(185 days)
Not Found
No
The summary describes a mechanical and electrical surgical instrument controlled by foot pedals, with no mention of AI or ML capabilities.
Yes.
The device is intended for therapeutic purposes like grasping, blunt dissection, bipolar coagulation, and mechanical transection, which are all medical treatments or procedures.
No
Explanation: The device is described as a surgical instrument for grasping, dissecting, coagulating, and transecting tissue and vessels. Its "Intended Use" explicitly states its function as a surgical tool, not for diagnosis.
No
The device description clearly states it is a physical instrument with a distal wristed end effector, proximal housing, tubular shaft, integrated cord, electrode sealing surface, and cutting blade. It is a hardware device used with a surgical system and generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for grasping, dissection, coagulation, and transection of tissue and vessels within the body during surgery.
- Device Description: The description details a surgical instrument with jaws, a cutting blade, and electrical components for use with a surgical system and generator.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of these samples.
The device described is a surgical instrument used for performing procedures on the patient, not for analyzing samples from the patient.
N/A
Intended Use / Indications for Use
The EndoWrist Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Product codes
NAY
Device Description
The EndoWrist Vessel Sealer Extend is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The EndoWrist Vessel Sealer Extend device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the IESU. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.
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
The EndoWrist® Vessel Sealer Extend was evaluated using bench testing, clinical models (animals/cadavers) and a chronic animal study (in-vivo, animal) to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench testing): The subject device, EndoWrist® Vessel Sealer Extend, was subjected to 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 device meets the:
- Physical Specifications
- Mechanical Requirements
- Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements
Design Validation (animal/cadaver): The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine models (in vivo) and cadavers to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use, including indicated vessel sizes, have been met.
Chronic Animal Study (animal): A chronic animal study was performed to evaluate the clinical performance (long-term seal quality) of the subject device EndoWrist Vessel Sealer Extend as compared to the predicate device, EndoWrist Vessel Sealer. This study allowed for the clinical assessment of vascular seal performance and the vascular healing response in a live animal model with similar human tissue characteristics and a similar abdominal cavity.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 26, 2018
Intuitive Surgical, Inc. Crystal Ong Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K173337
Trade/Device Name: Intuitive Surgical EndoWrist Vessel Sealer Extend Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: April 9, 2018 Received: April 10, 2018
Dear Crystal Ong:
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, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-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. Jennifer R. Stevenson -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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number ( if known ) | K173337 |
|---|---|
| Device Name | EndoWrist Vessel Sealer Extend |
| Indications for Use (Describe) | The EndoWrist Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. |
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
[As Required by 21 CFR 807.92(c)]
December 8, 2017
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Crystal Ong
Sr. Regulatory Engineer
Ph: 408-523-8636
Fax: 408-523-8907 |
| Trade Name: | Intuitive Surgical EndoWrist® Vessel Sealer Extend |
| Common Name: | System, surgical, computer controlled instrument |
| Classification: | Endoscope and accessories, 21 CFR 876.1500, NAY
Predicate Device: Intuitive Surgical EndoWrist® Vessel Sealer (K170865) |
Device Description: The EndoWrist Vessel Sealer Extend is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The EndoWrist Vessel Sealer Extend device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the IESU. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.
Intended Use:
The EndoWrist Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer Extend has not been shown to be effective for tubal
4
sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Technological Characteristics: The EndoWrist® Vessel Sealer Extend is equivalent to the predicate device in terms of its indications for use, design, technology, and performance specifications. Modifications from the predicate include a change in material and location of electrode spacers on the end effector (jaw). The changes to the instrument tip do not substantively change the function of the subject device to the function of the predicate device.
Performance Data: The EndoWrist® Vessel Sealer Extend was evaluated using bench testing, clinical models (animals/cadavers) and a chronic animal study (in-vivo, animal) to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench testing): The subject device, EndoWrist® Vessel Sealer Extend, was subjected to 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 device meets the:
- Physical Specifications ●
- Mechanical Requirements
- . Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements ●
Design Validation (animal/cadaver): The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine models (in vivo) and cadavers to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use, including indicated vessel sizes, have been met.
Chronic Animal Study (animal): A chronic animal study was performed to evaluate the clinical performance (long-term seal quality) of the subject device EndoWrist Vessel Sealer Extend as compared to the predicate device, EndoWrist Vessel Sealer. This study allowed for the clinical assessment of vascular seal performance and the vascular healing response in a live animal model with similar human tissue characteristics and a similar abdominal cavity.
Summary: Based on the intended use, technical characteristics, and performance data, the EndoWrist® Vessel Sealer Extend is equivalent to the predicate device in terms of safety, effectiveness, and performance.