The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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 and general thoracoscopic surgical procedures. The system is indicated for adult 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.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

Device Description

The da Vinci Force Feedback Instruments are 8 mm, multi-use, endoscopic instruments intended for use with the da Vinci Surgical System, Model IS5000. These instruments have been designed with an articulating wrist that gives surgeons natural dexterity and range of motion, and have the ability to render forces measured at the instrument tip to the hand controls at the system Console.

The changes that are the basis for this submission are increasing the number of surgical uses (lives) and reprocessing cycles for the subject da Vinci Force Feedback Mega SutureCut Needle Driver and da Vinci Force Feedback ProGrasp Forceps compared to their respective predicate devices cleared in K232610, as summarized in Table 1 below.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Intuitive Surgical da Vinci Surgical System (IS5000) and specifically for the da Vinci Force Feedback Instruments. The submission focuses on increasing the number of surgical uses and reprocessing cycles for two specific instruments: the da Vinci Force Feedback Mega SutureCut Needle Driver and the da Vinci Force Feedback ProGrasp Forceps.

However, the document does not contain acceptance criteria or detailed results of a study proving the device meets specific performance metrics in terms of clinical effectiveness or accuracy compared to a ground truth. The performance data section broadly states that "Reliability (Life) Testing" was conducted to demonstrate substantial equivalence to predicate devices, but it does not provide quantitative acceptance criteria or detailed study results typical of AI/ML device evaluations.

Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test sets, expert details for ground truth, adjudication method, MRMC study details, standalone performance, ground truth type, training set details) cannot be extracted from the provided text. The submission is for a modification to an existing surgical instrument regarding its durability and reprocessing cycles, not for a new AI/ML diagnostic or assistive device that would typically involve such detailed performance metrics against a ground truth.

Based on the provided information, here's what can be answered:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria implicitly revolve around the instruments maintaining their functionality and safety over an increased number of uses and reprocessing cycles.

Reported Device Performance:

Device	Parameter	Predicate Devices (K232610)	Subject Devices (K241284)
da Vinci Force Feedback Mega SutureCut Needle Driver	Number of Uses	1	4
	Number of Reprocessing Cycles	3	6
da Vinci Force Feedback ProGrasp Forceps	Number of Uses	1	4
	Number of Reprocessing Cycles	3	6
Note: The document states "All testing passed and supports the subject devices' increased number of uses and reprocessing cycles," implying that the devices met the internal criteria for these parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document mentions "sufficient reprocessing and simulated surgical use cycles" but does not provide specific sample sizes for instruments tested. Data provenance regarding country of origin or retrospective/prospective nature is also not mentioned.

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)

Not applicable/Not specified. The testing described is "Reliability (Life) Testing" involving benchtop performance measurements, visual inspection, and functional performance evaluation. It does not involve expert-established ground truth in the context of clinical interpretation or diagnosis.

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

Not applicable/Not specified. This type of adjudication method is used for clinical interpretation ground truth, not for mechanical and functional performance testing.

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

No. This is not an AI/ML diagnostic device that would typically involve a MRMC study.

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

Not applicable. This device is a surgical instrument, not an algorithm.

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

The "ground truth" for this performance testing would be the engineering specifications and functional requirements for durability, mechanical integrity, and sensor performance over the specified number of uses and reprocessing cycles. This is based on internal testing protocols rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

Not applicable. The device is a surgical instrument with mechanical and sensor performance testing, not an AI/ML algorithm that requires a training set.

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

Not applicable.

In summary, the provided document details a 510(k) clearance for increased durability of existing surgical instruments, not a new AI/ML device requiring clinical performance metrics against an established ground truth. Therefore, most of the requested information regarding AI/ML study design and results is not present.

Summary

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July 3, 2024

Intuitive Surgical, Inc. Jennifer Karafin Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K241284

Trade/Device Name: da Vinci Surgical System (IS5000) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: May 3, 2024 Received: May 7, 2024

Dear Jennifer Karafin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.07.03 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

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Indications for Use

Submission Number (if known)

Device Name

da Vinci Surgical System (IS5000)

Indications for Use (Describe)

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.

Contraindication:

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

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Jennifer KarafinSenior Regulatory Affairs SpecialistIntuitive Surgical, Inc.1266 Kifer Road,Sunnyvale, CA 94086Phone: +1-315-447-6522Email: jennifer.karafin@intusurg.com
Date SummaryPrepared:	May 3, 2024
Trade Name:	da Vinci Force Feedback Instruments
Common Name:	Endoscopic instruments and accessories
Classification:	Class II, 21 CFR 876.1500, Endoscope and Accessories
Product Code:	NAY (System, Surgical, Computer Controlled Instrument)
Review Panel:	General and Plastic Surgery
Predicate Devices:	da Vinci Force Feedback Instruments (K232610)

Device Description:

Device	Model Number	Predicate Devices (K232610)		Subject Devices
		Number of Uses	Number of Reprocessing Cycles	Number of Uses	Number of Reprocessing Cycles
da Vinci Force Feedback MegaSutureCut Needle Driver	475309	1	3	4	6
da Vinci Force FeedbackProGrasp Forceps	475093	1	3	4	6

Table 1: Predicate and Subject Device Number of Uses and Reprocessing Cycles

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Indications for Use:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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 surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

lt 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.

Contraindication:

Technological Characteristics:

The subject da Vinci Force Feedback Mega SutureCut Needle Driver and da Vinci Force Feedback ProGrasp Forceps are technologically similar to their respective predicate devices. Changes that are the basis for this submission are limited to programming an increased number of uses into the instrument, and listing a higher number of uses and reprocessing cycles in the reprocessing manual.

Performance Data:

The following performance testing was conducted to demonstrate substantial equivalence to the predicate devices. All testing passed and supports the subject devices' increased number of uses and reprocessing cycles.

Reliability (Life) Testing: Instruments were subjected to sufficient reprocessing and simulated surgical use cycles to simulate their design life. Testing included benchtop performance measurements, visual inspection, and evaluation of functional performance to verify instrument mechanical and sensor performance at each cycle.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the subject da Vinci Force Feedback Instruments are substantially equivalent to and are as safe, as effective, and perform as well as their respective predicate devices.

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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.