The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System, Model IS4000) and the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model 154200) 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.

Device Description

The da Vinci XXi (IS4200/IS4000) 8mm EndoWrist Instruments have a unique articulating design at their distal tips the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, or tissue manipulation.

AI/ML Overview

This document describes the 510(k) premarket notification for the da Vinci Xi/X (IS4200/IS4000) 8mm Reusable Instruments. The submission focuses on changes to the labeling regarding an increased number of lives (uses) and reprocessing cycles for these instruments.

Here's a breakdown of the requested information:

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

The document does not explicitly state numerical acceptance criteria for each test in a table format, nor does it provide quantitative performance data for the subject device beyond stating that it "successfully met the acceptance criteria" or "meet the requirements." However, the general types of tests and their objectives serve as implicit acceptance criteria.

Type of Test	Implicit Acceptance Criteria (Objective)	Reported Device Performance
Cleaning Validation	Efficacy of manual and automated cleaning processes, meeting standards and guidance (FDA Guidance: "Reprocessing Medical Devices in Health Care Settings...", AAMI TIR 12:2020, AAMI TIR 30:2011/(R)2016, ANSI/AAMI ST15883-1:2009/(R)2014)	"The da Vinci X/Xi 8mm Reusable Instruments successfully met the acceptance criteria for all markers. The test results demonstrate that the da Vinci X/Xi 8mm Reusable Instruments can be cleaned using the following cleaning methods: Automated cleaning process using a compatible automated washer/disinfector. Manual cleaning process using an ultrasonic bath."
Reliability/Life Testing	Instruments are not adversely affected by the increased number of lives (uses) and reprocessing cycles specified in Table 1.	"Reliability/Life Testing was performed to ensure that da Vinci X/Xi 8mm Reusable Instruments are not adversely affected by the increased number of lives (uses) and reprocessing cycles for these as listed in Table 1." (It implicitly states they did ensure this by performance of the test, and the conclusion states substantial equivalence, meaning criteria were met).
Electrical Performance Testing	Meet requirements within the FDA guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued March 9, 2020, after multiple reuse and reprocessing cycles.	"This testing was performed to ensure the da Vinci X/Xi 8mm Extended Lives Instruments family (subject devices as listed in Table 1) meet the requirements within the FDA guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, Document Issued on March 9, 2020." (Implies requirements were met).
Thermal Effects Testing	Thermal effects on tissue are comparable between the subject and predicate devices, in accordance with the FDA guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued March 9, 2020.	"Thermal Effects testing was performed to confirm that thermal effects on tissue are comparable between the subject and predicate devices. The testing was performed in accordance with the FDA guidance, 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery', Document Issued on March 9, 2020." (Implies comparability was confirmed and guidance met).

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

The document does not specify exact sample sizes (e.g., number of instruments tested) for any of the performance tests (Cleaning Validation, Reliability/Life Testing, Electrical Performance Testing, Thermal Effects Testing). The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not mentioned, but the tests described are typically prospective, laboratory-based engineering and validation tests conducted by the manufacturer.

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

This information is not provided. The tests described are engineering and laboratory performance tests, not clinical studies involving expert interpretation of medical data (like imaging). The "ground truth" for these types of tests is generally defined by calibrated measurements against established standards and specifications, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The described tests are objective performance evaluations against predefined standards, not a review of clinical outcomes or imaging by experts.

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 document pertains to the reusability and safety of surgical instruments, not an AI-assisted diagnostic or interpretative device.

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

Not applicable. This document is about surgical instruments, not an algorithm.

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

For the performance tests:

Cleaning Validation: The ground truth is the absence of biological contaminants and residues, measured against specific acceptance criteria defined by industry standards (AAMI TIR 12, AAMI TIR 30, ANSI/AAMI ST15883-1) and FDA guidance for reprocessing.
Reliability/Life Testing: The ground truth is the continued functionality and integrity of the instruments after the increased number of uses and reprocessing cycles, as compared to design specifications.
Electrical Performance Testing: The ground truth is adherence to electrical safety and performance parameters outlined in FDA guidance for electrosurgical devices.
Thermal Effects Testing: The ground truth is comparability of thermal effects to the predicate device, consistent with FDA guidance for electrosurgical devices.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

August 15, 2022

Intuitive Surgical, Inc. Kunal Gunjal Sr. Regulatory Affairs Specialist 1266 Kifer Road, Building 101 Sunnyvale, California 94086

Re: K214095

Trade/Device Name: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: July 21, 2022 Received: July 22, 2022

Dear Kunal Gunjal:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Mark Trumbore 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) K214095

Device Name

da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K214095)

510(k) Owner	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact	Kunal GunjalSr. Regulatory Affairs SpecialistPhone Number: 408-523-8017Email: Kunal.Gunjal@intusurg.com
Date	12th August 2022
Trade Name	da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
Common Name	Endoscope and accessories
Classification	Class II,21 CFR 876.1500
Product Codes	NAY, GCJ
Review Panel	General and Plastic Surgery
Predicate Devices	K203632 (da Vinci X/Xi 8mm Reusable Instruments)

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Intuitive Surgical, Inc.

