(29 days)
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No
The document describes a mechanical trocar device and its components, with no mention of AI or ML capabilities in its function or design.
No.
The device provides a port of entry for endoscopic instruments and does not provide therapy or treatment.
No
Explanation: The device, the da Vinci Xi Bladeless Optical Obturator, is described as facilitating the placement of a cannula and providing a port of entry for endoscopic instruments. Its function is to aid in surgical access, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (shaft, handle, latches) and mentions bench testing for dimensional and mechanical requirements, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a port of entry for endoscopic instruments during surgical procedures. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a physical tool (obturator, shaft, handle, latches) used to facilitate the placement of a cannula in the body wall. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the da Vinci Xi Trocar, as described, is a surgical instrument and not an In Vitro Diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.
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
1
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 Road
Sunnyvale, CA 94086 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Vishal Kanani
Sr. Regulatory Affairs Specialist
Phone Number: 408-523-2035
Fax Number: 408-523-8907
Email: vishal.kanani@intusurg.com |
| Date Summary Prepared: | September 15, 2015 |
| Trade Name: | Bladeless Optical Obturator |
| Common Name: | Endoscope and accessories |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | GCJ |
| Classification Advisory
Committee: | 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".