(203 days)
Not Found
No
The summary focuses on the reprocessing instructions for the endoscopes and does not mention any AI/ML capabilities for image analysis, control, or other functions.
Yes.
The device is intended to assist in surgical procedures involving manipulation of tissue and placement of ablation probes, which are therapeutic interventions.
No
The provided text describes the device as a surgical system intended to assist in the accurate control of surgical instruments and provide real-time endoscopic visible and near-infrared fluorescence imaging during surgical procedures. Its stated purpose is not for diagnosis, but rather for assisting with surgical interventions and visualizing anatomical structures during these procedures. While it provides imaging, this imaging is explicitly for use during surgery to aid the surgeon, not for diagnostic purposes prior to or separate from surgical intervention.
No
The device description explicitly states that the system is used in conjunction with reusable da Vinci Endoscopes, which are hardware components. The 510(k) is specifically for changes to the reprocessing instructions for these hardware endoscopes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for 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, providing visualization of the surgical field, and enabling fluorescence imaging during surgery. This is a surgical device, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details the surgical system components, including endoscopes used for imaging the surgical field. It does not mention any components or processes related to analyzing biological samples or providing diagnostic results.
- Input Imaging Modality: While it uses imaging (visible light and near-infrared fluorescence), this imaging is used for real-time visualization during surgery, not for analyzing samples in vitro.
- Performance Studies: The performance studies described focus on the reprocessing instructions, cleaning validation, chemical disinfection efficacy and compatibility, and human factors testing. These are all related to the functionality and safety of a surgical device and its accessories, not the performance of a diagnostic test.
- Key Metrics: The key metric mentioned (reduction of vegetative organisms) is related to sterilization and disinfection, which are crucial for surgical instruments, not diagnostic accuracy.
In summary, the device's purpose is to facilitate surgical procedures and provide real-time visualization during those procedures. It does not perform any tests on biological specimens outside the body to provide diagnostic information, which is the defining characteristic of an In Vitro Diagnostic device.
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 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 da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
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 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 revasularization. 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 (comma separated list FDA assigned to the subject device)
NAY, GCJ, OWN, IZI
Device Description
The da Vinci IS2000 (S), IS3000 (Si), and IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Endoscopes to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Endoscopes.
The IS2000/IS3000 Endoscopes are used to provide an image of the surgical field to the surgeon side console and assistant monitors on the IS2000/IS3000 system. There are two diameters of the endoscopes (12mm or 8.5mm) with either a straight (0°) or angled (30°) tip.
da Vinci Endoscopes, 8.5mm/12mm are a part of the da Vinci Fluorescence Imaging Vision System which is an imaging system for high definition (HD) visible light and near-Infrared fluorescence Imaging during minimally invasive surgery. There are two diameters for the endoscopes (12mm or 8.5mm) with either a straight (0°) or angled (30°) tip.
The IS4000 Endoscope (8mm) is used to provide an image of the surgical field to the surgeon side console and assistant monitors on the IS4000 System. The IS4000 8 mm endoscope is available with either a straight (0°) or angled (30°) tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible light, near-infrared fluorescence imaging, intraoperative cholangiography
Anatomical Site
Urologic, general laparoscopic, gynecologic laparoscopic, transoral otolaryngology (benign and malignant tumors classified as T1 and T2, benign base of tongue), general thoracoscopic, thoracoscopically-assisted cardiotomy, coronary anastomosis (with adjunctive mediastinotomy). Specifically: vessels, blood flow and related tissue perfusion, and major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct).
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
Cleaning validation: efficacy of the cleaning process in the Reprocessing Instructions using qualitative visual inspection and quantitative endpoints.
Chemical Disinfection Efficacy Validation: efficacy of the chemical disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e. 6-10g10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
Chemical Disinfection Compatibility Validation: Devices were subjected to multiple chemical disinfection cycles and visually inspected for material changes and degradation.
Human Factors Testing: validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions. This included: Preliminary Evaluation, Usability Risk Analysis (URA), Design Team Participation, Formative Testing, and Validation Testing of representative Reprocessing Instructions with representative end users.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of cleaning validations, Human Factors validation studies, Chemical Disinfection Efficacy and Compatibility validation studies. Design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices.
