(193 days)
Not Found
No
The 510(k) summary describes a robotic surgical system and its instruments/accessories, focusing on reprocessing instructions and mechanical components. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as assisting in the accurate control of surgical instruments for various procedures; it does not directly provide therapy.
No
The provided text describes the da Vinci Surgical System as a tool intended to assist in the accurate control of surgical instruments for various surgical procedures. Its purpose is to manipulate tissue, cut, suture, and perform other surgical tasks, not to diagnose medical conditions or diseases.
No
The device description explicitly details physical components like instruments, accessories (cannulae, obturators, cords, Hasson Cone), and mentions reprocessing instructions for these reusable hardware components. The 510(k) is specifically for changes to these reprocessing instructions, not for a software-only component.
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 a surgical system and its accessories used to assist in controlling surgical instruments for various surgical procedures on patients. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the components of a surgical robot and its instruments, cannulas, and cords used during surgery. None of these components are designed for analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents or calibrators
The device is a surgical system used for performing procedures on the patient, not for diagnosing conditions from the patient's samples.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GCJ, GEI
Device Description
The da Vinci Xi EndoWrist Instruments (8mm), have an articulating design at their distal tips that mimics the human wrist. Each instrument is used to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.
da Vinci Xi Accessories mainly consists of:
Cannulae , which are essentially hollow tubes that provide a path for instruments to access the surgical site
Obturators , which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point.
"Other" Accessories, include an instrument release kit (IRK), an Insertion tool and Instrument introducer. These accessories have simple geometries with no long narrow lumens
The Monopolar and Bipolar Cautery Cords are accessories to electrosurgical instruments where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generator-mating connector on the other end.
The Hasson Cone, is a cone-shaped device which is intended to be used in endoscopic surgery to assist in establishing a port of entry through the abdominal wall for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, and compatible accessories. The Hasson Cone is available in two sizes; 8 mm and 12 mm & Stapler.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, Thermal Disinfection 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 validates the efficacy of the cleaning process in the Reprocessing Instructions in accordance with FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR 12:2010, and AAMI TIR 30: 2011. 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 using qualitative visual inspection and quantitative endpoints.
Thermal Disinfection Validation: The disinfection validation testing validates the efficacy of the disinfection process in the Reprocessing Instructions in accordance with FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and Medical Washer- Disinfectors". Efficacy of the thermal disinfection process was performed using devices within the product family that represent significant challenges to the disinfection step. The testing evaluated the efficacy of the disinfection process 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, Usability Risk Analysis (URA), Design Team Participation, Formative Testing, and Validation Testing with representative end users. This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K131861, K150284, K150837, K133167, K153126
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
7 510(k) Summary (K170645)
This 510(k) applies to multiple instruments and accessories that have been cleared through a number of 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 Table 7.1 (which is 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.
Image /page/0/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray capital letters, with a yellow dot above the "I". Below that, the word "SURGICAL" is in smaller, gray capital letters, with the registered trademark symbol to the right.
1
| 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
EndoWrist
Instruments and
Accessories | Monopolar and
Bipolar Cautery
Cord | da Vinci Xi Hasson Cone | |
| Common
Name | Endoscope and
accessories | Monopolar/
Bipolar
Electrosurgical
Cord | Endoscope and accessories | |
| Classification | Class II,
21 CFR
876.1500 | Class II,
21 CFR
878.4400 | Class II,
21 CFR 876.1500 | |
| Product Codes | NAY, GCJ | GEI | GCJ | |
| Classification
Advisory
Committee: | General and
Plastic Surgery | General and
Plastic Surgery | General and Plastic Surgery | |
| Predicate
Devices | K131861
(Clearance of
da Vinci
Endowrist
Instruments and
Accessories for
use with the
IS4000 system)
K150284
(Addition of 6
additional
instruments to
the da Vinci Xi
Instruments
Family)
K150837
(Addition of
Small Clip
Applier and
Long Bipolar
Grasper
Instruments to
the da Vinci Xi
Instruments
Family) | K133167 | K153126 | |
| Trade Name | da Vinci Xi
EndoWrist
Instruments | da Vinci Xi
Accessories | Monopolar and
Bipolar Cautery Cord | da Vinci Xi Hasson Cone |
| Device
Description | The da Vinci Xi EndoWrist
Instruments
(8mm), have an
articulating
design at their
distal tips that
mimics the
human wrist.
Each instrument
is used to
perform one or
more specific
surgical tasks
e.g., grasping,
suturing,
cutting,
cauterizing, or
tissue
manipulation. | da Vinci Xi
Accessories mainly
consists of:
Cannulae , which
are essentially
hollow tubes that
provide a path for
instruments to
access the surgical
site
Obturators , which
provide a means of
initially inserting the
seal and cannula
assemblies through
the body wall by
providing a fitted tip
that extends beyond
the cannula's most
distal point.
