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.
da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.
The da Vinci X/Xi (IS4200/IS4000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.
The provided document is a 510(k) premarket notification for da Vinci surgical instruments, focusing on the changes to their reprocessing instructions to include an optional automated cleaning and disinfection process. It doesn't contain a detailed study proving the device's clinical performance, but rather validation of its reprocessing efficacy. The focus is on ensuring the instruments remain safe and effective after being cleaned and disinfected by an automated washer-disinfector, similar to their prior manual cleaning method.
Here's an analysis of the acceptance criteria and the studies that address them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Efficacy of the automated cleaning process (using an automated washer-disinfector) for da Vinci S/Si and X/Xi Reusable Instruments, demonstrated in accordance with specific FDA guidance and AAMI standards. | The da Vinci S/Si and X/Xi Reusable Instruments successfully met the acceptance criteria for all markers (indicating cleanliness after automated reprocessing). This demonstrates the instruments can be cleaned effectively using an automated washer/disinfector. |
| Thermal Disinfection Validation | Efficacy of the thermal disinfection process for the subject devices within the automated washer/disinfector, per "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors." | The subject devices met the acceptance criteria, validating the efficacy of the thermal disinfection cycle within the automated washer/disinfector. |
| Reliability/Life Testing | da Vinci instruments are not adversely affected (e.g., in terms of function, structural integrity) by the use of an automated washer-disinfector for reprocessing. | The subject devices within the scope of this submission met the acceptance criteria, indicating they maintain reliability and lifespan after automated reprocessing. |
| Human Factors Testing | The Reprocessing Instructions are usable, effective, and safe for end-users, based on preliminary evaluation, usability risk analysis, design team participation, formative testing, and validation testing with representative end-users. | The Reprocessing Instructions underwent a rigorous Human Factors Testing process, including a preliminary evaluation, Usability Risk Analysis (URA), design team participation, formative testing, and validation testing. This assessed usability, effectiveness, and use safety. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of instruments, number of cycles) for the Cleaning Validation, Thermal Disinfection Validation, or Reliability/Life Testing.
- Cleaning Validation: "all markers" implies multiple types of soil/contaminants were tested.
- Thermal Disinfection Validation: "the subject devices" implies a representative set of instruments.
- Reliability/Life Testing: "the subject devices within the scope of this submission" implies a representative set of instruments was tested through multiple reprocessing cycles.
- Human Factors Testing: "representative end users" were used for validation testing.
Data Provenance: The studies were conducted by Intuitive Surgical, Inc. as part of their 510(k) submission to the FDA. The nature of these tests (validation of reprocessing) implies they were prospective studies performed specifically to support this regulatory submission. There is no information about the country of origin of the data, but given it's an FDA submission, the tests would conform to U.S. regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the test sets in the cleaning, disinfection, or reliability studies. These types of validation studies typically rely on established standards (e.g., AAMI, FDA guidance) for acceptance criteria rather than subjective expert consensus on "ground truth."
For Human Factors Testing:
- Experts involved: "Human Factors Engineers" participated in the design meetings.
- Ground Truth: For human factors, the "ground truth" is typically defined by the safe and effective execution of the reprocessing tasks by representative users, with risk analysis identifying potential use errors. The document states a "Usability Risk Analysis (URA)" was conducted and "validation test of representative Reprocessing Instructions was completed with representative end users," assessing "usability, effectiveness, and use safety." It does not specify how many experts defined the URA or evaluated the validation test outcomes.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1) for the test results. For cleaning, disinfection, and reliability tests, performance is usually objectively measured against predefined quantitative limits set by standards. For Human Factors, the validation testing would likely involve observation of user performance, identification of errors (critical and non-critical), and assessment against pre-defined safety and usability objectives. The report implies direct measurement and comparison to acceptance criteria.
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 done. The device in question (da Vinci surgical instruments) and the submission's focus (reprocessing instructions) are not related to AI-assisted reading or診断 (diagnosis). This is a submission for medical devices that are physical surgical instruments and the validation of their cleaning and disinfection protocols.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not Applicable. This is not an algorithmic or AI-based device, so the concept of standalone algorithm performance does not apply. The "device performance" here refers to the physical and functional integrity of the surgical instruments after undergoing a new reprocessing method (automated cleaning/disinfection) compared to how they performed after previous methods.
7. The Type of Ground Truth Used
- Cleaning Validation: Ground truth is established by quantitative measurement of residual soil/markers (e.g., protein, hemoglobin) against acceptance limits specified in recognized standards (AAMI TIR 30, AAMI TIR 12) and FDA guidance.
