Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the electro-mechanical and software control of the surgical system and instruments, with no mention of AI or ML capabilities for image analysis, decision support, or automated tasks beyond surgeon control.

Therapeutic

Yes

Explanation: The device is intended to assist in surgical procedures (urologic, general thoracoscopic, and transoral otolaryngology) for various interventions like grasping, cutting, dissection, ligation, electrocautery, and suturing, which are therapeutic actions aimed at treating or alleviating a condition.

Diagnostic

No

This device is a surgical system intended to assist in performing surgical procedures, not for diagnosing conditions. It is used to control surgical instruments and provide a view of patient anatomy during surgery.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "software-controlled, electro-mechanical system" and includes physical components like a Surgeon Console, Patient Cart, Vision Cart, Camera Instruments, and Accessories.

IVD (In Vitro Diagnostic)

Based on the provided information, the da Vinci SP Surgical System, Model SP1098, and its associated EndoWrist SP Instruments are not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the system is designed to "assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic and general thoracoscopic surgical procedures... and transoral otolaryngology surgical procedures." This describes a surgical tool used in vivo (within the living body) for performing surgical procedures.
Device Description: The description details a system with a Surgeon Console, Patient Cart, Vision Cart, and instruments used for manipulating tissue, cutting, suturing, etc., all within the patient's body.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The da Vinci SP system does not perform these functions. It is a surgical robot designed for performing procedures directly on the patient.

Therefore, the da Vinci SP Surgical System is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

NAY

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, three-dimensional 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.

Mentions image processing

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.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopic

Anatomical Site

urologic and general thoracoscopic surgical procedures, transoral otolaryngology surgical procedures in the oropharynx

Indicated Patient Age Range

adult use

Intended User / Care Setting

trained physicians in an operating room environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
Testing:
Physical specifications (dimensions, weight, materials)
Mechanical requirements (force, range of motion, accuracy)
Equipment interfaces (mechanical, electrical, software)
User interface and patient safety
Re-use and reliability
Environmental requirements
Cleaning, Disinfection and Sterilization
Shipping and storage
Package and labeling

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.

Human Factors:
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.
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.
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.
Formative usability evaluations were conducted during the development process to inform the device user interface design and confirm assessment of use-related risks.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K240502

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K180351

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Build Correspondence

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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

1

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

2

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:

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.

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.

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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 Instruments

Category	da Vinci SP Instrument Name	da Vinci SP Instrument Model Numbers
SP Force Bipolar
Instruments	SP Force Bipolar	430150
	SP Force Bipolar, Extended Range	431150
	SP Maryland Bipolar Forceps, Extended
Range	431152
	SP Cadiere Forceps, Extended Range	431300
SP "Extended Range"
Instruments	SP Needle Driver Extended Range	431200
	SP Monopolar Curved Scissors Extended
Range	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 II
21 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)
Predicate Device	SP Maryland Bipolar
Forceps	430010	K240502
	SP Cadiere Forceps	430009
	SP Needle Driver	430006
	SP Monopolar Curved
Scissors	430004
	SP Monopolar Cautery
Instrument	430007
	SP Fenestrated Bipolar
Forceps	430011
	SP Round Tooth Retractor	430002
	SP Medium-Large Clip
Applier	430005

Reference Device	EndoWrist® Mercury
Bipolar Grasper (also
referred to as da Vinci Xi
Force Bipolar)	470405	K180351

Table 2 : Predicate/Reference Devices

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Intuitive Surgical, Inc.

K241814

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.

UITIVF

8

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

9

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 to
as "Extended Range" Instruments) | da Vinci SP
Instrument Model
Numbers | da Vinci SP Standard
Joggle Instruments | da Vinci SP
Instrument Model
Numbers |
| SP Maryland Bipolar Forceps, Extended Range | 431152 | SP Maryland Bipolar
Forceps | 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 Curved
Scissors | 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.

12

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.

13

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

14

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 with
increased Wrist Range of Motion (ROM) (also
referred to as "Enhanced Wrist" Instruments) | da Vinci SP
Instrument Model
Numbers | da Vinci SP Standard
Joggle Instruments | da Vinci SP
Instrument Model
Numbers |
| SP Maryland Bipolar Forceps | 430152 | SP Maryland Bipolar
Forceps | 430010 |
| SP Cadiere Forceps | 430300 | SP Cadiere Forceps | 430009 |
| SP Needle Driver | 430200 | SP Needle Driver | 430006 |
| SP Monopolar Curved Scissors | 430100 | SP Monopolar Curved
Scissors | 430004 |
| SP Monopolar Cautery Instrument | 430101 | SP Monopolar Cautery
Instrument | 430007 |
| SP Fenestrated Bipolar Forceps | 430151 | SP Fenestrated Bipolar
Forceps | 430011 |

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

15

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)

16

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 SP
Instrument Model
Number | da Vinci SP Instrument | da Vinci SP
Instrument Model
Number |
| SP Medium-Large Clip Applier | 430250 | SP Medium-Large Clip
Applier | 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.

