(96 days)
No
The summary describes a software-controlled, electro-mechanical surgical system that assists surgeons with instrument control. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on the robotic control and visualization aspects of the system.
Yes.
The da Vinci Surgical System is used to assist in accurate control of surgical instruments for various surgical procedures, which are therapeutic interventions.
No
Explanation: The device description and intended use clearly state that the da Vinci Surgical System is designed for surgical procedures, assisting in the "accurate control of Intuitive Surgical Endoscopic Instruments" for various manipulations of tissue, rather than for diagnosing conditions.
No
The device description explicitly states that the da Vinci Xi Surgical System is a "software-controlled, electro-mechanical system" and lists hardware components such as a Surgeon Console, Patient Side Cart, and Vision Side Cart. This indicates it is not a software-only device.
Based on the provided information, the Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the system as assisting in the control of surgical instruments for manipulating tissue during various surgical procedures. This is a surgical device used in vivo (within the living body), not in vitro (outside the living body).
- Device Description: The description details a software-controlled, electro-mechanical system consisting of a console, carts, endoscope, and instruments. This aligns with a surgical robotic system, not a device used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
Therefore, the da Vinci Surgical System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System. Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic 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 laparossopic 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 pediatic 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
NAY
Device Description
This 510(k) is for a labeling modification only, to include "Inguinal Hernia Repair" procedures under the cleared "general laparoscopic surgical procedures" indication for the da Vinci Xi Surgical System (K131861). There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000, is a softwarecontrolled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is 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 pediatic use.
Intended User / Care Setting
trained physicians in an 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
A retrospective, multi-center, non-randomized controlled clinical study evaluating the use of the da Vinci Surgical System in Inguinal Hernia Repair procedures compared with open surgical procedures was conducted. This study included 652 and 602 subjects in the robotic-assisted and open cohorts, respectively, and was conducted at six (6) investigational sites in United States. Post operative data was collected throughout the thirty (30) day follow up period.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-Clinical Animal Study Data: This premarket notification is supported by animal study data including the results from six (6) evaluations in a total of 24 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Pyeloplasty, Nephrectomy, Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were submitted in support of clearance of the da Vinci Xi Surgical System (K131861).
Clinical Study Data: A retrospective, multi-center, non-randomized controlled clinical study evaluating the use of the da Vinci Surgical System in Inguinal Hernia Repair procedures compared with open surgical procedures was conducted. This study included 652 and 602 subjects in the robotic-assisted and open cohorts, respectively, and was conducted at six (6) investigational sites in United States. Post operative data was collected throughout the thirty (30) day follow up period. Longer term endpoints such as inguinal hernia repair recurrence and chronic pain were not assessed in this study, and thus no claims regarding these clinical outcomes data should be inferred. The results demonstrated the safety and effectiveness of robotic-assisted inguinal hernia repair procedures. Additionally, such data provides information comparing the use of the da Vinci System in Inguinal Hernia Repair procedures with open surgery in the following key measures:
- Length of Stay: comparable outpatient and inpatient lengths of hospital stay were reported for both the robotic-assisted and open cohorts. A statistically lower inpatient length of stay was found when propensity matched analysis was conducted.
- Intraoperative Complications: comparable intraoperative complication rates were reported for both the robotic-assisted and open cohorts.
- Transfusions: comparable blood transfusion rates were reported in both cohorts.
- Postoperative Complications through Discharge: comparable postoperative through discharge complication rates were reported for both the robotic-assisted and open cohorts.
- Postoperative Complications (Discharge through 30 days) -: a lower rate of postoperative complications from discharge through 30 day follow up was reported for the robotic-assisted cohort as compared to the open cohort.
- Readmission Rates: comparable readmission rates were reported for both the robotic-assisted and open cohorts.
- Reoperation Rates (Postoperative to Discharge): comparable reoperation rates were reported for the robotic-assisted cohort as compared to the open cohort.
- Reoperation Rates (Discharge through 30 days): lower reoperation rates were reported for the robotic-assisted cohort as compared to the open cohort. This statistically lower rate of reoperations was not observed in the propensity matched analysis. The results of the propensity matched analysis showed comparable reoperation rates.
- Mortality: comparable mortality rates were reported in both cohorts.
- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to open surgery.
