The 8 mm Trocar consists of a cannula, an obturator, and a universal cannula seal. It provides a port of entry for endoscopic instruments typically through the abdominal or chest wall of the patient during endoscopic surgery. It is available in standard and long versions. The universal seal contains a valve and stopcock to allow for insufflation and the cannula has a fin for attachment to the da Vinci Surgical System and markings for placing the remote center in the body wall. The three components are packaged as a kit, and the obturator and cannula seal also packaged individually.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the 8mm Trocar, and therefore does not contain the specific acceptance criteria and detailed study results typically found in a clinical trial report or a comprehensive performance validation study. The FDA 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving performance against specific numerical acceptance criteria through extensive clinical studies.

Here's a breakdown of the information that can be extracted, and what is not available from this document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Specific numerical acceptance criteria are not provided in this 510(k) summary. For devices like a surgical trocar, acceptance criteria would typically involve performance benchmarks for:
- Mechanical Strength: Withstand insertion forces, resist bending/breakage during use.
- Sealing Integrity: Maintain pneumoperitoneum/insufflation pressure.
- Leakage: Minimize gas leakage around instruments.
- Ease of Insertion/Withdrawal: Low friction for instruments.
- ** biocompatibility:** Materials ensure patient safety.
- Sterility: Achieved and maintained.
- Dimensional Accuracy: Meet specified tolerances.
- Human Factors/Usability: Safe and effective use by operators.
Reported Device Performance: The document states: "Performance test data (bench, animal and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and simulated use in animal and cadaver models." It also mentions a "summative usability validation study." These are general statements of compliance, but specific quantitative results or how they directly align with unstated acceptance criteria are not provided.

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

Test Set Sample Size: Not specified. The document mentions "bench, animal and cadaver tests" and a "summative usability validation study" but does not give the number of devices tested, animals used, cadaveric trials, or human participants.
Data Provenance: The document implies the data was generated by Intuitive Surgical, Inc. as part of this submission. It's an industry-sponsored study. It mentions "animal and cadaver models," suggesting prospective testing specific to this device. No country of origin for the data is explicitly stated, but as an FDA submission, the primary data generation likely took place in the US or in compliance with US regulatory standards.

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

For Performance Testing (Bench, Animal, Cadaver): The document does not specify the number or qualifications of experts involved in establishing ground truth for these tests. For these types of tests, "ground truth" would often be defined by engineering specifications, direct physical measurements, and observational outcomes.
For Usability Study: The document states: "A summative usability validation study was conducted with users (surgeons and operating room staff) for the 8 mm Trocar." It does not specify the number of surgeons or OR staff, nor their detailed qualifications (e.g., years of experience). These users would serve as the "experts" providing feedback on usability and safety.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating performance. For engineering and functional tests, results are typically objective measurements. For the usability study, standard human factors methodologies would be applied to analyze user feedback and performance observations.

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

No MRMC study was done. This type of study is typically relevant for interpretative diagnostic devices (e.g., AI for radiology images) where multiple human readers assess cases, and their performance is compared with and without AI assistance. The 8mm trocar is a surgical instrument, not a diagnostic device, so an MRMC study is not applicable.

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

Not applicable. The 8mm trocar is a physical surgical instrument, not an algorithm or AI system. Therefore, "standalone performance" in the context of an algorithm is not relevant. Its performance is always tied to human use (surgeon and OR staff).

7. Type of Ground Truth Used

For Engineering/Functional Tests: Ground truth would be based on objective measurements (e.g., dimensional accuracy, force measurements), defined specifications/requirements, and observational outcomes in animal/cadaver models (e.g., successful instrument passage, maintenance of insufflation, absence of damage).
For Usability Study: Ground truth is derived from user feedback and observations of task completion, errors, and critical incidents during simulated use cases, validated against predefined safety and effectiveness criteria.

8. Sample Size for the Training Set

Not applicable. The 8mm trocar is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's design is developed through engineering principles, bench testing, and iterative design, not by training an algorithm on a dataset.

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

Not applicable. As there is no training set for a physical device like a trocar, this question is not relevant. Design inputs and requirements guide the development, and "ground truth" for these are established through clinical need, engineering standards, and regulatory requirements.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

DEPA

February 19, 2014

Intuitive Surgical. Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

Re: K133845

Trade/Device Name: 8mm trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Disposable Surgical Trocar/Cannula Regulatory Class: Class II Product Code: GCJ Dated: January 24, 2014 Received: January 27, 2014

Dear Mr. Hansen:

We have reviewed vour 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. 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.

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 [OIR/IVD OPTION] and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR

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Page 2 - Mr. Brandon Hansen

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 [OIR/IVD OFTION] and Part 809), please contact 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Felipe Aguel

for

Binita S. Ashar. M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

......................... Indications for Use

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

510(k) Number (if known) K133845

Device Name S mm Tricar

Indications for Use (Describe)

The 8 mm Trocar has application in a variety of endoscopic provide a port of entry for endoscopic instruments.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpan D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Long H. Chen-A	for BSA
(Division Sign-off)
Division of Surgical Devices	510(k) Number: K133845
FORM FDA 3881 (1/14)	Page 1 of 2

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K133845

Page 1 of 2

510(k) Summary

FEB 1 9 2014

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Brandon HansenProject Manager, Regulatory AffairsPhone Number: 408-523-7485Fax Number: 408-523-8907Email: Brandon.Hansen@intusurg.com
Date Summary Prepared:	January 24, 2014
Trade Name:	8 mm Trocar
Common Name:	Disposable Surgical Trocar/Cannula
Classification:	Class II21 CFR 876.1500, Laparoscope, General & Plastic Surgery
Product Code:	GCJ
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	Unimax Trocar System (K112358)

Device Description:

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Intended Use:

To provide a port of entry for endoscopic instruments.

Indications for Use:

The 8 mm Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

Technological Characteristics:

The 8 mm Trocar is substantially equivalent to the Unimax Medical Systems, Inc., Trocar System (K112358) in terms of design, materials, technological characteristics and intended use.

Performance Data:

Performance test data (bench, animal and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and simulated use in animal and cadaver models.

Human Factors and Usability Testing:

A summative usability validation study was conducted with users (surgeons and operating room staff) for the 8 mm Trocar. This study was conducted in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation study and the other elements of the human factors engineering program provide evidence that the 8 mm Trocar is safe and effective when used by the intended users in the intended use environment.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the 8 mm Trocar is substantially equivalent to the Unimax Medical Systems, Inc., Trocar System (K112358)

INTUITIVE SURGICAL®

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.