17

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 Device
da Vinci SP Force Bipolar
Instruments
(K241814) | Predicate Device
da Vinci SP Fenestrated Bipolar Forceps
(K240502) | Reference Device
EndoWrist® 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 Bipolar
Instruments | da Vinci SP Fenestrated Bipolar Forceps | EndoWrist® Mercury Bipolar Grasper |
| Model # | da Vinci SP Force Bipolar (PN
430150)
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 Device
da Vinci SP Force Bipolar
Instruments
(K241814) | Predicate Device
da Vinci SP Fenestrated Bipolar Forceps
(K240502) | Reference Device
EndoWrist® Mercury Bipolar Grasper
(K180351) |
| Product Code | NAY, GCJ | IDENTICAL to the subject device | IDENTICAL to the subject device |
| Device
Classification | Class II | IDENTICAL to the subject device | IDENTICAL to the subject device |
| Classification
Advisory
Committee | General and Plastic Surgery | IDENTICAL to the subject device | IDENTICAL to the subject device |
| System
Compatibility | 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 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
| The Fenestrated Bipolar Forceps is
intended to be used with the da Vinci SP
System for dissecting, grasping,
manipulating, retracting, and
coagulating tissues and vessels. The SP
Fenestrated Bipolar Forceps is also
intended for grasping and manipulating
compatible bulldog clamps. | The EndoWrist Mercury Bipolar
Grasper is intended to be used with
compatible systems for endoscopic
manipulation of tissue, including
dissection, grasping, retraction, and
bipolar coagulation of tissue. |
| | da Vinci SP Surgical System, Model
SP1098: | | da Vinci Xi (IS4000) System |
| Indications for Use | 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, | IDENTICAL to the subject device | The Intuitive Surgical Endoscopic
Instrument Control System (da Vinci Xi
Surgical System, Model IS4000) is
intended to assist in the accurate control
of Intuitive Surgical Endoscopic
Instruments including rigid endoscopes,
blunt and sharp endoscopic dissectors,
scissors, scalpels, forceps/pick-ups,
needle holders, endoscopic retractors,
electrocautery and accessories for
endoscopic manipulation of tissue,
including grasping, cutting, blunt and
sharp dissection, approximation,
ligation, electrocautery, suturing, and
delivery and placement of microwave
and cryogenic ablation probes and
accessories, during urologic surgical
procedures, general laparoscopic
surgical procedures, gynecologic
laparoscopic surgical procedures,
general thoracoscopic surgical
procedures and thoracoscopically-
assisted cardiotomy procedures. The
system can also be employed with
adjunctive mediastinotomy to perform
coronary anastomosis during cardiac
revascularization. The system is
indicated for adult and 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. |
| | Subject Device | Predicate Device | Reference Device |
| Characteristic | da Vinci SP Force Bipolar
Instruments
(K241814) | da Vinci SP Fenestrated Bipolar Forceps
(K240502) | EndoWrist® Mercury Bipolar Grasper
(K180351) |
| | 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. | | |
| Characteristic | Subject Device
da Vinci SP Force Bipolar
Instruments
(K241814) | Predicate Device
da Vinci SP Fenestrated Bipolar Forceps
(K240502) | Reference Device
EndoWrist® Mercury Bipolar Grasper
(K180351) |
| Prescription use | Prescription/Physician use only | IDENTICAL to the subject device | IDENTICAL to the subject device |
| Number of Lives and
Reprocessing Cycles | Number of Lives: 20
Number of Reprocessing Cycles:
30 | IDENTICAL to the subject device | Number of Lives: 10
Number 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)

19

20

21

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Image /page/22/Picture/3 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. The word is centered in the image.

