(61 days)
No
The summary describes a robotic surgical system with articulating instruments controlled by a surgeon. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on mechanical control and reprocessing validation.
Yes
The device is described as assisting in surgical procedures and manipulating tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing. These actions are directly therapeutic interventions performed on the body to treat a condition.
No
Explanation: The "Intended Use" section explicitly states that the device is "intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments" for various surgical tasks like "grasping, cutting, blunt and sharp dissection," and "suturing," among others. There is no mention of the device being used to identify or diagnose medical conditions.
No
The device description explicitly mentions "EndoWrist Instruments" with "articulating design at their distal tips" and "end effectors/instrument tips," which are physical hardware components. The performance studies also focus on cleaning, disinfection, and reliability of these physical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to assist in the control of endoscopic instruments for various surgical procedures. It focuses on manipulating tissue within the body.
- Device Description: The device description details the mechanical aspects of the instruments and how they are controlled by a surgeon to perform surgical tasks.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used on the body during a procedure.
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/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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System, Model IS4000) 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, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approxination, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) 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, 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used 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
NAY, GCJ
Device Description
da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.
The da Vinci X/Xi (IS4200/IS4000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric use (except for transoral otolaryngology surgical procedures)
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)
- Cleaning Validation: Cleaning Validation was performed to validate the efficacy of the automated cleaning process using an automated washer-disinfector. The da Vinci S/Si and X/Xi Reusable Instruments successfully met the acceptance criteria for all markers. The test results demonstrate that the da Vinci S/Si and X/Xi Reusable Instruments can be cleaned using an automated washer/disinfector.
- Thermal Disinfection Validation: Efficacy of the thermal disinfection process was validated for the subject devices. The subject devices meet the acceptance criteria which validates the efficacy of the thermal disinfection cycle within the automated washer/disinfector.
- Reliability/Life Testing: Reliability/Life Testing was performed to ensure that da Vinci instruments are not adversely affected by the use of an automated washer-disinfector for reprocessing these instruments. The subject devices within the scope of this submission meet the acceptance criteria.
- Human Factors Testing: The Reprocessing Instructions underwent a rigorous Human Factors Testing process. This process included:
- Preliminary Evaluation: A preliminary evaluation was completed to better understand the users, uses, and use environment.
- Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions.
- Design Team Participation: Human Factors Engineers participated in design meetings and played a significant role in the visual design and content development.
- Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions.
- Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users. This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
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 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 10, 2021
Intuitive Surgical, Inc. Kunal Gunjal Sr. Regulatory Affairs Specialist 1266 Kifer Road, Building 101 Sunnyvale, California 94086
Re: K203632
Trade/Device Name: da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: December 10, 2020 Received: December 11, 2020
Dear Kunal Gunjal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K203632 |
| Device Name | da Vinci S/Si (IS2000/IS3000) EndoWrist Instruments (5mm and 8mm) |
| Indications for Use (Describe) | 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/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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. |
| Type of Use (Select one or both, as applicable) | |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing, Services (701)-443-6740 EF
Image /page/2/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and appears to be a bold typeface. The background is white.
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| mber (if known) |
510(k) Num K203632
Device Name
da Vinci Xi (IS4000) 8mm Instruments
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System, Model IS4000) 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, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approxination, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301)-443-6740
Image /page/3/Picture/20 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I". The font is sans-serif and the text is centered.
4
K203632 Automated Cleaning/Disinfection Process da Vinci S/Si and X/Xi Reusable Instruments
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K203632 |
| Device Name | da Vinci X (IS4200) 8mm Instruments |
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) 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, 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 and cryogenic ablation probes and
accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic
surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The
system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac
revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an
operating room environment in accordance with the representative, specific procedures set forth in the Professional
Instructions for Use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (701) 443-6740 EF
Image /page/4/Picture/11 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and the letters are evenly spaced.
5
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Sr. Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Email: Kunal.Gunjal@intusurg.com |
| Trade Name | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments (5mm & 8mm) |
| Common Name | Endoscope and accessories |
| Classification | Class II,
21 CFR 876.1500 |
| Product Codes | NAY |
| Review Panel | General and Plastic Surgery |
| Predicate Devices | K170644 (Clearance of Reprocessing Instructions for da Vinci S and Si
Reusable Instruments) |
Table 1: da Vinci S/Si (IS2000/IS3000) Reusable Instruments
INTUÍTIVE
6
Table 2: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Sr. Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Email: Kunal.Gunjal@intusurg.com |
| Trade Name | da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
| Common Name | Endoscope and accessories |
| Classification | Class II,
21 CFR 876.1500 |
| Product Codes | NAY, GCJ |
| Review Panel | General and Plastic Surgery |
| Predicate Devices | K170645 (Clearance of Reprocessing Instructions for da Vinci Xi 8mm Reusable Instruments) |
INTUIT
7
Device Description
Table 3 lists the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
| Trade Name | da Vinci S/ Si (IS2000/IS3000)
EndoWrist Instruments (5mm & 8mm) | da Vinci Xi/X (IS4000/IS4200)
Reusable Instruments (8mm) | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation. | The da Vinci X/Xi (IS4200/IS4000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation. | |
| Trade Name | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments (5mm & 8mm) | da Vinci Xi (IS4000) 8mm Reusable Instruments | da Vinci Xi (IS4200) 8mm Reusable Instruments |
| 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/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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) 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, 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4200) 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, 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. |
Table 3: da Vinci S/Si and X/Xi Reusable Instruments
8
Indications for Use:
Table 4 lists the Indications for Use for the devices impacted by the changes to the reprocessing instructions.