- Thermal Disinfection Validation: Ground truth is established by demonstrating the inactivation of microorganisms to a specified log reduction, as defined by FDA "Class II Special Controls Guidance Document."
- Reliability/Life Testing: Ground truth is established by verifying that the instruments maintain their functional and structural integrity after repeated reprocessing cycles, meeting specified performance criteria.
- Human Factors Testing: Ground truth is established by the successful, safe, and effective completion of reprocessing tasks by representative users, identifying and mitigating potential use errors through risk analysis and observed performance.
8. The Sample Size for the Training Set
Not Applicable. This submission is for physical surgical instruments and changes to their reprocessing instructions, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. See point 8.
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February 10, 2021
Intuitive Surgical, Inc. Kunal Gunjal Sr. Regulatory Affairs Specialist 1266 Kifer Road, Building 101 Sunnyvale, California 94086
Re: K203632
Trade/Device Name: da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: December 10, 2020 Received: December 11, 2020
Dear Kunal Gunjal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| Indications for Use | |
| 510(k) Number (if known) | K203632 |
| Device Name | da Vinci S/Si (IS2000/IS3000) EndoWrist Instruments (5mm and 8mm) |
| Indications for Use (Describe) | The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. |
| Type of Use (Select one or both, as applicable) | |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing, Services (701)-443-6740 EF
Image /page/2/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and appears to be a bold typeface. The background is white.
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| mber (if known) |
510(k) Num K203632
Device Name
da Vinci Xi (IS4000) 8mm Instruments
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approxination, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301)-443-6740
Image /page/3/Picture/20 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I". The font is sans-serif and the text is centered.
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K203632 Automated Cleaning/Disinfection Process da Vinci S/Si and X/Xi Reusable Instruments
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K203632 |
| Device Name | da Vinci X (IS4200) 8mm Instruments |
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to
assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp
endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and
accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation,
ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and
accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic
surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The
system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac
revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an
operating room environment in accordance with the representative, specific procedures set forth in the Professional
Instructions for Use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (701) 443-6740 EF
Image /page/4/Picture/11 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and the letters are evenly spaced.
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| 510(k) Owner | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact | Kunal GunjalSr. Regulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Email: Kunal.Gunjal@intusurg.com |
| Trade Name | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments (5mm & 8mm) |
| Common Name | Endoscope and accessories |
| Classification | Class II,21 CFR 876.1500 |
| Product Codes | NAY |
| Review Panel | General and Plastic Surgery |
| Predicate Devices | K170644 (Clearance of Reprocessing Instructions for da Vinci S and SiReusable Instruments) |
Table 1: da Vinci S/Si (IS2000/IS3000) Reusable Instruments
INTUÍTIVE
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Table 2: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
| 510(k) Owner | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact | Kunal GunjalSr. Regulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Email: Kunal.Gunjal@intusurg.com |
| Trade Name | da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
| Common Name | Endoscope and accessories |
| Classification | Class II,21 CFR 876.1500 |
| Product Codes | NAY, GCJ |
| Review Panel | General and Plastic Surgery |
| Predicate Devices | K170645 (Clearance of Reprocessing Instructions for da Vinci Xi 8mm Reusable Instruments) |
INTUIT
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Device Description
Table 3 lists the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
| Trade Name | da Vinci S/ Si (IS2000/IS3000)EndoWrist Instruments (5mm & 8mm) | da Vinci Xi/X (IS4000/IS4200)Reusable Instruments (8mm) | |
|---|---|---|---|
| Device Description | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation. | The da Vinci X/Xi (IS4200/IS4000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation. | |
| Trade Name | da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments (5mm & 8mm) | da Vinci Xi (IS4000) 8mm Reusable Instruments | da Vinci Xi (IS4200) 8mm Reusable Instruments |
| Indications for Use | The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. |
Table 3: da Vinci S/Si and X/Xi Reusable Instruments
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Indications for Use:
Table 4 lists the Indications for Use for the devices impacted by the changes to the reprocessing instructions.
