(86 days)
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.
The Intuitive Surgical® Endoscopic Instrument Control System (Model IS1200), also known as the da Vinci™ Surgical System, consists of three major integrated sub-systems. 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 provided text is a 510(k) summary for the Intuitive Surgical da Vinci Surgical System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices. However, this document does not contain a detailed study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/CAD-driven diagnostic device.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that if the new device is sufficiently similar to an already legally marketed device (the predicate), and it doesn't raise new questions of safety or effectiveness, it can be cleared for market. The "performance data" section explicitly states: "Design analysis and comparison as well as appropriate safety testing confirm that basic functional characteristics are substantially equivalent to the predicate device cited."
Therefore, I cannot populate most of the requested fields because the nature of the submission (510(k) for a surgical system based on substantial equivalence) does not involve the type of acceptance criteria and clinical study design typically associated with AI/CAD devices for diagnostic purposes.
Here's how I can address your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (equivalent to predicate) | Design analysis and comparison as well as appropriate safety testing confirm that basic functional characteristics are substantially equivalent to the predicate device cited. The device is described as "essentially identical in terms of shape, size, function, activation, and intended use" to the predicate device. Technological characteristics are "virtually identical" to the predicate devices. The FDA's decision to clear the device implies that the provided information was sufficient to establish safety and effectiveness for the stated indications when compared to the predicate. |
| Intended Use (consistent with predicate) | The device's "Intended Use" statement aligns with laparoscopic surgical procedures, including cholecystectomy, Nissen fundoplication, radical prostatectomy, and general non-cardiac thoracoscopic surgical procedures. The instruments are intended for manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing. This is presented as substantially equivalent to the predicate device. |
| Technological Characteristics (similar to predicate) | The technological characteristics of the subject device (Intuitive Surgical® da Vinci™ Surgical System) are stated to be "virtually identical" to the predicate devices. This includes the major integrated sub-systems: Endoscopic Instrument Control System (Surgeon Console, Patient Side Cart, Master Tool Manipulators, Patient Side Manipulators, Endoscope Camera Manipulator), Stereo View Endoscopic System (stereo endoscope, endoscopic camera, accessories, 3-D/2-D imaging), and Endoscopic Instruments (unique architecture, EndoWrist™ instruments like scissors, scalpels, graspers, needle holders, ultrasonic shears, electrocautery). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is based on "design analysis and comparison" and "appropriate safety testing," rather than a clinical trial with a specific test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Ground truth establishment for a test set is not described as part of this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are not applicable to the "design analysis and comparison" approach described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC comparative effectiveness study was done. The device is a surgical system, not an AI-assisted diagnostic tool, so the concept of "human readers improve with AI vs without AI assistance" does not apply in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. The da Vinci Surgical System is clearly a human-in-the-loop device, intended to be used by "trained physicians." It is a tool for surgeons, not an autonomous system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As a substantial equivalence submission for a surgical system, the "ground truth" implicitly refers to the established safety and efficacy of the predicate devices for their indicated uses, confirmed through design analysis and appropriate safety testing of the new device to demonstrate comparable performance. There is no mention of specific expert consensus, pathology, or outcomes data used to establish "ground truth" in the context of a performance study for the device itself.
8. The sample size for the training set
This information is not provided. The da Vinci Surgical System is a robotic surgical platform; the concept of a "training set" in the context of machine learning or AI algorithms is not directly applicable to a 510(k) submission for this type of hardware system based on substantial equivalence.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated above.
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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 Surgical950 Kifer RoadSunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | David Casal, Ph.D.Vice-President, Clinical, Regulatory and Quality AffairsTelephone: 408-523-2113Fax: 408-523-1390e-mail: david_casal@intusurg.com |
| Subject Device | ClassificationClass I/II - Gynecologic Laparoscope and Accessories,Electrocautery, Endoscope and AccessoriesTrade NameIntuitive Surgical® da Vinci™ Surgical SystemCommon NameEndoscopic Instrument Control System, Endoscopic Instrumentsand AccessoriesClassification NameEndoscope and Accessories (21 CFR 876.1500)Gynecologic Laparoscope and Accessories (21 CFR 884.1720) |
| PredicateDevices | da Vinci™ Surgical System(legally marketed under K965001/K990144/K002489/K011002) |
| DeviceDescription | 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 descriptionof each of these sub-systems is provided below while a more |
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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
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| instruments including: rigid endoscopes, blunt and sharp endoscopicdissectors, scissors, scalpels, forceps/pick-ups, needle holders,endoscopic retractors, stabilizers, electrocautery and accessoriesduring laparoscopic surgical procedures such as cholecystectomy,Nissen fundoplication, radical prostatectomy, and general non-cardiacthoracoscopic surgical procedures such as internal mammary arterymobilization. It is intended to be used by trained physicians in anoperating room environment. | |
|---|---|
| Intuitive Surgical® Endoscopic Instruments including scissors,scalpels, forceps/pick-ups, needle drivers and electrocautery areintended for endoscopic manipulation of tissue, including: grasping,cutting, blunt and sharp dissection, approximation, ligation,electrocautery and suturing. | |
| Comparison toPredicateDevice | The Intuitive Surgical® da Vinci™ Surgical System and EndoscopicInstruments described herein are essentially identical in terms ofshape, size, function, activation, and intended use to the predicateClass II endoscopic instrument cited. |
| TechnologicalCharacteristics | The technological characteristics of the subject devices are virtuallyidentical to the predicate devices. |
| PerformanceData | Design analysis and comparison as well as appropriate safety testingconfirm that basic functional characteristics are substantiallyequivalent 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 issubstantially equivalent to the current legally marketed predicatedevices. |
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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.
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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
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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 |
§ 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.