The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended 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

This SPECIAL 510(k) is being submitted for a design modification to the Intuitive Surgical EndoWrist Instruments to incorporate the functionality (vacuum stabilization, irrigation) of the Medtronic Octopus TE Tissue Stabilizer (class I, cardiovascular surgical instrument, Product Codes DWS and MWS, under CFR Section 870.4500) on an EndoWrist Instrument known as the EndoWrist Stabilizer. This modification affects the instrument only, and there are no changes to the da Vinci Surgical System associated with this pre-market notification.

The Intuitive Surgical EndoWrist Stabilizer is a multiple use instrument similar to existing EndoWrist instruments and has the following key features:

The EndoWrist Stabilizer incorporates collapsible "pods" as grips that provide suction based tissue stabilization. The collapsible feature allows the instrument to be used through a 12mm thoracic port.
A disposable, pre-packaged sterilized tubing assembly known as "ClearField" tubing is used to connect the instrument to pressurized irrigation fluid to irrigate the surgical site reducing the amount of blood on the stabilized tissue.
A disposable, pre-packaged sterilized tubing assembly known as "CardioVac" tubing provides vacuum suction to the stabilizer pods from the Vacuum Source tubing described below.
A disposable, pre-packaged sterilized tubing assembly known as "Vacuum Source" tubing that connects the CardioVac tubing to a canister with a four-meter vacuum hose, and also includes a two-meter vacuum hose (with filter) to connect to a regulated vacuum source.

The Intuitive Surgical Endowrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vincis S™ Surgical System. The surgeon sits at a Surgeon Console and controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon "locks" the stabilizer in position by switching MTM control away from the arm holding the tabilizer instrument by tapping a foot pedal on the Surgeon Console.

AI/ML Overview

The provided text describes a 510(k) Special submission for a design modification to the Intuitive Surgical EndoWrist Instruments, incorporating vacuum stabilization and irrigation functionality. This is a medical device submission, and as such, the concept of "acceptance criteria" is typically met through demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit numerical performance targets like those found in AI/ML performance studies.

Therefore, the "acceptance criteria" here refer to proving that the modified device is as safe and effective as the predicate devices, and that the design output meets the design input requirements without raising new safety or effectiveness concerns.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices: - Safety and effectiveness are comparable to legally marketed predicate devices. - No new issues of safety or effectiveness are introduced.	- "Design Analysis and comparison, as well as bench testing, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited..." - "...results of the design control process confirm that the design input meets the design output requirements, and that there are no new issues of safety or effectiveness."
Functional Equivalence (Vacuum Stabilization and Irrigation): - The incorporated vacuum stabilization and irrigation features perform comparably to the predicate Class I tissue stabilizer.	- "The vacuum stabilization and irrigation features are identical to the Medtronic Octopus TE Tissue Stabilizer and accessories cleared by FDA under K041338." - "...the stabilizer end effector and irrigation is the same as the Octopus TE Stabilizer (Medtronic)."
Compatibility with da Vinci Surgical System: - No changes in design, technology, materials, manufacturing, performance, specifications, or method of use for the da Vinci Surgical System.	- "This modification affects the instrument only, and there are no changes to the da Vinci Surgical System associated with this pre-market notification." - "The Intuitive Surgical Endowrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vincis S™ Surgical System."
Controlled Delivery and Use: - Instrument operation is consistent with other EndoWrist Instruments, allowing the surgeon to "lock" the stabilizer in position.	- "The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon 'locks' the stabilizer in position by switching MTM control away from the arm holding the tabilizer instrument by tapping a foot pedal on the Surgeon Console."
Material and Technological Characteristics: - Materials and technological characteristics are consistent with predicate devices for the robotic operation and architecture.	- "The technological characteristics of the subject device are the same as for the predicate device(s). The robotic operation and architecture are the same as existing Intuitive Surgical EndoWrist Instruments..."

Study Details

The provided document describes a 510(k) Special submission, which generally focuses on demonstrating substantial equivalence for a modification to a previously cleared device. It is not a clinical trial or performance study akin to those for AI/ML devices with specific numerical performance metrics.

Sample size used for the test set and the data provenance:
- The document mentions "bench testing" but does not specify a sample size for any test set (e.g., number of instruments tested or specific conditions).
- Data provenance is not explicitly stated but would typically be internal testing conducted by the manufacturer, Intuitive Surgical, Inc. This is not a clinical study with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of submission. "Ground truth" established by experts is relevant for diagnostic or AI/ML-driven devices where accuracy against a known standard is measured. Here, the focus is on functional verification against design requirements and comparison to predicate devices. The "ground truth" is primarily engineering specifications and functional performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not the nature of this submission. The "adjudication" is essentially the manufacturer's internal quality and design review process, and ultimately the FDA's regulatory review.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of an AI assistance tool on human performance (e.g., radiologists reading images with and without AI). The Intuitive Surgical EndoWrist Stabilizer is a surgical instrument, not an AI diagnostic or assistance tool.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No, this is a physical surgical instrument modification, not an algorithm. Therefore, a standalone algorithm-only performance study is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this regulatory submission is primarily based on engineering specifications, functional requirements, and direct comparison to the physical and functional characteristics of legally marketed predicate devices. This includes:
  - Demonstrating that the vacuum stabilization and irrigation capabilities are "identical" to the Medtronic Octopus TE Tissue Stabilizer.
  - Ensuring the instrument's mechanical and operational characteristics are "the same as" existing Intuitive Surgical EndoWrist Instruments.
  - Confirmation through "Design Analysis and comparison, as well as bench testing" that functional characteristics are met.
The sample size for the training set:
- This concept is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This submission is for a physical surgical instrument.
How the ground truth for the training set was established:
- This concept is not applicable. There is no training set for a physical surgical instrument.

