(20 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on mechanical stapling functionality.
Yes.
The device description states it is intended for "resection and/or creation of anastomoses," which are therapeutic surgical procedures.
No.
The document explicitly states the device's intended use is for "resection and/or creation of anastomoses," and places "multiple rows of implantable staples" followed by "cutting of the target tissue." These are surgical, therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description clearly states it is a "reusable surgical stapler system" and mentions physical components like "staples," "stapler motor pack," and "subassemblies," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery." This describes a surgical procedure performed on a patient's body, not a test performed on a sample taken from a patient's body.
- Device Description: The description details a "reusable surgical stapler system" used for "placing multiple rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection)." This is a description of a surgical instrument used for physical manipulation of tissue within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
In summary, the device is a surgical instrument used for performing procedures directly on a patient, which falls outside the definition of an In Vitro Diagnostic device.
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 IS3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line and tissue buttressing material (natural or synthetic).
Product codes
NAY, GDW
Device Description
The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and Accessories is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical System (Model IS3000). It is intended for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery by placing multiple 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 implantable staples, trade name Stapler 45 Reloads, are provided in a separate single use cartridge and are available in the following two configurations to accommodate tissues of various thickness:
- . 3.5 mm staple size single use reload (Blue Reload)
- . 4.3 mm staple size single use reload (Green Reload)
Accessories, including cannula, obturator, cannula reducer, and a cannula seal, are provided to support the interface of the EndoWrist® Stapler 45 with the da Vinci Surgical System (Model IS3000).
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
Physician use only / Hospital
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
Design Verification: Appropriate verification testing was performed on the subject device to evaluate design specifications such as physical, mechanical, and any requirements that may be affected by the design change. Distal subject device subassemblies built with the new cam material were subjected to a 3X the maximum calculated load. Subject devices were cleaned and sterilized and then tested for clamp, fire, electrical connectivity of reload and Stapler Motor Pack. Subject device and subject device sub-assemblies met design verification specifications.
Design Verification Sub-Assembly: Appropriate verification testing was performed on the subject device sub-assembly to evaluate design specifications such as environmental assisted cracking susceptibility and requirements that have been affected by the design change. Subject device sub-assemblies met design verification specifications.
Reliability/Life Testing: Verification testing was performed to evaluate requirements that may be affected by the design change. Subject devices were fired, clamped and reprocessed for the estimated life of the product. Subject device met reliability/life specifications.
Design Validation: Design Validation testing was performed on subject and predicate devices to confirm the subject device meets the user needs and intended use in a clinical setting. The testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model evaluated performance based on comparative tissue approximation, hemostasis, and staple formation in accordance with its intended use. Design Validation results confirm the design modifications to the Stapler 45 Instrument do not raise any new questions of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
K113706 – EndoWrist Stapler 45 System and Stapler 45 Reloads
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 a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH & HUMAN" is visible along the left side of the image, curving along the edge of the logo. To the right of the text is a symbol consisting of three stylized human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
May 31, 2017
Intuitive Surgical, Inc. Ms. Doreen Nakamura Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K171388
Trade/Device Name: EndoWrist Stapler 45 System and Stapler 45 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY. GDW Dated: May 10, 2017 Received: May 11, 2017
Dear Ms. Nakamura:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
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 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 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.
Image /page/1/Picture/8 description: The image shows the signature of Jennifer R. Stevenson. The signature is written in a clear, legible font. The word "Sincerely" is written above the signature. The signature appears to be from a formal document.
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
Indications for Use
510(k) Number (if known) K171388
Device Name
EndoWrist Stapler 45 System and Stapler 45 Reloads
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 IS3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line and 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."
3
K171388
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Doreen Nakamura, R.A.C.
Sr. Regulatory Affairs Specialist
Phone Number: 408-523-0595
Fax Number: 408-523-8907
Email: Doreen.Nakamura@intusurg.com |
| Date Summary Prepared: | May 16, 2017 |
| Trade Names: | EndoWrist® Stapler 45 System and Stapler 45 Reloads |
| Common Name: | Endoscopic instruments and accessories |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories
21 CRF 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)
GDW (Implantable Staple) |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Devices: | K113706– EndoWrist Stapler 45 System and Stapler 45
Reloads |
Device Description
The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and Accessories is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical System (Model IS3000). It is intended for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery by placing multiple rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
4
The implantable staples, trade name Stapler 45 Reloads, are provided in a separate single use cartridge and are available in the following two configurations to accommodate tissues of various thickness:
- . 3.5 mm staple size single use reload (Blue Reload)
- . 4.3 mm staple size single use reload (Green Reload)
Accessories, including cannula, obturator, cannula reducer, and a cannula seal, are provided to support the interface of the EndoWrist® Stapler 45 with the da Vinci Surgical System (Model IS3000).
Intended Use:
To resect, transect and/or create anastomoses in surgery.
Indications for Use:
The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) 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).
