← Product Code [NAY](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NAY) · K012833 # INTUITIVE SURGICAL BIPOLAR FORCEPS (K012833) _Intuitive Surgical, Inc. · NAY · Nov 16, 2001 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/NAY/K012833 ## Device Facts - **Applicant:** Intuitive Surgical, Inc. - **Product Code:** [NAY](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NAY.md) - **Decision Date:** Nov 16, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vinci Surgical System to transect soft tissues during endoscopic surgical procedures. ## Device Story Endoscopic bipolar forceps; grasping end effector; used with da Vinci Surgical System and external electrosurgical generator (ESU). Device connects to ESU via bipolar cable; surgeon controls end effector via da Vinci system interface; ESU activated by foot pedal. Current passes between two closely spaced grip electrodes to coagulate and transect soft tissue. Used in endoscopic surgical procedures; operated by surgeon via robotic system. Provides robotic-assisted precision for tissue manipulation and coagulation. ## Clinical Evidence Bench testing only; design analysis and in vitro testing performed to confirm functional equivalence to predicate. ## Technological Characteristics Endoscopic bipolar electrosurgical instrument; grasping end effector; bipolar electrosurgical energy source; reusable; robotic-controlled interface for da Vinci Surgical System. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Dexide Bipolar Forceps ([K991859](/device/K991859.md)) - da Vinci Surgical System ([K990144](/device/K990144.md)) ## Related Devices - [K061260](/device/K061260.md) — INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 · Intuitive Surgical, Inc. · May 18, 2006 - [K140189](/device/K140189.md) — ENDOWRIST VESSEL SEALER · Intuitive Surgical, Inc. · Jun 5, 2014 - [K091259](/device/K091259.md) — ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS · Ethicon Endo-Surgery, Inc. · Jan 15, 2010 - [K023813](/device/K023813.md) — BIPOLAR FORCEPS · Richard Wolf Medical Instruments Corp. · Jan 17, 2003 - [K130266](/device/K130266.md) — ENDOWRIST ONE VESSEL SEALER · Intuitive Surgical, Inc. · Aug 29, 2013 ## Submission Summary (Full Text) {0}------------------------------------------------ # Section II # NOV 1 6 2001 # 510(k) SUMMARY 012833 This summary of 510(k) safety and effectiveness information is submitted in accordance Tiffs summary of SMDA 1990 and 21 CFR 807.92. ## 510(k) Number: August 21, 2001 Date Prepared: ## Applicant Information: | Name: | Intuitive Surgical, Inc. | |----------|-------------------------------------------------------------| | Address: | 1340 W. Middlefield Road<br>Mountain View, California 94043 | Establishment Registration Number: 2955842 | Contact Person: | Michael Yramategui | |-------------------|------------------------------| | Phone Number: | (415) 237-7048 | | Facsimile Number: | (415) 526-2060 | | E-mail: | mike_yramategui@intusurg.com | #### Device Information: | Classification Name: | Electrosurgical cutting and coagulation device and<br>accessories (21 CFR §878.4400) | |----------------------|--------------------------------------------------------------------------------------| | Trade Name: | Intuitive Surgical® Endowrist™ Bipolar Forceps | | Common Name: | Bipolar Forceps | | Predicate Device(s): | | | United States Surgical | Dexide Bipolar Forceps | K991859 | |------------------------|--------------------------|---------| | Intuitive Surgical | da Vinci Surgical System | K990144 | #### Device Description: The Intuitive Surgical® Bipolar Forceps is an endoscopic instrument with a grasping end effector to be used in conjunction with the Intuitive Surgical® Endoscopic Instrument Control System and a standard external electrosurgical generator unit (ESU). It is a Contor System and a vical instrument connected to the ESU via a bipolar electrosurgical resposuble of our courged is activated by a foot pedal on the generator itself, controls the Cable. The 1500, willer grasping end effector (or grips) of the device. A coagulation {1}------------------------------------------------ current passes from the ESU between the two closely spaced grip electrodes then back to current passes non the 200 beine tissue coagulation. The device is similar in size and the generator, anowing for pressil Endowrist™ Endoscopic Instruments #### Intended Use: The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vincipal The Internet of Surgical "Dipolar Forcept to as a transect soft tissues during endoscopic surgical procedures. ## Comparison to Predicate Device: The Intuitive Surgical® Bipolar Forceps is essentially identical in terms of size, function, I he intentive Surgical "Dipolar Forespons costing instrument cited Dexide Bipolar Forceps II, K991859). The primary differences between the subject and Bibliate devices are the following: 1) the subject device is resposable