The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic and general thoracoscopic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist SP Instruments:

Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single port. The system is indicated for urologic and general thoracoscopic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use 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 SP Surgical System, Model SP1098 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instruments, and Accessories. The surgeon seated at the Surgeon Console controls all movement of the EndoWrist SP Instrument by using two Master Controls and a set of foot pealals. 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 Cart is positioned at the operating room table and has four instrument drives on a single arm that is positioned over the target patient anatomy. A Camera Instrument attaches onto one instrument drive and provides the surgeon a high resolution, threedimensional view of the patient anatomy. A suite of da Vinci SP Instruments can be attached from the other three instrument drives, enabling the surgeon to perform various surgical tasks. The Camera Instruments can be used simultaneously, entering the patient through a single port. Accessories including a cannula, an ontry guide, SP Access Port and disposable tips for selected instruments, instrument sheaths, and a drape are needed to perform procedures with the system.

The EndoWrist SP Instruments come in various configurations such as graspers, scissors, and needle drivers. The da Vinci SP instruments have a unique articulating design at the distal tip that mimics the human wrist, shoulder, and elbow to enable triangulation and X-Y movement of the instrument in the body. Each instrument is used to perform specific surgical tasks such as grasping, suturing, tissue manipulation, and electrocautery. The da Vinci SP Instruments can be used only with the SP1098 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.

AI/ML Overview

The provided document describes the FDA's 510(k) premarket notification acceptance for new da Vinci SP Instruments, a robotic surgical system. It focuses on the substantial equivalence of the new instruments (subject devices) to previously cleared predicate devices. The acceptance criteria and supporting studies are detailed, primarily through comparisons to existing devices and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/CADe device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various performance tests and comparisons.

The general acceptance criteria are implied to be that the new instruments do not raise new questions of safety and effectiveness compared to the predicate devices and meet established performance benchmarks.

The reported device performance is described qualitatively as:

Acceptance Criteria (Implied)	Reported Device Performance
No new questions of safety or effectiveness	Performance test data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and does not raise different questions of safety and effectiveness than the predicate device.
Meets physical, mechanical, user interface, and equipment interface requirements	Bench verification testing confirmed that the design meets physical specifications (dimensions, weight, materials), mechanical requirements (force, range of motion, accuracy), and equipment interfaces (mechanical, electrical, software). User interface and patient safety (re-use, reliability, environmental, cleaning, disinfection, sterilization, shipping, storage, package, labeling) were also verified.
Clinical performance (anatomical access and reach)	Cadaver models were used to demonstrate clinical performance for anatomical access and reach for SP Instruments.
Safety and performance in live tissue	Live animal models were used to assess safety and performance for SP Instruments in cases where a live tissue model was required, replicating factors experience during clinical use (perfused organs, bleeding, hemostasis).
No significant user-facing changes (human factors)	No significant user-facing changes were identified for the SP Force Bipolar Instruments, SP Extended Range Instruments, or Enhanced Wrist Instruments compared to their respective predicates. Therefore, human factors testing performed on predicate devices was leveraged.
Grip characteristics (for SP Force Bipolar)	The Strong Grip Mode provides grip characteristics that are 50% greater than the Force Bipolar default mode. The default grip is the same as the predicate SP Fenestrated Bipolar Forceps.
Wrist ROM updates (for Extended Range and Enhanced Wrist)	The wrist range of motion is increased from 72 degrees (predicate physical limit) to 86 degrees (subject device software limit).
Life and Reprocessing Cycles (Increased for some instruments)	Number of Lives and Reprocessing Cycles increased for several new instruments (e.g., SP Maryland Bipolar Forceps, Extended Range: 25 lives, 38 reprocessing cycles; Predicate: 20 lives, 30 reprocessing cycles).
No change in Principle of Operation	There are no changes to the Principle of Operation between the subject and predicate devices for all categories of new instruments.

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

The document does not specify a distinct "test set" in the context of an AI/algorithm evaluation with a fixed sample size of data points. The assessment involves a combination of engineering tests and biological models:

Bench Verifications: The sample size for each specific physical, mechanical, electrical, or software test is not detailed.
Cadaver Models: The number of cadaver models used is not specified. Data provenance is implied to be laboratory-based (experimental).
Animal Models: The number of animal models used is not specified. Data provenance is implied to be laboratory-based (experimental).

There is no mention of retrospective or prospective data in the sense of clinical patient data for algorithm testing.

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

This information is not applicable in the traditional sense for this type of device submission. There is no mention of experts establishing a "ground truth" for a test set of medical images or diagnostic data. Instead, the evaluation relies on:

Engineering specifications and measurements: For bench testing.
Surgical observation and performance assessment by trained personnel (likely surgeons and researchers): For cadaver and animal studies. While these individuals are experts in surgery, their role is not described as establishing ground truth for an AI algorithm's output.

4. Adjudication method for the test set

This information is not applicable as there is no mention of a "test set" of diagnostic cases requiring expert adjudication for ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this submission. The device is a surgical instrument system, not an AI-assisted diagnostic or interpretative tool for "human readers" in the context of medical image analysis. Human factors evaluation focused on user-device interaction and leveraging prior human factors testing for predicate devices.

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

Not applicable. The device is a robotic surgical instrument system, which by its nature operates with a human surgeon in the loop. There is a software algorithm, "GripSelect," mentioned for the SP Force Bipolar Instruments, but its performance is integrated into the instrument's function and assessed through overall device performance rather than standalone algorithmic accuracy.

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

The concept of "ground truth" as typically applied to AI/diagnostic device evaluation (e.g., pathology for disease detection) is not directly present in this submission. For this medical device, the "ground truth" and evidence of safety and effectiveness are established by:

Engineering specifications and test results: Verifying that the instruments meet design requirements (e.g., force, range of motion, durability).
Physiological and anatomical performance in biological models: Demonstrating effective manipulation, dissection, grasping, and coagulation in cadaver and animal models, ensuring the instruments function as intended in a surgical environment.
Historical safety and effectiveness of predicate devices: The primary argument for substantial equivalence relies heavily on the similarity and demonstrated safety/effectiveness of previously cleared devices.

