(86 days)
Not Found
No
The description focuses on the mechanical and optical aspects of the robotic surgical system and does not mention any AI or ML components.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is an instrument control system and accessories used during surgical procedures; it assists with procedures but does not inherently treat a condition itself.
No
The device is described as an "Endoscopic Instrument Control System" intended "to assist in the accurate control of Intuitive Surgical® endoscopic instruments" during surgical procedures. Its purpose is to manipulate tissues, grasp, cut, dissect, etc., which are all therapeutic actions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a Surgeon Console, Patient Side Cart, Master Tool Manipulators, Patient Side Manipulators, Endoscope Camera Manipulator, stereo endoscope, endoscopic camera, light source, light guides, and various endoscopic instruments. This is a complex electromechanical system, not a software-only device.
Based on the provided text, the Intuitive Surgical® Endoscopic Instrument Control System (da Vinci™ System) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is "intended to assist in the accurate control of Intuitive Surgical® endoscopic instruments... during laparoscopic surgical procedures". This describes a surgical assistance system used during a procedure on a patient, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a surgical system with a surgeon console, patient side cart, endoscopic instruments, and a vision system. This aligns with a surgical tool, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), providing diagnostic results, or being used in a laboratory setting.
Therefore, the da Vinci™ System, as described, is a surgical system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical® endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy, Nissen fundoplication, radical prostatectomy, and general non-cardiac thoracoscopic surgical procedures such as internal mammary artery mobilization. It is intended to be used by trained physicians in an operating room environment.
Intuitive Surgical Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The Intuitive Surgical® Endoscopic Instrument Control System (Model IS1200), also known as the da Vinci™ Surgical System, consists of three major integrated sub-systems.
Intuitive Surgical® Endoscopic Instrument Control System: This sub-system of the da Vinci™ Surgical System is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls virtually all critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM), also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via a cable array. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci™ Surgical System, known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) of the surgical field.
Intuitive Surgical® Endoscopic Instruments: The da Vinci™ Surgical System is designed to use unique endoscopic instruments utilizing a proprietary architecture conveying movements similar to those of the human wrist. These movements - yaw, pitch, rotation, and insertion/withdrawal - are controlled by the surgeon seated at the Surgeon Console. These endoscopic instruments, many of which are referred to as EndoWrist™ endoscopic instruments, include scissors. scalpels, graspers/forceps/pick-ups, needle holders, ultrasonic shears, and electrocautery instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic vision system (stereo endoscope, endoscopic camera)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians in an operating room environment
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 analysis and comparison as well as appropriate safety testing confirm that basic functional characteristics are substantially equivalent to the predicate device cited.
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.
K965001/K990144/K002489/K011002
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
JUN 2 6 2002
Section II
510(k) SUMMARY
Ko21036
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
| Date | March 29, 2002 |
|---|---|
| Submitter | Intuitive Surgical |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | David Casal, Ph.D. |
| Vice-President, Clinical, Regulatory and Quality Affairs | |
| Telephone: 408-523-2113 | |
| Fax: 408-523-1390 | |
| e-mail: david_casal@intusurg.com | |
| Subject Device | Classification |
| Class I/II - Gynecologic Laparoscope and Accessories, | |
| Electrocautery, Endoscope and Accessories |
Trade Name
Intuitive Surgical® da Vinci™ Surgical System
Common Name
Endoscopic Instrument Control System, Endoscopic Instruments
and Accessories
Classification Name
Endoscope and Accessories (21 CFR 876.1500)
Gynecologic Laparoscope and Accessories (21 CFR 884.1720) |
| Predicate
Devices | da Vinci™ Surgical System
(legally marketed under K965001/K990144/K002489/K011002) |
| Device
Description | The Intuitive Surgical® Endoscopic Instrument Control System
(Model IS1200), also known as the da Vinci™ Surgical System,
consists of three major integrated sub-systems . A brief description
of each of these sub-systems is provided below while a more |
1
000007
Device Description (continued)
comprehensive description of their characteristics is provided in subsequent sections of this document. The major sub-systems are as follows:
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem of the da Vinci™ Surgical System is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls virtually all critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM), also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via a cable array. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci™ Surgical System, known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) of the surgical field.
Intuitive Surgical® Endoscopic Instruments: The da Vinci™ Surgical System is designed to use unique endoscopic instruments utilizing a proprietary architecture conveying movements similar to those of the human wrist. These movements - yaw, pitch, rotation, and insertion/withdrawal - are controlled by the surgeon seated at the Surgeon Console. These endoscopic instruments, many of which are referred to as EndoWrist™ endoscopic instruments, include scissors. scalpels, graspers/forceps/pick-ups, needle holders, ultrasonic shears, and electrocautery instruments.
The Intuitive Surgical® Endoscopic Instrument Control System Intended Use (hereinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical® endoscopic
2
| | instruments including: rigid endoscopes, blunt and sharp endoscopic
dissectors, scissors, scalpels, forceps/pick-ups, needle holders,
endoscopic retractors, stabilizers, electrocautery and accessories
during laparoscopic surgical procedures such as cholecystectomy,
Nissen fundoplication, radical prostatectomy, and general non-cardiac
thoracoscopic surgical procedures such as internal mammary artery
mobilization. It is intended to be used by trained physicians in an
operating room environment. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intuitive Surgical® Endoscopic Instruments including scissors,
scalpels, forceps/pick-ups, needle drivers and electrocautery are
intended for endoscopic manipulation of tissue, including: grasping,
cutting, blunt and sharp dissection, approximation, ligation,
electrocautery and suturing. |
| Comparison to
Predicate
Device | The Intuitive Surgical® da Vinci™ Surgical System and Endoscopic
Instruments described herein are essentially identical in terms of
shape, size, function, activation, and intended use to the predicate
Class II endoscopic instrument cited. |
| Technological
Characteristics | The technological characteristics of the subject devices are virtually
identical to the predicate devices. |
| Performance
Data | Design analysis and comparison as well as appropriate safety testing
confirm that basic functional characteristics are substantially
equivalent to the predicate device cited. |
| Conclusion | Based upon the product technical information provided, intended use,
and performance information provided in this pre-market notification,
the Intuitive Surgical® da Vinci™ Surgical System described herein is
substantially equivalent to the current legally marketed predicate
devices. |
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系
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, but it is also composed of three human profiles facing to the right.
JUN 2 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc David Casal, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs 950 Kifer Road Sunnyvale, California 94086
Re: K021036
Trade Name: Intuitive Surgical® DaVinci Surgical System, Model IS1200 Regulation Number: 876.1500 Regulation Name: Endoscopic instrument control system and Endoscopic instruments Regulatory Class: II Product Code: NAY Dated: March 29, 2002 Received: April 1, 2002
Dear Dr. Casal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Dr. David Casal
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
5
Section III
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Intuitive Surgical® Endoscopic Instrument Control System and Device name: Endoscopic Instruments.
Indications for Use:
The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical® endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy, Nissen fundoplication, radical prostatectomy, and general non-cardiac thoracoscopic surgical procedures such as internal mammary artery mobilization. It is intended to be used by trained physicians in an operating room environment.
Intuitive Surgical Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | L | Over-the Counter Use | |
|---|---|---|---|
| (per 21 CFR §801.109 | (Optional Format 1-2-96) | ||
| (Division Sign-Off) | |||
| Intuitive Surgical® | Division of General, Restorative and Neurological Devices | da Vinci™ Surgical System 510(k) | |
| 510(k) Number | K021036 |