(59 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a surgical seal, with no mention of AI or ML capabilities.
No
The device is described as a port of entry for instruments and maintains an air-tight system; it does not directly treat or diagnose a disease.
No
The device is a surgical accessory (cannula seal) used to maintain an airtight system during endoscopic procedures, not to diagnose medical conditions.
No
The device description clearly describes a physical, sterile, single-use seal with an insufflation port and lever, 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 device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a mechanical seal and insufflation port used to maintain an airtight system during surgery. This aligns with surgical instrumentation, not IVD components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the da Vinci Trocar, as described, is a surgical instrument and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The da Vinci 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 Universal Cannula Seal (5-12 mm) is a sterile, single-use (disposable) seal used with da Vinci cannula, obturators, and reducers. The Universal Cannula Seal has an opening that is sized to allow specific diameter ranges of instruments and surgical accessories to pass through to the surgical site while maintaining an air-tight system and an insufflated body cavity. Identical to the predicate seals, the subject seal has an insufflation port with a universal luer fitting and an insufflation lever.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 the 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. The testing identified no new issues of safety or effectiveness and no new risks.
Design Verification: The subject device was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the subject device meets physical, mechanical, user interface, labeling, and packaging requirements. The verification test cases included:
- Number of seals per package
- Single use disposable product
- Diameter/instrument compatibility markings
- Position and use of insufflation valve
- Standard luer fitting attachment
- Insufflation valve open and close
- Stopcock rotation
- No Natural rubber latex
- Stopcock axial load
- Depression of seal latches
- Seal latch strength
- Installation of seal onto cannula
- Rotation of seal on cannula
- Obturator compatibility
- Torque limits
- Force limits
- Flow rate without device
- Leak test seal without device
- Leak test seal with compatible devices
- Seal removal force
Reliability/Life Testing: The subject device underwent reliability (life) testing to confirm that the subject device meets the design inputs throughout its intended life of one procedure.
Design Validation: The design validation testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model and a cadaver were performed to confirm that the subject device functions in accordance with its intended use.
Human Factors: In conformance with applicable FDA Guidance and international standards on human factors and usability engineering, a thorough analysis and internal risk assessment has been reviewed for the subject device. No new usability risk scenarios are associated with the differences between the subject device and the predicate devices. Therefore, additional human factors studies were not performed.
Sterilization: Sterilization validation and Bacterial Endotoxins Testing have been performed on the subject device and demonstrates compliance with applicable FDA Guidance for sterile devices.
Biocompatibility Testing: Biocompatibility testing was successfully completed in accordance with applicable FDA Guidance and international standards related to ISO 10993-1.
Packaging Verification: Package transit verification testing was performed to demonstrate that the packaging maintains package integrity and product functionality in simulated storage and shipping conditions. Shelf life testing was performed to verify the Universal Cannula Seal and its packaging for the time specified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K133845 – 8MM Trocar Kit, K170508 – EndoWrist® Stapler 45 and Stapler 45 Reloads
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.
Not Found
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).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 27, 2018
Intuitive Surgical, Inc. Ms. Cheryl Wu Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K181395
Trade/Device Name: Universal Cannula Seal (5-12 mm) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 25, 2018 Received: May 29, 2018
Dear Ms. Wu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -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
2
Indications for Use
510(k) Number (if known) K181395
Device Name Universal Cannula Seal (5-12 mm)
Indications for Use (Describe)
The da Vinci 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Traditional 510(k)
510(k) Summary
| 510(k) Submitter: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Contact: | Cheryl Wu |
| Regulatory Affairs Engineer | |
| Phone: 408-523-6401 | |
| Fax: 408-523-1390 | |
| Email: cheryl.wu@intusurg.com | |
| Date Summary Prepared: | July 26, 2018 |
| Trade Name: | Universal Cannula Seal (5-12 mm) |
| 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(s): | K133845 – 8MM Trocar Kit |
| K170508 – EndoWrist® Stapler 45 and Stapler 45 Reloads |
Intended Use:
To provide a port of entry for endoscopic instruments.
Indications for Use:
The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Device Description:
The Universal Cannula Seal (5-12 mm) is a sterile, single-use (disposable) seal used with da Vinci cannula, obturators, and reducers. The Universal Cannula Seal has an opening that is sized to allow specific diameter ranges of instruments and surgical accessories to pass
Image /page/3/Picture/11 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 a smaller font and also in a light gray color, with the registered trademark symbol to the right of it.
4
through to the surgical site while maintaining an air-tight system and an insufflated body cavity. Identical to the predicate seals, the subject seal has an insufflation port with a universal luer fitting and an insufflation lever.
Technological Characteristics:
The Universal Cannula Seal is equivalent to the predicate devices in terms of its intended use, design, technology, and performance specifications. The Universal Cannula Seal combines the instrument and accessory size compatibility ranges from both predicate seals. Modifications also include a change in material formulation and a change in packaging configuration.
These modifications do not affect the intended use or the fundamental technology of the subject device relative to that of the predicate device.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of the 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. The testing identified no new issues of safety or effectiveness and no new risks.
Design Verification:
The subject device was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the subject device meets physical, mechanical, user interface, labeling, and packaging requirements. The verification test cases included:
- Number of seals per package ●
- Single use disposable product
- Diameter/instrument compatibility markings ●
- Position and use of insufflation valve ●
- Standard luer fitting attachment
- Insufflation valve open and close
- . Stopcock rotation
- No Natural rubber latex
- Stopcock axial load
- Depression of seal latches
- Seal latch strength
- Installation of seal onto cannula ●
Image /page/4/Picture/22 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 also in all caps and in a smaller font size, with the registered trademark symbol next to it.
5
- Rotation of seal on cannula
- Obturator compatibility ●
- Torque limits
- . Force limits
- Flow rate without device
- Leak test seal without device ●
- Leak test seal with compatible devices
- Seal removal force ●
Reliability/Life Testing:
The subject device underwent reliability (life) testing to confirm that the subject device meets the design inputs throughout its intended life of one procedure.
Design Validation:
The design validation testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model and a cadaver were performed to confirm that the subject device functions in accordance with its intended use.
Human Factors:
In conformance with applicable FDA Guidance and international standards on human factors and usability engineering, a thorough analysis and internal risk assessment has been reviewed for the subject device. No new usability risk scenarios are associated with the differences between the subject device and the predicate devices. Therefore, additional human factors studies were not performed.
Sterilization:
Sterilization validation and Bacterial Endotoxins Testing have been performed on the subject device and demonstrates compliance with applicable FDA Guidance for sterile devices.
Biocompatibility Testing:
Biocompatibility testing was successfully completed in accordance with applicable FDA Guidance and international standards related to ISO 10993-1.
Packaging Verification:
Package transit verification testing was performed to demonstrate that the packaging maintains package integrity and product functionality in simulated storage and shipping
Image /page/5/Picture/22 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and is above the word "SURGICAL". There is a yellow dot above the word "INTUITIVE". There is a registered trademark symbol next to the word "SURGICAL".
6
conditions. Shelf life testing was performed to verify the Universal Cannula Seal and its packaging for the time specified.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the subject device Universal Cannula Seal (5-12 mm) is substantially equivalent to currently marketed predicate devices in terms of safety, effectiveness, and performance.
Image /page/6/Picture/5 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in all caps, with a small yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in a smaller font size. The logo is simple and modern, and the use of the color yellow adds a touch of warmth.