Device Description:

Indications for Use:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) and 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gyneologic 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.

Image /page/4/Picture/6 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and the letters are evenly spaced.

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Intuitive Surgical, Inc.

Table 1 includes a comparison between the subject devices and predicate devices.

Characteristic	Predicate Deviceda Vinci X/Xi (IS4200/IS4000) EndoWrist (8mm) Instruments(K203632)			Subject Deviceda Vinci X/Xi (IS4200/IS4000) EndoWrist (8mm)Instruments (K214095)
	da Vinci X/Xi 8mm Reusable Instruments	Model Number	Number of Lives and Reprocessing Cycles	da Vinci X/Xi 8mm Reusable Instruments	Model Number	Number of Lives and Reprocessing Cycles
			Number of Lives Number of Reprocessing Cycles					Number of Lives Number of Reprocessing Cycles

Number of LivesandReprocessingCycles	8mm Maryland Bipolar Forceps	470172	10 15			8mm Maryland Bipolar Forceps	471172	14 19
	8mm Fenestrated Bipolar Forceps	470205	10 15			8mm Fenestrated Bipolar Forceps	471205	14 19
	8mm Force Bipolar	470405	10 15			8mm Force Bipolar	471405	12 17
	8mm Large Needle Driver	470006	10 15			8mm Large Needle Driver	471006	15 20
	8mm Mega SutureCut Needle Driver	470309	10 15			8mm Mega SutureCut Needle Driver	471309	15 20
	8mm Cadiere Forceps	470049	10 15			8mm Cadiere Forceps	471049	18 23
	8mm ProGrasp Forceps	470093	10 15			8mm ProGrasp Forceps	471093	18 23
	8mm Micro Bipolar Forceps	470171	10 15			8mm Micro Bipolar Forceps	471171	14 19
	8mm Curved Bipolar Dissector	470344	10 15			8mm Curved Bipolar Dissector	471344	14 19
	8mm Long Bipolar Grasper	470400	10 15			8mm Long Bipolar Grasper	471400	14 19
	8mm Large SutureCut Needle Driver	470296	10 15			8mm Large SutureCut Needle Driver	471296	15 20
	8mm Long Tip Forceps	470048	10 15			8mm Long Tip Forceps	471048	18 23
	8mm Cobra Graspers	470190	10 15			8mm Cobra Graspers	471190	18 23

		Table 1: Comparison of Predicate and Subject Devices (da Vinci X/Xi EndoWrist 8mm Instruments)
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Technological Characteristics:

There are changes to the do Vinci X/Xi 8mm Reusable Instruments labeling, with increased number of lives (uses) and reprocessing cycles. The impacted Product Part number of lives (uses) and reprocessing cycles for the subject devices are listed in Table 1.

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Performance Data:

Performance test data demonstrates that the subject device is substantially equivalent to the predicate device. The testing conducted consisted of Cleaning Validation, Reliability/Life Testing, Electrical Performance Testing and Thermal Effects Testing.

Cleaning Validation: Cleaning Validation was performed to validate the efficacy of the manual and automated cleaning process in accordance with the following standards and guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", document issued on: March 17, 2015 (Amended on June 9, 2017).
- AAM TIR 12:2020 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR 30: 2011/(R)2016, A compendium of processes, materials, and acceptance criteria for cleaning reusable medical devices
- ANSI/AAMI ST15883-1:2009/(R) 2014. Washer-disinfectors: General requirements, terms and definitions and tests

The da Vinci X/Xi 8mm Reusable Instruments successfully met the acceptance criteria for all markers. The test results demonstrate that the da Vinci X/Xi 8mm Reusable Instruments can be cleaned using the following cleaning methods:

Automated cleaning process using a compatible automated washer/disinfector. ।
Manual cleaning process using an ultrasonic bath. -
o Reliability/Life Testing: Reliability/Life Testing was performed to ensure that da Vinci X/Xi 8mm Reusable Instruments are not adversely affected by the increased number of lives (uses) and reprocessing cycles for these as listed in Table 1.
o Electrical Performance Testing: Electrical Performance Testing was performed after subjecting the representative subject devices/instruments (which have "active components/accessories") to multiple reuse and reprocessing cycles (including both manual and automated cleaning process). This testing was performed to ensure the da Vinci X/X 8mm Extended Lives Instruments family (subject devices as listed in Table 1) meet the requirements within the FDA guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, Document Issued on March 9, 2020.

O INTUITIVE

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Intuitive Surgical, Inc.

o Thermal Effects testing: Thermal Effects testing was performed to confirm that thermal effects on tissue are comparable between the subject and predicate devices. The testing was performed in accordance with the FDA guidance, "Premarket Notification (510(k)) Submissions for Glectrosurgical Devices for General Surgery", Document Issued on March 9, 2020.

Conclusion:

Based on the intended use, indications for use, technological characteristics and performance data, the subject device is substantially equivalent to the proposed predicate device.

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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.