(212 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000 and 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.
The modifications to the da Vinci Xi and X Surgical Systems adds a hardware component called the Advanced Processor (AP4000) as well software components, both on the Advanced Processor and a separate iOS app, to the surgical system.
These modifications enable the following functionality: Video recording/Image capture, WiFi pairing of iOS devices with the Advanced Processor, an iOS app to view live endoscopic video once the iOS device has been paired and data logging on the AP4000 hard disk (stereo endoscopic video, kinematics and real time events). This allows surgeons to initiate and control video recordings as well as capture endoscopic images. These modifications also allow OR staff and others present in the OR to pair their iOS mobile devices with the Advanced Processor in order to view the live endoscopic video.
This FDA 510(k) summary describes modifications to the da Vinci Xi and X Surgical Systems, not a new AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies and acceptance criteria is not applicable to this document. The document focuses on regulatory clearance for hardware and software modifications that enhance existing functionalities of a robotic surgical system, rather than an AI-driven diagnostic or treatment recommendation system requiring clinical performance studies against a ground truth.
Specifically, the modifications enable:
- Video recording/Image capture.
- WiFi pairing of iOS devices with an Advanced Processor.
- An iOS app to view live endoscopic video.
- Data logging (stereo endoscopic video, kinematics, real-time events).
The submission asserts that these modifications do not affect the substantial equivalence of the device to its predicate because "verification and validation testing have established there are no new issues of safety or effectiveness."
Here's an attempt to answer the questions based on the provided document, highlighting what is not applicable due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for modifications to an existing device, and not a new diagnostic or prognostic AI/ML device, there are no specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) reported in this document. The "acceptance criteria" for these modifications appear to be successful completion of verification and validation testing, and compliance with relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| All required specifications met | "The subject device met all required specifications and functioned as intended." |
| Functioned as intended | "The modifications enable the following functionality: Video recording/Image capture, WiFi pairing of iOS devices with the Advanced Processor, an iOS app to view live endoscopic video once the iOS device has been paired and data logging on the AP4000 hard disk (stereo endoscopic video, kinematics and real time events)." and "These modifications do not affect the substantial equivalence of the subject device to the predicate as verification and validation testing have established there are no new issues of safety or effectiveness." |
| Safety and performance evaluated/verified | "Safety and performance of the da Vinci Xi/X Surgical System has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." |
| Compliance with IEC 62304:2006/AC:2015 | "software validation activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software - Software life cycle processes" |
| Compliance with FDA Guidance for Software in Medical Devices | "in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."" |
| Compliance with EMC, Electrical Safety, and Wireless Coexistence | "electromagnetic compatibility testing (in accordance with ISO 60601-1-2:2015 / IEC 60601-1-2:2014), electrical safety testing (in accordance with IEC 60601-1: 2012) and wireless coexistence testing were performed." |
| No new questions of safety or effectiveness | "The da Vinci Xi/X Surgical System raises no new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes verification and validation testing of software and hardware modifications for a robotic surgical system, not a clinical study involving a test set of patient data for an AI/ML diagnostic or prognostic algorithm. The testing would involve engineering and software validation tests, not clinical data sets in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth establishment by experts is relevant for AI/ML algorithms performing tasks like diagnosis or detection. The current submission focuses on verifying the functionality and safety of video recording, streaming, and data logging features.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device provides tools for surgeons (video recording, streaming), but it is not an AI assistant meant to improve human reader performance in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The modifications are for a human-controlled surgical system, enhancing its capabilities rather than introducing a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" for the verification and validation of these modifications would be the functional specifications and safety requirements met through engineering and software testing.
8. The sample size for the training set
This information is not applicable. This document does not pertain to the development or validation of an AI/ML algorithm that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable. As no AI/ML training set is mentioned or implied, the method for establishing its ground truth is irrelevant to this submission.
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April 29, 2020
Intuitive Surgical Crystal Ong Senior Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K192803
Trade/Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: March 11, 2020 Received: March 12, 2020
Dear Crystal Ong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Je Hi An, Ph.D. Acting 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
Enclosure
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Indications for Use
510(k) Number (if known) K192803
Device Name da Vinci Xi Surgical System - Model IS4000
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi 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, 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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Indications for Use
510(k) Number (if known) K192803
Device Name da Vinci X Surgical System - Model IS4200
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, 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 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
[As Required by 21 CFR 807.92(c)]
September 27, 2019
| Submitter: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Official Contact: | Crystal Ong |
| Sr. Regulatory Engineer | |
| Ph: 408-523-8636 | |
| Fax: 408-523-8907 | |
| Trade Name: | da Vinci Xi Surgical System, da Vinci X Surgical System |
| Common Name: | system, surgical, computer controlled instrument |
| Classification: | Endoscope and Accessories (21 CFR 876.1500), NAY |
| Predicate Device: | da Vinci Surgical System (Model Xi), K131861; da Vinci Surgical System(Model X), K171294 |
Device Description: The modifications to the da Vinci Xi and X Surgical Systems adds a hardware component called the Advanced Processor (AP4000) as well software components, both on the Advanced Processor and a separate iOS app, to the surgical system.
These modifications enable the following functionality: Video recording/Image capture, WiFi pairing of iOS devices with the Advanced Processor, an iOS app to view live endoscopic video once the iOS device has been paired and data logging on the AP4000 hard disk (stereo endoscopic video, kinematics and real time events). This allows surgeons to initiate and control video recordings as well as capture endoscopic images. These modifications also allow OR staff and others present in the OR to pair their iOS mobile devices with the Advanced Processor in order to view the live endoscopic video.
Intended Use/Indications for Use:
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These hardware and software modifications are compatible with both the da Vinci Xi Surgical System Model IS4000 and the da Vinci X Surgical System Model IS4200. Indications for Use statements are identical except for the name of the surgical system.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000 and 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.
Technological Characteristics: The da Vinci Xi/X Surgical System is equivalent to the predicate device in terms of its indications for use, design, technology, and performance specifications. Modifications from the predicate include the ability to stream live endoscopic images to users' iOS devices (via the Streme app), and the ability to record still and endoscopic video. These modifications do not affect the substantial equivalence of the subject device to the predicate as verification and validation testing have established there are no new issues of safety or effectiveness.
Performance Data: The da Vinci Xi/X Surgical System modifications were verified and validated according to a Major Level of Concern software device. The subject device met all required specifications and functioned as intended. Safety and performance of the da Vinci Xi/X Surgical System has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices.". Additional testing, such as electromagnetic compatibility testing (in accordance with ISO 60601-1-2:2015 / IEC 60601-1-2:2014), electrical
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safety testing (in accordance with IEC 60601-1: 2012) and wireless coexistence testing were performed.
Summary: The da Vinci Xi/X Surgical System raises no new questions of safety or effectiveness. Based on the intended use, technical characteristics, and performance data, the modified da Vinci Xi/X Surgical System is equivalent to the predicate device in terms of safety, effectiveness, and performance.
§ 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.