da Vinci SP Instruments (SP1098)

K241814 · Intuitive Surgical, Inc. · NAY · Nov 18, 2024 · Gastroenterology, Urology

Device Facts

Record IDK241814
Device Nameda Vinci SP Instruments (SP1098)
ApplicantIntuitive Surgical, Inc.
Product CodeNAY · Gastroenterology, Urology
Decision DateNov 18, 2024
DecisionSESU
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

The da Vinci SP Surgical System (Model SP1098) is a software-controlled, electro-mechanical system for minimally invasive surgery. It comprises a Surgeon Console, Patient Cart, and Vision Cart. Surgeons control EndoWrist SP Instruments via master controls and foot pedals while viewing 3D endoscopic images. The Patient Cart, positioned at the OR table, holds a camera and three instruments, all entering through a single port. Instruments include graspers, scissors, needle drivers, and clip appliers. The system enables triangulation and X-Y movement mimicking human wrist/shoulder/elbow motion. New 'Extended Range' instruments feature longer forearms for increased lateral motion; 'Enhanced Wrist' instruments feature increased wrist range of motion (86 degrees vs 72 degrees). The 'GripSelect' algorithm allows toggling between default and strong grip modes for bipolar instruments. The system assists trained physicians in performing tissue manipulation, dissection, suturing, and electrocautery, potentially improving surgical precision and patient outcomes in single-port procedures.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench verification (physical, mechanical, software, sterilization, reliability), cadaver models for anatomical access/reach, and live animal models for safety/performance (hemostasis, tissue manipulation).

Technological Characteristics

Electro-mechanical, software-controlled surgical system. Instruments feature articulating distal tips (wrist, shoulder, elbow mimicry). Materials: metal. Energy: bipolar/monopolar electrosurgical. Connectivity: system-integrated. Sterilization: reusable instruments with defined life cycles. Software: GripSelect algorithm for grip strength control.