and 2) the surgeon predicate devices are the following: 1) the subject device is responsible and consi predicate devices and positions the subject device using the Intuitive Surgical® Endoscopic Instrument Control System while the predicate device is handheld. #### In Vitro Test Data: Design analysis and comparison as well as in vitro testing confirm that basic functional Design and your and betantially equivalent to the predicate device cited. #### Summary: Based upon the product technical information provided, intended use, and performance Dason apon the provided in this pre-market notification, the Intuitive Surgical® Bipolar Information provided in this pro hauntially equivalent to a currently marketed predicate device. Intuitive™ and Intuitive Surgical® is a registered trademark of Intuitive Surgical, Inc. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the United States Department of Health and Human Services, which is an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Michael Yramategui Director, Regulatory and Quality Affairs Intuitive Surgical, Inc. 1340 W. Middlefield Road Mountain View, California 94043 Re: K012833 : KV12633 Trade/Device Name: Intuitive Surgical Endowrist™ Bipolar Forceps Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NA Y Dated: August 21, 2001 Received: August 23, 2001 Dear Mr. Yramategui: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premained is substantially equivalent (for the indications referenced above and have determined the devices merketed in interstate referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regally marketed producal Device Americal Device America Andress, or to commerce prior to May 26, 1970, the chariners and the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA). and Cosmetic Act (Act) that do not require approval of a proval application of the Act. Th and Cosmetic Act (Act) that to not require approvate of the general controls of the Act. The Act. The You may, therefore, market the device, subject to the general magate You may, therefore, market the device, secject to since of manual registration, listing of general controls provisions of the Act mercise requirement and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it can If your device is classified (see above) into chair case regulations affecting your device can may be subject to such additional controls. Title Co., In addition, FDA may may be subject to such additional controlis. Existing mays 800 to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Peacharter regarming 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 FDA s Issualice of a successful other requirements of the Act that FDA has made a determination that your device and only . Every and that FDA has made a decermination that your cover Federal agencies: "You must or any Federal statutes and regulations administered of online to: registration and listing (21) comply with all the Act's requirements, including, but not institus mosting m comply with all the Act Stequirements, monumations practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the ollectronic CFR Part 807); labelling (21 CFR Part 800); good if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 {3}------------------------------------------------ Page 2 -- Mr. Michael Yramategui This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your artial equivalence of your device to a legally premarket notification. The PDA miding of successification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice tor your covices devices), please contact the Office of additionally 21 CFK Fall 809.10 for in the underions on the promotion and advertising of Compliance at (301) 594-4037. Tidationally to qualier at (301) 594-4639. Also, please note the your device, prease comace the Orited on oremarket notification" (21CFF Part 807.97). regulation entitled, "Misbranding by reference to premarket notification" (21 and from t regulation entitled, "Misoranumig by referents to pr pr may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050 2011 fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Sincerely yours, Mark N Millikan Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ NQV 1 6 2001 ## Section III # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Device name: Intuitive Surgical® Bipolar Forceps Indications for Use: The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vincito Surgical I he intuitive Surgical - Dipolar Fereops to transect soft tissues during endoscopic surgical procedures. Mark N. Millerson 0000 Restorative **510(k) Number** K012833 # PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the Counter Use (per 21 CFR §801.109 (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/NAY/K012833](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/NAY/K012833) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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