8. The sample size for the training set

Not applicable. The document describes a medical device (surgical instruments) that underwent engineering verification and validation studies. It does not refer to an AI algorithm that would require a "training set" of data in the machine learning sense. The "GripSelect" software algorithm mentioned is likely a deterministic control algorithm rather than a learned AI model.

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

Not applicable. As there is no training set mentioned for an AI algorithm, the method for establishing its ground truth is not relevant to this submission.

Summary

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Build Correspondence

Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

November 18, 2024

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

Re: K241814

Trade/Device Name: da Vinci SP Instruments (SP1098) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: June 20, 2024 Received: June 24, 2024

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 (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 and the limitations described below. 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.

The OHT4: Office of Surgical and Infection Control Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling:

The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port urological and general thoracoscopic surgical procedures and for transoral otolaryngology surgical

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procedures in the oropharynx for benign tumors and malignant tumors classified as T1 and T2 with the da Vinci EndoWrist SP Instruments and the da Vinci SP Surgical System (SP1098).

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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).

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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR

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830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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 medical devices and radiation-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 BLETA BLETA VUNIQI VUNIQI -S Date: 2024.11.18 17:41:04 -5 -05'00' for Binita Ashar, M.D., M.B.A., F.A.C.S. M.A.M.S.E. Director 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below

Submission Number (if known)

K241814

Device Name

da Vinci SP Instruments (SP1098)

Indications for Use (Describe)

da Vinci SP Surgical System, Model SP1098:

EndoWrist SP Instruments:

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)

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 reqarding 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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K241814

510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.
	1266 Kifer Road
	Sunnyvale, CA 94086
Contact:	Kunal Gunjal
	Senior Regulatory Affairs Specialist
	Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared:	November 18, 2024
Trade Name:	da Vinci SP Instruments as listed in Table 1:

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

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				Table 1: da Vinci SP Instruments
--	--	--	--	----------------------------------

SP InstrumentsCategory	da Vinci SP Instrument Name	da Vinci SP Instrument Model Numbers
SP Force BipolarInstruments	SP Force Bipolar	430150
	SP Force Bipolar, Extended Range	431150
	SP Maryland Bipolar Forceps, ExtendedRange	431152
	SP Cadiere Forceps, Extended Range	431300
SP "Extended Range"Instruments	SP Needle Driver Extended Range	431200
	SP Monopolar Curved Scissors ExtendedRange	431100
	SP Round Tooth Retractor Extended Range	431301
	SP Maryland Bipolar Forceps	430152
SP "Enhanced Wrist"Instruments	SP Cadiere Forceps	430300
	SP Needle Driver	430200
	SP Monopolar Curved Scissors	430100
	SP Monopolar Cautery Instrument	430101
	SP Fenestrated Bipolar Forceps	430151
	SP Medium Large Clip Applier	430250

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Intuitive Surgical, Inc.

Common Name:	Endoscope and accessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
Classification Advisory
Committee:	General and Plastic Surgery

Predicate/Reference Devices: Refer to Predicate and Reference Devices listed in Table 2.

Predicate/Reference Devices	da Vinci SP Instruments	Model #(s)	510(k) #
Predicate Device	SP Maryland BipolarForceps	430010	K240502
	SP Cadiere Forceps	430009
	SP Needle Driver	430006
	SP Monopolar CurvedScissors	430004
	SP Monopolar CauteryInstrument	430007
	SP Fenestrated BipolarForceps	430011
	SP Round Tooth Retractor	430002
	SP Medium-Large ClipApplier	430005

Reference Device	EndoWrist® MercuryBipolar Grasper (alsoreferred to as da Vinci XiForce Bipolar)	470405	K180351

Table 2 : Predicate/Reference Devices

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Intuitive Surgical, Inc.

K241814

Device Description

The Vision Cart includes the supporting electronic and video processing equipment for the system.

UITIVF

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Indications for Use:

da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic and general thoracoscopic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx and malignant tumors classified as T1 and T2. The system is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist SP Instruments:

Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System. Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissors, 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, and suturing through a single port. The system is indicated for urologic and general procedures that are appropriate for a single port approach and transoral procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is intended for use by trained for use by trained physicans in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

NTILITIVF

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Comparison of Technological Characteristics with the Predicate/Reference Device(s)

The modifications to the SP1098 System include introduction of new SP Instruments:

SP Force Bipolar Instruments

The Force Bipolar is intended to be used with the da Vinci SP system for dissecting, grasping, manipulating, retracting, and coagulating tissues and vessels. The Force Bipolar is also intended for grasping and manipulating compatible bulldog clamps. The Force Bipolar is a 6 mm, multi-use instrument with bipolar energy capability. This instrument allows the user to temporarily apply a Strong Grip Mode, depending on surgical needs. The default SP Force Bipolar grip is the same as the SP Fenestrated Bipolar Forceps (PN 43001), cleared in the predicate device submission, K240502) and operates in this grip until the user applies Strong Grip Mode. While operating in Strong Grip Mode, the instrument has grip characteristics that are 50% greater than the Force Bipolar default mode. The change in the grip mode setting from DEFAULT to STRONG and vice versa is enabled by a software algorithm, "GripSelect". The Grip Selection feature on the subject device essentially combines the capabilities of two instruments into a single instrument. The "Grip Selection feature" on the subject devices (SP Force Bipolar Instruments) is IDENTICAL to the reference device (EndoWrist® Mercury Bipolar Grasper, also referred to as da Vinci Xi Force Bipolar cleared via K180351). The SP Force Bipolar Instrument is available in two versions: SP Force Bipolar, Standard Range (PN 430150) and SP Force Bipolar, Extended Range (PN 431150). The Standard and Extended Range instruments have the Extended Range instruments have a longer forearm allowing for extended lateral range of motion (as shown in Figure 1).

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Image /page/10/Figure/2 description: The image shows a surgical instrument with three labeled parts. Part 1 is the upper arm of the instrument, part 2 is the lower arm of the instrument, and part 3 is the grasping end of the instrument. The instrument is made of metal and has a series of holes along the arms.

