The Intuitive Surgical® da Vinci® Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (153000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectorny and salpingo- oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.

Device Description

The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site Port (with insufflation adapter and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.

The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clipligation, electrocautery, and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).

AI/ML Overview

This submission pertains to a modification of the Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories, specifically a change in the material formulation of the Single-Site Port. The core of the submission argues for substantial equivalence to the predicate device due to this material change.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal table of "acceptance criteria" with numerical targets and corresponding "reported device performance" values for all tests. Instead, it describes general categories of verification and validation testing, with the implicit acceptance criterion being that the new material formulation performs equivalently to the predicate.

Category	Test Description	Test Methods	Implicit Acceptance Criteria	Reported Device Performance (Summary)
Biocompatibility	Biocompatibility	ISO 10993 (Parts 1-12), FDA's 510(k) Memorandum #G95-1	The new silicone material must meet biological safety standards for "limited duration contact (< 24 hours), external communicating device (blood path, indirect)."	Evaluated by a third-party lab in compliance with GLP and guidance, indicating it met the standards.
Physical Requirements	Configuration	Visual Observation	Configuration of the new port must conform to design specifications.	Testing performed, implying conformity.
	Dimension	Measurements	Dimensions of the new port must be within specified tolerances.	Testing performed, implying conformity.
	Hardness	Measurements	Hardness of the new material must be within specified range.	Testing performed, implying conformity.
Equipment Interface Requirements	Insufflation equipment	Measurements	The Single-Site Port must maintain its performance with insufflation equipment.	Testing performed, implying conformity.
Reliability/Durability	Simulated clinical use	Not specified	The Single-Site Port must function and resist wear during its useful life (single-use) for a simulated worst-case scenario.	Demonstrated ability to function and resist wear during simulated clinical use, with repetitions determining maximum maneuvers.
Design Validation	Port in live tissue	Porcine model	The Single-Site Port must demonstrate its ability to meet intended use without raising safety or effectiveness issues when placed in the abdominal wall.	Design validation performed in a porcine model; no safety or effectiveness issues raised.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated for each test. For reliability testing, it mentions "Single-Site Ports were tested" but doesn't provide a number. For design validation, it says "The Single Site Port was placed into the abdominal wall in a porcine model," implying a limited number of models.
Data Provenance:
- Biocompatibility: Performed by a "third-party lab."
- Bench (Physical, Equipment Interface, Reliability): Performed by the manufacturer (Intuitive Surgical, Inc.).
- Animal (Design Validation): Porcine model.
- All data appears to be prospective as it was generated specifically for this 510(k) submission to demonstrate the equivalence of the modified device.
- Country of origin: Not explicitly stated for the third-party lab for biocompatibility. Bench and animal testing would presumably be conducted in the US by the manufacturer (Sunnyvale, CA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

For the technical and bench tests (physical, equipment interface, reliability), "ground truth" is defined by the device's design specifications and performance metrics, which are established by the manufacturer's engineering and quality teams. No external experts are mentioned for establishing ground truth for these tests.
For the animal model, the assessment of safety and effectiveness (e.g., effect on tissue) would have been conducted by specialists involved in animal studies, likely veterinary professionals or surgeons. No specific number or qualifications are provided in the document.

4. Adjudication Method for the Test Set:

Not applicable as the tests described are primarily objective measurements (e.g., dimensions, hardness, insufflation pressure, wear resistance) or biological assessments (biocompatibility, tissue reaction in animal model). There is no mention of subjective assessments requiring adjudication or consensus among multiple reviewers.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a material change in a surgical port, not a diagnostic or AI-assisted system that would typically warrant such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm only) performance study was not done. This device is a passive surgical accessory (port), not an algorithm or an AI system.

7. The Type of Ground Truth Used:

Bench Testing (Physical, Equipment Interface, Reliability): Ground truth is based on design specifications and performance requirements established by the manufacturer, often derived from industry standards and internal engineering targets.
Biocompatibility: Ground truth is established by international standards (ISO 10993) and FDA guidance documents, with testing conducted to evaluate compliance against these established biological safety benchmarks.
Design Validation (Animal Model): Ground truth relates to observable biological effects and functional performance in a live tissue environment, assessed by researchers/veterinary staff against expected normal physiological responses and proper device function.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical surgical accessory and does not involve AI/machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Intuitive Surgical, Inc.

