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 and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
The da Vinci Sinale-Site Instruments and Accessories are a new set of devices developed by Intuitive Surgical to enable single incision cholecystectorny using the IS3000 da Vinci Si Surgical System.
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae, an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator, and a single fascial 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 provide arasping, cautery, cutting, clip ligation 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 existina IS3000 da Vinci Si Surgical System.
This document is a 510(k) summary for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for a new performance claim. Therefore, much of the requested information about acceptance criteria and study details for meeting them is not present. This type of regulatory submission primarily relies on showing that the new device operates similarly to existing, already-approved devices, rather than proving a new, quantitative performance benchmark.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given document. The 510(k) summary states, "Bench, animal, and clinical data demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or efficacy as compared to the predicate devices."
This indicates that internal design input verification and validation were performed, and a comparison to predicate devices was made, but specific quantitative acceptance criteria or detailed performance metrics against those criteria are not publicly disclosed in this summary. The focus is on substantial equivalence rather than meeting specific statistical performance targets for a novel claim.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given document. The document vaguely mentions "Bench, animal, and clinical data," but does not specify sample sizes for these tests or the provenance of the data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the given document. For a 510(k) demonstrating substantial equivalence, ground truth as typically understood in AI/diagnostic studies (e.g., expert consensus on image interpretation) is not a primary focus. The "bench, animal, and clinical data" would likely involve surgical outcomes, device functionality, and safety assessments, rather than expert interpretation of a test set in the conventional sense.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Given the nature of the device (surgical instruments) and the regulatory pathway (510(k) for substantial equivalence), a formal adjudication method for a "test set" in the context of diagnostic interpretation is not applicable or described.
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
This information is not provided and is not applicable to this device. This device is a set of surgical instruments, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, an MRMC study comparing human performance with/without AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable to this device. As explained above, this is a set of surgical instruments, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly detailed beyond the mention of "bench, animal, and clinical data." For surgical instruments, "ground truth" would generally relate to successful completion of surgical tasks, device functionality validation, and patient outcomes (e.g., absence of complications, effective tissue manipulation, etc.) as observed during animal and clinical trials. It would not be expert consensus on imaging or pathology reports in the context of diagnostic devices.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to this device. This device is a set of surgical instruments, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable to this device, as there is no "training set" for surgical instruments in this context.
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DEC - 8 2011
510(k) Summary [As Required by 21 CFR 807.92(c)]
- 510(k) Owner: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086
Official Contact: Brandon Hansen S. Manager, Regulatory Affairs 408-523-7485 (phone) 408-523-1390 (fax) brandon.hansen@intusurg.com
Date Summary Prepared: October 26, 2011
Trade Name: Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories
Common Name: system, surgical, computer controlled instrument
Product Code: NAY, GCJ, GEI
Classification: Endoscope and Accessories, 21 CFR 876.1500
Predicate Devices:
- · Intuitive Surgical IS3000 da Vinci Si Surgical System with Instruments and Accessories (K081137)
- · Covidien SILS™ Port, (cleared under K082619)
- · Transenterix Spider Surgical Instruments (K091697)
- · Transenterix Spider Flex Monopolar Hook (K102646)
- · Transenterix Spider Single Port Surgical Device, Support Arm Accessory (K090902)
Device Description:
The da Vinci Sinale-Site Instruments and Accessories are a new set of devices developed by Intuitive Surgical to enable single incision cholecystectorny using the IS3000 da Vinci Si Surgical System.
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae, an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator, and a single fascial port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
P. 1/2
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The da Vinci Single-Site Instruments and Accessories include instruments to provide arasping, cautery, cutting, clip ligation 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 existina 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, cuttina, blunt and sharp dissection, approximation, clip- ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
Technological Characteristics:
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories are equivalent to the predicate devices in terms of their indications for use and technological characteristics.
Performance Data:
Bench, animal, and clinical data demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or efficacy as compared to the predicate devices.
Summary:
Based on the 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 in terms of safety, effectiveness, and performance,
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 8 2011
Intuitive Surgical, Inc. % Ms. Melissa Gonzalez Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K112208
Trade/Device Name: Intuitive Surgical 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, GCJ Dated: October 26, 2011 Received: October 28, 2011
Dear Ms. Gonzalez:
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). 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.
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 procedures have not been established. This device is only intended to be used for single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and the da Vinci Si Surgical System (IS3000).
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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 device-related 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 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.
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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, oreman
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration
Enclosure
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510/k) Number if known: Device Name: da Vinci® Single-Site™ Instruments and Accessories
INDICATION FOR 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 and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
Prescription Use X (Per 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-the-Counter Use (Per 21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thil RP. Ogle for mkm
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112208
Intuitive Surgical, Inc.
Confidential
§ 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.