1. Extended Range instrument forearm

Standard instrument forearm
Lateral range increase

Figure 1: Standard versus Extended Range SP Force Bipolar Instrument Comparison

Image /page/10/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I". The font is sans-serif and the letters are evenly spaced.

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K241814

SP Instruments with Long Joggle (also referred to as "Extended Range Instruments")

Introduction of long joggle versions of SP instruments (also referred to as "Extended Range" Instruments), as compared joggle instruments (previously cleared in the predicate device submission, K240502), as listed in Table 3, intended to be used with da Vinci SP Surgical System. The Standard Range instruments have the same features and the same overall instrument length, except the Extended Range instruments have a longer forearm allowing for extended lateral range of motion (as shown in Figure 2 and 3).

Additionally, the wrist range of motion is increased from 72 degrees (predicate device instrument's physical limit) to 86 degrees (subject device instrument's software limit), as shown in Figure 4.

Subject Device SP Instruments(K241814)	Predicate Device SP Instruments(K240502)
da Vinci SP Long Joggle Instruments (also referred toas "Extended Range" Instruments)	da Vinci SPInstrument ModelNumbers	da Vinci SP StandardJoggle Instruments	da Vinci SPInstrument ModelNumbers
SP Maryland Bipolar Forceps, Extended Range	431152	SP Maryland BipolarForceps	430010
SP Cadiere Forceps, Extended Range	431300	SP Cadiere Forceps	430009
SP Needle Driver, Extended Range	431200	SP Needle Driver	430006
SP Monopolar Curved Scissors, Extended Range	431100	SP Monopolar CurvedScissors	430004
SP Round Tooth Retractor, Extended Range	431301	SP Round Tooth Retractor	430002

Table 3 : Subject Devices and Predicate Devices, da Vinci SP Instruments

Note: The only change to the SP Round Tooth (PN 43130) as compared to its predicate device (SP Round Tooth Retractor, PN 43000) are Wrist ROM changes. Both the subject and predicate SP Round Tooth Retractor instruments have a long joggle.

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Image /page/12/Figure/2 description: The image shows two different types of joggle tools, labeled as "Long Joggle" and "Standard Joggle". The "Long Joggle" tool appears to have a longer section with circular cutouts compared to the "Standard Joggle" tool. Both tools have similar end pieces and handle designs, but the length of the joggle section differentiates them. The image provides a clear comparison between the two joggle tool variations.

Figure 2: Subject Devices and Predicate Device, da Vinci SP Instruments (Long Joggle and Standard Joggle)

Image /page/12/Figure/4 description: The image shows two identical objects, one above the other. Each object has a long, cylindrical body with a textured section at one end and a larger, more complex structure at the other. The complex structure appears to be composed of multiple components, including a blue, curved section and a green, rectangular section. The objects are oriented horizontally, with the textured end pointing to the left and the complex structure pointing to the right.

Figure 3: Standard Joggle versus Long Joggle Instrument Comparison – Same Overall Instrument Length

Image /page/12/Picture/6 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is a sans-serif font.

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Image /page/13/Picture/2 description: The image shows two diagrams of a mechanical arm with angle measurements. On the left, the arm is split into a Y shape, with the top left arm angled at 86 degrees and the top right arm angled at 72 degrees. On the right, the arm is bent in a curve, with the top arm angled at 72 degrees.

Figure 4: Right- Standard Joggle Instruments (Predicate devices, cleared via K241502) VS Left- Long Joggle "Extented Ranger" Instruments (subject devices)

INTUÍTIVE

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SP Instruments with increased Wrist Range of Motion (ROM), also referred to as "Enhanced Wrist" Instruments

Introduction of new SP Instruments with increased Wrist Range of Motion (ROM) (also referred to as "Enhanced Wrist" Instruments), as compared to the standard joggle instruments (previously cleared in the predicate device submission, K240502), as listed in Table 4, intended to be used with da Vinci SP Surgical System.

The Enhanced Wrist SP Instruments (subject device instruments have the same features and the same overall instrument length, except the wrist range of motion is increased from 72 degrees (predicate device instrument's physical limit) to 86 degrees (subject device instrument's software limit), as shown in Figure 5.

Subject Device SP Instruments(K241814)		Predicate Device SP Instruments(K240502)
da Vinci SP Standard Joggle Instruments withincreased Wrist Range of Motion (ROM) (alsoreferred to as "Enhanced Wrist" Instruments)	da Vinci SPInstrument ModelNumbers	da Vinci SP StandardJoggle Instruments	da Vinci SPInstrument ModelNumbers
SP Maryland Bipolar Forceps	430152	SP Maryland BipolarForceps	430010
SP Cadiere Forceps	430300	SP Cadiere Forceps	430009
SP Needle Driver	430200	SP Needle Driver	430006
SP Monopolar Curved Scissors	430100	SP Monopolar CurvedScissors	430004
SP Monopolar Cautery Instrument	430101	SP Monopolar CauteryInstrument	430007
SP Fenestrated Bipolar Forceps	430151	SP Fenestrated BipolarForceps	430011

Table 4 : Subject Devices and Predicate Devices, da Vinci SP Instruments

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Image /page/15/Picture/2 description: The image shows two different configurations of a mechanical arm. On the left, the arm is split into a Y shape, with the top two segments angled at 86 and 72 degrees relative to the vertical. On the right, the arm is bent in a more complex configuration, with the top segment angled at 72 degrees relative to the vertical.

Figure 5: Right-Standard Joggle Instruments (Predicate via K240502) VS Left-Standard Joggle "Enhanced Wriss" Instruments (subject devices)

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SP Medium-Large Clip Applier

There are no design changes to the SP Medium-Large Clip Applier, relative to the predicate device. The labeled and programmed Model (#) was updated as noted in Table 5.

Subject Device SP Instrument(K241814)		Predicate Device SP Instrument(K240502)
da Vinci SP Instrument	da Vinci SPInstrument ModelNumber	da Vinci SP Instrument	da Vinci SPInstrument ModelNumber
SP Medium-Large Clip Applier	430250	SP Medium-Large ClipApplier	430005

Table 5 : Subject Device and Predicate Device, da Vinci SP Instruments
------------------------------------------------------------------------	--	--	--

Image /page/16/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.