K133203 Page 1 of 3 Traditional 510(k)

510(k) Summary [As Required by 21 CFR 807.92(c)]

MAY 0 9 2014

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
---------------	--------------------------------------------------------------------

Official Contact: Einav Yemini Associate Regulatory Engineer 408-523-2656 (phone) 408-523-8907 (fax) einav.yemini@intusurg.com

Date Summary Prepared: May 1, 2014

Trade Name:	Intuitive Surgical® da Vinci® Single-Site™ Instruments andAccessories
Common Name:	Endoscope and accessories
Product Code:	NAY, GCJ
Classification:	Endoscope and Accessories, 21 CFR 876.1500
Predicate Devices:	Intuitive Surgical® da Vinci® Single-Site™ Instruments andAccessories K130726

Device Description:

{1}------------------------------------------------

Intuitive Surgical, Inc.

Intended Use:

i The Intuitive Surgical® da Vinciø Single-Site™ Instruments and Accessories used with the da Vincio Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingooophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.

The indications for use are unchanged from the predicate (K130726).

Technological Characteristics:

The Single-Site Port that is the subject of this notification is a functionally equivalent version of the most recently cleared Single-Site Port (K 130726), which was unchanged from the original Single-Site clearance (K112208). The only change to the cleared da Vinci Single-Site Instruments and Accessories is a change in material formulation of the Single-Site Port. The port material is changing due to material availability. The supplier has changed the material composition to a chemically equivalent material with a slightly different formulation. The Single-Site Port is equivalent to the predicate Single-Site Port in terms of its technological characteristics, and the intended use is identical.

Performance Data:

Biocompatibility of the new silicone material has been evaluated by a third party lab in compliance with Good Laboratory Practices (GLP) and in accordance with the following guidance and standard:

FDA's 510(k) Memorandum #G95-1 ●
ISO 10993 (Parts 1 12): Biological evaluation of medical devices .

The Single-Site Port is classified as "limited duration contact (< 24 hours), external communicating device (blood path, indirect)" based on its intended use.

Bench and animal testing demonstrated that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The difference in material formulation does not raise any new issues of safety or effectiveness as compared to the predicate device.

Design verification tests were performed on the Single-Site Ports to evaluate the port requirements/specifications and also to demonstrate that it is substantially equivalent to the predicate. Verification testing included:

{2}------------------------------------------------

K133203 Page 3 of 3 Traditional 510(k)

Intuitive Surgical, Inc.

Category	Test Description	Test Methods
Physical	Configuration	Visual observation
requirements	Dimension	Measurements
	Hardness	Measurements
Equipment Interface	Insufflation	Measurements
requirements	equipment

Single-Site Ports were tested for reliability through the port's useful life (single use). The test evaluated the ability of the Single-Site Port to function and resist wear during a simulated clinical use. The surgical tasks were designed to simulate actual maneuvers performed with the instruments and camera during minimally invasive surgical operations throughout the expected use of the port. Specifically, the number of repetitions was determined by anticipating the maximum number of such maneuvers performed during a worst case scenario.

Design validation was performed for the subject Single-Site Port to demonstrate its ability to meet its intended use and did not raise any issues of safety or effectiveness. The Single Site Port was placed into the abdominal wall in a porcine model to evaluate the port in live tissue, specifically, the effect of the port on the skin, fascia, fat, etc., that are between the flanges.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci Single-Site Instruments and Accessories with the modified Single-Site Port are substantially equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus, a symbol of medicine, in its talons.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

MAY - 9 2014

Intuitive Surgical, Inc. Einav Yemini 1266 Kifer Road Bldg. 101 Sunnyvale, CA 94086-5206 US

Re: KI33203 :

Trade/Device Name: Single-site port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope & Accessories Regulatory Class: Class II Product Code: GCJ, NAY Dated: April 4, 2014 Received: October 21, 2013

Dear Einav Yemini:

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. 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 Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the | device's labeling:

The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery or general gynecological surgery procedures have not been established. This device is only intended to be used for single incision laparoscopic cholecystectory, benign hysterectoriy, and salpingo-oophrectomy with the da Vinci Single Site Instruments and the da Vinci Si Surgical System (IS3000).

{4}------------------------------------------------

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours. Christy L. Foreman -S

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133203

Device Name

Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE ONLY BEATH OF CONTRACT OF CONFOR FOR FOR USE ONLY BEA (CAST AND THE COLLECTION COLLEGION

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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.