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.
K050369, K090993, K123329, K080155, K081137, K101077, K124031, K131861, K141077
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
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.
September 21, 2017
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road. Building 101 Sunnyvale, California 94086
Re: K170641
Trade/Device Name: Da Vinci S/Si Endoscopes, Da Vinci Xi Endoscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ, OWN, IZI Dated: August 24, 2017 Received: August 25, 2017
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. The general controls provisions of the Actinclude 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The name is stacked vertically, with "Jennifer R." on top and "Stevenson -S3" below. The text is dark, and the background is light. The letters are clear and easy to read.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170641
Device Name
da Vinci S/Si Endoscopes (8.5mm and 12mm)
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 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 (8/14)
Page 1 of 1
Image /page/2/Picture/21 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" followed by the registered trademark symbol.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170641
Device Name
da Vinci Endoscopes, 8.5mm and 12mm (Fluorescence Imaging Vision System)
Indications for Use (Describe)
The da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
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 (8/14)
Image /page/3/Picture/23 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
4
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) K170641
Device Name
da Vinci Xi Endoscopes
Indications for Use (Describe)
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 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 revasularization. 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 (8/14)
Image /page/4/Picture/21 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a light gray color, with the registered trademark symbol to the right of the word.
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K170641 |
| Device Name | da Vinci Endoscopes used with the da Vinci Firefly Imaging system |
| Indications for Use (Describe) | The da Vinci® Firefly™ Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. |
| 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
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 (8/14)
Page 1 of 1
PSC Publishing Sarvices (301) 443-6740
Image /page/5/Picture/8 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, lighter sans-serif font, with a registered trademark symbol next to it. The logo is simple and modern.
6
510(k) Summary (K170641)
This 510(k) applies to multiple endoscopes that have been cleared through a number of previous 510(k) Premarket Notifications. It concerns the Reprocessing Instructions provided to users for reprocessing of endoscopes intended for multiple usage. For ease of review, the subject devices have been listed in Tables 1.1 through 1.3 (which are structured based on the device and the da Vinci Surgical System with which it is used). No changes have been made in the design or materials of the subject devices.
| 510(k) Owner | Intuitive Surgical, Inc. | ||
|---|---|---|---|
| 1266 Kifer Road | |||
| Sunnyvale, CA 94086 | |||
| Contact | Kunal Gunjal | ||
| Regulatory Affairs Specialist, Regulatory Affairs | |||
| Phone Number: 408-523-8017 | |||
| Fax Number: 408-523-8907 | |||
| Email: Kunal.Gunjal@intusurg.com | |||
| Date | |||
| Summary | |||
| Prepared | September 20, 2017 | ||
| Trade Name | da Vinci S (IS2000) | ||
| 12mm Endoscopes | da Vinci S (IS2000) | ||
| 8.5 mm Endoscopes | da Vinci Si Endoscopes (8.5mm and 12mm) | ||
| Common | |||
| Name | Endoscope and | ||
| accessories | Endoscope and | ||
| accessories | Endoscope and accessories | ||
| Classification | Class II, | ||
| 21 CFR 876.1500 | Class II, | ||
| 21 CFR 876.1500 | Class II, | ||
| 21 CFR 876.1500 | |||
| Classification | |||
| Advisory | |||
| Committee: | General and Plastic | ||
| Surgery | General and Plastic | ||
| Surgery | General and Plastic Surgery | ||
| Product | |||
| Codes for | |||
| Subject | |||
| Devices | |||
| (K170641) | NAY | NAY, GCJ | NAY |
| Product | |||
| Codes for | |||
| Predicate | |||
| Devices | NAY | NAY, GCJ | NAY |
| Predicate | |||
| Devices | K050369 (use with | ||
| IS2000 Surgical | |||
| System), K090993 | |||
| (TORS indication) | |||
| and K123329 | |||
| (updated TORS | |||
| indication) | K080155( use with | ||
| IS2000 system), | |||
| K090993 (TORS | |||
| indication) and | |||
| K123329 (updated | |||
| TORS indication) | K081137 (use with IS3000 system), | ||
| K090993 (TORS indication) and K123329 | |||
| (updated TORS indication) |
Image /page/6/Picture/6 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that is the word "SURGICAL" in a smaller font size, also in light gray, with the registered trademark symbol to the right of it. There is a yellow dot above the "I" in "INTUITIVE".