K241814

Comparison of Predicate and Subject Devices (da Vinci SP Force Bipolar Instruments)

Table 6 includes a comparison of the subject devices (da Vinci SP Force Bipolar Instruments) and the Predicated Bipolar Forceps cleared via K240502 and Reference Device, EndoWrist® Mevoury Bipolar Grasper, also referred to as da Vinci Xi Force Bipolar cleared via K180351. Differences in the Characteristics as noted by GREYING OUT the specific rows. Additionally, any differences in the specific characteristics within these rows are BOLDED.

The SP Force Bipolar instruments allow the user to temporarily apply a Strong Grip Mode, depending on surgical needs. The default SP Force Bipolar grip is the same as the SP Fenestrated Bipolar Ecreed in the predicate device submission, K240502) and operates in this grip until the user applies Strong Grip Mode. While operating in Strong Grip Mode, the instrument has grip characteristics that are 50% greater than the Force Bipolar default mode. The change in the grip mode setting from DEFAULT to STRONG and vice versa is enabled by a software algorithm, "GripSelect". The Grip Selection feature essentially combines the capabilities of two instruments into a single instrument. The "Grip Selection feature" on the subject devices (SP Force Bipolar Instruments) is IDENTICAL to the reference device (EndoWrist® Mercurv Bipolar Grasper, also referred to as da Vinci Xi Force Bipolar cleared via K180351).

There are no significant user facing changes on the SP Force Bipolar Instruments, as compared to the predicated Bipolar Forceps, cleared in K240502) and the reference device (da Vinci Xi Force Bipolar Grasper, cleared in K180351). The user facing changes to the SP Force Bipolar Instruments (subject devices), regarding changing the grip strength from "Default" mode to "Strong" mode, and vice versa, from the Surgeon Console is identical to the reference device, the da Vinci Xi Force Bipolar Instrument (cleared via K18035 }). Additionally, both the Xi and SP Surgical System use the same Surgeon Console sub-system.

No additional human factors testing was warranted for the SP Force Bipolar Instruments and the human factors validation testing which was performed on the predicate and reference devices (K240502 and K180351), was leveraged for the SP Force Bipolar Instruments.

Performance testing (bench, animal, and cadaver tests) on the subject devices (SP Force Bipolar Instruments), as summarized in Table 10, demonstrates that the subject devices are substantially equivalent to the predicate device (K240502) and does not raise of safety and effectiveness than the predicate device.

{18}------------------------------------------------

Characteristic	Subject Deviceda Vinci SP Force BipolarInstruments(K241814)	Predicate Deviceda Vinci SP Fenestrated Bipolar Forceps(K240502)	Reference DeviceEndoWrist® Mercury Bipolar Grasper(K180351)
General Information
Manufacturer	Intuitive Surgical, Inc.	IDENTICAL to the subject device	IDENTICAL to the subject device
Trade Name	da Vinci SP Force BipolarInstruments	da Vinci SP Fenestrated Bipolar Forceps	EndoWrist® Mercury Bipolar Grasper
Model #	da Vinci SP Force Bipolar (PN430150)da Vinci SP Force Bipolar,Extended Range (PN 431150)	da Vinci SP Fenestrated Bipolar Forceps(PN 430011)	EndoWrist® Mercury Bipolar Grasper(PN 470405)
Common Name	Endoscope and accessories	IDENTICAL to the subject device	IDENTICAL to the subject device
Regulation Number	21 CFR 876.1500	IDENTICAL to the subject device	IDENTICAL to the subject device
Characteristic	Subject Deviceda Vinci SP Force BipolarInstruments(K241814)	Predicate Deviceda Vinci SP Fenestrated Bipolar Forceps(K240502)	Reference DeviceEndoWrist® Mercury Bipolar Grasper(K180351)
Product Code	NAY, GCJ	IDENTICAL to the subject device	IDENTICAL to the subject device
DeviceClassification	Class II	IDENTICAL to the subject device	IDENTICAL to the subject device
ClassificationAdvisoryCommittee	General and Plastic Surgery	IDENTICAL to the subject device	IDENTICAL to the subject device
SystemCompatibility	Compatible with the SP1098 system	Compatible with the SP1098 system	Compatible with the da Vinci Xi System
Intended Use	The Force Bipolar is intended to beused with the da Vinci SP Systemfor dissecting, grasping,manipulating, retracting, andcoagulating tissues and vessels. TheForce Bipolar is also intended forgrasping and manipulating	The Fenestrated Bipolar Forceps isintended to be used with the da Vinci SPSystem for dissecting, grasping,manipulating, retracting, andcoagulating tissues and vessels. The SPFenestrated Bipolar Forceps is alsointended for grasping and manipulatingcompatible bulldog clamps.	The EndoWrist Mercury BipolarGrasper is intended to be used withcompatible systems for endoscopicmanipulation of tissue, includingdissection, grasping, retraction, andbipolar coagulation of tissue.
	da Vinci SP Surgical System, ModelSP1098:		da Vinci Xi (IS4000) System
Indications for Use	The Intuitive Surgical EndoscopicInstrument Control System (daVinci SP Surgical System, ModelSP1098) is intended to assist in theaccurate control of Intuitive SurgicalEndoWrist SP Instruments duringurologic and general thoracoscopicsurgical procedures that areappropriate for a single portapproach and transoralotolaryngology surgical proceduresin the oropharynx restricted tobenign tumors and malignant tumorsclassified as T1 and T2. The systemis indicated for adult use. It isintended for use by trainedphysicians in an operating roomenvironment in accordance with therepresentative, specific proceduresset forth in the ProfessionalInstructions for Use.EndoWrist SP Instruments:Intuitive Surgical EndoWrist SPInstruments are controlled by the daVinci SP Surgical System, ModelSP1098, and include flexibleendoscopes, blunt and sharpendoscopic dissectors, scissors,forceps/pick-ups, needle holders,	IDENTICAL to the subject device	The Intuitive Surgical EndoscopicInstrument Control System (da Vinci XiSurgical System, Model IS4000) isintended to assist in the accurate controlof Intuitive Surgical EndoscopicInstruments including rigid endoscopes,blunt and sharp endoscopic dissectors,scissors, scalpels, forceps/pick-ups,needle holders, endoscopic retractors,electrocautery and accessories forendoscopic manipulation of tissue,including grasping, cutting, blunt andsharp dissection, approximation,ligation, electrocautery, suturing, anddelivery and placement of microwaveand cryogenic ablation probes andaccessories, during urologic surgicalprocedures, general laparoscopicsurgical procedures, gynecologiclaparoscopic surgical procedures,general thoracoscopic surgicalprocedures and thoracoscopically-assisted cardiotomy procedures. Thesystem can also be employed withadjunctive mediastinotomy to performcoronary anastomosis during cardiacrevascularization. The system isindicated for adult and pediatric use. It isintended to be used by trained physiciansin an operating room environment inaccordance with the representative,specific procedures set forth in theProfessional Instructions for Use.
	Subject Device	Predicate Device	Reference Device
Characteristic	da Vinci SP Force BipolarInstruments(K241814)	da Vinci SP Fenestrated Bipolar Forceps(K240502)	EndoWrist® Mercury Bipolar Grasper(K180351)
	endoscopic retractors, electrocauteryand accessories for endoscopicmanipulation of tissue, includinggrasping, cutting, blunt and sharpdissection, approximation, ligation,electrocautery, and suturing througha single port. The system isindicated for urologic and generalthoracoscopic surgical proceduresthat are appropriate for a single portapproach and transoralotolaryngology surgical proceduresin the oropharynx restricted tobenign tumors and malignant tumorsclassified as T1 and T2. The systemis indicated for adult use. It isintended for use by trainedphysicians in an operating roomenvironment in accordance with therepresentative, specific proceduresset forth in the ProfessionalInstructions for Use.
Characteristic	Subject Deviceda Vinci SP Force BipolarInstruments(K241814)	Predicate Deviceda Vinci SP Fenestrated Bipolar Forceps(K240502)	Reference DeviceEndoWrist® Mercury Bipolar Grasper(K180351)
Prescription use	Prescription/Physician use only	IDENTICAL to the subject device	IDENTICAL to the subject device
Number of Lives andReprocessing Cycles	Number of Lives: 20Number of Reprocessing Cycles:30	IDENTICAL to the subject device	Number of Lives: 10Number of Reprocessing Cycles: 15
Where used(hospital, home,ambulance, etc)	Hospital	IDENTICAL to the subject device	IDENTICAL to the subject device