Table 4: da Vinci S/Si and X/Xi Reusable Instruments
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Table 5 and Table 6 includes a comparison between the subject devices and predicate devices.
| Table 5: Comparison of Predicate and Subject Devices (da Vinci S/Si EndoWrist 5mm and 8mm | |||
|---|---|---|---|
| instruments) | |||
| Characteristic | Subject Deviceda Vinci IS2000/IS3000 5mm and 8mmInstruments (K203632) | Predicate Deviceda Vinci IS2000/IS3000 5mm and 8mmInstruments (K170644) | |
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. | |
| Trade Name | da Vinci S/Si (IS2000/IS3000) 5mm/8mminstruments | SAME as subject device | |
| Common Name | Endoscope and accessories | SAME as subject device | |
| Regulation No. | 21 CFR 876.1500 | SAME as subject device | |
| Product Code | NAY | SAME as subject device | |
| Device Class/Regulation Name | Class II | SAME as subject device | |
| ClassificationAdvisoryCommittee | General and Plastic Surgery | SAME as subject device | |
| Characteristic | Subject Device | Predicate Device | |
| da Vinci IS2000/IS3000 5mm and 8mm Instruments (K203632) | da Vinci IS2000/IS3000 5mm and 8mm Instruments (K170644) | ||
| Indications for Use | The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | SAME as subject device | |
| Prescription use | Physician use only | SAME as subject device | |
| Characteristic | Subject Deviceda Vinci IS2000/IS3000 5mm and 8mmInstruments (K203632) | Predicate Deviceda Vinci IS2000/IS3000 5mm and 8mmInstruments (K170644) | |
| Where used(hospital, home,ambulance, etc) | Hospital | SAME as subject device | |
| SterilizationMethod | Steam sterilization | SAME as subject device | |
| Sterility /Disposable orMultiple use | Multiple use | SAME as subject device | |
| ReprocessingInstructions | Reprocessing Instructions have beenupdated to include an optional automatedcleaning and disinfection process using anautomated washer/disinfector. | Reprocessing Instructions include amanual cleaning process using anultrasonic bath.Reprocessing Instructions includethermal disinfection parameters. | |
| Packaging | Non-sterile packaging, reusable | SAME as subject device |
INTUI
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INTUITIVE
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| Table 6: Comparison of Predicate and Subject Devices (da Vinci X/Xi EndoWrist 8mm Instruments) | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | ------------------------------------------------------------------------------------------------ |
| Characteristic | Subject Deviceda Vinci X/Xi (IS4200/IS4000)EndoWrist (8mm) Instruments(K203632) | Predicate Deviceda Vinci Xi (IS4000) EndoWrist(8mm) Instruments(K170645) |
|---|---|---|
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. |
| Trade Name | da Vinci X/Xi EndoWrist (8mm)Instruments | da Vinci Xi EndoWrist (8mm)Instruments |
| Common Name | Endoscope and accessories | SAME as subject device |
| Regulation No. | 21 CFR 876.1500 | SAME as subject device |
| Product Code | NAY, GCJ | SAME as subject device |
| Device Class/Regulation Name | Class II | SAME as subject device |
| ClassificationAdvisoryCommittee | General and Plastic Surgery | SAME as subject device |
| Characteristic | Subject Deviceda Vinci X/Xi (IS4200/IS4000)EndoWrist (8mm) Instruments(K203632) | Predicate Deviceda Vinci Xi (IS4000) EndoWrist(8mm) Instruments(K170645) |
| Indications forUse for da VinciXi (IS4000)EndoWrist 8mmInstruments | The Intuitive Surgical EndoscopicInstrument Control System (da VinciSurgical System, Model IS4000) isintended to assist in the accuratecontrol of Intuitive SurgicalEndoscopic Instruments includingrigid endoscopes, blunt and sharpendoscopic dissectors, scissors,scalpels, forceps/pick-ups, needleholders, endoscopic retractors,electrocautery and accessories forendoscopic manipulation of tissue,including grasping, cutting, blunt andsharp dissection, approximation,ligation, electrocautery, suturing, anddelivery and placement of microwaveand cryogenic ablation probes andaccessories, during urologic surgicalprocedures, general laparoscopicsurgical procedures, gynecologiclaparoscopic surgical procedures,general thoracoscopic surgicalprocedures and thoracoscopically-assisted cardiotomy procedures. Thesystem can also be employed withadjunctive mediastinotomy to performcoronary anastomosis during cardiacrevascularization. The system isindicated for adult and pediatric use.It is intended to be used by trainedphysicians in an operating roomenvironment in accordance with therepresentative, specific procedures setforth in the Professional Instructionsfor Use. | SAME as subject device |
| Characteristic | Subject Deviceda Vinci X/Xi (IS4200/IS4000)EndoWrist (8mm) Instruments(K203632) | Predicate Deviceda Vinci Xi (IS4000) EndoWrist(8mm) Instruments(K170645) |
