(181 days)
Not Found
No
The summary describes a surgical stapling instrument and its accessories, focusing on mechanical function and compatibility with the da Vinci surgical system. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or validation.
No.
The device is described as a surgical tool for resection, transection, and creation of anastomoses by placing staples and cutting tissue, which is an operative function, not a therapeutic one that treats a disease or condition.
No
The device is a surgical stapler used for resection, transection, and creation of anastomoses, which are surgical procedures, not diagnostic functions.
No
The device description clearly outlines physical components such as instruments, reloads, cannulae, and obturators, indicating it is a hardware-based medical device used in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Intuitive Surgical EndoWrist Stapler System is a surgical instrument used for resection, transection, and/or creation of anastomoses (joining of tissues) during surgical procedures. It physically interacts with and modifies tissue within the body.
- Intended Use: The intended use is for surgical procedures in various anatomical sites (General, Gynecologic, Urologic, Thoracic).
- Device Description: The description details the mechanical function of the stapler (delivering staples, cutting tissue) and its components (instrument, reloads, accessories).
There is no mention of the device analyzing biological samples or providing diagnostic information based on such analysis. It is a surgical tool used for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model 1S3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The devices can be used with staple line or tissue buttressing material.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GDW, GCJ
Device Description
Endowrist Stapler Instrument (used with the IS3000 System): The Endowrist Stapler Instrument, when used with the compatible Stapler 45 Reloads, delivers multiple rows of staples and transects the tissue along the middle of the staple line. The Endowrist Stapler Instrument is a reusable device while the Stapler 45 reloads (available in various sizes) are single-use/disposable devices.
EndoWrist Stapler 45 Instrument (used with the IS4000 system): The EndoWrist Stapler 45 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
IS4000 EndoWrist Stapler 30 Instrument (used with the IS4000 system): IS4000 EndoWrist Stapler 30 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip.
EndoWrist Stapler Accessories (used with the IS3000 system): EndoWrist Stapler Reusable Accessories consist of a Stapler Cable, Stapler Release Kit, Stapler Cannula, Blunt Obturator, Stapler Cannula Reducer, and Stapler Motor Pack (SMP).
EndoWrist Stapler 45 Accessories (used with the IS4000 system): EndoWrist Stapler 45 Accessories mainly consist 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 the SRK (Stapler Release Kit).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General, Gynecologic, Urologic, Thoracic surgery
Indicated Patient Age Range
adult and pediatric use
Intended User / Care Setting
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 (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.
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.
K140553, K143217, K152421, K113706, K171388
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2017
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road, Building 101 Sunnyvale, California 94086
Re: K170879
Trade/Device Name: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ, GDW Dated: August 24, 2017
Dear Kunal Gunjal:
Received: August 25, 2017
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 comples with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
Image /page/0/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 symbol that resembles three human profiles facing to the right, stacked on top of each other.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The text is black, and the background is white. The letters "FDA" are faintly visible in the background, suggesting the image may be related to the Food and Drug Administration.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||||
|---|---|---|---|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) K170879
Device Name
EndoWrist Stapler 45 Instrument and Accessories
Indications for Use (Describe)
The Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads are intended
to be used with the da Vinci Si Surgical System (Model 1S3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Image /page/2/Picture/22 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.
3
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) K170879
Device Name
EndoWrist Stapler 45 Instrument and Accessories
Indications for Use (Describe)
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
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 Sorvices (101) 443-6340 E
Image /page/3/Picture/21 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 "INTUITIVE" is the word "SURGICAL" in a smaller font, with the registered trademark symbol.
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|---|
| Indications for Use | Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K170879 |
|---|---|
| Device Name | IS4000 EndoWrist Stapler 30 Instrument |
| Indications for Use (Describe) | The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The devices can be used with staple line or tissue buttressing material. |
| 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."
5
510(k) Summary (K170879)
This 510(k) applies to da Vinci Si and Xi Stapler 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 Table 1.1 (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/5/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a light gray color, with the registered trademark symbol to the right of the word.