Table 6: Comparison of Predicate and Subject Devices (da Vinci SP Force Bipolar Instruments)

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Comparison of Predicate and Subject Devices, SP Instruments with Long Joggle (also referred to as "Extended Range" Instruments)

Table 7 includes a comparison of the subjects) (SP Instruments with Long Joggle, also referred to as "Extended Range" Instruments) and the predicate device(s) (SP Instruments cleared via K240502). Differences in the Characteristics as noted in Table 7 are marked by GREYNG OUT the specific rows. Additionally, any differences in the specific characteristics within these rows are BOLDED.

The technological characteristics such as principles of operation remain unchanged between the subject devices. The subject devices (da Vinci SP Instruments with Long Joggle, also referred to as "Extended Range" Instruments) include the following design changes as compared to the standard joggle SP Instruments (predicate devices cleared via K240502):

0 Longer Joggle Length (as shown in Figure 2 and Figure 3)
Wrist ROM updates (as shown in Figure 4) O
Design Changes to support increased Wrist ROM on Long Joggle "Extended Range" SP Instruments O

There are no significant user facing change Instruments (subject devices), as compared to the predicate SP Instruments (cleared in K240502). Hence no additional human factors testing was warranted for the SP Extended Range factors testing which was performed on the predicate devices (K240502), was leveraged for the subject devices.

Performance testing (bench, animal, and cadaver tests), as summarized in Table 10, demonstrate that the subject device (SP Extended Range Instruments) is substantially equivalent to the predicate device (K240502) and does not raise differents than the predicate device.

{24}------------------------------------------------

Table 7: Comparison of Predicate and Subject Devices (SP Instruments with Long Joggle (also referred to as "Extentents)

