(29 days)
The da Vinci Xi Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The da Vinci Xi Bladeless Optical Obturators are used with the da Vinci Xi Cannulas and da Vinci Xi Cannula Seals to facilitate placement of the Cannula in the body wall. The Bladeless Optical Obturators consist of three components - a shaft, a handle, and two latches that allow the obturator to latch onto the Cannula Seal. The handle has an opening which allows the insertion of a size-compatible endoscope into the Bladeless Optical Obturator. The subject devices are single use devices and are offered in two sizes, 8 mm and 12 mm and in two lengths (standard and long) to match the Cannula lengths and to meet users' needs.
The provided document is a 510(k) summary for the "Bladeless Optical Obturators" by Intuitive Surgical, Inc. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
However, the document does not contain detailed acceptance criteria or numerical performance metrics typically found in a comprehensive study report. It states that design verification and validation testing were conducted, but only summarizes the types of tests performed.
Therefore, much of the requested information cannot be extracted from this document, particularly numerical data, sample sizes for specific tests, and expert involvement.
Here's a breakdown of what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document in a clear, quantifiable table format. The document generally states that "design verification and design validation testing were conducted on the subject devices to confirm that the design outputs meet design input requirements and that the devices are safe and effective for its intended use."
The types of tests mentioned for verification are:
- Dimensional
- Mechanical
- Labeling requirements
- Drop test
- Axial load bearing capacity of the connection between the Obturator and Cannula Seal
- Maximum diametrical clearance when the Obturator is used with the Cannula
- Ability to differentiate between colors when used with a size-compatible endoscope
- Maximum length of the Obturator shaft past the distal end of the Cannula
- Adequacy of labeling to communicate compatibility
The types of tests mentioned for validation are:
- General, functional, and interaction (compatibility) requirements
- Latching mechanism assessment
- Verification that the obturator does not catch on tissue (tested in an animal model)
- Compatibility with cannulas, cannula seals, and size-compatible endoscopes to ensure they maintain insufflation
No specific acceptance criteria (e.g., "must withstand X N of force," "clearance must be less than Y mm," "color differentiation accuracy Z%") or reported performance values are given.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the individual tests. The document only generically mentions "the subject device" or "the subject devices."
- Data Provenance: The tests were conducted internally by Intuitive Surgical, Inc. No information about country of origin of data or whether it was retrospective/prospective is provided. The tests appear to be prospective design verification and validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is typically relevant for studies involving subjective assessments or interpretation (e.g., image analysis by radiologists). For a physical device's mechanical and functional performance tests, ground truth is established by engineering specifications and objective measurements. The document does not mention any expert panel or subjective assessment directly related to establishing "ground truth" for these engineering tests.
4. Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in subjective assessments, often by multiple human readers. Since the performance tests described are objective engineering and functional assessments, such adjudication is not relevant or mentioned.
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:
- No. This is a medical device for surgical access (trocar system), not an AI/imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical surgical instrument, not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The type of ground truth used:
- For Design Verification: The ground truth would be based on engineering specifications and measurable design inputs. For example, a specified axial load, a defined diametrical clearance, or a quantifiable measure of color differentiation (though the specific metrics are not provided).
- For Design Validation: The ground truth would likely be functional performance criteria (e.g., successful latching, no tissue catching, maintenance of insufflation) established during risk analysis and design input definition. The animal model study indicates an in vivo assessment of functionality.
8. The sample size for the training set:
- Not applicable/Not provided. This device does not involve machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set for an AI model is involved.
In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence through a general overview of design verification and validation. It lacks the granular detail about specific acceptance criteria, numerical results, and study methodology (like sample sizes and expert involvement) that would be present in a comprehensive study report for an AI or diagnostic device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Intuitive Surgical, Inc. Vishal Kanani Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
October 16, 2015
Re: K152663
Trade/Device Name: Bladeless Optical Obturators Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 15, 2015 Received: September 17, 2015
Dear Vishal Kanani:
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. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152663
Device Name Bladeless Optical Obturators
Indications for Use (Describe)
The da Vinci Xi Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
| 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)
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510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact: | Vishal KananiSr. Regulatory Affairs SpecialistPhone Number: 408-523-2035Fax Number: 408-523-8907Email: vishal.kanani@intusurg.com |
| Date Summary Prepared: | September 15, 2015 |
| Trade Name: | Bladeless Optical Obturator |
| Common Name: | Endoscope and accessories |
| Classification: | Class II21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | GCJ |
| Classification AdvisoryCommittee: | General and Plastic Surgery |
| Predicate Device: | K133845 – 8MM Trocar Kit |
Device Description
The da Vinci Xi Bladeless Optical Obturators are used with the da Vinci Xi Cannulas and da Vinci Xi Cannula Seals to facilitate placement of the Cannula in the body wall. The Bladeless Optical Obturators consist of three components - a shaft, a handle, and two latches that allow the obturator to latch onto the Cannula Seal. The handle has an opening which allows the insertion of a size-compatible endoscope into the Bladeless Optical Obturator. The subject devices are single use devices and are offered in two sizes, 8 mm and 12 mm and in two lengths (standard and long) to match the Cannula lengths and to meet users' needs.
Intended Use/Indications for Use:
The da Vinci Xi Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Image /page/3/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a sans-serif font. There is a yellow dot above the "I" in "INTUITIVE". Below "INTUITIVE" is the word "SURGICAL" in a smaller font with the registered trademark symbol.
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Technological Characteristics:
The subject Bladeless Optical Obturators are very similar to the predicate devices, 8 mm Bladeless Obturators (K133845). They have the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate devices. Modifications include the presence of an opening in the handle of the subject device and the change in material of the tip of the obturator, from grav polycarbonate to clear polycarbonate.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modifications on the predicate devices. Design verification and design validation testing were conducted on the subject devices to confirm that the design outputs meet design input requirements and that the devices are safe and effective for its intended use.
Design Verification:
The bench testing summarized in this submission verifies dimensional, mechanical, and labeling requirements for the subject device. Drop test, axial load bearing capacity of the connection between the Obturator and Cannula Seal, maximum diametrical clearance when the Obturator is used with the Cannula, ability to differentiate between colors when used with a size-compatible endoscope, and maximum length of the Obturator shaft past the distal end of the Cannula were tested along with adequacy of labeling required to communicate compatibility of the subject device.
Design Validation:
The testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model were performed to assess the subject device's latching mechanism and verify that the obturator does not catch on tissue. The subject devices' compatibility with the cannulas, cannula seals, and size-compatible endoscopes were tested to ensure they maintain insufflation when used together.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the subject Bladeless Optical Obturators are substantially equivalent to the predicate 8 mm Bladeless Obturators cleared in K133845.
Image /page/4/Picture/13 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in smaller font and also in light gray. There is a yellow dot above the word "INTUITIVE".
§ 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.