Summary

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Ko6039/

APR 1 0 2006

Section II

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:

Date	13 February 2006
Submitter	Intuitive Surgical, Inc.950 Kifer RoadSunnyvale, CA 94086
ER Number	2955842
Contact	Mike YramateguiDirector, Regulatory and Quality AffairsTelephone: (408) 523 - 2145Fax: (408) 523 - 1390e-mail: mike.yramategui@intusurg.com
SubjectDevice	Trade Name: Intuitive Surgical EndoWrist® StabilizerClassification Name: System, Surgical, Computer Controlled Instrument(21 CFR 876.1500)Common Name: Cardiovascular Surgical Instrument / Heart Stabilizer
PredicateDevices	Intuitive Surgical da Vinci® Surgical System and Endoscopic Instrumentsis the predicate device (legally marketed under K990144, modified underK050369, and labeling modified under K050802). The MedtronicOctopus TE Tissue Stabilizer, K041338, is listed as a secondary predicatedevice, due to this submission being a design modification of theIntuitive Surgical instruments to incorporate the features of theMedtronic Octopus TE Tissue Stabilizer as described in this submission.

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Device Description

The Intuitive Surgical EndoWrist Stabilizer is a multiple use instrument similar to existing EndoWrist instruments and has the following key features:

The EndoWrist Stabilizer incorporates collapsible "pods" as grips that ্ত provide suction based tissue stabilization. The collapsible feature allows the instrument to be used through a 12mm thoracic port.
o A disposable, pre-packaged sterilized tubing assembly known as "ClearField" tubing is used to connect the instrument to pressurized irrigation fluid to irrigate the surgical site reducing the amount of blood on the stabilized tissue.
A disposable, pre-packaged sterilized tubing assembly known as o "CardioVac" tubing provides vacuum suction to the stabilizer pods from the Vacuum Source tubing described below.
O A disposable, pre-packaged sterilized tubing assembly known as "Vacuum Source" tubing that connects the CardioVac tubing to a canister with a four-meter vacuum hose, and also includes a two-meter vacuum hose (with filter) to connect to a regulated vacuum source.

The Intuitive Surgical Endoscopic Instrument Control System is intended Intended Use to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories

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	for endoscopic manipulation of tissue, including grasping, cutting, bluntand sharp dissection, approximation, ligation, electrocautery, suturing, anddelivery and placement of microwave ablation probes and accessoriesduring urologic surgical procedures, general laparoscopic surgicalprocedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopicallyassisted cardiotomy procedures,. The system can also be employed withadjunctive mediastinotomy to perform coronary anastomosis during cardiacrevascularization. The system is indicated for adult and pediatric use. It isintended for use by trained physicians in an operating room environment inaccordance with the representative, specific procedures set forth in theProfessional Instructions for Use.
Comparison toPredicateDevice	The Intuitive Surgical EndoWrist Stabilizer is identical to existing IntuitiveSurgical endoscopic instruments as cleared by FDA under K050369 withthe additional functionality of vacuum stabilization and irrigation asincorporated on a Class I tissue stabilizer. The vacuum stabilization andirrigation features are identical to the Medtronic Octopus TE TissueStabilizer and accessories cleared by FDA under K041338. There are nochanges in the design, technology, materials, manufacturing, performance,specifications, and method of use for the da Vinci Surgical System.
TechnologicalCharacteristics	The technological characteristics of the subject device are the same as forthe predicate device(s). The robotic operation and architecture are thesame as existing Intuitive Surgical EndoWrist Instruments; the stabilizerend effector and irrigation is the same as the Octopus TE Stabilizer(Medtronic).
PerformanceData	Design Analysis and comparison, as well as bench testing, has beenconducted to confirm that basic functional characteristics are substantiallyequivalent to the predicate devices cited, and that the design output meetsthe design input requirements.
Conclusion	Based upon the technical information, intended use, and performance dataprovided in this pre-market notification, the Intuitive Surgical EndoWristStabilizer as used with the da Vinci S Surgical System described herein, hasbeen shown to be substantially equivalent to current legally marketedpredicate devices, and the results of the design control process confirm thatthe design input meets the design output requirements, and that the thereare no new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three wing-like shapes, representing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol.

APR 1 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intuitive Surgical, Inc. c/o Mr. Michael H. Yramategui Senior Director, Regulatory & Quality Affairs 950 Kifer Road Sunnyvale, California 94086

Re: K060391

Trade/Device Name: Intuitive Surgical Endowrist® Stabilizer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: March 16, 2006 Received: March 21, 2006

Dear Mr. Yramategui:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements.set

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Page 2 - Mr. Michael H. Yramategui

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Intuitive Surgical Endowrist® Stabilizer For use with Intuitive Surgical Endoscopic Instrument Control System

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

l.gll.

Division of General. Restorative. and Neurological Devices

Page 1 of 1

Kobo39 1 510(k) Number

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.