(24 days)
No
The description focuses on the electro-mechanical control system and software for surgeon-controlled manipulation of instruments, with no mention of AI or ML algorithms for image analysis, decision support, or autonomous functions. The software testing mentioned is general verification/validation, not specific to AI/ML.
Yes
The device is a surgical system intended to assist in the manipulation of tissues during surgical procedures, which are forms of therapy.
No
The device is described as a surgical system "intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments" for performing various surgical tasks such as grasping, cutting, and suturing. Its primary function is to manipulate tissue during surgical procedures, not to diagnose conditions.
No
The device description clearly outlines multiple hardware components including a Surgeon Console, Patient Cart, Vision Cart, endoscope, and instruments. While software is mentioned as controlling the system, it is an integral part of a larger electro-mechanical system, not a standalone software device.
Based on the provided information, the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the system as assisting in the control of surgical instruments for performing various surgical procedures on patients. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details a surgical system with a surgeon console, patient cart, and vision cart used with instruments and an endoscope to perform surgery. This aligns with a surgical robot system, not a device used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
Therefore, the da Vinci X Surgical System is a surgical device used for performing procedures on patients, not an IVD device used for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model 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 revascularization.
Product codes
NAY
Device Description
The da Vinci X Surgical System, Model IS4200 is a modification to the Patient Side Cart of the da Vinci Xi Surgical System, Model IS4000, cleared under K131861. The arms of the IS4000 have been grafted onto the setup structure of the da Vinci Si Surgical System Patient Cart (K081137). The da Vinci X Patient Cart utilizes the same electronics as the da Vinci Xi Patient Cart with some minor modifications. The da Vinci X Patient Cart is run by the same software and is to be used with the Surgeon Console and Vision Cart of the da Vinci Xi Surgical System. All of the da Vinci Xi instruments and accessories, including advanced instruments (e.g., Single Site, Vessel Sealer, Stapler, etc.), are compatible with the da Vinci X Surgical System.
The da Vinci X Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The da Vinci X Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an Endoscope, EndoWrist Instruments, and Accessories.
The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes the supporting electronic and video processing equipment for the system.
The Patient Side Cart is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system. The da Vinci X Surgical System Patient Cart has the same arms as the da Vinci Xi Surgical System Patient Cart and is compatible with all of the base, Single-Site, and advanced instruments and accessories (with the exception of the column drape) cleared for use with the da Vinci Xi Surgical System (K131861).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic
Anatomical Site
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.
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)
Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. Hardware verification, human factors testing, and preclinical validation testing were performed. Software testing was also conducted to support this modification. The software testing included user interface, algorithm, and software verification/validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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May 26, 2017
Intuitve Surgical, Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K171294
Trade/Device Name: da Vinci X Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: April 28, 2017 Received: May 2, 2017
Dear Mr. Hansen:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
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1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
da Vinci® X Surgical System
Special 510(k): Device Modification
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K171294 |
|---|---|
| Device Name | da Vinci X Surgical System |
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model 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
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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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da Vinci® X Surgical System
Special 510(k): Device Modification
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510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brandon Hansen
Regulatory Affairs
Phone Number: 408-523-7485
Fax Number: 408-523-8907
Email: brandon.hansen@intusurg.com |
| Date Summary Prepared: | May 1, 2017 |
| Trade Name: | da Vinci® X Surgical System |
| Common Name: | Endoscopic instrument control system |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | da Vinci® Xi™ Surgical System device, K131861 |
Device Description
The da Vinci X Surgical System, Model IS4200 is a modification to the Patient Side Cart of the da Vinci Xi Surgical System, Model IS4000, cleared under K131861. The arms of the IS4000 have been grafted onto the setup structure of the da Vinci Si Surgical System Patient Cart (K081137). The da Vinci X Patient Cart utilizes the same electronics as the da Vinci Xi Patient Cart with some minor modifications. The da Vinci X Patient Cart is run by the same software and is to be used with the Surgeon Console and Vision Cart of the da Vinci Xi Surgical System. All of the da Vinci Xi instruments and accessories, including advanced instruments (e.g., Single Site, Vessel Sealer, Stapler, etc.), are compatible with the da Vinci X Surgical System.
The da Vinci X Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The da Vinci X Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an Endoscope, EndoWrist Instruments, and Accessories.
The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which
4
K171294
da Vinci® X Surgical System
provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes the supporting electronic and video processing equipment for the system.
The Patient Side Cart is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system. The da Vinci X Surgical System Patient Cart has the same arms as the da Vinci Xi Surgical System Patient Cart and is compatible with all of the base, Single-Site, and advanced instruments and accessories (with the exception of the column drape) cleared for use with the da Vinci Xi Surgical System (K131861).
Intended Use/Indications for Use:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model 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.
Technological Characteristics:
In terms of technological characteristics, the da Vinci X Surgical System is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861. The da Vinci X Surgical System uses the same Surgeon Console, Vision Cart, Software, Instruments, and Accessories as the predicate da Vinci Xi Surgical System.
Performance Data:
Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. Hardware verification, human factors testing, and preclinical validation testing were performed. Software
5
da Vinci@ X Surgical System
Special 510(k): Device Modification
testing was also conducted to support this modification. The software testing included user interface, algorithm, and software verification/validation testing.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci X Surgical System is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861.
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