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.

Device Description

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 all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera imansional (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 support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart 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 subject device changes are limited software, specifically modifications to the surgical instrument control algorithms. Two new functions are being added: instrument compensation under load and instrument grip compensation. The instrument control algorithm changes are being made to provide more consistent performance in specific situations. There are no labeling or user interface changes associated with the enhanced instrument control algorithms.

AI/ML Overview

The provided text is a 510(k) summary for the da Vinci SP Surgical System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the text states: "Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified. The subject device met the same acceptance criteria as the predicate of or regression test cases. Additional new test cases within the algorithm the new instrument control algorithm risk mitigations are effective at reducing new risks to acceptable risk levels. Therefore, the test results device is substantially equivalent to its predicate device."

While this confirms that testing was done and acceptance criteria were met, it does not provide:

A specific table of acceptance criteria and reported device performance.
Sample sizes used for the test set or data provenance.
Number of experts and their qualifications for ground truth establishment.
Adjudication method.
Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a surgical system, not typically an AI-driven image analysis tool, so MRMC studies might not be applicable here.
Information on a standalone (algorithm only) performance study. Again, this is a surgical system, not a diagnostic algorithm.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Therefore, I cannot fully complete the table and answer all your questions based on the provided document.

However, I can extract what is stated about the testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
Safety and Effectiveness	"no issues of safety or effectiveness and no additional unexpected risks were identified."
Predicate Equivalence	"met the same acceptance criteria as the predicate of or regression test cases."¹
Risk Mitigation Effectiveness	"new test cases within the algorithm the new instrument control algorithm risk mitigations are effective at reducing new risks to acceptable risk levels."

Missing Information (Not Available in the Provided Text):

Specific quantitative acceptance criteria (e.g., maximum force, precision of movement, control latency).
Detailed quantitative performance results for each criterion.
The exact "regression test cases" and "new test cases" mentioned.

Regarding the other points you requested:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in the document. Given it's a surgical system, "ground truth" would likely relate to objective performance metrics in simulated or cadaveric settings, or possibly clinical outcomes for predicate devices, rather than expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided in the document, and likely not applicable. The da Vinci SP Surgical System is a robotic surgical system that assists surgeons in performing procedures, not a diagnostic AI system meant to assist human "readers" (like radiologists). Its "AI" component refers to instrument control algorithms, not interpretative intelligence.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided in the document. The device is inherently "human-in-the-loop" as it is controlled by a surgeon. The software modifications are for "instrument compensation under load and instrument grip compensation," enhancing the existing human-controlled system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. For a surgical system, "ground truth" for performance would likely involve objective measurements in engineering tests (e.g., force feedback accuracy, range of motion, vibration reduction), and potentially clinical performance metrics from prior human use (for comparison).
8. The sample size for the training set: Not provided in the document. The software changes are described as "modifications to the surgical instrument control algorithms" adding "instrument compensation under load and instrument grip compensation." This implies an engineering/control systems approach rather than a machine learning model requiring a large "training set" in the traditional sense of AI for image analysis.
9. How the ground truth for the training set was established: Not provided in the document. Similarly, if it's an algorithm modification, "training set ground truth" might refer to performance targets or parameters derived from engineering principles and existing operational data.

This implies that the acceptance criteria are largely aligned with those previously established for the predicate device (K211316). The document states the "indications for use are unchanged". ↩

Summary

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September 29, 2021

Intuitive Surgical, Inc. Connor McCarty Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K212747

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 26, 2021 Received: August 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)

K212747

Device Name

da Vinci SP Surgical System (SP1098)

Indications for Use (Describe)

Da Vinci SP Surgical System, Model SP1098:

EndoWrist SP Instruments:

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summarv

Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Intuitive Surgical, Inc.
Applicant Address	1266 Kifer Road Sunnyvale CA 94086 US
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
K211316	da Vinci SP Surgical System	NAY
Device Description Summary	21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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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 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 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 SP 1098, 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 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 previously-cleared version of the system (K211316).

Technological Comparison

The technological differences from the most recent clearance (K211316) are limited to the system software, so the surgical instrument control algorithms are being added instrument compliance compensation under load and instrument grip compensation. The instrument control algorithm changes are being made to provide more consistent performance in specific situations.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified. The subject device met the same acceptance criteria as the predicate of or regression test cases. Additional new test cases within the algorithm the new instrument control algorithm risk mitigations are effective at reducing new risks to acceptable risk levels. Therefore, the test results device is substantially equivalent to its predicate device.

21 CFR 807.92(a)(6)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Footnotes

Indications for Use

EndoWrist SP Instruments:

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

510(k) Summarv

Intended Use/Indications for Use

Da Vinci SP Surgical System, Model SP1098:

EndoWrist SP Instruments:

Indications for Use Comparison

21 CFR 807.92(a)(5)

Technological Comparison

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

21 CFR 807.92(a)(6)

§ 876.1500 Endoscope and accessories.