(94 days)
Not Found
No
The 510(k) summary explicitly states that there are "no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use" and that the submission is for a "labeling change / clarification". It also does not mention AI, DNN, or ML in the dedicated section or elsewhere in the document.
Yes
The device is described as assisting in surgical procedures, including actions like cutting, dissection, ligation, electrocautery, and suturing, which are therapeutic interventions.
No
The device is described as an "Endoscopic Instrument Control System" and its intended use involves "manipulation of tissue" for surgical procedures like "grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave ablation probes and accessories." This explicitly points to therapeutic and surgical functions, not diagnostic ones. Although it includes a "Stereo View Endoscopic System" for visualization, its primary purpose is to assist in surgical intervention, not to identify or characterize diseases or conditions.
No
The device description clearly outlines hardware components including the Surgeon Console, Patient Side Cart, Master Tool Manipulators, Patient Side Manipulators, Endoscope Camera Manipulator, stereo endoscope, endoscopic camera, light source, and light guides. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for controlling surgical instruments during various endoscopic surgical procedures. This involves direct manipulation of tissue within the body.
- Device Description: The description details a robotic surgical system with a surgeon console and patient-side cart, designed to assist in performing surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) to perform surgical procedures.
N/A
Intended Use / Indications for Use
The Intuitive Surgical® Endoscopic Instrument Control 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/pickups, 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 probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, general non-cardiovascular 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
NA Y
Device Description
This 510(k) is being submitted for a labeling change / clarification on the da Vinci ® Surgical System. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System. The only change is an updated indication statement to clarify use in broad urologic surgical procedures.
The da Vinci ® Surgical System consists of two integrated sub-systems as follows:
Intuitive Surgical® Endoscopic Instrument Control System: This sub-Device system is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects (continued) withe seated at the builting movement of the endoscopic instruments and of the procourty, moe operative field. Endoscopic instrument and camera ondooops, within 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 the tion (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. 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, also 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) image of the surgical field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic, general laparoscopic, general non-cardiovascular thoracoscopic surgical procedures, heart (cardiotomy, coronary anastomosis)
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 confirms that basic functional characteristics are substantially equivalent to the predicate devices cited.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K990144, K002489, K011002, K013416, K021036, K022574, K040237, K042855
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
43288
Section II
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:
| Date | November 23, 2004 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Usha Kreaden, M.Sc. |
| Director, Clinical & Regulatory Affairs | |
| Telephone: (408) 523 -- 2140 | |
| Fax: (408) 523 - 1390 | |
| e-mail: usha.kreaden@intusurg.com | |
| Subject | |
| Device | Name: Intuitive Surgical ® da Vinci ® Surgical System and Endoscopic |
| 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/K042855); | |
| Device | |
| Description | This 510(k) is being submitted for a labeling change / clarification on the |
| da Vinci ® Surgical System. There are no changes in the design, | |
| technology, materials, manufacturing, performance, specifications, and | |
| method of use for the da Vinci Surgical System. The only change is an | |
| updated indication statement to clarify use in broad urologic surgical | |
| procedures. | |
| The da Vinci ® Surgical System consists of two integrated sub-systems as | |
| follows: |
1
Intuitive Surgical® Endoscopic Instrument Control System: This sub-Device system is comprised of the Surgeon Console and Patient Side Cart. Description While seated at the Surgeon Console, the surgeon controls critical aspects (continued) withe seated at the builting movement of the endoscopic instruments and of the procourty, moe operative field. Endoscopic instrument and camera ondooops, within 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 the tion (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. 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, also 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) image of the surgical field.
- The Intuitive Surgical Endoscopic Instrument Control System is Intended Use 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/pickups, 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 probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, general non-cardiovascular 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.
There are no changes in the design, technology, materials, Comparison to manufacturing, performance, specifications, and method of use for the da Predicate
2
| Device | Vinci® Surgical System. The only difference is an updated indication
statement that provides a clarification that the da Vinci Surgical System
can be used in urologic surgical procedures. This change does not impact
the operational characteristics or change the intended use of the device. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The technological characteristics of the subject devices are the same as
for the predicate devices. |
| Performance
Data | Design analysis and comparison confirms that basic functional
characteristics are substantially equivalent to the predicate devices cited. |
| Conclusion | Based upon the technical information, intended use, and performance
information 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 devices. |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 - 2005
Ms. Usha Kreaden MS. Osna Rrounical and Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086
Re: K043288
K043288
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NA Y Dated: January 28, 2005 Received: January 31, 2005
Dear Ms. Kreaden:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivale referenced above and nave decimined the arrests to carees marketed in interstate for use stated in the enclosure) to regary market date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chaements with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with expreval application (PMA) devices that have been recults approval of accordance approval application (PMA).
and Cosmetic Act (Act) that do not require approval estarsh provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general provisions of the Act. You may, therefore, market the device, backed to the general controls provisions of the recenters and prohibitions against 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) not chair case arections affecting your device can
may be subject to such additional controls. The one of to addition, EDA may may be subject to such additional controlls. Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In be found in the Code of Pederal Regarations, in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination noc not moan Please be advised that FDA s issualize of a subscara and other requirements of the Act
that FDA has made a determination that your device complies . You must that I DA has made a decemmanon that Jour acreed by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (2.1
comply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, meranagement of the practice requirements as se CFR Part 807), labeling (21 CFR Part 807), government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 (1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -- Ms. Usha Kreaden
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notheadon. The PDA maing of cassification 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 80) ), please if you desire specific advice for your ac not the read tool sales mote the regulation entitled, contact the Office of Comphance at (210) 216-6 or on (21CFR Part 807.97). You may obtain "Misbranding by reference to premance notifications of the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Consanter >16www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ir. Miriam C. Parret
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
Indications for Use
K043288 510(k) Number (if known):
Intuitive Surgical® Endoscopic Instrument Control System Device Name:
Indications For Use:
The Intuitive Surgical® Endoscopic Instrument Control System is intended to assist in the The Intuitive Surgical Endoscopic Instrained Sunstrales including rigid endoscopes, accurate control of Multive Surgicul - Endosophe shears, forception one accessories for blunt and sharp endoscopic retractors, stabilizers, electrocautery and accessories for ups, needle nolders, endoscopic retractors, cutting, blunt and shap dissection,
endoscopic manipulation of tissue, including graspilled discement of microwave endoscopic manipulation of ussue, incrianting grasping, can delivery and placement of microwave
approximation, ligation, electrocautery, suturing, and delivery and planes, ge approximation, ligation, electrocation, surgical procedures, general laparoscopic ablation probes and accessories during arong as surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with thoracoscopically assisted cardioloniy procedures. In an operating more on operating room adjunctive mediasmodonly to perform over by trained physicians in an operating room 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam L Provost
Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number KC43258
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