(132 days)
No
The summary describes a standard electrosurgical instrument for grasping, sealing, and cutting tissue. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device's functions are controlled by the surgical system's foot pedals and manual user actions.
Yes
The device is described as a bipolar electrosurgical instrument intended for coagulation and mechanical transection of vessels and tissue bundles, which are functions performed to treat or manage a medical condition, classifying it as a therapeutic device.
No
The device is described as a surgical instrument for grasping, bipolar coagulation, and mechanical transection, not for diagnosis.
No
The device description clearly details a physical, sterile, single-use instrument with mechanical components (jaws, cutting blade, slider, lock button, release buttons) and an integrated cord for electrical connection. It is a hardware device used in conjunction with a surgical system and an electrosurgical generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EndoWrist® Vessel Sealer is a surgical instrument used during surgery for grasping, bipolar coagulation, and mechanical transection of vessels and tissue bundles. It directly interacts with tissue within the body.
- Intended Use: The intended use clearly describes a surgical procedure, not a diagnostic test performed on a sample outside the body.
Therefore, the function and intended use of the EndoWrist® Vessel Sealer fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Model IS4000 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 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, GEI
Device Description
The EndoWrist Vessel Sealer 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 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 the da Vinci Model 154000 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 da Vinci Model IS4000 Surgical System foot pedals.
A slider on the housing allows the user to manually open and close the instrument jaws for intraoperative cleaning and grip release. A lock button on the housing allows the user to hold the jaws open for intraoperative cleaning. Two release buttons on the housing allow removal of the Vessel Sealer from the sterile adapter on the da Vinci Model IS4000 System instrument arm.
The ERBE VIO dV generator provides the high frequency (radio frequency) electrical current for tissue sealing.
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
Surgeons and Operating Room (OR) staff; simulated operating room (OR)
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
A summative usability validation study was conducted with sixteen (16) teams of users (Surgeons and Operating Room (OR) staff). The study was conducted in a simulated operating room (OR) and involved representative typical workflow scenarios as well as certain troubleshooting scenarios that encompassed safety-critical tasks. The EndoWrist Vessel Sealer (subject device) training material and user manual were developed in concert with the products and were incorporated in the validation study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: Design verification testing of the EndoWrist Vessel Sealer (subject device) was performed on an IS4000 da Vinci Xi Surgical System. Architectural and functional requirements (e.g., physical dimension, range of motion, cutting/dissecting capabilities, creepage and clearance, force withstand, intuitive motion, electrical, programming, and general features) were tested. Reliability testing was conducted on the subject device to confirm the requirement for the disposable instrument to withstand use over its useful life (single use). Burst pressure testing was conducted on the device to demonstrate that the subject device, Endo Wrist Vessel Sealer, has seal performance on tissue bundles comparable to the predicate device, the EndoWrist One Vessel Sealer, and that the subject device effectively transects tissue bundles.
Animal and Cadaver Testing: A series of tests were performed using simulated clinical models (animal) to evaluate the performance of the EndoWris! Vessel Sealer (subject device). This included clinical validation to confirm the device meets the user needs and intended use. A porcine model was utilized in clinical validation testing to provide a test model with similar characteristics to human tissue and a similar abdominal cavity for evaluation of tissue effect and tissue interaction. Testing was done at normal systolic blood pressure levels. Simulated pelvic and gynecologic, renal and upper GI surgical procedures were performed during testing. In-vivo tissue bundle testing was also conducted to assess the device seal and transection performance on tissue bundles and to demonstrate that the subject device has seal performance comparable to the predicate device, the EndoWrist One Vessel Sealer. A living animal model was utilized for tissue bundle testing because it was necessary to perform the surgery where tissue consistency, bleeding vessels, beating hearts, etc., simulate what will be encountered in human patients. The porcine model provides effective simulation of tissue characteristics of a human specimen.
Human Factors Evaluation: A summative usability validation study was conducted with sixteen (16) teams of users (Surgeons and Operating Room (OR) staff). The study was conducted in a simulated operating room (OR) and involved representative typical workflow scenarios as well as certain troubleshooting scenarios that encompassed safety-critical tasks. The study assessed the following: ensure intended users could perform essential and high risk tasks in the expected use environments in a safe and effective manner; validate that use-related risks have been mitigated to acceptable levels of residual risk; assess the overall ease of use and usability of the EndoWrist Vessel Sealer; and evaluate whether the design introduced any previously unknown use-related risks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EndoWrist® One Vessel Sealer (K130266, August 29, 2013 and K110639, December 28, 2011)
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.
0
EndoWrist® Vessel Sealer
Traditional 510(k) K140189
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nadine Nasr, RAC
Regulatory Affairs
Phone Number: 408-523-7093
Fax Number: 408-523-8907
Email: Nadine.nasr@intusurg.com |
| Date Summary Prepared: | January 17, 2014 |
| Trade Name: | EndoWrist® Vessel Sealer |
| Common Name: | System, surgical, computer controlled instrument |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | EndoWrist® One Vessel Sealer (K130266, August 29, 2013 and
K110639, December 28, 2011) |
510(k) Summary
:
រ
CONFIDENTIAL
Page 2 of 5
1
Device Description
The EndoWrist Vessel Sealer 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 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 the da Vinci Model 154000 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 da Vinci Model IS4000 Surgical System foot pedals.
