(172 days)
Not Found
No
The 510(k) summary describes surgical instruments and accessories for robotic surgical systems, focusing on reprocessing instructions and mechanical functions. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is described as being used for "endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy," which are all therapeutic medical procedures.
No
The device is described as surgical instruments and accessories used for endoscopic manipulation of tissue, cutting, suturing, and cautery during surgical procedures, not for diagnostic purposes.
No
The device description explicitly states that the submission is for changes to reprocessing instructions for reusable instruments and accessories used with surgical systems. These are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, dissection, cautery, and suturing during surgical procedures. This is a description of a surgical instrument used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The device description details surgical instruments like graspers, dissectors, needle drivers, scissors, cautery tools, and cannulae. These are all tools used directly on tissue during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside the body to provide diagnostic information. The focus is entirely on performing surgical actions.
Therefore, the device described is a surgical system and its associated instruments, not an In Vitro Diagnostic device.
N/A
Input Imaging Modality: Not Found
Image Processing: Not Found
AI, DNN, or ML: Not Found
Anatomical Site: Not Found
Indicated Patient Age Range: Not Found
Description of the training set, sample size, data source, and annotation protocol: Not Found
Description of the test set, sample size, data source, and annotation protocol: Not Found
Summary of Performance Studies:
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 of cleaning validations, disinfection efficacy validation and Human Factors 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.
Thermal Disinfection Validation:
The disinfection validation testing summarized in this submission validates the efficacy of the 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 thermal disinfection process (as described in the Reprocessing Instructions) was performed using devices within the product family that represent significant challenges to the disinfection step within the scope of the intended use). The thermal disinfection efficacy testing evaluated the efficacy of the disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e. 6-log10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
Human Factors Testing:
The Reprocessing Instructions underwent a rigorous Human Factors testing process included:
- Preliminary Evaluation: A preliminary evaluation was completed to better understand the users, uses, and use environment.
- Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions.
- Design Team Participation: Human Factors Engineers participated in design meetings and played a significant role in the visual design and content development.
- Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions.
- Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.
This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
Key Metrics: Not Found
Intended Use / Indications for Use
The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.
The Intuitive Surgical da Vinci® Xi™ Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.
Product codes
NAY, GCJ
Device Description
The da Vinci IS3000 (Si) and IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Single-Site Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Si and Xi Single-Site Instruments and Accessories.
The da Vinci Single-Site Instruments include instruments to perform grasping, cautery, cutting, clip ligation, suturing, and suction/irrigation functions. They are intended to be used with the IS3000 da Vinci Si Surgical System.
da Vinci Si Single-Site Accessories consist of fixed Shape Curved Cannulas (250mm and 300mm length), accessory cannulae for insertion of manual laparoscopic instruments, and semi-rigid blunt obturators (250mm and 300mm length).
The da Vinci Xi Single-Site Instruments enables single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.
The da Vinci Xi Single-Site Accessories include: 5mm Curved Cannulae, 5mm and 10mm straight cannulae, 8mm endoscope cannula, and flexible and rigid blunt obturators that enable single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 of cleaning validations, disinfection efficacy validation and Human Factors 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 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.
Efficacy of the thermal disinfection process (as described in the Reprocessing Instructions) was performed using devices within the product family that represent significant challenges to the disinfection step within the scope of the intended use). The thermal disinfection efficacy testing evaluated the efficacy of the disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e. 6-log10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
The Reprocessing Instructions underwent a rigorous Human Factors testing process included: Preliminary Evaluation: A preliminary evaluation was completed to better understand the users, uses, and use environment. Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions. Design Team Participation: Human Factors Engineers participated in design meetings and played a significant role in the visual design and content development. Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions. Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users. This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
Key Metrics
Not Found
Predicate Device(s)
K122532, K130726, K141075, K152448
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2017
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K170875
Trade/Device Name: Da Vinci Si Single-Site Instruments and Accessories, Da Vinci Xi Single-Site Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: August 14, 2017 Received: August 15, 2017
Dear Kunal Gunjal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting 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.
Jennifer R.
Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K170875
Changes to Reprocessing Instructions
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)
K170875
Device Name
da Vinci Si Single-Site Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical® da Vinci® Sinele-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (153000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clectrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectorny with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.
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
EF PSC Publishing Services (301) 443-6740
Image /page/2/Picture/24 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 a registered trademark symbol.
3
K170875
Changes to Reprocessing Instructions
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)
Device Name
da Vinci Xi Single-Site Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical da Vinci@ XiTM Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clectrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.
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)
PSC Publishing Services (301) 443-6740
Image /page/3/Picture/23 description: The image contains the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font, followed by the registered trademark symbol.
4
7 510(k) Summary (K170875)
This 510(k) applies to multiple instruments and accessories that have been cleared through previous 510(k) Premarket Notifications. It concerns the Reprocessing Instructions provided to users for reprocessing of instruments and accessories intended for multiple usage. For ease of review, the subject devices have been listed in Tables 7.1 and 7.2 (which are structured based on the da Vinci Surgical System with which it is used). No changes have been made in the design or materials of the subject devices.