| Indications forUse for da Vinci X(IS4200)EndoWrist 8mmInstrumentsNOTE: The sameda VinciEndoWrist 8mminstruments areused with the daVinci X (IS4200)system and daVinci Xi (IS4000)system | The Intuitive Surgical EndoscopicInstrument Control System (da VinciX Surgical System, Model IS4200) isintended to assist in the accuratecontrol of Intuitive SurgicalEndoscopic Instruments includingrigid endoscopes, blunt and sharpendoscopic dissectors, scissors,scalpels, forceps/pick-ups, needleholders, endoscopic retractors,electrocautery and accessories forendoscopic manipulation of tissue,including grasping, cutting, blunt andsharp dissection, approximation,ligation, electrocautery, suturing, anddelivery and placement of microwaveand cryogenic ablation probes andaccessories, during urologic surgicalprocedures, general laparoscopicsurgical procedures, gynecologiclaparoscopic surgical procedures,general thoracoscopic surgicalprocedures and thoracoscopically-assisted cardiotomy procedures. Thesystem can also be employed withadjunctive mediastinotomy to performcoronary anastomosis during cardiacrevascularization. The system isindicated for adult and pediatric use. Itis intended to be used by trainedphysicians in an operating roomenvironment in accordance with therepresentative, specific procedures setforth in the Professional Instructionsfor Use. | The Intuitive Surgical EndoscopicInstrument Control System (da VinciSurgical System, Model IS4000) isintended to assist in the accuratecontrol of Intuitive SurgicalEndoscopic Instruments includingrigid endoscopes, blunt and sharp |
| Characteristic | Subject Deviceda Vinci X/Xi (IS4200/IS4000)EndoWrist (8mm) Instruments(K203632) | Predicate Deviceda Vinci Xi (IS4000) EndoWrist(8mm) Instruments(K170645) |
| Prescription use | Physician use only | SAME as subject device |
| Where used(hospital, home,ambulance, etc) | Hospital | SAME as subject device |
| SterilizationMethod | Steam sterilization | SAME as subject device |
| Sterility /Disposable orMultiple use | Multiple use | SAME as subject device |
| ReprocessingInstructions | Reprocessing Instructions have beenupdated to include an optionalautomated cleaning and disinfectionprocess using an automatedwasher/disinfector. | Reprocessing Instructions include amanual cleaning process using anultrasonic bath.Reprocessing Instructions includethermal disinfection parameters. |
| Packaging | Non-sterile packaging, reusable | SAME as subject device |
INTUÍTIVE
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Technological Characteristics:
There were no changes to design including technological characteristics for the subject devices as a result of the reprocessing instructions changes to include use of an automated washer/disinfector.
Performance Data:
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device. The testing conducted consisted of Cleaning Validation, Thermal Disinfection validation, Reliability/Life Testing and Human factors testing.
- Cleaning Validation: Cleaning Validation was performed to validate the efficacy of the O automated cleaning process using an automated washer-disinfector in accordance with the following standards and guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", document issued on: March 17, 2015
- AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- -AAMI TIR 30: 2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- ANSI/AAMI ST15883-1:2009/(R) 2014, Washer-disinfectors: General requirements, terms and definitions and tests
The da Vinci S/Si and X/Xi Reusable Instruments successfully met the acceptance criteria for all markers. The test results demonstrate that the da Vinci S/Si and X/Xi Reusable Instruments can be cleaned using an automated washer/disinfector.
- Thermal Disinfection Validation: Efficacy of the thermal disinfection process was validated for O the subject devices per the FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors: Guidance for the Medical Device Industry and FDA Review Staff", Document Issued on February 7, 2002. The subject devices meet the acceptance criteria which validates the efficacy of the thermal disinfection cycle within the automated washer/disinfector.
- Reliability/Life Testing: Reliability/Life Testing was performed to ensure that da Vinci O instruments are not adversely affected by the use of an automated washer-disinfector for reprocessing these instruments. The subject devices within the scope of this submission meet the acceptance criteria.
- Human Factors Testing: The Reprocessing Instructions underwent a rigorous Human Factors O Testing process. This process included:
- Preliminary Evaluation: A preliminary evaluation was completed to better understand the users, uses, and use environment.
- -Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions.
- Design Team Participation: Human Factors Engineers participated in design meetings and played a significant role in the visual design and content development.
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- -Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions.
- Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.
This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
Summary:
Based on the intended use, indications for use, technological characteristics and performance data, the subject device is substantially equivalent to the predicate devices listed in Table 1 and Table 2.
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§ 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.