(85 days)
No
The description focuses on the mechanical and electrical function of a bipolar forceps used with a robotic surgical system, with no mention of AI or ML capabilities.
Yes.
The device is used to "transect soft tissues" and for "precise tissue coagulation" during surgical procedures, indicating a direct therapeutic effect on the body.
No
The device description states its purpose is to "transect soft tissues" and perform "precise tissue coagulation" during endoscopic surgical procedures. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly details a physical instrument (endoscopic instrument with a grasping end effector) that connects to other hardware (da Vinci Surgical System, ESU, electrosurgical cable). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transect soft tissues during endoscopic surgical procedures." This describes a surgical tool used on the patient's body during a procedure.
- Device Description: The description details a surgical instrument with a grasping end effector and bipolar electrosurgical capabilities for tissue coagulation. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on samples.
The device is a surgical instrument used in vivo (within the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vinci Surgical System to transect soft tissues during endoscopic surgical procedures.
Product codes
NA Y
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
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.
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
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 |
| 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
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)