(203 days)
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.
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.
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.
This document describes the reprocessing instructions for da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes, and da Vinci Endoscopes used with the da Vinci Firefly Imaging system. The submission (K170641) addresses modifications to the reprocessing instructions for these multiple-use endoscopes. No changes were made to the design or materials of the devices themselves.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside reported device performance in a summary format with specific quantitative metrics for all performance data types. However, based on the descriptions of the validation studies, we can infer the general acceptance criteria and the successful outcome for the different types of testing.
| Acceptance Criteria (Inferred from study descriptions) | Reported Device Performance |
|---|---|
| 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 specified standards and guidance documents. This implies that the cleaning process was effective and met the standards. |
| Efficacy of cleaning process (qualitative visual inspection and quantitative endpoints). Conformance to FDA Guidance"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR 12:2010, and AAMI TIR 30: 2011. | |
| 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 specified guidance documents. Efficacy was evaluated using a quantitative endpoint of 6-log10 reduction of typical vegetative organisms. This indicates that the disinfection process achieved the required reduction in microorganisms. |
| Efficacy of chemical disinfection process: Quantitative endpoint of 6-log10 reduction of typical vegetative organisms (e.g., Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella-Enterobacter group). Conformance to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors". | |
| 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. This suggests that the endoscopes remained compatible without material degradation. |
| Compatibility of endoscopes with chemical disinfection process: No material changes or degradation after multiple cycles (assessed via visual inspection). | |
| Human Factors Testing: | This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions. The summary states that validation testing was "completed with representative end users," implying a successful outcome regarding usability, effectiveness, and safety of the instructions. |
| Usability, effectiveness, and use safety of the Reprocessing Instructions (evaluated through Preliminary Evaluation, Usability Risk Analysis, Design Team Participation, Formative Testing, and Validation Testing). |
Overall Summary of Performance: "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."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for the test sets used in cleaning, disinfection, or human factors validation. It mentions "devices within the product family that represent the greatest challenge" for cleaning, and "devices that represent significant challenges to the disinfection step" for chemical disinfection efficacy. For human factors, it states "Validation test of representative Reprocessing Instructions was completed with representative end users."
- Data Provenance: The document does not explicitly state the country of origin of the data. Given it's an FDA submission, the tests were likely conducted in accordance with US regulatory standards, implying US-based or internationally recognized testing facilities. The studies are described as nonclinical tests and validation studies, indicating they are prospective tests designed to prove the efficacy and safety of the reprocessing instructions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not mention the use of "experts" in the sense of clinical specialists establishing a ground truth for a diagnostic or clinical performance. Instead, the "ground truth" for the reprocessing instructions' effectiveness is established through adherence to recognized scientific standards and guidance documents (AAMI, FDA guidances) and objective measurements (e.g., quantitative reduction of microorganisms, visual inspection for cleanliness/degradation).
- For Human Factors Testing, "Human Factors Engineers" participated in design and content development, and "representative end users" were involved in validation testing. Their specific qualifications (e.g., years of experience) are not detailed.
4. Adjudication method for the test set
- Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers or experts are interpreting results (e.g., medical imaging). This document describes validation studies for reprocessing instructions, which are primarily objective performance tests and human factors assessments. Therefore, traditional adjudication methods are not applicable here. Performance is assessed against defined technical standards and criteria as detailed above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This submission is for reprocessing instructions for surgical endoscopes, not for an AI-powered diagnostic or predictive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device described is a surgical endoscope, and the studies reported concern the validation of its reprocessing instructions, not an algorithm's standalone performance.
7. The type of ground truth used
The "ground truth" for the validation of the reprocessing instructions comes from:
- Technical Standards and Guidance Documents: Adherence to established industry standards (AAMI TIR 12, AAMI TIR 30) and FDA guidance documents related to medical device reprocessing, cleaning, and disinfection.
- Objective Quantitative and Qualitative Measurements:
- Cleaning: Qualitative visual inspection and quantitative endpoints (specific metrics not detailed but implied to meet standards).
- Disinfection: Quantitative endpoint of 6-log10 reduction of vegetative organisms.
- Compatibility: Visual inspection for material changes and degradation.
- Usability Feedback: From "representative end users" for the human factors testing, assessing effectiveness and safety of the instructions themselves.
8. The sample size for the training set
- This question is not applicable. The document describes validation studies for medical device reprocessing instructions, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no training set mentioned or implied in the provided document.
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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
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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
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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.
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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.
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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.
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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.
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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 | |||
| DateSummaryPrepared | 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) |
| CommonName | Endoscope andaccessories | Endoscope andaccessories | Endoscope and accessories |
| Classification | Class II,21 CFR 876.1500 | Class II,21 CFR 876.1500 | Class II,21 CFR 876.1500 |
| ClassificationAdvisoryCommittee: | General and PlasticSurgery | General and PlasticSurgery | General and Plastic Surgery |
| ProductCodes forSubjectDevices(K170641) | NAY | NAY, GCJ | NAY |
| ProductCodes forPredicateDevices | NAY | NAY, GCJ | NAY |
| PredicateDevices | K050369 (use withIS2000 SurgicalSystem), K090993(TORS indication)and K123329(updated TORSindication) | K080155( use withIS2000 system),K090993 (TORSindication) andK123329 (updatedTORS 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".
