(84 days)
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, 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.
The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.
The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.
The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is the surgical port and to manipulate the surgical instruments and is positioned at the operating room table and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.
The provided text does not contain information about specific acceptance criteria, study details, or performance metrics for the da Vinci SP Surgical System (SP1098).
The document is a 510(k) premarket notification clearance letter from the FDA. It states that the device is "substantially equivalent" to a legally marketed predicate device (K202968, Da Vinci SP Surgical System). The clearance is based on a review of the device's indications for use and a comparison to the predicate device.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that:
- Nonclinical testing was "limited to software verification and a human factors evaluation, analogous to the testing of Dual Console mode for the reference device."
- Verification and validation testing "confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified, analogous to the reference device verification and validation testing for Dual Console mode."
This means the study described is primarily a software verification and validation and a human factors evaluation focused on the new "Dual Console" feature, rather than a clinical trial or performance study against specific acceptance criteria for the surgical system's overall function. The FDA's decision relies on the analogy to the predicate device's prior substantial equivalence determination.
Therefore, I cannot provide the requested table or detailed answers to questions 1-9 based on the provided text. The document does not describe:
- Specific acceptance criteria for the device's clinical performance.
- Reported device performance against such criteria.
- Sample sizes for test sets (beyond general software V&V or human factors, which are not detailed).
- Data provenance, expert qualifications, or adjudication methods for ground truth because a clinical performance study with such elements is not described.
- Whether MRMC or standalone performance studies were done for clinical effectiveness.
- Type of ground truth used for performance validation.
- Training set sample size or how ground truth was established for a training set, as it seems the evaluation focused on incremental changes rather than a de novo AI performance assessment.
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July 23, 2021
Intuitive Surgical, Inc. Connor McCarty Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K211316
Trade/Device Name: da Vinci SP Surgical System (SP1098) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: April 26, 2021 Received: April 30, 2021
Dear Connor McCarty:
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:
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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 devicerelated 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/guidanceregulatory-information/postmarketing-safety-reporting-combination-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 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-devices/medical-devicesafety/medical-device-reporting-mdr-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/medical-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
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devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-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
Submission Number (if known)
Device Name
da Vinci SP Surgical System (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 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.
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) Sumn
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | Intuitive Surgical, Inc. | |
| Applicant Address | 1266 Kifer Road Sunnyvale CA 94086 United States of America | |
| Applicant Contact Telephone | 805-798-4205 | |
| Applicant Contact | Mr. Connor McCarty | |
| Applicant Contact Email | connor.mccarty@intusurg.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | da Vinci SP Surgical System (SP1098) | |
| Common Name | Endoscope and accessories | |
| Classification Name | System, Surgical, Computer Controlled Instrument | |
| Regulation Number | 876.1500 | |
| Product Code | NAY | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K202968 | Da Vinci SP Surgical System | NAY |
Device Description Summary
The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.
The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.
The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is the surgical port and to manipulate the surgical instruments and is positioned at the operating room table and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
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
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accurate control of Intuitive Surgical EndoWrit SP Instruments during urologic surgical procedures that are 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.
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 surgical procedures that are appropriate for a single port approach and transoral otolary surgical procedures in the oropharynx restricted to benign tumors 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.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are unchanged from the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The technological changes that are the submission are limited to modified software. The software changes allow the da Vinci SP Surgical System to support the optional connection of two Surgeon Consoles (referred to as "Dual Console"), and then for control of the instruments to be transferred between consoles during surgery. In the Dual Console configuration, each console has equivalent capabilities and functionality. Both surgeons see the same 3D view from the endoscope and instrument overlays. Only one surgeon controls the instruments at a time. The user is identical to the predicate, with the exception of functionality that allows the surgeons to transfer control of the instruments between consoles, and a virtual pointer for instruction.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Nonclinical testing of the subject device was limited to software verification and a human factors evaluation, analogous to the testing of Dual Console mode for the reference device.
Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified, analogous to the reference device verification and validation testing for Dual Console mode. Therefore, the test results demonstrate that the subject device is substantially equivalent to its predicate device, in the same way that the reference device was determined to be substantially equivalent to its predicate.
§ 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.