(299 days)
Not Found
No
The description focuses on the electrosurgical and mechanical functions of the device, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a surgical instrument for sealing and cutting vessels and tissue, which is an interventional function, not a therapeutic one. It facilitates surgical procedures rather than directly treating a disease or condition.
No
This device is described as an electrosurgical instrument for bipolar coagulation and mechanical transection, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines a physical instrument with a shaft, jaws, electrodes, and a cutting blade, intended for use with a surgical system and electrosurgical generator. This indicates a hardware device, not software only.
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 (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states the device is a "bipolar electrosurgical instrument" used for "bipolar coagulation and mechanical transection of vessels... and tissue bundles." This is a surgical tool used inside the body (in vivo) to directly manipulate tissue.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's condition. Its purpose is therapeutic (sealing and cutting tissue during surgery).
Therefore, the EndoWrist One Vessel Sealer falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One 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
Device Description
The EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunction with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. The outside diameter (O.D.) of the instrument shaft is 8.5 mm and the working length is 38 cm. The instrument is provided sterile and is a single-use, disposable device. The distal end has jaws with bipolar electrodes for sealing vessels and contains a cutting blade that extends through the jaws to transect sealed vessels and other tissues. The sealing and cutting functions are operated by the da Vinci Si Surgical System foot pedals.
The ERBE VIO 300 D 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
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)
Performance tests (bench and animal lab tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or effectiveness as compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
K//0639
DEC 2 8 2011
510(k) Summary [As Required by 21 CFR 807.92(c)]
Date Summary Prepared: March 2, 2011
Submitter: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086
- Official Contact: Brandon Hansen Sr. Manager, Regulatory Affairs Ph: 408-523-7485 Fax: 408-523-1390 brandon.hansen@intusurg.com
Trade Name: Intuitive Surgical EndoWrist One Vessel Sealer
Common Name: System, Surgical, Computer Controlled Instrument
Product Code: NAY
- Classification: Endoscope and accessories, 21 CFR 876.1500
Predicate Devices: Intuitive Surgical EndoWrist Bipolar Instrument (K012833) SurgRX, Inc., EnSeal PTC (K071728)
Device Description:
The EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunction with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. The outside diameter (O.D.) of the instrument shaft is 8.5 mm and the working length is 38 cm. The instrument is provided sterile and is a single-use, disposable device. The distal end has jaws with bipolar electrodes for sealing vessels and contains a cutting blade that extends through the jaws to transect sealed vessels and other tissues. The sealing and cutting functions are operated by the da Vinci Si Surgical System foot pedals.
The ERBE VIO 300 D generator provides the high frequency (radio frequency) electrical current for tissue sealing.
Intuitive Surgical, Inc.
Confidential
$\rho. i/2$
1
Intended Use/Indications for Use:
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One 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 EndoWrist One Vessel Sealer system is substantially equivalent to the predicate devices in terms of its indications for use, design, technology and performance.
Performance Data: Performance tests (bench and animal lab tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or effectiveness as compared to the predicate devices.
Summary: Based on the indications for use, design, technological characteristics and performance data, the EndoWrist One Vessel Sealer system is substantially equivalent to the predicate devices in terms of intended use, safety, effectiveness, and performance.
1.2/2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 8 2011
Intuitive Surgical, Inc. % Mr. Brandon Hansen Sr. Regulatory Affairs Manager 1266 Kifer Road Sunnyvale, California 94086
Re: K110639
Trade/Device Name: EndoWrist One Vessel Sealer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NA Y Dated: December 20, 2011 Received: December 23, 2011
Dear Mr. Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be clevice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary to regard to the Medical Device Amendments, or to commerce prior to May 20, 1978, are exam
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). and Cosment Act (Act) that do not require approvince the general controls provisions of the Act. The f ou may, therefore, manel me de rees, books in the ments for annual registration, listing of general controls provisions of the rict labeling, and prohibitions against misbranding and devices, good manufacturing praction as a magines information related to contract liability.
The adulteration. Please note: CDRH does not evaluate information of any materi adulteration. Frease note: CDICT does not evaluate must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or classion on he If your device is classified (300 a0070) mo regulations affecting your device can be
may be subject to additional controls. Existing major regulations FFA move may be subject to additional controls. "Encling and on 898. In addition, FDA may found in the Code of Peacharterging your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualles of a basevice complies with other requirements of the Act
that FDA has made a determination that your device complies with on any must that FDA has made a determination that your are federal agencies. You must
3
Page 2 – Mr. Brandon Hansen
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with all the Act 3 requirements, increases, convice reporting (reporting of medical CFK Part 807), iabeing (21 CFR 1 art 007); good manufacturing practice requirements as settings as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 1000, 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 811), please If you desire specific advice for your doviee of the sales offices/ucm 115809.htm for go to hip.//www.ida.gov/Abouti DFF CeHealth's (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of CDRH (21 CFF) P the Center for Devices and Radioneground by reference to premarket notification (21 CFR Pattern (2) note the regulation cinned, "Misoraname of activerse 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 Ittp://www.raa.go/Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
(600) 050-2041 01 (301) +2017 +281) +21 (2017) 12 +11 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 +1 + + + + + + + + + + + + + + + + + + + + + + + +
Sincerely yours,
Mark N. Millhussen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number if known: Device Name: EndoWrist One Vessel Sealer
INDICATIONS FOR USE:
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-the-Counter Use _ (Per 21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
(Division Sign-Off) (Division Sign-Orgical, Orthopedic, Delsionative Devices
K110634
510(k) Number
Intuitive Surgical, Inc.
Confidential