(367 days)
Not Found
No
The document describes a robotic surgical system with software control and advanced robotic technology for instrument movement. It mentions software updates and testing but does not include any terms or descriptions indicative of AI or ML capabilities, such as learning, adaptation, predictive analysis, or specific AI/ML algorithms. The performance studies focus on software functionality, human factors, and task completion, not on the performance of an AI/ML model.
Yes
Explanation: The device is intended to assist in surgical procedures (urologic and transoral otolaryngology) to manipulate tissue (grasping, cutting, dissection, ligation, electrocautery, suturing), which are therapeutic interventions.
No
The device is described as a surgical system intended to assist in the accurate control of surgical instruments for performing urologic and transoral otolaryngology surgical procedures. Its purpose is to facilitate therapy, not to diagnose a condition.
No
The device description explicitly states that the system includes three major subsystems (Surgeon Console, Vision Cart, Patient Cart) and is used with instruments and accessories, indicating significant hardware components beyond just software. While the system is software-controlled and a software update is part of the 510(k), it is not a software-only device.
Based on the provided information, the da Vinci SP® Surgical System, Model SP1098, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is intended to "assist in the accurate control of Intuitive Surgical EndoWrist SP® Instruments during urologic surgical procedures... and transoral otolaryngology surgical procedures." This describes a surgical tool used on the patient during a procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description focuses on the robotic technology, instruments, and subsystems used for surgical manipulation. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described (Design Verification, Design Validation, Human Factors Validation) focus on the system's functionality, safety, and usability during surgical tasks. They do not involve the analysis of patient samples for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The da Vinci SP Surgical System does not perform this function. It is a surgical robotic system used to facilitate surgical procedures.
N/A
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 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, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign 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 subject da Vinci SP Surgical System, Model SP1098, uses advanced robotic technology to facilitate accurate movement of EndoWrist SP™ Instruments through a single surgical port. The System includes three major subsystems (Surgeon Console, Vision Cart, Patient Cart), which are used with instruments and accessories. The system is software controlled.
There are two types of changes that are the focus of this 510(k). The first change is a modification to the Surgeon Console's FootSwitch Panel. The second change is an update to the System Software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic 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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: Design Verification and Validation were performed on the subject device to demonstrate that the design outputs meet the design inputs and the device performs as intended. The subject device met all required specifications and functioned as intended.
Design Verification: The subject device, da Vinci SP Surgical System, was subjected to a series of software tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. The software design verification testing included confirmation that the device meets the user interface and software specifications.
Design Validation (animal/cadaver): The design validation testing summarized in this submission validates general, functional and interaction (compatibility) requirements for the subject device. Tests with animal model and cadaver models were performed to confirm that the subject device functions in accordance with its intended use.
Human Factors Validation: The use-safety and usability of the SP1098 Surgical System with P3 Software was validated across two studies with a mix of RASD (Robotically Assisted Surgical Device) and non-RASD experienced surgeons. Based on these two validation studies, which included analysis of participant performance and subjective data, the SP1098 Surgical System with P3 software has been determined to be substantially equivalent to the predicate for its intended uses by intended users in the intended use environment.
In this study, representative end users (participants) completed a series of intra-operative tasks designed to be representative of those performed during actual SP1098 surgical procedures. This effort assessed how various system features and functions support users while accomplishing specific tasks. This study did not assess the system's ability to deliver the intended clinical therapy. The tasks performed during the study focused on those tasks considered Critical Tasks/Primary Operating Functions (POFs) and Essential Tasks pertaining to the software modifications made to the SP1098 Surgical System with P3 Software release:
- . Critical Tasks (Primary Operating Functions) - User tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user.
- . Essential Tasks - User tasks that are necessary to complete to ensure effectiveness of the medical device (no direct impact on safety).
The usability risk analysis was used to identify which tasks were included in this study based on the impact of the changes to use-related safety and effectiveness.
The primary objectives of this study were to ensure:
- . The participants were able to use the device in a safe and effective manner (e.g., minimize use errors and the severity of resulting hazards);
- . The participants were able to safely complete critical tasks; and
- . The participants were able to complete essential tasks.
Additionally, this study assessed whether use-related hazards impacted by the P3 software release resulted in unacceptable residual risk to users or patients. This study also validated design mitigations / risk control measures were implemented to minimize use-related hazards that have unacceptable pre-mitigated risk levels.
A complete assessment of the study results supports the following conclusions:
- . Participants are able to perform Critical Tasks (Primary Operating Functions) and Essential Tasks presented during the study, safely and effectively. All residual risks remain acceptable.
- . Participant subjective feedback indicated that the use safety of the SP1098 Surgical System with P3 software is acceptable.
- . There were no newly identified risks or use errors identified during the validation study that result in unacceptable residual risk (post-mitigated).
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.
da Vinci SP® Surgical System (K182371)
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.