"Other"
Accessories, include
an instrument
release kit (IRK), an
Insertion tool and
Instrument
introducer. These
accessories have
simple geometries
with no long narrow
lumens | The Monopolar and
Bipolar Cautery
Cords are accessories
to electrosurgical
instruments where
monopolar or bipolar
electrosurgical cutting
and coagulation is
desired during surgery.
The Monopolar and
Bipolar Cautery Cords
are insulated cords
with an instrument-
mating connector on
one end and generator-
mating connector on
the other end. | The Hasson Cone, is a cone-shaped device
which is intended to be used in endoscopic
surgery to assist in establishing a port of entry
through the abdominal wall for Intuitive
Surgical da Vinci Xi EndoWrist Instruments,
endoscopes, and compatible accessories. The
Hasson Cone is available in two sizes; 8 mm
and 12 mm & Stapler. |
Table 7.1: Reusable Instruments and Accessories used with the da Vinci Xi (IS4000) System
Image /page/1/Picture/4 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.
2
Device Description
The da Vinci IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Xi Instruments and Accessories. Table 7.2 lists the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
Table 7.2: Reusable Instruments and Accessories used with the da Vinci Xi (IS4000) System
Image /page/2/Picture/6 description: The image shows 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 the word "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font, with the registered trademark symbol to the right of the word.
3
Indications for Use:
Table 7.3 lists the Indications for Use for the devices impacted by the reprocessing instructions. There is no change in the Indications for Use between the subject and predicate devices.
| Trade Name | da Vinci Xi EndoWrist Instruments and
Accessories | Monopolar and Bipolar Cautery Cords | da Vinci Xi Hasson Cone |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Intuitive Surgical Endoscopic
Instrument Control System (da Vinci
Surgical System, Model IS4000) is
intended to assist in the accurate
control of Intuitive Surgical
Endoscopic Instruments including rigid
endoscopes, blunt and sharp
endoscopic dissectors, scissors,
scalpels, forceps/pick-ups, needle
holders, endoscopic retractors,
electrocautery and accessories for
endoscopic manipulation of tissue,
including grasping, cutting, blunt and
sharp dissection, approximation,
ligation, electrocautery, suturing, and
delivery and placement of microwave
and cryogenic ablation probes and
accessories, during urologic surgical
procedures, general laparoscopic
surgical procedures, gynecologic
laparoscopic surgical procedures,
general thoracoscopic surgical
procedures and thoracoscopically-
assisted cardiotomy procedures. The
system can also be employed with
adjunctive mediastinotomy to perform
coronary anastomosis during cardiac
revascularization. The system is
indicated for adult and pediatric use. It
is intended to be used by trained
physicians in an operating room
environment in accordance with the
representative, specific procedures set
forth in the Professional Instructions
for Use. | The Monopolar and Bipolar Cautery Cords
are intended for connecting
monopolar/bipolar electrosurgical
instruments to an electrosurgical generator
to provide transmission of high frequency
current from the electrosurgical generator
to the surgical instrument. | The da Vinci Xi Hasson Cone has
applications in laparoscopic surgery to
establish a port of entry for Intuitive
Surgical da Vinci Xi EndoWrist
Instruments, endoscopes, or compatible
accessories. |
Table 7.3: Reusable Instruments and Accessories used with the da Vinci Xi (IS4000) system
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, Thermal Disinfection 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.
Image /page/3/Picture/11 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray capital letters, with a yellow dot above the "U". Below that, the word "SURGICAL" is also in gray capital letters, but in a smaller font size.
4
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
- o 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.
- 0 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.
Image /page/4/Picture/20 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a light gray sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, light gray sans-serif font, with the registered trademark symbol next to it.
5
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 nonelinical 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 Table7.1.
Image /page/5/Picture/5 description: The image shows 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 the word "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the yellow dot adds a touch of color.
6
Changes to Reprocessing Instructions
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)
Device Name
da Vinci Xi Instruments and Accessories
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 placement of microwave and cryogenic ablation probes and accessories, during urologie 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)
X 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 Sarvices (301)-40-4740 10
Image /page/6/Picture/25 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.
7
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 Monopolar and Bipolar Cautery Cords
Indications for Use (Describe)
The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
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
PSC Publishing Services (301) 443-6740 EF
Image /page/7/Picture/23 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font in all caps, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, sans-serif font, also in all caps. The logo is simple and modern.
8
Changes to Reprocessing Instructions
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)
Device Name da Vinci Xi Hasson Cone
Indications for Use (Describe)
The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.
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
PSC Publishing Services (301) 443-6740 EF
Image /page/8/Picture/24 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 a registered trademark symbol.
9
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2017
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K170645
Trade/Device Name: Da Vinci Xi Endowrist Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ, GEI 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 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.
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 (reporting of medical device-
Image /page/9/Picture/11 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 a stylized image of three human profiles facing to the right, stacked on top of each other.
10
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
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