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| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Contact | Kunal Gunjal
Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Fax Number: 408-523-8907
Email: Kunal.Gunjal@intusurg.com | | |
| Date Summary
Prepared | September 21, 2017 | | |
| Trade Name | EndoWrist Stapler
45 Instrument and
Accessories | IS4000 EndoWrist
Stapler 30
Instrument | Endowrist
Stapler Instrument and Accessories |
| Common Name | Endoscope and
accessories | Endoscope and
accessories | Endoscope and accessories |
| Classification | Class II,
21 CFR 876.1500 | Class II,
21 CFR 876.1500 | Class II,
21 CFR 876.1500 |
| Classification
Advisory
Committee: | General and Plastic
Surgery | General and Plastic
Surgery | General and Plastic Surgery |
| Product Codes
for Subject
Devices
(K170879) | NAY, GDW and
GCJ | NAY and GDW | NAY and GDW |
| Product Codes
for Predicate
Devices | NAY, GDW and
GCJ | NAY and GDW | NAY and GDW |
| Predicate Devices | K140553
(Clearance of
Stapler 45
instrument and
reusable
accessories for use
with the IS4000
system)
K143217 (Addition
of the 12mm &
Stapler Bladeless
Obturators for Use
with the IS4000
System) | K152421
(Clearance of
Stapler 30
instrument for use
with the IS4000
system) | K113706 and K171388 (use with
the IS3000 system) |
| Table 1.1: da Vinci Si and Xi Stapler Instruments and Accessories |
|---|
Image /page/6/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the space between the "T" and the "U". Below that, the word "SURGICAL" is in a smaller font, with the registered trademark symbol to the right.
7
Device Description
Table 1.2 lists the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
| Trade Name | Endowrist Stapler Instrument
(used with the IS3000 System) | EndoWrist Stapler 45 Instrument
(used with the IS4000 system) | IS4000 EndoWrist Stapler 30 Instrument (used
with the IS4000 system) | EndoWrist Stapler Accessories (used with
the IS3000 system) | EndoWrist Stapler 45 Accessories (used with
the IS4000 system) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The Endowrist Stapler Instrument, when used with the compatible Stapler 45 Reloads, delivers multiple rows of staples and transects the tissue along the middle of the staple line. The Endowrist Stapler Instrument is a reusable device while the Stapler 45 reloads (available in various sizes) are single-use/disposable devices | The EndoWrist Stapler 45 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). | IS4000 EndoWrist Stapler 30 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip | EndoWrist Stapler Reusable Accessories consist of a Stapler Cable, Stapler Release Kit, Stapler Cannula, Blunt Obturator, Stapler Cannula Reducer, and Stapler Motor Pack (SMP). | EndoWrist Stapler 45 Accessories mainly consist 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 the SRK (Stapler Release Kit). |
Table 1.2: da Vinci Si and Xi Stapler Instruments and Accessories
Image /page/7/Picture/6 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, the word "SURGICAL" is in a smaller font, with the registered trademark symbol next to it.
8
Indications for Use:
Table 1.3 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 | Endowrist
Stapler and its reusable Accessories | EndoWrist Stapler 45
Instrument and Accessories | IS4000 EndoWrist Stapler 30
Instrument |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Intuitive Surgical EndoWrist®
Stapler 45 System and Stapler 45
Reloads are intended
to be used with the da Vinci Si Surgical
System (Model 1S3000) for resection,
transection and/or creation of
anastomoses in General, Gynecologic,
and Urologic surgery. The device can
be used with staple line or tissue
buttressing material (natural or
synthetic). | The Intuitive Surgical EndoWrist
Stapler 45, Stapler 45 Reloads and
other Stapler Accessories (including
the bladeless obturators) are intended
to be used with the da Vinci Surgical
System (Model IS4000) for resection,
transection and/or creation of
anastomoses in General, Thoracic,
Gynecologic, and Urologic surgery.
The device can be used with staple line
or tissue buttressing material (natural
or synthetic). | The Intuitive Surgical EndoWrist® Stapler
30 Instrument and Stapler 30 Reloads are
intended to be used with the da Vinci
Surgical System (Model IS4000) for
resection, transection and/or creation of
anastomoses in General, Thoracic,
Gynecologic, and Urologic surgery. The
device is indicated for adult and pediatric
use. The devices can be used with staple
line or tissue buttressing material. |
| Table 1.3: da Vinci Si and Xi Stapler Instruments and Accessories | |
|---|---|
| ------------------------------------------------------------------- | -- |
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.
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 Table 1.1.