A slider on the housing allows the user to manually open and close the instrument jaws for intraoperative cleaning and grip release. A lock button on the housing allows the user to hold the jaws open for intraoperative cleaning. Two release buttons on the housing allow removal of the Vessel Sealer from the sterile adapter on the da Vinci Model IS4000 System instrument arm.
The ERBE VIO dV generator provides the high frequency (radio frequency) electrical current for tissue sealing.
Intended Use/Indications for Use:
The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Model IS4000 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 has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Technological Characteristics:
The Intuitive Surgical EndoWrist Vessel Sealer is equivalent to the predicate device, the EndoWrist® One Vessel Sealer, in terms of intended use, indications for use, and technological characteristics. Modifications from the predicate include new features and changes in the functional design of the back end and instrument tip. 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:
Performance test data (bench, animal and cadaver tests and human factors assessment) 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
| N T U I T I V E らしべるぽくない。
CONFIDENTIAL
2
dimensional measurements, mechanical and functional verification, electrical safety, simulated use in animal and cadaver models and human factors assessment as follows:
Bench Testing
Design verification testing of the EndoWrist Vessel Sealer (subject device) was performed on an IS4000 da Vinci Xi Surgical System. Architectural and functional requirements (e.g., physical dimension, range of motion, cutting/dissecting capabilities, creepage and clearance, force withstand, intuitive motion, electrical, programming, and general features) were tested.
Reliability testing was conducted on the subject device to confirm the requirement for the disposable instrument to withstand use over its useful life (single use).
Burst pressure testing was conducted on the device to demonstrate that the subject device, Endo Wrist Vessel Sealer, has seal performance on tissue bundles comparable to the predicate device, the EndoWrist One Vessel Sealer, and that the subject device effectively transects tissue bundles.
Animal and Cadaver Testing
A series of tests were performed using simulated clinical models (animal) to evaluate the performance of the EndoWris! Vessel Sealer (subject device). This included clinical validation to confirm the device meets the user needs and intended use.
A porcine model was utilized in clinical validation testing to provide a test model with similar characteristics to human tissue and a similar abdominal cavity for evaluation of tissue effect and tissue interaction. Testing was done at normal systolic blood pressure levels. Simulated pelvic and gynecologic, renal and upper GI surgical procedures were performed during testing.
In-vivo tissue bundle testing was also conducted to assess the device seal and transection performance on tissue bundles and to demonstrate that the subject device has seal performance comparable to the predicate device, the EndoWrist One Vessel Sealer,
A living animal model was utilized for tissue bundle testing because it was necessary to perform the surgery where tissue consistency, bleeding vessels, beating hearts, etc., simulate what will be encountered in human patients. The porcine model provides effective simulation of tissue characteristics of a human specimen.
Human Factors Evaluation
A Human Factor (HF) engineering process was followed in accordance with FDA guidelines for medical devices:
- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk . Management, 2000
- Draft Guidance for Industry and Food and Drug Administration Staff Applying Human . Factors and Usability Engineering to Optimize Medical Device Design, 2011
INTUITIVE らこれじゃないと
CONFIDENTIAL
3
EndoWrist® Vessel Sealer
The human factors engineering process focused on identifying critical tasks and ensuring the safe and effective use of the EndoWrist Vessel Sealer device.
A summative usability validation study was conducted with sixteen (16) teams of users (Surgeons and Operating Room (OR) staff). The study was conducted in a simulated operating room (OR) and involved representative typical workflow scenarios as well as certain troubleshooting scenarios that encompassed safety-critical tasks. The EndoWrist Vessel Sealer (subject device) training material and user manual were developed in concert with the products and were incorporated in the validation study. The study assessed the following:
- . ensure intended users could perform essential and high risk tasks in the expected use environments in a safe and effective manner;
- . validate that use-related risks have been mitigated to acceptable levels of residual risk;
- assess the overall ease of use and usability of the EndoWrist Vessel Sealer; and .
- . evaluate whether the design introduced any previously unknown use-related risks.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the Intuitive Surgical EndoWrist Vessel Sealer, is substantially equivalent to the predicate device, the Intuitive Surgical EndoWrist One Vessel Sealer.
INTUITIVE 56 & G R C . C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONFIDENTIAL
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenus Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2014
Intuitive Surgical Incorporated Ms. Nadine Nasr. RAC Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K140189
Trade/Device Name: EndoWrist" Vessel Sealer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GEI Dated: May 6, 2014 Received: May 7, 2014
Dear Ms. Nasr:
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 docs 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 device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set
5
Page 2 - Ms. Nadine Nasr, RAC
forth in 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" (21CFR 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/ReportalProblem/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 yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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)
K140189
Device Name EndoWrist® Vessel Sealer
Indications for Use (Describe)
The EndoWrist® Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping 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 has not been shown to be effective for tubal sterilization or tubal coagulation procedures, and should not be used for these procedures.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
O 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)
FORM FDA 3881 (1/14)