Indications for Use

Indicated for adult patients undergoing urologic, general thoracoscopic, or transoral otolaryngology surgical procedures (oropharynx, benign/malignant T1/T2 tumors) using a single-port approach.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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 {3}------------------------------------------------ ### 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. 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." {4}------------------------------------------------ ## 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. {5}------------------------------------------------ | | | | | Table 1: da Vinci SP Instruments | |--|--|--|--|----------------------------------| |--|--|--|--|----------------------------------| | SP Instruments<br>Category | da Vinci SP Instrument Name | da Vinci SP Instrument Model Numbers | |------------------------------------|------------------------------------------------|--------------------------------------| | SP Force Bipolar<br>Instruments | SP Force Bipolar | 430150 | | | SP Force Bipolar, Extended Range | 431150 | | | SP Maryland Bipolar Forceps, Extended<br>Range | 431152 | | | SP Cadiere Forceps, Extended Range | 431300 | | SP "Extended Range"<br>Instruments | SP Needle Driver Extended Range | 431200 | | | SP Monopolar Curved Scissors Extended<br>Range | 431100 | | | SP Round Tooth Retractor Extended Range | 431301 | | | SP Maryland Bipolar Forceps | 430152 | | SP "Enhanced Wrist"<br>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 | {6}------------------------------------------------ ### Intuitive Surgical, Inc. | Common Name: | Endoscope and accessories | |-------------------------|--------------------------------------------------------| | Classification: | Class II<br>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) | 510(k) # | |-----------------------------|-----------------------------------------------------------------------------------------------------------|------------|----------| | Predicate Device | SP Maryland Bipolar<br>Forceps | 430010 | K240502 | | | SP Cadiere Forceps | 430009 | | | | SP Needle Driver | 430006 | | | | SP Monopolar Curved<br>Scissors | 430004 | | | | SP Monopolar Cautery<br>Instrument | 430007 | | | | SP Fenestrated Bipolar<br>Forceps | 430011 | | | | SP Round Tooth Retractor | 430002 | | | | SP Medium-Large Clip<br>Applier | 430005 | | | | | | | | Reference Device | <i>EndoWrist®</i> Mercury<br>Bipolar Grasper (also<br>referred to as <i>da Vinci Xi</i><br>Force Bipolar) | 470405 | K180351 | ### Table 2 : Predicate/Reference Devices {7}------------------------------------------------ ### 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). {10}------------------------------------------------ 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 2. Standard instrument forearm 3. 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. {11}------------------------------------------------ ### 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<br>(K241814) | Predicate Device SP Instruments<br>(K240502) | | | |-------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------|--------------------------------------------| | da Vinci SP Long Joggle Instruments (also referred to<br>as "Extended Range" Instruments) | da Vinci SP<br>Instrument Model<br>Numbers | da Vinci SP Standard<br>Joggle Instruments | da Vinci SP<br>Instrument Model<br>Numbers | | SP Maryland Bipolar Forceps, Extended Range | 431152 | SP Maryland Bipolar<br>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<br>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<br>(K241814) | | Predicate Device SP Instruments<br>(K240502) | | |---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------|--------------------------------------------| | da Vinci SP Standard Joggle Instruments with<br>increased Wrist Range of Motion (ROM) (also<br>referred to as "Enhanced Wrist" Instruments) | da Vinci SP<br>Instrument Model<br>Numbers | da Vinci SP Standard<br>Joggle Instruments | da Vinci SP<br>Instrument Model<br>Numbers | | SP Maryland Bipolar Forceps | 430152 | SP Maryland Bipolar<br>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<br>Scissors | 430004 | | SP Monopolar Cautery Instrument | 430101 | SP Monopolar Cautery<br>Instrument | 430007 | | SP Fenestrated Bipolar Forceps | 430151 | SP Fenestrated Bipolar<br>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<br>(K241814) | | Predicate Device SP Instrument<br>(K240502) | | |-------------------------------------------|-------------------------------------------|---------------------------------------------|-------------------------------------------| | da Vinci SP Instrument | da Vinci SP<br>Instrument Model<br>Number | da Vinci SP Instrument | da Vinci SP<br>Instrument Model<br>Number | | SP Medium-Large Clip Applier | 430250 | SP Medium-Large Clip<br>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<br>da Vinci SP Force Bipolar<br>Instruments<br>(K241814) | Predicate Device<br>da Vinci SP Fenestrated Bipolar Forceps<br>(K240502) | Reference Device<br>EndoWrist® Mercury Bipolar Grasper<br>(K180351) | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Information | | | | | Manufacturer | Intuitive Surgical, Inc. | IDENTICAL to the subject device | IDENTICAL to the subject device | | Trade Name | da Vinci SP Force Bipolar<br>Instruments | da Vinci SP Fenestrated Bipolar Forceps | EndoWrist® Mercury Bipolar Grasper | | Model # | da Vinci SP Force Bipolar (PN<br>430150)<br>da Vinci SP Force Bipolar,<br>Extended Range (PN 431150) | da Vinci SP Fenestrated Bipolar Forceps<br>(PN 430011) | EndoWrist® Mercury Bipolar Grasper<br>(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<br>da Vinci SP Force Bipolar<br>Instruments<br>(K241814) | Predicate Device<br>da Vinci SP Fenestrated Bipolar Forceps<br>(K240502) | Reference Device<br>EndoWrist® Mercury Bipolar Grasper<br>(K180351) | | Product Code | NAY, GCJ | IDENTICAL to the subject device | IDENTICAL to the subject device | | Device<br>Classification | Class II | IDENTICAL to the subject device | IDENTICAL to the subject device | | Classification<br>Advisory<br>Committee | General and Plastic Surgery | IDENTICAL to the subject device | IDENTICAL to the subject device | | System<br>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<br>used with the da Vinci SP System<br>for dissecting, grasping,<br>manipulating, retracting, and<br>coagulating tissues and vessels. The<br>Force Bipolar is also intended for<br>grasping and manipulating<br> | The Fenestrated Bipolar Forceps is<br>intended to be used with the da Vinci SP<br>System for dissecting, grasping,<br>manipulating, retracting, and<br>coagulating tissues and vessels. The SP<br>Fenestrated Bipolar Forceps is also<br>intended for grasping and manipulating<br>compatible bulldog clamps. | The EndoWrist Mercury Bipolar<br>Grasper is intended to be used with<br>compatible systems for endoscopic<br>manipulation of tissue, including<br>dissection, grasping, retraction, and<br>bipolar coagulation of tissue. | | | da Vinci SP Surgical System, Model<br>SP1098: | | da Vinci Xi (IS4000) System | | Indications for Use | The Intuitive Surgical Endoscopic<br>Instrument Control System (da<br>Vinci SP Surgical System, Model<br>SP1098) is intended to assist in the<br>accurate control of Intuitive Surgical<br>EndoWrist SP Instruments during<br>urologic and general thoracoscopic<br>surgical procedures that are<br>appropriate for a single port<br>approach and transoral<br>otolaryngology surgical procedures<br>in the oropharynx restricted to<br>benign tumors and malignant tumors<br>classified as T1 and T2. The system<br>is indicated for adult use. It is<br>intended for use by trained<br>physicians in an operating room<br>environment in accordance with the<br>representative, specific procedures<br>set forth in the Professional<br>Instructions for Use.<br><br>EndoWrist SP Instruments:<br><br>Intuitive Surgical EndoWrist SP<br>Instruments are controlled by the da<br>Vinci SP Surgical System, Model<br>SP1098, and include flexible<br>endoscopes, blunt and sharp<br>endoscopic dissectors, scissors,<br>forceps/pick-ups, needle holders, | IDENTICAL to the subject device | The Intuitive Surgical Endoscopic<br>Instrument Control System (da Vinci Xi<br>Surgical System, Model IS4000) is<br>intended to assist in the accurate control<br>of Intuitive Surgical Endoscopic<br>Instruments including rigid endoscopes,<br>blunt and sharp endoscopic dissectors,<br>scissors, scalpels, forceps/pick-ups,<br>needle holders, endoscopic retractors,<br>electrocautery and accessories for<br>endoscopic manipulation of tissue,<br>including grasping, cutting, blunt and<br>sharp dissection, approximation,<br>ligation, electrocautery, suturing, and<br>delivery and placement of microwave<br>and cryogenic ablation probes and<br>accessories, during urologic surgical<br>procedures, general laparoscopic<br>surgical procedures, gynecologic<br>laparoscopic surgical procedures,<br>general thoracoscopic surgical<br>procedures and thoracoscopically-<br>assisted cardiotomy procedures. The<br>system can also be employed with<br>adjunctive mediastinotomy to perform<br>coronary anastomosis during cardiac<br>revascularization. The system is<br>indicated for adult and pediatric use. It is<br>intended to be used by trained physicians<br>in an operating room environment in<br>accordance with the represen…
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