23

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 Device
SP Instruments with Long Joggle (also referred to as "Extended
Range" Instruments
(K241814) | Predicate Device
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 Long Joggle Instruments (also referred to as "Extended Range" Instruments)
SP Maryland Bipolar Forceps, Extended Range
SP Cadiere Forceps, Extended Range
SP Needle Driver, Extended Range
SP Monopolar Curved Scissors, Extended Range
SP Round Tooth Retractor, Extended Range | da Vinci SP Standard Joggle Instruments
SP Maryland Bipolar Forceps
SP Cadiere Forceps
SP Needle Driver
SP Monopolar Curved Scissors
SP Round Tooth Retractor |
| | Model #
431152
431300
431200
431100
431301 | Model #
430010
430009
430006
430004
430002 |
| Common Name | Endoscope and accessories | IDENTICAL to the subject device |
| Characteristic | Subject Device
SP Instruments with Long Joggle (also referred to as "Extended
Range" Instruments
(K241814) | Predicate Device
da Vinci SP Instruments (K240502) |
| Regulation
Number | 21 CFR 876.1500 | IDENTICAL to the subject device |
| Product Code | NAY, GCJ | IDENTICAL to the subject device |
| Device
Classification | Class II | IDENTICAL to the subject device |
| Classification
Advisory
Committee | General and Plastic Surgery | IDENTICAL to the subject device |
| System
Compatibility | Compatible with the SP1098 system | IDENTICAL to the subject device |
| Characteristic | Subject Device
SP Instruments with Long Joggle (also referred to as "Extended
Range" Instruments
(K241814) | Predicate Device
da Vinci SP Instruments (K240502) |
| Intended Use | Intended Use:
SP Maryland Bipolar Forceps, Extended Range: The
Maryland Bipolar Forceps is intended to be used with
the da Vinci SP System for dissecting, grasping,
manipulating, retracting, and coagulating tissues and
vessels. SP Cadiere Forceps, Extended Range: The Cadiere
Forceps is intended to be used with the da Vinci SP
System for dissecting, grasping, manipulating, and
retracting tissues. The SP Cadiere Forceps is also
intended for grasping and manipulating compatible
bulldog clamps. SP Needle Driver, Extended Range: The Needle Driver
is intended to be used with the da Vinci SP System to
drive needles through tissue and handle and tie suture. SP Monopolar Curved Scissors, Extended Range: The
Monopolar Curved Scissors with MCS Tip is intended
to be used with the da Vinci SP System for
manipulating, 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 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: | |
| Indications for
Use | 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. | IDENTICAL to the subject device |
| Characteristic | Subject Device
SP Instruments with Long Joggle (also referred to as “Extended
Range” Instruments
(K241814) | Predicate Device
da 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 |

25

26

27

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Image /page/28/Picture/3 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. The word is centered in the image.

29

| Characteristic | Subject Device
SP Instruments with Long Joggle (also referred to as “Extended
Range” Instruments
(K241814) | | | | Predicate Device
da Vinci SP Instruments (K240502) | | | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------------|-------------------------------------|-------------------------------------------------------|--------------------------------------------|--------------------|-------------------------------------|
| | Subject Device SP Instruments | | | | Predicate Device SP Instruments (K240502) | | | |
| Number of Lives
and
Reprocessing
Cycles | da Vinci SP Long Joggle
Instruments (also referred to as
“Extended Range”
Instruments) | da Vinci SP
Instrument
Model Numbers | Number
of Lives | Number of
Reprocessing
Cycles | da Vinci SP
Standard Joggle
Instruments | da Vinci SP
Instrument
Model Numbers | Number
of Lives | Number of
Reprocessing
Cycles |
| | SP Maryland Bipolar Forceps,
Extended Range | 431152 | 25 | 38 | SP Maryland
Bipolar Forceps | 430010 | 20 | 30 |
| | SP Cadiere Forceps, Extended
Range | 431300 | 25 | 38 | SP Cadiere
Forceps | 430009 | 22 | 33 |
| | SP Needle Driver, Extended
Range | 431200 | 25 | 38 | SP Needle Driver | 430006 | 22 | 33 |
| | SP Monopolar Curved Scissors,
Extended Range | 431100 | 25 | 38 | SP Monopolar
Curved Scissors | 430004 | 20 | 30 |
| | SP Round Tooth Retractor,
Extended Range | 431301 | 25 | 38 | SP Round Tooth
Retractor | 430002 | 20 | 30 |
| Compatible
System | SP1098 Surgical System | | | | IDENTICAL to the subject device | | | |
| Principle of
Operation | There are no changes to the Principle of Operation between the subject and predicate devices. | | | | | | | |

30

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.

31

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 430152
SP Cadiere Forceps 430300
SP Needle Driver 430200
SP Monopolar Curved Scissors 430100
SP Monopolar Cautery Instrument 430101
SP Fenestrated Bipolar Forceps 430151	SP Maryland Bipolar Forceps 430010
SP Cadiere Forceps 430009
SP Needle Driver 430006
SP Monopolar Curved Scissors 430004
SP Monopolar Cautery Instrument 430007
SP Fenestrated Bipolar Forceps 430011
Common Name	Endoscope and accessories	IDENTICAL to the subject device
Characteristic	Subject Device
da Vinci SP Instruments with increased WRIST Range of Motion
(ROM) (also referred to as “Enhanced Wrist” Instruments)
(K241814)	Predicate Device
da Vinci SP Instruments (K240502)
Regulation
Number	21 CFR 876.1500	IDENTICAL to the subject device
Product Code	NAY, GCJ	IDENTICAL to the subject device
Device
Classification	Class II	IDENTICAL to the subject device
Classification
Advisory
Committee	General and Plastic Surgery	IDENTICAL to the subject device
System
Compatibility	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)