Characteristic	Subject DeviceSP Instruments with Long Joggle (also referred to as "ExtendedRange" Instruments(K241814)	Predicate Deviceda Vinci SP Instruments (K240502)
General Information
Manufacturer	Intuitive Surgical, Inc.	IDENTICAL to the subject device
Trade Name	da Vinci SP Instruments	IDENTICAL to the subject device
Model #	da Vinci SP Long Joggle Instruments (also referred to as "Extended Range" Instruments)SP Maryland Bipolar Forceps, Extended RangeSP Cadiere Forceps, Extended RangeSP Needle Driver, Extended RangeSP Monopolar Curved Scissors, Extended RangeSP Round Tooth Retractor, Extended Range	da Vinci SP Standard Joggle InstrumentsSP Maryland Bipolar ForcepsSP Cadiere ForcepsSP Needle DriverSP Monopolar Curved ScissorsSP Round Tooth Retractor
	Model #431152431300431200431100431301	Model #430010430009430006430004430002
Common Name	Endoscope and accessories	IDENTICAL to the subject device
Characteristic	Subject DeviceSP Instruments with Long Joggle (also referred to as "ExtendedRange" Instruments(K241814)	Predicate Deviceda Vinci SP Instruments (K240502)
RegulationNumber	21 CFR 876.1500	IDENTICAL to the subject device
Product Code	NAY, GCJ	IDENTICAL to the subject device
DeviceClassification	Class II	IDENTICAL to the subject device
ClassificationAdvisoryCommittee	General and Plastic Surgery	IDENTICAL to the subject device
SystemCompatibility	Compatible with the SP1098 system	IDENTICAL to the subject device
Characteristic	Subject DeviceSP Instruments with Long Joggle (also referred to as "ExtendedRange" Instruments(K241814)	Predicate Deviceda Vinci SP Instruments (K240502)
Intended Use	Intended Use:SP Maryland Bipolar Forceps, Extended Range: TheMaryland Bipolar Forceps is intended to be used withthe da Vinci SP System for dissecting, grasping,manipulating, retracting, and coagulating tissues andvessels. SP Cadiere Forceps, Extended Range: The CadiereForceps is intended to be used with the da Vinci SPSystem for dissecting, grasping, manipulating, andretracting tissues. The SP Cadiere Forceps is alsointended for grasping and manipulating compatiblebulldog clamps. SP Needle Driver, Extended Range: The Needle Driveris intended to be used with the da Vinci SP System todrive needles through tissue and handle and tie suture. SP Monopolar Curved Scissors, Extended Range: TheMonopolar Curved Scissors with MCS Tip is intendedto be used with the da Vinci SP System formanipulating, cutting, and dissecting tissue, coagulating	IDENTICAL to the subject device
	da Vinci SP Surgical System, Model SP1098:
	The Intuitive Surgical Endoscopic Instrument Control System(da Vinci SP Surgical System, Model SP1098) is intended toassist in the accurate control of Intuitive Surgical EndoWrist SPInstruments during urologic and general thoracoscopic surgicalprocedures that are appropriate for a single port approach andtransoral otolaryngology surgical procedures in the oropharynxrestricted to benign tumors and malignant tumors classified asT1 and T2. The system is indicated for adult use. It is intendedfor use by trained physicians in an operating room environmentin accordance with the representative, specific procedures setforth in the Professional Instructions for Use.EndoWrist SP Instruments:
Indications forUse	Intuitive Surgical EndoWrist SP Instruments are controlled bythe da Vinci SP Surgical System, Model SP1098, and includeflexible endoscopes, blunt and sharp endoscopic dissectors,scissors, forceps/pick-ups, needle holders, endoscopic retractors,electrocautery and accessories for endoscopic manipulation oftissue, including grasping, cutting, blunt and sharp dissection,approximation, ligation, electrocautery, and suturing through asingle port. The system is indicated for urologic and generalthoracoscopic surgical procedures that are appropriate for asingle port approach and transoral otolaryngology surgicalprocedures in the oropharynx restricted to benign tumors andmalignant tumors classified as T1 and T2. The system isindicated for adult use. It is intended for use by trainedphysicians in an operating room environment in accordancewith the representative, specific procedures set forth in theProfessional Instructions for Use.	IDENTICAL to the subject device
Characteristic	Subject DeviceSP Instruments with Long Joggle (also referred to as “ExtendedRange” Instruments(K241814)	Predicate Deviceda Vinci SP Instruments (K240502)

Prescription use	Prescription/Physician use only	IDENTICAL to the subject device
Where used(hospital, home,ambulance, etc)	Hospital	IDENTICAL to the subject device

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Characteristic	Subject DeviceSP Instruments with Long Joggle (also referred to as “ExtendedRange” Instruments(K241814)				Predicate Deviceda Vinci SP Instruments (K240502)
	Subject Device SP Instruments				Predicate Device SP Instruments (K240502)
Number of LivesandReprocessingCycles	da Vinci SP Long JoggleInstruments (also referred to as“Extended Range”Instruments)	da Vinci SPInstrumentModel Numbers	Numberof Lives	Number ofReprocessingCycles	da Vinci SPStandard JoggleInstruments	da Vinci SPInstrumentModel Numbers	Numberof Lives	Number ofReprocessingCycles
	SP Maryland Bipolar Forceps,Extended Range	431152	25	38	SP MarylandBipolar Forceps	430010	20	30
	SP Cadiere Forceps, ExtendedRange	431300	25	38	SP CadiereForceps	430009	22	33
	SP Needle Driver, ExtendedRange	431200	25	38	SP Needle Driver	430006	22	33
	SP Monopolar Curved Scissors,Extended Range	431100	25	38	SP MonopolarCurved Scissors	430004	20	30
	SP Round Tooth Retractor,Extended Range	431301	25	38	SP Round ToothRetractor	430002	20	30
CompatibleSystem	SP1098 Surgical System				IDENTICAL to the subject device
Principle ofOperation	There are no changes to the Principle of Operation between the subject and predicate devices.

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Intuitive Surgical, Inc.

K241814

Comparison of Predicate and Subject Devices (da Vinci SP Instruments with increased Wrist Range of Motion (ROM) (also referred to as "Enhanced Wrist" Instruments)

Table 8 includes a comparison of the subjects | da Vinci SP Instruments with Standard Joggle with increased Wrist Range of Motion (ROM), also referred to as "Enhanced Wrist" Instruments) and the predicate device(s) (SP Instruments cleared via K240502). Differences in the Characteristics as noted in 7thle 8 are marked by GREYNG OUT the specific rows. Additionally, any differences in the specific characteristics within these rows are BOLDED.

The technological characteristics such as principles of operation remain unchanged between the subject devices. The subject devices (da Vinci SP Instruments with increased Wrist Range of Motion (ROM), also referred to as "Enhanced Wrist " Instruments), include the following design changes as compared to the standard joggle SP Instruments (predicate devices cleared in K240502):

Wrist ROM updates (as shown in Figure 5)
Design Changes to support increased Wrist ROM

There are no significant user facing chanced Wrist Instruments (subject devices), as compared to the predicate SP Instruments (cleared in K240502). Hence no additional human factors testing was warranted Wrist Instruments, and the human factors testing which was performed on the predicate devices (K240502), was leveraged for the subject devices.

Performance testing (bench, animal, and cadaver tests), as summarized in Table 10, demonstrate that the subject device (SP Eirhanced Wrist Instruments) is substantially equivalent to the predicate device (K240502) and does not raise of safety and effectiveness than the predicate device.

