(74 days)
Not Found
No
The summary describes a robotic surgical system controlled by a surgeon, with no mention of AI or ML capabilities for autonomous operation, image analysis, or decision support.
Yes
Explanation: The device is intended to assist in various surgical procedures, including cutting, grasping, and suturing, which are therapeutic interventions.
No
The device is a surgical system intended for controlling endoscopic instruments during various surgical procedures, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including the Surgeon Console, Patient Side Cart, Master Tool Manipulators, Patient Side Manipulators, Endoscope Camera Manipulator, surgical arms, stereo endoscope, endoscopic camera, light source, and light guides. This is not a software-only device.
Based on the provided information, the Intuitive Surgical® da Vinci® Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is designed to assist in surgical procedures by controlling endoscopic instruments for manipulating tissue within the patient's body. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a surgical system with a surgeon console, patient side cart, and endoscopic instruments. These components are used for performing surgical actions directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, tissue) outside the body to diagnose a condition, monitor treatment, or screen for diseases.
Therefore, the da Vinci Surgical System falls under the category of a surgical robot or surgical assistance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical da Vinci Surgical System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave ablation probos and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The da Vinci Surgical System, consists of three integrated sub-systems as follows: Endoscopic Instrument Control System: The Endoscopic Instrument Control System is comprised of two sub-systems - the Surgeon Console, Model IS2000-SSC, and Patient Side Cart. Model IS2000-PSC. While seated at the Surgeon Console, the surgeon controls 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 lixed position (with respect to the patient) by cither two (or optionally three) unique manipulators 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 manipulator, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC). The PSM and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console arc relayed to the PSC, which is located immediately adjaccnt to the patient, via a cable. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC. Stereo View Endoscopic Vision System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite Vision System. Model VS1000, 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) image of the surgical field.
Mentions image processing
Yes
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 bench testing and risk analysis activities, have been conducted to confirm that the characteristics of the modified device are substantially equivalent to the predicate devices 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.
K990144, K002489, K011002, K013416, K021036, K022574, K040237, K043153, K050005
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
Section II
APR 2 9 2005
510(k) SUMMARY
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: K050369
| Date | April 26, 2005 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Mike Yramategui |
| Director, Regulatory Affairs | |
| Telephone: (408) 523 - 2145 | |
| Fax: (408) 523 - 1390 | |
| e-mail: mike.yramategui@intusurg.com | |
| Subject | |
| Device | Name: Intuitive Surgical® da Vinci® Surgical System and Endowrist™ |
| Instruments | |
| Classification Name: System, Surgical, Computer Controlled Instrument | |
| (21 CFR 876.1500) | |
| Common Name: Endoscopic Instrument Control System, Endoscopic | |
| Instruments, and accessories | |
| Predicate | |
| Devices | Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments |
| (legally marketed under K990144 / K002489 / K011002 / K013416 / | |
| K021036 / K022574 / K040237 / K043153 / K050005) | |
| Device | |
| Description | The da Vinci Surgical System, consists of three integrated sub-systems as |
| follows: | |
| Endoscopic Instrument Control System: The Endoscopic Instrument | |
| Control System is comprised of two sub-systems - the Surgeon Console, | |
| Model IS2000-SSC, and Patient Side Cart. Model IS2000-PSC. While | |
| seated at the Surgeon Console, the surgeon controls 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 |
1
Device Description (continued)
use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a lixed position (with respect to the patient) by cither two (or optionally three) unique manipulators 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 manipulator, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC). The PSM and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console arc relayed to the PSC, which is located immediately adjaccnt to the patient, via a cable. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Stereo View Endoscopic Vision System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite Vision System. Model VS1000, 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) image of the surgical field.
Intended Use
The Intuitive Surgical da Vinci Surgical System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, clectrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave ablation probos and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
2
| Comparison to
Predicate
Device | This 510(k) notification is submitted for design modifications to the
Endoscopic Instrument Control System. These modifications affect
primarily the PSM, ECM, and the Patient Side Cart in order to enhance
case of use. There are also associated minor changes to the Surgeon
Console and endoscopic instruments. The user interface design is
essentially identical to the predicate device except for minor
modifications to accommodate the aforementioned changes. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device operation, functionality, and methods of use for the subject device
are identical to the predicate device. The technology, materials,
manufacturing methods, and performance are essentially the same for the
predicate device as the subject device. The primary differences are 1)
changes to the PSM and ECM form factor and associated
electromechanical components; 2) changes to the Patient Side Cart
mechanics and circuitry to accommodate the modified PSM and ECM;
and 3) changes to the Surgeon Console and software to accommodate the
modified Patient Side Cart. Minor mechanical modifications to the
endoscopic instruments to interface with the modified PSM are also
described. |
| Technological
Characteristics | The technological characteristics of the subject devices are essentially the
same as for the predicate devices. |
| Performance
Data | Design analysis and comparison, as well as bench testing and risk
analysis activities, have been conducted to confirm that the
characteristics of the modified device are substantially equivalent to the
predicate devices cited. |
| Conclusion | Based upon the device's general specifications, intended use, and results
of risk analysis and performance testing provided in this pre-market
notification, the da Vinci Surgical System described herein has been
shown to be substantially equivalent to current legally marketed predicate
device. |
1
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3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2005
Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086
Re: K050369
K050507
Trade/Device Name: Intuitive Surgical da Vinci Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NA Y Dated: February 10, 2005 Received: February 14, 2005
Dear Mr. Yramategui:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premainter is substantially equivalent (for the indications referenced above and nave determined the arrest are devices marketed in interstate for use stated in the enclosure) to tegally manced profithe Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the enactition with the provisions of the Federal Food, Drug, devices that have been recrassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require apperal controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general consucted pos You may, inerefore, market the device, belyer to meet general controls provisions of the Fet merade requirements of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis chairs are regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may may be subject to such additional controlis. Entroling and on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peacharies.
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 Please be advised that FDA s issualice of a substitive only other requirements of the Act
that FDA has made a determination that your device acteral agencies. You must that FDA has made a determination that your arrest by other Federal agencies. You must and or any Federal statutes and regulations and united to: registration and listing (21)
comply with all the Act's requirements, including, but not one provine moutrements as set comply with all the Act s requirements, mendanturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR 1 at 601); god manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
4
Page 2 – Mr. Michael H. Yramategui
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your article equivalence of your device to a legally
premarket notification. The FDA finding of sybstantial end this permits yo premarket notification. The FDA multing of substantial equive 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), please
rs of the may of the more of 0115. All any desse not the requiries entitled If you desire specific advice for your ac not on on success note the regulation entitled, the regulation entitled, contact the Office of Complaned at (210) 276 - 1 - 1 - (21)FR Part 807.97). You may obtain "Misbranding by reference to premarket nothleadon (en oet from the Division of Small
other general information on your responsibilities under the Act from number (800) 638-20 other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-findex html Manufacturers, international and Consulter Abolokation and Consultances of the new onlines.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K050369
Intuitive Surgical® da Vinci® Surgical System and Endowrist 60 Device Name: Instrumicats
Indications For Use:
The Intuitive Surgical" da Vinci" Surgical System is intended to assist in the accurate control of Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp cadoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, clectrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and shapp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probos and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to norform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating toom environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDCO)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
tive
Ko 50369
Page 1 of 1
Intuitive Surgical" da Vinci Surgical System
SIO(k) Section III, Page 1 of 1