The data from both cohorts of the retrospective study are compared to data on laparoscopic procedures from eleven (11) publications referenced in Bittner, et al., "Update of guidelines on laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia (International Endohernia Society", Chapter 4: "TEP versus TAPP: which is better?" Surg Endosc 29:289-321 (2015).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length of Stay (Inpatient and Outpatient)
- Intraoperative Complications
- Transfusions (Intraoperative and Perioperative)
- Postoperative Complications (Postop to discharge, Post discharge to 30 days)
- Readmission Rates
- Reoperation Rates (Postop to discharge, Post discharge to 30 days)
- Mortality
- Operative Time
- Adverse Events
- All Complications
- Conversion Rate
Predicate Device(s)
Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, K152578, K153276, K161178), and Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2017
Intuitive Surgical, Inc. % Ms. Cindy Domecus Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K170713
Trade/Device Name: da Vinci Xi Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: March 7, 2017 Received: March 9, 2017
Dear Ms. Domecus:
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. The general controls provisions of the Actinclude 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System. Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic 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 laparossopic 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 pediatic 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary (21 CFR § 807.92(c))
I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc. | ||
|---|---|---|---|
| 1266 Kifer Road | |||
| Sunnyvale, CA 94086 | |||
| Contact: | Cindy Domecus, R.A.C. (US & EU) | ||
| Principal, Domecus Consulting Services LLC | |||
| Chief Regulatory Advisor to Intuitive Surgical | |||
| Telephone: 650.343.4813 | |||
| Fax: 650.343.7822 | |||
| Email: domecusconsulting@comcast.net | |||
| Date Summary Prepared: | June 1, 2017 | ||
| II. SUBJECT DEVICE INFORMATION | |||
| Device Trade Name: | da Vinci® Surgical System, Model IS4000 | ||
| Common Name: | System, Surgical, Computer Controlled Instrument | ||
| Classification Name: | Endoscope and Accessories (21 CFR §876.1500) | ||
| Regulatory Class: | II | ||
| Product Code: | NAY |
Traditional 510(k)
III. PREDICATE DEVICE INFORMATION:
Following are the two predicate devices for this 510(k):
Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, K152578, K153276, K161178), and Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)
IV. DEVICE DESCRIPTION:
Submission Type:
This 510(k) is for a labeling modification only, to include "Inguinal Hernia Repair" procedures under the cleared "general laparoscopic surgical procedures" indication for the da Vinci Xi Surgical System (K131861). There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000, is a softwarecontrolled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.
V. INDICATIONS FOR USE
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) 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 surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy
4
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 was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) 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. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System (IS4000) proposed in this submission.
VII. PERFORMANCE DATA
Pre-Clinical Animal Study Data
This premarket notification is supported by animal study data including the results from six (6) evaluations in a total of 24 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Pyeloplasty, Nephrectomy, Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were submitted in support of clearance of the da Vinci Xi Surgical System (K131861).
Clinical Study Data
A retrospective, multi-center, non-randomized controlled clinical study evaluating the use of the da Vinci Surgical System in Inguinal Hernia Repair procedures compared with open surgical procedures was conducted. This study included 652 and 602 subjects in the robotic-assisted and open cohorts, respectively, and was conducted at six (6) investigational sites in United States. Post operative data was collected throughout the thirty (30) day follow up period. Longer term endpoints such as inguinal hernia repair recurrence and chronic pain were not assessed in this study, and thus no claims regarding these clinical outcomes data should be inferred. The results demonstrated the safety and effectiveness of robotic-assisted inguinal hernia repair procedures. Additionally, such data provides information comparing the use of the da Vinci System in Inguinal Hernia Repair procedures with open surgery in the following key measures :
- Length of Stay: comparable outpatient and inpatient lengths of hospital stay were reported for both the robotic-assisted and open cohorts. A statistically lower inpatient length of stay was found when propensity matched analysis was conducted.
- Intraoperative Complications: comparable intraoperative complication rates were reported for both the robotic-assisted and open cohorts.
- Transfusions: comparable blood transfusion rates were reported in both cohorts.
- Postoperative Complications through Discharge: comparable postoperative through discharge complication rates were reported for both the robotic-assisted and open cohorts.
4 Propensity matched results are the same as the reported outcomes unless stated otherwise.
5
- Postoperative Complications (Discharge through 30 days) -: a lower rate of postoperative complications from discharge through 30 day follow up was reported for the robotic-assisted cohort as compared to the open cohort.
- Readmission Rates: comparable readmission rates were reported for both the robotic-assisted and open cohorts.
- Reoperation Rates (Postoperative to Discharge): comparable reoperation rates were reported for the robotic-assisted cohort as compared to the open cohort.
- Reoperation Rates (Discharge through 30 days): lower reoperation rates were reported for the robotic-assisted cohort as compared to the open cohort. This statistically lower rate of reoperations was not observed in the propensity matched analysis. The results of the propensity matched analysis showed comparable reoperation rates.
- Mortality: comparable mortality rates were reported in both cohorts.
- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to open surgery .
The data from both cohorts of the retrospective study are compared to data on laparoscopic procedures from eleven (11) publications referenced in Bittner, et al., "Update of guidelines on laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia (International Endohernia Society", Chapter 4: "TEP versus TAPP: which is better?" Surg Endosc 29:289-321 (2015).