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K241814

Characteristic	Subject Device	Predicate Device
	da Vinci SP Instruments with increased WRIST Range of Motion(ROM) (also referred to as “Enhanced Wrist” Instruments)(K241814)	da Vinci SP Instruments (K240502)
General Information
Manufacturer	Intuitive Surgical, Inc.	IDENTICAL to the subject device
Trade Name	da Vinci SP Instruments	IDENTICAL to the subject device
Model #	da Vinci SP Instruments with Enhanced WRIST Range of Motion (ROM)	da Vinci SP Standard Joggle Instruments
	SP Maryland Bipolar Forceps 430152SP Cadiere Forceps 430300SP Needle Driver 430200SP Monopolar Curved Scissors 430100SP Monopolar Cautery Instrument 430101SP Fenestrated Bipolar Forceps 430151	SP Maryland Bipolar Forceps 430010SP Cadiere Forceps 430009SP Needle Driver 430006SP Monopolar Curved Scissors 430004SP Monopolar Cautery Instrument 430007SP Fenestrated Bipolar Forceps 430011
Common Name	Endoscope and accessories	IDENTICAL to the subject device
Characteristic	Subject Deviceda Vinci SP Instruments with increased WRIST Range of Motion(ROM) (also referred to as “Enhanced Wrist” Instruments)(K241814)	Predicate Deviceda Vinci SP Instruments (K240502)
RegulationNumber	21 CFR 876.1500	IDENTICAL to the subject device
Product Code	NAY, GCJ	IDENTICAL to the subject device
DeviceClassification	Class II	IDENTICAL to the subject device
ClassificationAdvisoryCommittee	General and Plastic Surgery	IDENTICAL to the subject device
SystemCompatibility	Compatible with the SP1098 system	IDENTICAL to the subject device

Table 8: Comparison of Predicate and Subject Devices (da Vinci SP Instruments with increased Wrist Range of Motion (ROM) (also referred to as "Enhanced Wrist" Instruments)

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Characteristic	Subject Deviceda Vinci SP Instruments with increased WRIST Range of Motion(ROM) (also referred to as "Enhanced Wrist” Instruments)(K241814)				Predicate Deviceda Vinci SP Instruments (K240502)
	Subject Device SP Instruments				Predicate Device SP Instruments (K240502)
Number ofLives andReprocessingCycles	da Vinci SP Instruments withEnhanced WRIST Range ofMotion (ROM)	da Vinci SPInstrumentModel Numbers	Numberof Lives	Number ofReprocessingCycles	da Vinci SPStandard JoggleInstruments	da Vinci SPInstrumentModel Numbers	Number ofLives	Number ofReprocessingCycles
	SP Maryland Bipolar Forceps	430152	25	38	SP MarylandBipolar Forceps	430010	20	30
	SP Cadiere Forceps	430300	25	38	SP CadiereForceps	430009	22	33
	SP Needle Driver	430200	25	38	SP NeedleDriver	430006	22	33
	SP Monopolar Curved Scissors	430100	25	38	SP MonopolarCurved Scissors	430004	20	30
	SP Monopolar CauteryInstrument	430101	25	38	SP MonopolarCauteryInstrument	430007	25	39
	SP Fenestrated Bipolar Forceps	430151	25	38	SP FenestratedBipolar Forceps	430011	20	30

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Characteristic	Subject Device	Predicate Device
	da Vinci SP Instruments with increased WRIST Range of Motion(ROM) (also referred to as “Enhanced Wrist” Instruments)(K241814)	da Vinci SP Instruments (K240502)
Intended Use	Intended Use:SP Maryland Bipolar Forceps: The Maryland BipolarForceps is intended to be used with the da Vinci SP Systemfor dissecting, grasping, manipulating, retracting, andcoagulating tissues and vessels. SP Cadiere Forceps: The Cadiere Forceps is intended to beused with the da Vinci SP System for dissecting, grasping,manipulating, and retracting tissues. The SP Cadiere Forcepsis also intended for grasping and manipulating compatiblebulldog clamps. SP Needle Driver: The Needle Driver is intended to be usedwith the da Vinci SP System to drive needles through tissueand handle and tie suture. SP Monopolar Curved Scissors: The Monopolar CurvedScissors with MCS Tip is intended to be used with the daVinci SP System for manipulating, cutting, and dissectingtissue, coagulating and transecting tissue using monopolarelectrosurgical energy, and cutting suture. SP Monopolar Cautery Instrument: The Monopolar CauteryInstrument with the 5 mm Cautery Hook Tip or 5 mmCautery Spatula Tip is intended to be used with the da VinciSP System for manipulating and dissecting tissue andcoagulating and transecting tissue using monopolarelectrosurgical energy. SP Fenestrated Bipolar Forceps: The Fenestrated BipolarForceps is intended to be used with the da Vinci SP Systemfor dissecting, grasping, manipulating, retracting, andcoagulating tissues and vessels. The SP Fenestrated BipolarForceps is also intended for grasping and manipulatingcompatible bulldog clamps.	IDENTICAL to the subject device
	da Vinci SP Surgical System, Model SP1098:
	The Intuitive Surgical Endoscopic Instrument Control System(da Vinci SP Surgical System, Model SP1098) is intended toassist in the accurate control of Intuitive Surgical EndoWrist SPInstruments during urologic and general thoracoscopic surgicalprocedures that are appropriate for a single port approach andtransoral otolaryngology surgical procedures in the oropharynxrestricted to benign tumors and malignant tumors classified asT1 and T2. The system is indicated for adult use. It is intendedfor use by trained physicians in an operating room environmentin accordance with the representative, specific procedures setforth in the Professional Instructions for Use.EndoWrist SP Instruments:
Indications forUse	Intuitive Surgical EndoWrist SP Instruments are controlled bythe da Vinci SP Surgical System, Model SP1098, and includeflexible endoscopes, blunt and sharp endoscopic dissectors,scissors, forceps/pick-ups, needle holders, endoscopic retractors,electrocautery and accessories for endoscopic manipulation oftissue, including grasping, cutting, blunt and sharp dissection,approximation, ligation, electrocautery, and suturing through asingle port. The system is indicated for urologic and generalthoracoscopic surgical procedures that are appropriate for asingle port approach and transoral otolaryngology surgicalprocedures in the oropharynx restricted to benign tumors andmalignant tumors classified as T1 and T2. The system isindicated for adult use. It is intended for use by trainedphysicians in an operating room environment in accordancewith the representative, specific procedures set forth in theProfessional Instructions for Use.	IDENTICAL to the subject device
Characteristic	Subject Deviceda Vinci SP Instruments with increased WRIST Range of Motion(ROM) (also referred to as "Enhanced Wrist" Instruments)(K241814)	Predicate Deviceda Vinci SP Instruments (K240502)

Prescription use	Physician's use only	IDENTICAL to the subject device
Where used(hospital, home,ambulance, etc)	Hospital	IDENTICAL to the subject device
Principle ofOperation	There are no changes to the Principle of Operation between the subject and predicate devices.