7
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Fax Number: 408-523-8907
Email: Kunal.Gunjal@intusurg.com | |
| Date
Summary
Prepared | September 20, 2017 | |
| Trade Name | da Vinci Endoscopes, 12mm
(Fluorescence Imaging Vision
System) | da Vinci Endoscopes, 8.5 mm
(Fluorescence Imaging Vision
System) |
| Common
Name | Endoscopic Instrument Control
System | Endoscopic Instrument Control
System |
| Classification | Class II, 21 CFR 876.1500 | Class II, 21 CFR 876.1500 |
| Classification
Advisory
Committee: | General and Plastic Surgery | General and Plastic Surgery |
| Product Codes
for Subject
Devices
(K170641) | OWN, IZI, NAY and GCJ | OWN |
| Product Codes
for Predicate
Devices | OWN, IZI, NAY and GCJ | OWN |
| Predicate
Devices | K101077 (for use with the da
Vinci Fluorescence Imaging
Vision System) with additional
indications cleared under
K124031 (expanded indications to
include visual assessment of extra-
hepatic bile ducts) | K124031 (for use with the da
Vinci Fluorescence Imaging
Vision System) |
Table 1.2: Endoscopes Used with the da Vinci Fluorescence Imaging Vision System
Image /page/7/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, light gray font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
8
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Fax Number: 408-523-8907
Email: Kunal.Gunjal@intusurg.com |
| Date Summary
Prepared | September 20, 2017 |
| Trade Name | da Vinci Xi Endoscopes |
| Common Name | Endoscope and accessories |
| Classification | Class II,
21 CFR 876.1500 |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Product Codes for
Subject Devices
(K170641) | NAY, GCJ and IZI |
| Product Codes for
Predicate Devices | NAY, GCJ and IZI |
| Predicate Devices | K131861 (Clearance of da Vinci Endoscopes
for use with the IS4000 system)
K141077 (Clearance of da Vinci Endoscopes
for use with the da Vinci Firefly Imaging
System) |
Table 1.3: Reusable Endoscopes Used with the da Vinci Xi (IS4000) System and da Vinci Firefly Imaging System
Device Description
The da Vinci IS2000 (S), IS3000 (Si), and IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Endoscopes to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Endoscopes. Tables 1.4 to 1.6 list the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
| Table 1.4: Endoscopes Used with the da Vinci S/Si (IS2000/IS3000) System | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | --------------------------------------------------------------------------- | -- |
| Trade Name | da Vinci S/Si Endoscopes (8.5mm and 12mm) |
|---|---|
| Device Description | The IS2000/IS3000 Endoscopes are used to provide an image of the surgical field to the surgeon side console and assistant monitors on the IS2000/IS3000 system. There are two diameters of the endoscopes (12mm or 8.5mm) with either a straight (0°) or angled (30°) tip. |
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| Trade Name | da Vinci Endoscopes, 8.5mm/12mm (Fluorescence Imaging Vision System) |
|---|---|
| Device Description | da Vinci Endoscopes, 8.5mm/12mm are a part of the da Vinci Fluorescence Imaging Vision System which is an imaging system for high definition (HD) visible light and near-Infrared fluorescence Imaging during minimally invasive surgery. There are two diameters for the endoscopes (12mm or 8.5mm) with either a straight (0°) or angled (30°) tip. |
Table 1.5: Reusable Endoscopes Used with the da Vinci Fluorescence Imaging Vision System
Table 1.6: Reusable Endoscopes Used with the da Vinci Xi (IS4000) System
| Trade Name | da Vinci Xi Endoscopes |
|---|---|
| Device | |
| Description | The IS4000 Endoscope (8mm) is used to provide an image of the surgical field to the |
| surgeon side console and assistant monitors on the IS4000 System. The IS4000 8 mm | |
| endoscope is available with either a straight (0°) or angled (30°) tip. |
Indications for Use:
Tables 1.7 to 1.9 list the Indications for Use for the devices impacted by the changes to the reprocessing instructions. There is no change in the Indications for Use between the subject and predicate devices.
