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, 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 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.

da Vinci X system (Model IS4200)

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, 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 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.

The subject IS4000/IS4200 Endoscope Plus is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

Device Description

Similar to the predicate device, the subject IS4000/IS4200 Endoscope Plus is a reusable, sterilizable unit that includes two cameras (left and right eyes) and an integrated cable to connect the endoscope to the Endoscope Controller. The two cameras generate the stereo image of the surgical site. Both the subject and the predicate device endoscopes include light fibers that transmit light from the light source in the Endoscope Controller into the surgical field. Similar to the predicate device, the subject endoscope, can be used laparoscopically (hand-held) at the start of a surgery and then be installed on any Patient Cart Arm. Both the subject and the predicate endoscopes are available in two configurations, 0° and 30° tip angle. However, the subject device has a few design modifications as compared to the predicate device. Some of the design modifications include new image sensor, modified optical assembly, new PCA board, modified thermal management design, and modified cable design.

AI/ML Overview

This 510(k) summary describes a new version of the da Vinci Xi/X Endoscope Plus, an endoscopic instrument for robotic-assisted surgery. It is a re-submission of a previous device (K171426) with several design modifications.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding reported device performance values. Instead, it describes general categories of testing and confirms that the device meets those requirements.

Acceptance Criteria Category	Reported Device Performance
Physical Specifications	Confirmed to meet design input requirements.
Mechanical Specifications	Confirmed to meet design input requirements.
Electrical Specifications	Confirmed to meet design input requirements.
User Interface Specifications	Confirmed to meet design input requirements.
Software Specifications	Confirmed to meet design input requirements.
General Functional Requirements	Validated.
Interaction (Compatibility) Requirements	Validated.
Electrical Safety	Testing performed to confirm proposed design modifications do not raise new questions of safety and effectiveness.
EMC Compatibility	Testing performed to confirm proposed design modifications do not raise new questions of safety and effectiveness.
Intended Use Performance	Functioning in accordance with its intended use (confirmed through animal model testing).

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes for any of the tests, nor does it explicitly mention the provenance (country of origin, retrospective/prospective) of any data beyond indicating "testing with an animal model was performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not describe the use of experts to establish ground truth for any test set. The validation appears to rely on engineering and animal model testing rather than human expert interpretation of results for performance metrics like sensitivity or specificity.

4. Adjudication method for the test set

Not applicable, as there's no mention of human-interpreted test sets requiring adjudication.

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

Not applicable. This device is an endoscope, a piece of hardware, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm, but a physical device. Performance testing was done on the device itself and its interaction with the da Vinci surgical system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance claims appears to be based on:

Pre-defined design input requirements for physical, mechanical, electrical, user interface, and software specifications.
The expected functional behavior of the device as demonstrated in an animal model.

8. The sample size for the training set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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July 26, 2019

Intuitive Surgical, Inc. Vishal Kanani Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K191736

Trade/Device Name: da Vinci X/Xi 8mm Endoscope Plus, 0 degree, da Vinci X/Xi 8mm Endoscope Plus, 30 degree Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: June 24, 2019 Received: June 28, 2019

Dear Vishal Kanani:

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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191736

Device Name

da Vinci Xi/X Endoscope Plus, 0 degree, da Vinci Xi/X Endoscope Plus, 30 degree

Indications for Use (Describe)

da Vinci Xi system (Model IS4000)

da Vinci X system (Model IS4200)

X 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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ട 510(k) Summarv

[As Required by 21 CFR 807.92(c)]

June 24, 2019

Submitter: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 Official Contact: Vishal Kanani Sr. Regulatory Affairs Specialist Ph: 408-523-2035 Fax: 408-523-8907 da Vinci Xi/X Endoscope Plus, 0º (PN 470056); Trade Name: da Vinci Xi/X Endoscope Plus, 30º (PN 470057) Common Name: Endoscopic instrument control system, endoscopic instruments and accessories Classification name Endoscope and accessories Regulation: 21 CFR 876.1500 Product Code: NAY and GCJ Predicate Device: da Vinci Xi/X 8mm Endoscope, 0º (K171426); da Vinci Xi/X 8mm Endoscope, 30º (K171426)

Device Description:

INTUITIVE

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device. Some of the design modifications include new image sensor, modified optical assembly, new PCA board, modified thermal management design, and modified cable design.

Intended Use:

The subject IS4000/IS4200 Endoscope Plus is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

Indications for Use:

da Vinci Xi system (Model IS4000)

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, 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.

da Vinci X system (Model IS4200)

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.

INTUITIVE

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Technological Characteristics:

The subject IS4000/IS4200 Endoscope Plus is equivalent to its predicate, IS4000/IS4200 8mm Endoscope in terms of its indications for use, intended use, design, technology, and performance specifications. The subject device has a few design modifications as compared to the predicate device such as new image sensor, modified optical assembly, new PCA board, modified thermal management design, and modified cable design.

Performance Data:

Design Verification and Validation were performed on the subject IS4000/IS4200 Endoscope Plus to demonstrate that the design outputs meet the design inputs and the device performs as intended.

Design Verification: The subject device was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the device meets the physical, mechanical, electrical, user interface and software specifications.

Design Validation:

The design validation testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Testing with an animal model was performed to confirm that the subject device functions in accordance with its intended use.

Electrical Safety and EMC Compatibility:

Electrical safety and EMC Compatibility testing were performed on the subject device to confirm that the proposed design modifications do not raise new questions of safety and effectiveness.

Summary:

Based on the intended use, technical characteristics, and performance data, the subject IS4000/IS4200 Endoscope Plus is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.

Regulation Number and Section

§ 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.