(206 days)
Not Found
No
The description focuses on the mechanical and electrical functions of the device for tissue sealing and cutting, with no mention of AI or ML technologies.
Yes.
The device is used for bipolar coagulation and mechanical transection of vessels and tissue bundles, which are direct therapeutic interventions.
No
The device is an electrosurgical instrument intended for grasping, blunt dissection, bipolar coagulation, and mechanical transection of vessels and tissue bundles. Its functions are therapeutic (sealing and cutting) rather than diagnostic (identifying or characterizing disease).
No
The device description clearly details a physical instrument with a shaft, jaws, electrodes, and a cutting blade, which is a hardware component. It is used in conjunction with other hardware systems (da Vinci Si Surgical System and ERBE VIO 300 D generator).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a surgical instrument used during surgery for grasping, dissecting, coagulating, and transecting tissue and vessels within the body. It uses electrosurgery and mechanical action.
- No Mention of Samples: There is no mention of the device being used to analyze samples taken from the body.
Therefore, the EndoWrist® One Vessel Sealer is a surgical device, 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 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 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 (comma separated list FDA assigned to the subject device)
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 actuated by the daVinci 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)
Design validation and animal testing demonstrates that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The differences do not raise different questions of safety or effectiveness as compared to the predicate devices.
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.
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
K1302.66
Intuitive Surgical, Inc.
Traditional 510(k) EndoWrist® One Vessel Sealer
510(k) Summary [As Required by 21 CFR 807.92(c)]
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|--------------------------------------------------------------------------|
| Official Contact: | Crystal Ong
Sr. Regulatory Affairs Specialist
408-523-8636 (phone) |
408-523-8907 (fax)
AUG 2 9 2013
Date Summary Prepared: February 1, 2013
Trade Name: 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's EndoWrist® One Vessel Sealer(K110639) .
- Ethicon Endo-Surgery's 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 actuated by the daVinci Si Surgical System foot pedals.
1
The ERBE VIO 300 D generator provides the high frequency (radio frequency) electrical current for tissue sealing.
Intended 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 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 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 subject EndoWrist One Vessel Sealer is identical to the predicate EndoWrist One Vessel Sealer device in terms of technological characteristics. The proposed indications for use are a subset of the indications cleared for the Ethicon-EndoSurgery predicate device.
Performance Data:
Design validation and animal testing demonstrates that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The differences do not raise different questions of safety or effectiveness as compared to the predicate devices.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the Intuitive Surgical EndoWrist One Vessel Sealer is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 29, 2013
Intuitive Surgical, Inc. Crystal Ong Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale. California 94086
Re: K130266
Trade/Device Name: EndoWrist One Vessel Sealer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: July 16, 2013 Received: July 17, 2013
Dear Ms. 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 10 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 (sec 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
3
Page 2 - Crystal Ong
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 Small Manufacturers, International and Consumer Assistance 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,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
4
510(k) Number if known: K130266 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 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 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 X AND/OR Over-the-Counter Use __ . (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
(Division Sign-off) Division of Surgical Devices 510(k) Number K130266