Table 4: da Vinci S/Si and X/Xi Reusable Instruments
9
Table 5 and Table 6 includes a comparison between the subject devices and predicate devices.
| Table 5: Comparison of Predicate and Subject Devices (da Vinci S/Si EndoWrist 5mm and 8mm | |||
|---|---|---|---|
| instruments) | |||
| Characteristic | Subject Device | ||
| da Vinci IS2000/IS3000 5mm and 8mm | |||
| Instruments (K203632) | Predicate Device | ||
| da Vinci IS2000/IS3000 5mm and 8mm | |||
| Instruments (K170644) | |||
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. | |
| Trade Name | da Vinci S/Si (IS2000/IS3000) 5mm/8mm | ||
| instruments | SAME as subject device | ||
| Common Name | Endoscope and accessories | SAME as subject device | |
| Regulation No. | 21 CFR 876.1500 | SAME as subject device | |
| Product Code | NAY | SAME as subject device | |
| Device Class/ | |||
| Regulation Name | Class II | SAME as subject device | |
| Classification | |||
| Advisory | |||
| Committee | General and Plastic Surgery | SAME as subject device | |
| Characteristic | Subject Device | Predicate Device | |
| da Vinci IS2000/IS3000 5mm and 8mm Instruments (K203632) | da Vinci IS2000/IS3000 5mm and 8mm Instruments (K170644) | ||
| 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/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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | SAME as subject device | |
| Prescription use | Physician use only | SAME as subject device | |
| Characteristic | Subject Device | ||
| da Vinci IS2000/IS3000 5mm and 8mm | |||
| Instruments (K203632) | Predicate Device | ||
| da Vinci IS2000/IS3000 5mm and 8mm | |||
| Instruments (K170644) | |||
| Where used | |||
| (hospital, home, | |||
| ambulance, etc) | Hospital | SAME as subject device | |
| Sterilization | |||
| Method | Steam sterilization | SAME as subject device | |
| Sterility / | |||
| Disposable or | |||
| Multiple use | Multiple use | SAME as subject device | |
| Reprocessing | |||
| Instructions | Reprocessing Instructions have been | ||
| updated to include an optional automated | |||
| cleaning and disinfection process using an | |||
| automated washer/disinfector. | Reprocessing Instructions include a | ||
| manual cleaning process using an | |||
| ultrasonic bath. | |||
| Reprocessing Instructions include | |||
| thermal disinfection parameters. | |||
| Packaging | Non-sterile packaging, reusable | SAME as subject device |
INTUI
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INTUITIVE
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Image /page/11/Picture/3 description: The image shows the word "INTUITIVE" in all capital letters. The word is written in a blue sans-serif font. There is a small blue circle above the letter "U" in the word.
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| Table 6: Comparison of Predicate and Subject Devices (da Vinci X/Xi EndoWrist 8mm Instruments) | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | ------------------------------------------------------------------------------------------------ |
| Characteristic | Subject Device
da Vinci X/Xi (IS4200/IS4000)
EndoWrist (8mm) Instruments
(K203632) | Predicate Device
da Vinci Xi (IS4000) EndoWrist
(8mm) Instruments
(K170645) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. |
| Trade Name | da Vinci X/Xi EndoWrist (8mm)
Instruments | da Vinci Xi EndoWrist (8mm)
Instruments |
| Common Name | Endoscope and accessories | SAME as subject device |
| Regulation No. | 21 CFR 876.1500 | SAME as subject device |
| Product Code | NAY, GCJ | SAME as subject device |
| Device Class/
Regulation Name | Class II | SAME as subject device |
| Classification
Advisory
Committee | General and Plastic Surgery | SAME as subject device |
| Characteristic | Subject Device
da Vinci X/Xi (IS4200/IS4000)
EndoWrist (8mm) Instruments
(K203632) | Predicate Device
da Vinci Xi (IS4000) EndoWrist
(8mm) Instruments
(K170645) |
| Indications for
Use for da Vinci
Xi (IS4000)
EndoWrist 8mm
Instruments | The Intuitive Surgical Endoscopic
Instrument Control System (da Vinci
Surgical System, Model IS4000) 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,
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
and cryogenic ablation probes and
accessories, during urologic surgical
procedures, general laparoscopic
surgical procedures, gynecologic
laparoscopic surgical procedures,
general thoracoscopic surgical
procedures and thoracoscopically-
assisted cardiotomy procedures. The
system can also be employed with
adjunctive mediastinotomy to perform
coronary anastomosis during cardiac
revascularization. The system is
indicated for adult and pediatric use.
