(269 days)
No
The document explicitly states "There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission." and does not mention AI or ML in the description or performance studies.
Yes
The device is described as assisting in the accurate control of surgical instruments for manipulation of tissue and delivery/placement of probes during various surgical procedures, indicating direct involvement in treatment, thus classifying it as a therapeutic device.
No.
This device is an instrument control system intended to assist in the manipulation of tissue during various surgical procedures. It is not described as analyzing or interpreting data to provide a diagnosis.
No
The device description explicitly states that the da Vinci Xi Surgical System is a "software-controlled, electro-mechanical system" and consists of hardware components like a Surgeon Console, Patient Side Cart, and Vision Side Cart. This indicates it is not a software-only device.
Based on the provided text, 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 minimally invasive surgical procedures on patients. This involves manipulating tissues, using instruments, and controlling endoscopes within the patient's body.
- Device Description: The device description details a software-controlled, electro-mechanical system consisting of a console, patient cart, and vision cart, used with instruments and an endoscope. This is consistent with a surgical robot, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue samples, etc.)
- Providing information about a patient's health status based on the analysis of specimens
- Reagents, calibrators, or controls used for testing
The device is clearly intended for direct surgical intervention on a living patient, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System, Model IS4000) 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, 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 laparosopic 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.
Product codes
NAY
Device Description
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" general indication for the da Vinci Xi Surgical System (K131861): Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection and Lymphadenectomy. 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 software-controlled, 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 pediatric
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)
Pre-Clinical Animal Study Data: Animal performance data were provided, including results from three (3) evaluations in a total of twenty (20) animals demonstrating use of da Vinci Xi Surgical System in Lung Resection and Lobectomy procedures.
Clinical Study Data: Published clinical data support use of the da Vinci Xi Surgical System for the representative, specific procedures that fall under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" Indication for Use.
Umbrella Procedures: Published clinical data were provided for Lobectomy, Mediastinal Mass Resection and Thymectomy. Forty (40) publications were identified based on specific search criteria and filters. These publications included retrospective, comparative and single arm studies.
Lobectomy: da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable complications; comparable or lower blood transfusion rates; and comparable or shorter lengths of hospital stay as compared to both open and VATS surgical procedures. Five (5) studies reported comparable or shorter operative times for da Vinci-assisted procedures; thirteen (13) publications noted increased operative times, but this increase did not correlate with an increase in mortality rates. Comparable or lower conversion rates for da Vinci-assisted procedures as compared to VATS procedures.
Mediastinal Mass Resection: Comparative publications demonstrate that da Vinci-assisted procedures are associated with comparable mortality rates and operative times, comparable or lower complication rates and comparable or shorter lengths of hospital stay as compared to open surgical procedures. Data from five (5) single-arm studies using the da Vinci System for mediastinal mass resection procedures demonstrate that use of the da Vinci System can be accomplished with no reports of mortality and low complication rates. Intraoperative complications were
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The profiles are arranged in a row, facing to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2016
Intuitive Surgical, Inc. % Ms. Cindy Domecus Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services, LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K153276
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: July 15, 2016 Received: July 18, 2016
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 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 yours,
Christopher J. Ronk -S
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) K153276
Device Name
da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System, Model IS4000) 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, 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 laparosopic 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.
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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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: | August 1, 2016 |
| 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 |
| Submission Type: | Traditional 510(k) |
| III. PREDICATE DEVICE INFORMATION: | |
Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, Predicate Device:
K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)
IV. DEVICE DESCRIPTION:
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" general indication for the da Vinci Xi Surgical System (K131861): Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection and Lymphadenectomy. 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 software-controlled, 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
4
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 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 do Vinci Xi Surgical System (IS4000) proposed in this submission.
VII. PERFORMANCE DATA
Pre-Clinical Animal Study Data
Animal performance data were provided in this premarket notification, including the results from three (3) evaluations in a total of twenty (20) animals demonstrating use of da Vinci Xi Surgical System in Lung Resection and Lobectomy procedures. These data were also submitted in support of clearance of two (2) Xi EndoWrist Staplers (K140553 and K152421).
Clinical Study Data
Published clinical data support use of the da Vinci Xi Surgical System for the representative, specific procedures that fall under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the more complex/higher risk representative, specific procedures (referred to as "umbrella" procedures). The published data on these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk procedures (referred to as "covered" procedures), so published clinical data on the covered procedures were not provided.
Umbrella Procedures
Published clinical data were provided for the following umbrella procedures: Lobectomy, Mediastinal Mass Resection and Thymectomy. Forty (40) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included retrospective, comparative and single arm studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-3 below.
The findings from the Lobectomy publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable complications; comparable or lower blood transfusion rates; and comparable or shorter lengths of hospital stay as compared to both open and VATS surgical procedures. Five (5) studies reported comparable or shorter operative times for da Vinci
5
assisted procedures as compared to VATS procedures. Thirteen (13) publications noted increased operative times in the da Vinci-assisted procedures as compared to open and VATS procedures; however, this increase did not correlate with an increase in the reported mortality rates. Lastly, these publications report comparable or lower conversion rates for da Vinci-assisted procedures as compared to VATS procedures.
Outcomes reported in the Mediastinal Mass Resection comparative publications demonstrate that da Vinci-assisted procedures are associated with comparable mortality rates and operative times, comparable or lower complication rates and comparable or shorter lengths of hospital stay as compared to open surgical procedures. Data from five (5) publications reporting on single-arm studies using the da Vinci System for mediastinal mass resection procedures demonstrate that use of the da Vinci System can be accomplished with no reports of mortality and low complication rates. Intraoperative complications were 24 hours; ^Return to OR; *Intraoperative values; **Air leak > 5 days; ^^Bleeding requiring reoperation; Major Complications; *Authors reported all complications which included latrogenic Complications (i.e., Intraoperative Complications)
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TABLE 2: Comparison of da Vinci vs. Open and Single Arm Mediastinal Mass Resection Procedures
*Mean or median reported
TABLE 3: Comparison of da Vinci vs. Open and VATS and Single Arm Thymectomy Procedures
| Publications | Sample Size (N) | Operative Time (minutes)* | Transfusions (%) and/or EBL (ml) | Length of Stay (days)* | Complications (%) |
|---|---|---|---|---|---|
| 1. Weksler (2011) da Vinci | 15 | 130.0 | 41.67 ml | 1.0 | 6.7 |
| Open | 35 | NR | 151.43 ml | 4.0 | 57.1 |
| 2. Ye (2014) da Vinci | 23 | 97.0 | 0% / 61.3 ml | 3.7 | 4.3 |
| Open | 51 | 214.5 | 0% / 466.1 ml | 11.6 | 3.9 |
| 3. Renaud (2013) da Vinci | 6 | 189.2 |