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Intuitive Surgical, Inc.

K241814

Comparison of Predicate and Subject Device (da Vinci SP Medium-Large Clip Applier)

Table 9 includes a comparison of the subject device (da Vinci SP Medium-Large Clip Applier) and the predicate device (da Vinci SP Medium-Large Clip Applier cleared via K240502). Differences in the Characteristics as noted in Table 9 are marked by GREYNG OUT the specific rows. Additionally, any differences in the specific characteristics within these rows are BOLDED.

Characteristic	Subject Device	Predicate Device
	da Vinci SP Medium-Large Clip Applier(K241814)	da Vinci SP Medium-Large Clip Applier(K240502)
General Information
Manufacturer	Intuitive Surgical, Inc.	IDENTICAL to the subject device
Trade Name	da Vinci SP Medium-Large Clip Applier	IDENTICAL to the subject device
Model #	430250	430005
Common Name	Endoscope and accessories	IDENTICAL to the subject device
RegulationNumber	21 CFR 876.1500	IDENTICAL to the subject device

Table 9: Comparison of Predicate and Subject Devices (da Vinci SP Medium-Large Clip Applier)

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	Subject Device	Predicate Device
Characteristic	da Vinci SP Medium-Large Clip Applier(K241814)	da Vinci SP Medium-Large Clip Applier(K240502)
Product Code	NAY, GCJ	IDENTICAL to the subject device
DeviceClassification	Class II	IDENTICAL to the subject device
ClassificationAdvisoryCommittee	General and Plastic Surgery	IDENTICAL to the subject device
SystemCompatibility	Compatible with the SP1098 system	IDENTICAL to the subject device
Intended Use	The Medium-Large Clip Applier is intended to be used with theda Vinci SP System for the application of compatible clips.	IDENTICAL to the subject device
	da Vinci SP Surgical System, Model SP1098:The Intuitive Surgical Endoscopic Instrument Control System(da Vinci SP Surgical System, Model SP1098) is intended toassist in the accurate control of Intuitive Surgical EndoWrist SPInstruments during urologic and general thoracoscopic surgicalprocedures that are appropriate for a single port approach andtransoral otolaryngology surgical procedures in the oropharynxrestricted to benign tumors and malignant tumors classified as
	T1 and T2. The system is indicated for adult use. It is intendedfor use by trained physicians in an operating room environmentin accordance with the representative, specific procedures setforth in the Professional Instructions for Use.EndoWrist SP Instruments:
Indications forUse	Intuitive Surgical EndoWrist SP Instruments are controlled bythe da Vinci SP Surgical System, Model SP1098, and includeflexible endoscopes, blunt and sharp endoscopic dissectors,scissors, forceps/pick-ups, needle holders, endoscopic retractors,electrocautery and accessories for endoscopic manipulation oftissue, including grasping, cutting, blunt and sharp dissection,approximation, ligation, electrocautery, and suturing through asingle port. The system is indicated for urologic and generalthoracoscopic surgical procedures that are appropriate for asingle port approach and transoral otolaryngology surgicalprocedures in the oropharynx restricted to benign tumors andmalignant tumors classified as T1 and T2. The system isindicated for adult use. It is intended for use by trainedphysicians in an operating room environment in accordancewith the representative, specific procedures set forth in theProfessional Instructions for Use.	IDENTICAL to the subject device
Characteristic	Subject Device	Predicate Device
Prescription use	Physician's use only	IDENTICAL to the subject device
Number of LivesandReprocessingCycles	Number of Lives: 150 closuresNumber of Reprocessing Cycles: 38	Number of Lives: 150 closuresNumber of Reprocessing Cycles: 39
Where used(hospital, home,ambulance, etc)	Hospital	IDENTICAL to the subject device
Principle ofOperation	There are no changes to the Principle of Operation between the subject and predicate device.

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Performance Data:

Performance test data (bench, animal, and cadaver tests) demonstrate that the substantially equivalent to the predicate device and does not raise different questions of safety and effectiveness than the predicate device.

Bench Verifications

Testing was performed on the subject SP1098 Instruments (as listed in Table 1) to verify that the design meets physical, mechanical, user interface, and equipment interface requirements. A summary of the bench verification testing for the SP1098 instruments is described in Table 10.

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Subject Device	Testing
da Vinci SP Instruments	Physical specifications (dimensions, weight, materials)Mechanical requirements (force, range of motion, accuracy)Equipment interfaces (mechanical, electrical, software)User interface and patient safetyRe-use and reliabilityEnvironmental requirementsCleaning, Disinfection and SterilizationShipping and storagePackage and labeling

Table 10: Summary of the bench verification testing for the SP1098 instruments

Cadaver and Animal Validations

Cadaver models were used to demonstrate clinical performance for anatomical access and reach for SP Instruments. Live animal models were used to assess safety and performance for SP Instruments in cases where a live tissue model was required. These models replicate factors experienced during clinical use, including working with perfused organs, bleeding, and ensuring that appropriate hemostasis is achieved and maintained. Procedures were chosen on the basis of the types of surgical tasks that are performed, and which SP instruments are needed for the tasks.

{42}------------------------------------------------

Human Factors

Human Factors process conducted for the subject devices included the following activities:

o Known use-related issues for predicate devices and devices similar to the subject devices were analyzed using post-market data and the MAUDE database. All identified use-related issues that are relevant to the use of the subject devices were documented in the risk analysis.
o A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user-device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
o A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for each user task identified as New or Modified from the predicate in the CTA.
o Formative usability evaluations were conducted during the development process to inform the device user interface design and confirm assessment of use-related risks.

Summary:

Based on the intended use, indications for use, technological characteristics and performance data, the subject device(s), da Vinci SP Instruments are substantially equivalent to their respective predicate devices.

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.