32

33

| Characteristic | Subject Device
da Vinci SP Instruments with increased WRIST Range of Motion
(ROM) (also referred to as "Enhanced Wrist” Instruments)
(K241814) | | | | Predicate Device
da Vinci SP Instruments (K240502) | | | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------------|-------------------------------------|-------------------------------------------------------|--------------------------------------------|--------------------|-------------------------------------|
| | Subject Device SP Instruments | | | | Predicate Device SP Instruments (K240502) | | | |
| Number of
Lives and
Reprocessing
Cycles | da Vinci SP Instruments with
Enhanced WRIST Range of
Motion (ROM) | da Vinci SP
Instrument
Model Numbers | Number
of Lives | Number of
Reprocessing
Cycles | da Vinci SP
Standard Joggle
Instruments | da Vinci SP
Instrument
Model Numbers | Number of
Lives | Number of
Reprocessing
Cycles |
| | SP Maryland Bipolar Forceps | 430152 | 25 | 38 | SP Maryland
Bipolar Forceps | 430010 | 20 | 30 |
| | SP Cadiere Forceps | 430300 | 25 | 38 | SP Cadiere
Forceps | 430009 | 22 | 33 |
| | SP Needle Driver | 430200 | 25 | 38 | SP Needle
Driver | 430006 | 22 | 33 |
| | SP Monopolar Curved Scissors | 430100 | 25 | 38 | SP Monopolar
Curved Scissors | 430004 | 20 | 30 |
| | SP Monopolar Cautery
Instrument | 430101 | 25 | 38 | SP Monopolar
Cautery
Instrument | 430007 | 25 | 39 |
| | SP Fenestrated Bipolar Forceps | 430151 | 25 | 38 | SP Fenestrated
Bipolar Forceps | 430011 | 20 | 30 |

34

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 Bipolar
Forceps is intended to be used with the da Vinci SP System
for dissecting, grasping, manipulating, retracting, and
coagulating tissues and vessels. SP Cadiere Forceps: The Cadiere Forceps is intended to be
used with the da Vinci SP System for dissecting, grasping,
manipulating, and retracting tissues. The SP Cadiere Forceps
is also intended for grasping and manipulating compatible
bulldog clamps. SP Needle Driver: The Needle Driver is intended to be used
with the da Vinci SP System to drive needles through tissue
and handle and tie suture. SP Monopolar Curved Scissors: The Monopolar Curved
Scissors with MCS Tip is intended to be used with the da
Vinci SP System for manipulating, cutting, and dissecting
tissue, coagulating and transecting tissue using monopolar
electrosurgical energy, and cutting suture. SP Monopolar Cautery Instrument: The Monopolar Cautery
Instrument with the 5 mm Cautery Hook Tip or 5 mm
Cautery Spatula Tip is intended to be used with the da Vinci
SP System for manipulating and dissecting tissue and
coagulating and transecting tissue using monopolar
electrosurgical energy. SP Fenestrated Bipolar Forceps: The Fenestrated Bipolar
Forceps is intended to be used with the da Vinci SP System
for dissecting, grasping, manipulating, retracting, and
coagulating tissues and vessels. The SP Fenestrated Bipolar
Forceps is also intended for grasping and manipulating
compatible 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 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:
Indications for
Use	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.	IDENTICAL to the subject device
Characteristic	Subject Device
da Vinci SP Instruments with increased WRIST Range of Motion
(ROM) (also referred to as "Enhanced Wrist" Instruments)
(K241814)	Predicate Device
da 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 of
Operation	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
Regulation
Number	21 CFR 876.1500	IDENTICAL to the subject device

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

Image /page/37/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. The word is centered in the image.

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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
Device
Classification	Class II	IDENTICAL to the subject device
Classification
Advisory
Committee	General and Plastic Surgery	IDENTICAL to the subject device
System
Compatibility	Compatible with the SP1098 system	IDENTICAL to the subject device
Intended Use	The Medium-Large Clip Applier is intended to be used with the
da 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 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:
Indications for
Use	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.	IDENTICAL to the subject device
Characteristic	Subject Device	Predicate Device
Prescription use	Physician's use only	IDENTICAL to the subject device
Number of Lives
and
Reprocessing
Cycles	Number of Lives: 150 closures
Number of Reprocessing Cycles: 38	Number of Lives: 150 closures
Number of Reprocessing Cycles: 39
Where used
(hospital, home,
ambulance, etc)	Hospital	IDENTICAL to the subject device
Principle of
Operation	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 safety
Re-use and reliability
Environmental requirements
Cleaning, Disinfection and Sterilization
Shipping and storage
Package 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.

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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.