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| 510(k) Owner | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 | |
|---|---|---|
| Contact | Kunal GunjalRegulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com | |
| DateSummaryPrepared | September 20, 2017 | |
| Trade Name | da Vinci Endoscopes, 12mm(Fluorescence Imaging VisionSystem) | da Vinci Endoscopes, 8.5 mm(Fluorescence Imaging VisionSystem) |
| CommonName | Endoscopic Instrument ControlSystem | Endoscopic Instrument ControlSystem |
| Classification | Class II, 21 CFR 876.1500 | Class II, 21 CFR 876.1500 |
| ClassificationAdvisoryCommittee: | General and Plastic Surgery | General and Plastic Surgery |
| Product Codesfor SubjectDevices(K170641) | OWN, IZI, NAY and GCJ | OWN |
| Product Codesfor PredicateDevices | OWN, IZI, NAY and GCJ | OWN |
| PredicateDevices | K101077 (for use with the daVinci Fluorescence ImagingVision System) with additionalindications cleared underK124031 (expanded indications toinclude visual assessment of extra-hepatic bile ducts) | K124031 (for use with the daVinci Fluorescence ImagingVision 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.
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| 510(k) Owner | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact | Kunal GunjalRegulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com |
| Date SummaryPrepared | September 20, 2017 |
| Trade Name | da Vinci Xi Endoscopes |
| Common Name | Endoscope and accessories |
| Classification | Class II,21 CFR 876.1500 |
| Classification AdvisoryCommittee: | General and Plastic Surgery |
| Product Codes forSubject Devices(K170641) | NAY, GCJ and IZI |
| Product Codes forPredicate Devices | NAY, GCJ and IZI |
| Predicate Devices | K131861 (Clearance of da Vinci Endoscopesfor use with the IS4000 system)K141077 (Clearance of da Vinci Endoscopesfor use with the da Vinci Firefly ImagingSystem) |
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 |
|---|---|
| DeviceDescription | The IS4000 Endoscope (8mm) is used to provide an image of the surgical field to thesurgeon side console and assistant monitors on the IS4000 System. The IS4000 8 mmendoscope 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 accuratecontrol of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharpendoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders,endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation oftissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation,electrocautery, suturing, and delivery and placement of microwave and cryogenic ablationprobes and accessories, during urologic surgical procedures, general laparoscopic surgicalprocedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgicalprocedures restricted to benign and malignant tumors classified as TI and T2, and for benignbase of tongue resection procedures, general thoracoscopic surgical procedures, andthoracoscopically assisted cardiotomy procedures. The system can also be employed withadjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.The system is indicated for adult and pediatric use (except for transoral otolaryngology surgicalprocedures). It is intended to be used by trained physicians in an operating room environment inaccordance with the representative, specific procedures set forth in the Professional Instructionsfor 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-timeendoscopic visible and near-infrared fluorescence imaging. The da Vinci FluorescenceImaging Vision System enables surgeons to perform minimally invasive surgery usingstandard endoscopic visible light as well as visual assessment of vessels, blood flow andrelated 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 VisionSystem is intended for use with standard of care white light and, when indicated,intraoperative cholangiography. The device is not intended for standalone use for biliaryduct 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 VinciFirefly Imaging System |
|---|---|---|
| Indications for Use | The Intuitive Surgical EndoscopicInstrument Control System (da VinciSurgical System, Model IS4000) isintended to assist in the accurate controlof Intuitive Surgical EndoscopicInstruments including rigid endoscopes,blunt and sharp endoscopic dissectors,scissors, scalpels, forceps/pick-ups,needle holders, endoscopic retractors,electrocautery and accessories forendoscopic manipulation of tissue,including grasping, cutting, blunt andsharp dissection, approximation, ligation,electrocautery, suturing, and delivery andplacement of microwave and cryogenicablation probes and accessories, duringurologic surgical procedures, generallaparoscopic surgical procedures,gynecologic laparoscopic surgicalprocedures, general thoracoscopicsurgical procedures andthoracoscopically-assisted cardiotomyprocedures. The system can also beemployed with adjunctivemediastinotomy to perform coronaryanastomosis during cardiacrevascularization. The system isindicated for adult and pediatric use. It isintended to be used by trained physiciansin an operating room environment inaccordance with the representative,specific procedures set forth in theProfessional Instructions for Use. | The da Vinci® Firefly™ Imaging System isintended to provide real-time endoscopicvisible and near-infrared fluorescenceimaging. The da Vinci Firefly ImagingSystem enables surgeons to performminimally invasive surgery using standardendoscopic visible light as well as visualassessment of vessels, blood flow and relatedtissue perfusion, and at least one of the majorextra-hepatic bile ducts (cystic duct, commonbile duct or common hepatic duct), using nearinfrared imaging.Fluorescence imaging of biliary ducts withthe da Vinci Firefly Imaging System isintended for use with standard of care whitelight and, when indicated, intraoperativecholangiography. The device is not intendedfor standalone use for biliary ductvisualization. |
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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.
§ 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.