| 510(k) Owner | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Contact | Kunal Gunjal |
| Regulatory Affairs Specialist, Regulatory Affairs | |
| Phone Number: 408-523-8017 | |
| Fax Number: 408-523-8907 | |
| Email: Kunal.Gunjal@intusurg.com | |
| Date Summary | August 14, 2017 |
| Prepared | |
| Trade Name | da Vinci Si Single-Site Instruments and Accessories |
| Common Name | Endoscope and accessories |
| Classification | Class II, 21 CFR 876.1500 |
| Product Codes | NAY, GCJ |
| Classification | General and Plastic Surgery |
| Advisory | |
| Committee: | |
| Predicate Devices | K122532 (use with IS3000 System) |
| K130726 (Addition of Permanent Cautery Hook to the IS3000 Single-Site | |
| Instruments Family) | |
| K141075 (Addition of Wristed Needle Driver to the IS3000 Single-Site | |
| Instruments Family) |
| Table 7.1: Reusable da Vinci Si (IS3000) Single-Site Instruments and Accessories | |||||
|---|---|---|---|---|---|
| ----------------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
Image /page/4/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, the word "SURGICAL" is also in all caps and in a smaller font size, with the registered trademark symbol next to it. There is a yellow dot above the "U" in "INTUITIVE".
5
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Fax Number: 408-523-8907
Email: Kunal.Gunjal@intusurg.com |
| Date Summary
Prepared | August 14, 2017 |
| Trade Name | da Vinci Xi Single-Site Instruments and Accessories |
| Common Name | Endoscope and accessories |
| Classification | Class II,
21 CFR 876.1500 |
| Product Codes | NAY, GCJ |
| Classification
Advisory
Committee: | General and Plastic Surgery |
| Predicate Devices | K152448 |
Table 7.2: Reusable da Vinci Xi (IS4000) Single-Site Instruments and Accessories
Device Description
The da Vinci IS3000 (Si) and IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Single-Site Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Si and Xi Single-Site Instruments and Accessories.
Tables 7.3 to 7.6 list the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
| Trade Name | da Vinci Si Single-Site Instruments |
|---|---|
| Device | |
| Description | The da Vinci Single-Site Instruments include instruments to perform |
| grasping, cautery, cutting, clip ligation, suturing, and suction/irrigation | |
| functions. They are intended to be used with the IS3000 da Vinci Si | |
| Surgical System. |
| Table 7.4: Reusable da Vinci Si (IS3000) Single-Site Accessories |
|---|
| ------------------------------------------------------------------- |
| Trade Name | da Vinci Si Single-Site Accessories |
|---|---|
| Device | |
| Description | da Vinci Si Single-Site Accessories consist of fixed Shape Curved |
| Cannulas (250mm and 300mm length), accessory cannulae for insertion | |
| of manual laparoscopic instruments, and semi-rigid blunt obturators | |
| (250mm and 300mm length). |
Image /page/5/Picture/12 description: The image contains 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" followed by the registered trademark symbol. The overall design is clean and modern.
6
| Trade Name | da Vinci Xi Single-Site Instruments |
|---|---|
| Device | |
| Description | The da Vinci Xi Single-Site Instruments enables single incision |
| laparoscopic cholecystectomy, benign hysterectomy, and salpingo | |
| oophorectomy using the da Vinci Xi (IS4000) Surgical System. |
Table 7.5: Reusable da Vinci Xi (IS4000) Single-Site Instruments
Table 7.6: Reusable da Vinci Xi (IS4000) Single-Site Accessories
| Trade Name | da Vinci Xi Single-Site Accessories |
|---|---|
| Device Description | The da Vinci Xi Single-Site Accessories include: 5mm Curved Cannulae, 5mm and 10mm straight cannulae, 8mm endoscope cannula, and flexible and rigid blunt obturators that enable single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System. |
Indications for Use:
Tables 7.7 to 7.8 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 Si Single-Site Instruments and Accessories |
|---|---|
| Indications for | |
| Use | The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with |
| the da Vinci® Si Surgical System (IS3000) are indicated for use by trained physicians in an | |
| operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt | |
| and sharp dissection, approximation, clip-ligation, electrocautery and suturing during | |
| single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo- | |
| oophorectomy with the da Vinci Single-Site Instruments and Accessories, including | |
| graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar | |
| cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt | |
| obturators, and the Single-Site Port. |
Table 7.8: Reusable da Vinci Xi (IS4000) Single-Site Instruments and Accessories
| Trade Name | da Vinci Xi Single-Site Instruments and Accessories |
|---|---|
| Indications for Use | The Intuitive Surgical da Vinci® Xi™ Single-Site Instruments and Accessories used |
| with the da Vinci Xi Surgical System (IS4000) are indicated for use by trained | |
| physicians in an operating room environment for endoscopic manipulation of tissue, | |
| grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, | |
| electrocautery, suction/irrigation and suturing during single incision laparoscopic | |
| cholecystectomy, benign hysterectomy and salpingo oophorectomy with the da Vinci Xi | |
| Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, | |
| scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm | |
| curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, | |
| flexible and rigid blunt obturators, cannula seal, and the Single-Site Port. |
7
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 of cleaning validations, disinfection efficacy validation and Human Factors 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 0 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.
Thermal Disinfection Validation
The disinfection validation testing summarized in this submission validates the efficacy of the disinfection process in the Reprocessing Instructions in accordance with the following guidance documents:
- o 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 thermal disinfection process (as described in the Reprocessing Instructions) was performed using devices within the product family that represent significant challenges to the disinfection step within the scope of the intended use). The thermal disinfection efficacy testing evaluated the efficacy of the disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e. 6-log10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
Image /page/7/Picture/17 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.
8
Human Factors Testing
The Reprocessing Instructions underwent a rigorous Human Factors testing 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.
- o 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 7.1 and 7.2.
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