Not Found
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2020
Intuitive Surgical Inc. Brandon Hansen Regulatory Submissions Manager 1266 Kifer Road Sunnyvale, California 94086
Re: K192717
Trade/Device Name: da Vinci SP Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: August 17, 2020 Received: August 18, 2020
Dear Brandon Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act 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 located at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device's labeling:
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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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 procedures and for transoral otolaryngology surgical 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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatory
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assistance/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,
For Binita Ashar, M.D., M.B.A., F.A.C.S. 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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Indications for Use
510(k) Number (if known) K192717
Device Name
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
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 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, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
[As Required by 21 CFR 807.92(c)]
September 25, 2020
| Submitter: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Official Contact: | Brandon Hansen |
| Regulatory Submissions Manager | |
| Ph: 408-523-7485 | |
| Fax: 408-523-8907 | |
| Trade Name: | da Vinci SP® Surgical System |
| Common Name: | System, surgical, computer controlled instrument |
| Classification: | Endoscope and accessories, 21 CFR 876.1500, NAY |
| Predicate Device: | da Vinci SP® Surgical System (K182371) |
Device Description:
The subject da Vinci SP Surgical System, Model SP1098, uses advanced robotic technology to facilitate accurate movement of EndoWrist SP™ Instruments through a single surgical port. The System includes three major subsystems (Surgeon Console, Vision Cart, Patient Cart), which are used with instruments and accessories. The system is software controlled.
There are two types of changes that are the focus of this 510(k). The first change is a modification to the Surgeon Console's FootSwitch Panel. The second change is an update to the System Software.
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®
Image /page/4/Picture/12 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the "I" in "INTUITIVE". The letters are all capitalized, and there is a small "TM" symbol in the bottom right corner of the image. The background is white.
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Instruments during urologic 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 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.
Technological Characteristics: The modified da Vinci SP Surgical System is substantially equivalent to the predicate device in terms of its indications for use, design, technology and performance specifications. Modifications from the predicate device includes:
-
- Hardware: The Footswitch Panel on the Surgeon Console is updated to remove the center guard dividing the control pedals and the energy pedals and removed the relocate pedal, which is now activated via the system software.
-
- System Software: The modifications to the system software include changes to the user interface to allow the surgeon more control over the Erbe VIO dV ESU from the surgeon console; a new user interface activation method for the relocate mode; two new camera auto poses to control the camera control joints; a few bug fixes and other minor updates.
These modifications do not affect the substantial equivalence of the subject device to the predicate as verification and validation testing have established there are no new or different questions of safety and effectiveness.
Performance Data: Design Verification and Validation were performed on the subject device to demonstrate that the design outputs meet the design inputs and the device performs as intended. The subject device met all required specifications and functioned as intended.
Image /page/5/Picture/10 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I" in the word. The letters are all capitalized, and there is a trademark symbol after the letter "E".
6
Design Verification: The subject device, da Vinci SP Surgical System, was subjected to a series of software tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. The software design verification testing included confirmation that the device meets the user interface and software specifications.
Design Validation (animal/cadaver): The design validation testing summarized in this submission validates general, functional and interaction (compatibility) requirements for the subject device. Tests with animal model and cadaver models were performed to confirm that the subject device functions in accordance with its intended use.
Human Factors Validation: The use-safety and usability of the SP1098 Surgical System with P3 Software was validated across two studies with a mix of RASD (Robotically Assisted Surgical Device) and non-RASD experienced surgeons. Based on these two validation studies, which included analysis of participant performance and subjective data, the SP1098 Surgical System with P3 software has been determined to be substantially equivalent to the predicate for its intended uses by intended users in the intended use environment.
In this study, representative end users (participants) completed a series of intra-operative tasks designed to be representative of those performed during actual SP1098 surgical procedures. This effort assessed how various system features and functions support users while accomplishing specific tasks. This study did not assess the system's ability to deliver the intended clinical therapy. The tasks performed during the study focused on those tasks considered Critical Tasks/Primary Operating Functions (POFs) and Essential Tasks pertaining to the software modifications made to the SP1098 Surgical System with P3 Software release:
- . Critical Tasks (Primary Operating Functions) - User tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user.
- . Essential Tasks - User tasks that are necessary to complete to ensure effectiveness of the medical device (no direct impact on safety).
The usability risk analysis was used to identify which tasks were included in this study based on the impact of the changes to use-related safety and effectiveness.
The primary objectives of this study were to ensure:
- . The participants were able to use the device in a safe and effective manner (e.g., minimize use errors and the severity of resulting hazards);
- . The participants were able to safely complete critical tasks; and
- . The participants were able to complete essential tasks.
Image /page/6/Picture/13 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I" in the word. The letters are all capitalized, and the word is written in a sans-serif font. The letters are evenly spaced, and the word is centered in the image.
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Additionally, this study assessed whether use-related hazards impacted by the P3 software release resulted in unacceptable residual risk to users or patients. This study also validated design mitigations / risk control measures were implemented to minimize use-related hazards that have unacceptable pre-mitigated risk levels.
A complete assessment of the study results supports the following conclusions:
- . Participants are able to perform Critical Tasks (Primary Operating Functions) and Essential Tasks presented during the study, safely and effectively. All residual risks remain acceptable.
- . Participant subjective feedback indicated that the use safety of the SP1098 Surgical System with P3 software is acceptable.
- . There were no newly identified risks or use errors identified during the validation study that result in unacceptable residual risk (post-mitigated).
Based on the results from these validation studies with a mix of RASD and non-RASD experienced surgeons, the SP1098 Surgical System with P3 software has been determined to be substantially equivalent to the predicate device for its intended uses and by intended users in the intended use environment.
Summary: Based on the intended use, technical characteristics, and performance data, the da Vinci SP Surgical System with modifications is substantially equivalent to the predicate device (da Vinci SP Surgical System, K182371) in terms of safety, effectiveness, and performance.
Image /page/7/Picture/9 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the "U" in the word. The letters are all capitalized, and there is a small "TM" symbol to the right of the "E".