| Trade Name | da Vinci S/Si Endoscopes (8.5mm and 12mm) |
|---|---|
| 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. |
| Table 1.7: Endoscopes Used with the da Vinci S/Si (IS2000/IS3000) System | |||
|---|---|---|---|
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| Trade Name | da Vinci Endoscopes, 8.5mm/12mm (Fluorescence Imaging Vision System) |
|---|---|
| Indications for Use | The da Vinci Fluorescence Imaging Vision System is intended to provide real-time |
| endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence | |
| Imaging Vision System enables surgeons to perform minimally invasive surgery using | |
| standard endoscopic visible light as well as visual assessment of vessels, blood flow and | |
| related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, | |
| common bile duct and common hepatic duct), using near infrared imaging. |
Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision
System is intended for use with standard of care white light and, when indicated,
intraoperative cholangiography. The device is not intended for standalone use for biliary
duct visualization. |
Table 1.8: Endoscopes Used with the da Vinci Fluorescence Imaging Vision System
| Table 1.9: Reusable Endoscopes Used with the da Vinci Xi (IS4000) system and | ||||
|---|---|---|---|---|
| da Vinci Firefly Imaging System |
| Trade Name | da Vinci Xi Endoscopes | da Vinci Endoscopes Used with the da Vinci
Firefly Imaging System |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications 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 da Vinci® Firefly™ Imaging System is
intended to provide real-time endoscopic
visible and near-infrared fluorescence
imaging. The da Vinci Firefly Imaging
System enables surgeons to perform
minimally invasive surgery using standard
endoscopic visible light as well as visual
assessment of vessels, blood flow and related
tissue perfusion, and at least one of the major
extra-hepatic bile ducts (cystic duct, common
bile duct or common hepatic duct), using near
infrared imaging.
Fluorescence imaging of biliary ducts with
the da Vinci Firefly Imaging System is
intended for use with standard of care white
light and, when indicated, intraoperative
cholangiography. The device is not intended
for standalone use for biliary duct
visualization. |
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Technological Characteristics:
The technological characteristics of the subject devices are identical to the predicate devices.
Performance Data:
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of cleaning validations, Human Factors validation studies, Chemical Disinfection Efficacy and Compatibility validation studies. Design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices.
Cleaning Validation
The cleaning validation testing summarized in this submission validates the efficacy of the cleaning process in the Reprocessing Instructions 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 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
Cleaning validation testing was performed using devices within the product family that represent the greatest challenge for the cleaning process. The Cleaning Efficacy test evaluated the cleaning process (as described in the Reprocessing Instructions) for the devices using qualitative visual inspection and quantitative endpoints.
Chemical Disinfection Efficacy Validation
The disinfection validation testing summarized in this submission validates the efficacy of the chemical disinfection process in the Reprocessing Instructions in accordance with the following guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation . Methods and Labeling", document issued on: March 17, 2015
- 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.
Efficacy of the chemical disinfection process (as described in the Reprocessing Instructions) was performed using devices that represent significant challenges to the disinfection step within the scope of the intended use. The chemical disinfection efficacy testing evaluated the efficacy of the
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disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e. 6-10g10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
Chemical Disinfection Compatibility Validation
The chemical disinfection compatibility validation testing summarized in this submission validates the compatibility of the da Vinci Endoscopes with the chemical disinfection process. Devices were subjected to multiple chemical disinfection cycles and visually inspected for material changes and degradation.
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.
Summary:
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate devices listed in Tables 1.1 to 1.3.
Image /page/12/Picture/15 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. There is a yellow dot above the "I" in Intuitive. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font size and also in a light gray color with the registered trademark symbol.