² Based on the results of the multivariate analysis, age greater than 65 years, presence of comorbidities and open inguinal hernia repair are associated with a higher likelihood of a postoperative complication within 30 days of surgery. Furthermore, propensity matched analyses showed that age greater than 65 years and open inguinal hernia are associated with a higher likelihood of a postoperative complication within 30 days of surgery.
The longer operative time for the robotic-assisted cohort was not associated with increases in the complication, readmission, reoperation or mortality rates.
6
| Outcome | Robotic-Assisted
Cohort N=6521 | Open Cohort
N=6021 | Laparoscopic
Cohort N = 20 – N
= 3,4572 |
|-------------------------------------|-----------------------------------|------------------------|-----------------------------------------------|
| Patient Demographics | | | |
| Mean age, y (± SD or range) | 55.8 ± 15.6 | 57.2 ± 16.6 | 34.91 – 62.3 |
| Female Gender, n (%) | 64 (9.8) | 60 (10.0) | 0 – 6.1% |
| Male Gender, n (%) | 588 (90.2) | 542 (90.0) | 88 – 100% |
| Mean BMI, kg/ m2 (± SD or range) | 27.3 ± 5.1 | 26.7 ± 5.0 | 22.4 – 26.8 |
| Length of Stay | | | |
| Inpatient (days) | 3.01 ± 4.65 (n=52) | 4.866 ± 5.35
(n=51) | 0.8 – 5 days |
| Outpatient (hours) | 7.16 ± 3.01 | 6.89 ± 2.77 | |
| Intraoperative Complications, n (%) | 2 (0.3) | 0 | 0 – 8% |
| Transfusions, n (%) | | | |
| Intraoperative | 0 | 0 | Not Reported |
| Perioperative | 2 (0.3) | 2 (0.3) | |
| Postoperative Complications, n (%) | | | |
| Postop to discharge | 15 (2.3) | 10 (1.7) | 0 – 36%2a |
| Post discharge to 30 days | 28 (4.3) | 44 (7.3)7 | |
| Readmission Rates, n (%)* | 23 (3.5) | 26 (4.3)9 | Not Reported |
| Reoperation Rates | | | |
| Postop to discharge | 3 (0.5)* | 2 (0.3)* | 0 – 2.5%2a |
| Post discharge to 30 days | 0* | 8 (1.3)*8 | |
| Mortality, n | 0 | 1 | 0 |
| Operative Time, min (± SD or range) | 79.7 ± 31.7 | 45.0 ± 21.7 | 32.6 – 110 |
| Adverse Events, n3 | 44 | 4910 | Not Applicable |
| All Complications, n (%)4 | 45 (6.9) | 51 (8.5)11 | 7.9 – 8.7% |
| Conversion Rate, n (%) | 6 (0.9) | Not Applicable | 0 – 4% |
| TABLE 1: da Vinci, Open and Laparoscopic Inguinal Hernia Repair | ||||
|---|---|---|---|---|
| ----------------------------------------------------------------- | -- | -- | -- | -- |
*Related to Inguinal Hernia Repair Procedure
් Data from a retrospective, multi-center, non-randomized clinical study evaluating the use of the da Vinci Surgical System in Inguinal Hernia Repair procedures compared with open surgical procedures. This table includes all subjects with complete data (missing data is omitted), despite propensity scores showing that one third of investigational subjects did not have an appropriate match among control subjects and large site to site differences.
් Data from eleven (11) publications referenced in Bittner, et al., "Update of guidelines on laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia (International Endohernia Society", Chapter 4: "TEP versus TAPP: which is better?" Surq Endosc 29:289-321 (2015).
4 Post operative complications and reoperation rates were not segregated by specific timeframes. [Note: One publication (Bracale, et al (2012) reported only relative risk and mean differences for post operative complications and operative time / length of stay.]
് Adverse Events defined as death or serious injury (i.e., Clavien Grade Illa or higher). Publications cited in Bittner, et al. did not categorize complications/events by severity (i.e., serious).
All complications defined as all intraoperative complications for the robotic-assisted and open cohorts. In the laparoscopic cohort, one publication cited in Bittner, et al reported "overall morbidity".
3Inguinal hernia recurrence and chronic pain were not assessed in this study.
6 The results are heavily influenced by one site. See also other footnotes below. Without this site, the mean number of inpatient days for open procedures is 3.00.
728/44 complications came from one of the 6 sites.
8 Of the 10 reoperations, 80% (8/10)were done at one site.
ి14/26 readmissions were at one site
10 30/49 AEs occurred at one site
14 30/51 were reported at one site.
7
VIII. CONCLUSION
Based on the information provided in this premarket notification, the inclusion "Inguinal Hernia Repair" procedures under the da Vinci Xi Surgical System "general laparoscopic surgical procedure" indication is substantially equivalent to the predicate devices. The basis of this substantial equivalence determination was an assessment of the immediate post-operative outcomes comparing the robotic-assisted surgery inguinal hernia repair versus laparoscopic surgery inguinal hernia repair.