The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® 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 salpingo-oophorectomy 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 5 mm Single-Site Port.

Device Description

The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae (250 mm and 300 mm length), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm length), and a Single-Site Port (with insufflation tubing 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 grasping, cautery, cutting, clip ligation, suturing, and suction/irrigation functions. The instruments are non-wristed (similar to the predicate laparoscopic instruments). The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing IS3000 da Vinci Si Surgical System.

AI/ML Overview

The provided document is a 510(k) summary for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories. This type of regulatory submission in the US is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance acceptance criteria via a comprehensive clinical study in the same way a PMA or a de novo submission might.

Therefore, the document does not contain the detailed information typically found in a study demonstrating how a device meets specific acceptance criteria with reported device performance against those criteria, sample sizes for test sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

However, I can extract information regarding the performance data mentioned and the type of studies conducted to support substantial equivalence.

Here's an attempt to answer your request based on the available information, noting where specific details are not provided:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Overview: The document states that "Bench, and cadaver testing demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements." Additionally, "an acute animal study was performed to validate the quality and effectiveness of closure of suture lines with the Single-Site Needle Driver and to establish substantial equivalence between the curved needle driver and the SILS Port and manual single incision instruments."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific acceptance criteria or quantitative reported device performance metrics. Instead, it broadly states that "design output meets the design input requirements" and that the testing "demonstrate[s] that the subject device is substantially equivalent to the predicate devices."

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

Sample Size for Test Set: Not specified for the bench, cadaver, or animal studies.
Data Provenance:
- Bench and Cadaver Testing: The document does not specify the country of origin. This testing is typically conducted in a laboratory setting.
- Acute Animal Study: The document does not specify the species or country of origin for the animal study.
- Retrospective or Prospective: These studies would typically be considered prospective for the purpose of generating data to support the 510(k) submission.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For an animal study involving surgical procedures, it is implied that qualified veterinary surgeons or equivalent personnel would be involved.

4. Adjudication Method for the Test Set

Not applicable/Not specified. The document does not describe a clinical study with an adjudication process for a test set. The validation in the animal study likely involved direct observation and measurement of surgical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Existence of Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is more common for imaging or diagnostic AI devices where human reader performance is being evaluated.
Effect Size of Human Readers with/without AI Assistance: Not applicable, as no MRMC study was performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Existence of Study: No, a standalone algorithm-only study was not conducted or described. The device is a surgical instrument system, which inherently requires human-in-the-loop operation.

7. Type of Ground Truth Used

The document implies that "ground truth" was established through direct observation and measurement of outcomes in the bench, cadaver, and acute animal studies. For example, in the animal study, the "quality and effectiveness of closure of suture lines" would be the ground truth being assessed, likely through pathological examination or direct surgical assessment.

8. Sample Size for the Training Set

Not applicable. This device is a surgical instrument system, not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable, as no training set for an AI/ML model is mentioned.

Summary of Device Performance Claims in the Document:

The performance data primarily aims to demonstrate substantial equivalence to predicate devices. The key statements are:

"Bench, and cadaver testing demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements."
"The differences do not raise any new issues of safety or effectiveness as compared to the predicate devices."
An "acute animal study was performed to validate the quality and effectiveness of closure of suture lines with the Single-Site Needle Driver and to establish substantial equivalence between the curved needle driver and the SILS Port and manual single incision instruments."

Summary

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

122532

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

510(k) Owner: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086
Melissa S. Gonzalez Official Contact: Sr. Regulatory Affairs Specialist 408-523-8684 (phone) 408-523-8907 (fax) melissa.gonzalez@intusurg.com

Date Summary Prepared: February 21, 2013

Trade Name: Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories

Common Name:	Endoscope and accessories
Product Code:	NAY, GCJ
Classification:	Endoscope and Accessories, 21 CFR 876.1500

Predicate Devices:

Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories . (K112208/K120215)
SILSTM Clincher, SILS™ Dissector, SILS™ Grasper, SILS™ L-Hook, SILSTM . Shears (K091869)
Intuitive Surgical® da Vincio Surgical System and Endoscopic Instruments ● (K081137/K050404)

Device Description:

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

The da Vinci Single-Site Instruments and Accessories include instruments to perform grasping, cautery, cutting, clip ligation, suturing, and suction/irrigation functions. The instruments are non-wristed (similar to the predicate laparoscopic instruments). The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing IS3000 da Vinci Si Surgical System.

Intended Use:

The Intuitive Surgical® da Vinci� Single-Site™ Instruments and Accessories used with the da Vinci® 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 salpingo-oophorectomy 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 5 mm Single-Site Port.

Technological Characteristics:

The Intuitive Surgical da Vinci Single-Site Instruments and Accessories are identical to the predicate Single-Site devices in terms of their technological characteristics. The only change to the cleared da Vinci Single-Site Instruments and Accessories is the addition of two instruments (Single-Site Needle Driver and Single-Site Bipolar Maryland), both of which are substantially equivalent to previously cleared versions of these instruments used with the da Vinci Multi-Port System. The proposed indications for use are a subset of the indications cleared for the Covidien predicate device.

Performance Data:

Bench, and cadaver testing demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The differences do not raise any new issues of safety or effectiveness as compared to the predicate devices. In addition, an acute animal study was performed to validate the quality and effectiveness of closure of suture lines with the Single-Site Needle Driver and to establish substantial equivalence between the curved needle driver and the SILS Port and manual single incision instruments.

Summary:

Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci Single-Site Instruments and Accessories are substantially equivalent to the predicate devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a person embracing another person. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center- WO66-G609 Silver Spring, MD 209930002

Letter dated: March 5, 2013

Intuitive Surgical, Incorporated % Ms. Melissa S. Gonzalez Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086-5206

Re: K122532

Trade/Device Name: da Vinci® Single-Site™ Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: December 28, 2012 Received: January 02, 2013

Dear Ms. Gonzalez:

This letter corrects our substantially equivalent letter of February 19, 2013.

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 (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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number if known: K122532

Device Name: da Vincio Single-Site™ Instruments and Accessories

INDICATIONS FOR USE:

The Intuitive Surgical® da Vinci�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 salpingo-oophorectomy 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 5 mm Single-Site Port.

Prescription Use _ X _ _ _ _ _ AND/OR Over-the-Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C)

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

Long H. Chen -A for MXM (Division Sign-Off) Division of Surgical Devices

510(k) Number _ K122532

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.