20, 7.30] | 5.42 [4.30, 8.00] | 5.49 [4.17, 7.23] | 5.49 [4.31, 7.96] | |||
| Among N with non-missing value | 4,567 | 1,020 | 956.10 | 199.90 | |||
| Preoperative PSA categories, ng/mL; n (%) | |||||||
| 0.025. no subsequent endpoints would have been evaluated |
VIII. Conclusion
RWE was provided to demonstrate that the retrospective clinical data met all overall survival endpoints. This supports the modification of the Precaution for Representative Uses statement so that it does not apply to RP performed using the subject devices. These data prove the utility of RWE in support of premarket submissions.
The observed all-cause mortality in this study is similar to rates found in a systematic literature review performed by FDA. Based on tipping-point analyses performed by FDA, more than 28% differential bias in all-cause mortality ascertainment between RASD arms of this study would be needed to alter the results of the primary non-inferiority analysis. Additionally, examination of the data did not suggest presence of differential bias in all-cause mortality ascertainment between RASD and non-RASD arms of this study.