It is intended to be used by trained
physicians in an operating room
environment in accordance with the
representative, specific procedures set
forth in the Professional Instructions
for Use. | SAME as subject device |
| Characteristic | Subject Device
da Vinci X/Xi (IS4200/IS4000)
EndoWrist (8mm) Instruments
(K203632) | Predicate Device
da Vinci Xi (IS4000) EndoWrist
(8mm) Instruments
(K170645) |
| Indications for
Use for da Vinci X
(IS4200)
EndoWrist 8mm
Instruments
NOTE: The same
da Vinci
EndoWrist 8mm
instruments are
used with the da
Vinci X (IS4200)
system and da
Vinci Xi (IS4000)
system | The Intuitive Surgical Endoscopic
Instrument Control System (da Vinci
X Surgical System, Model IS4200) 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,
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
and cryogenic ablation probes and
accessories, during urologic surgical
procedures, general laparoscopic
surgical procedures, gynecologic
laparoscopic surgical procedures,
general thoracoscopic surgical
procedures and thoracoscopically-
assisted cardiotomy procedures. The
system can also be employed with
adjunctive mediastinotomy to perform
coronary anastomosis during cardiac
revascularization. The system is
indicated for adult and pediatric use. It
is intended to be used by trained
physicians in an operating room
environment in accordance with the
representative, specific procedures set
forth in the Professional Instructions
for Use. | The Intuitive Surgical Endoscopic
Instrument Control System (da Vinci
Surgical System, Model IS4000) is
intended to assist in the accurate
control of Intuitive Surgical
Endoscopic Instruments including
rigid endoscopes, blunt and sharp
|
| Characteristic | Subject Device
da Vinci X/Xi (IS4200/IS4000)
EndoWrist (8mm) Instruments
(K203632) | Predicate Device
da Vinci Xi (IS4000) EndoWrist
(8mm) Instruments
(K170645) |
| Prescription use | Physician use only | SAME as subject device |
| Where used
(hospital, home,
ambulance, etc) | Hospital | SAME as subject device |
| Sterilization
Method | Steam sterilization | SAME as subject device |
| Sterility /
Disposable or
Multiple use | Multiple use | SAME as subject device |
| Reprocessing
Instructions | Reprocessing Instructions have been
updated to include an optional
automated cleaning and disinfection
process using an automated
washer/disinfector. | Reprocessing Instructions include a
manual cleaning process using an
ultrasonic bath.
Reprocessing Instructions include
thermal disinfection parameters. |
| Packaging | Non-sterile packaging, reusable | SAME as subject device |
INTUÍTIVE
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INTUITIVE
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INTUITIVE
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INTUÍTIVE
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Technological Characteristics:
There were no changes to design including technological characteristics for the subject devices as a result of the reprocessing instructions changes to include use of an automated washer/disinfector.
Performance Data:
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device. The testing conducted consisted of Cleaning Validation, Thermal Disinfection validation, Reliability/Life Testing and Human factors testing.
- Cleaning Validation: Cleaning Validation was performed to validate the efficacy of the O automated cleaning process using an automated washer-disinfector in accordance with the following standards and guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", document issued on: March 17, 2015
- AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- -AAMI TIR 30: 2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- ANSI/AAMI ST15883-1:2009/(R) 2014, Washer-disinfectors: General requirements, terms and definitions and tests
The da Vinci S/Si and X/Xi Reusable Instruments successfully met the acceptance criteria for all markers. The test results demonstrate that the da Vinci S/Si and X/Xi Reusable Instruments can be cleaned using an automated washer/disinfector.
- Thermal Disinfection Validation: Efficacy of the thermal disinfection process was validated for O the subject devices per the FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors: Guidance for the Medical Device Industry and FDA Review Staff", Document Issued on February 7, 2002. The subject devices meet the acceptance criteria which validates the efficacy of the thermal disinfection cycle within the automated washer/disinfector.
- Reliability/Life Testing: Reliability/Life Testing was performed to ensure that da Vinci O instruments are not adversely affected by the use of an automated washer-disinfector for reprocessing these instruments. The subject devices within the scope of this submission meet the acceptance criteria.
- Human Factors Testing: The Reprocessing Instructions underwent a rigorous Human Factors O Testing process. This process included:
- Preliminary Evaluation: A preliminary evaluation was completed to better understand the users, uses, and use environment.
- -Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions.
- Design Team Participation: Human Factors Engineers participated in design meetings and played a significant role in the visual design and content development.
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- -Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions.
- Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.
This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
Summary:
Based on the intended use, indications for use, technological characteristics and performance data, the subject device is substantially equivalent to the predicate devices listed in Table 1 and Table 2.
Image /page/17/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the "U" in the word. The font is a simple sans-serif font. The background is white.