Technological Characteristics:
The modification to the design of the predicate Stapler 45 Instrument is a change in materials to the distal end of the device. This change does not impact the intended use and the fundamental scientific technology of the device. The modified device (subject) and the current device (predicate) share similar technological characteristics.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of design modifications on the predicate device. Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its intended use.
Image /page/4/Picture/15 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 lighter gray color with a registered trademark symbol to the right of it. There is a small yellow dot above the "I" in "INTUITIVE".
5
Comparison:
The predicate device used for the determination of substantial equivalence is the previously cleared EndoWrist Stapler 45 System and Stapler 45 Reloads (K113706). See comparison in Table 1.
| Item | Subject Device
EndoWrist Stapler 45 System and
Stapler 45 Reloads | Predicate Device
EndoWrist Stapler
45 System and
Stapler 45
Reloads
(K113706) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Devices, Trade Name | EndoWrist® Stapler 45 System and
Stapler 45 Reloads | IDENTICAL |
| Product Code | NAY | IDENTICAL |
| Regulation Number
and Name | 21 CFR 876.1500, Endoscope and
Accessories | IDENTICAL |
| Classification Advisory
Committee | General and Plastic Surgery | IDENTICAL |
| Classification | II | IDENTICAL |
| Intended Use | To resect, transect and/or create
anastomoses in surgery. | IDENTICAL |
| Indications for Use | The EndoWrist Stapler 45 System and
EndoWrist Stapler 45 Reloads are
intended to be used with the da Vinci Si
Surgical System (Model IS3000) 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). | IDENTICAL |
| Prescription Use | Physician use only | IDENTICAL |
| Where used (hospital,
home ambulance, etc.) | Hospital | IDENTICAL |
| Mechanism of action | The stapler instrument achieves its
intended function by placing multiple
staggered rows of implantable staples
in the target tissue followed by cutting
of the target tissue along the middle of
the staple line. | IDENTICAL |
| Table 1: Device Comparison | ||
|---|---|---|
| Item | Subject Device | |
| EndoWrist Stapler 45 System and | ||
| Stapler 45 Reloads | Predicate Device | |
| EndoWrist Stapler | ||
| 45 System and | ||
| Stapler 45 | ||
| Reloads | ||
| Stapler Motor Pack and | ||
| cable | Stapler Motor Pack 372300 | |
| Cable 372032 | (K113706) | |
| IDENTICAL | ||
| Stapler Reloads | ||
| Sterilization Method | Blue 41645B | |
| Green 41445G | ||
| EO | IDENTICAL | |
| IDENTICAL | ||
| Manual Unclamp Tool | ||
| (EndoWrist Stapler | ||
| Release Kit) | EndoWrist Stapler Release Kit 381181 | IDENTICAL |
| Stapler Cannula Kit | EndoWrist Stapler Cannula Kit 420378 | IDENTICAL |
| Stapler Sheath | Stapler Sheath 410370 | IDENTICAL |
| Stapler 45 Instrument | ||
| Type of Use | ||
| Sterilization Method | Stapler 45 Instrument 410298 | |
| Reusable | ||
| ● | ||
| Steam | ||
| ● | IDENTICAL | |
| Stapler 45 Instrument | ||
| Labeling Change | Labeling divided into two documents | |
| and added Wall Chart | ||
| Stapler Instrument and | ||
| ● | ||
| Accessories Manual | ||
| Reprocessing Instructions | ||
| ● | ||
| Wall Chart (derivative of | ||
| ● | ||
| Reprocessing Instructions) | Stapler | |
| Instrument and | ||
| Accessories | ||
| Manual | ||
| containing | ||
| Reprocessing | ||
| Instructions. | ||
| Section 4 | ||
| Stapler 45 Instrument | ||
| Cam Change | Stainless steel with better corrosion | |
| resistant properties and carbon coating | ||
| on all surfaces | Stainless steel, no | |
| coating | ||
| Stapler 45 Instrument | ||
| Anvil Change | Carbon coating removed from anvil | |
| surfaces interfacing with cam | Carbon coating | |
| present on all | ||
| surfaces, except | ||
| for cosmetic top | ||
| surface | ||
| Stapler 45 Instrument | ||
| Marking Change | "Autoclave" added to instrument | |
| housing | Not present |
6
EndoWrist Stapler 45 System and Stapler 45 Reloads
7
EndoWrist Stapler 45 System and Stapler 45 Reloads
Design Verification
Table 2 lists design verification testing performed on both subject and predicate devices and sub- assemblies.
| Testing | Summary |
|---|---|
| Design | |
| Verification | Appropriate verification testing was performed on the subject |
| device to evaluate design specifications such as physical, | |
| mechanical, and any requirements that may be affected by the | |
| design change. |
Distal subject device subassemblies built with the new cam material
were subjected to a 3X the maximum calculated load.
Subject devices were cleaned and sterilized and then tested for
clamp, fire, electrical connectivity of reload and Stapler Motor
Pack.
Subject device and subject device sub-assemblies met design
verification specifications. |
| Design
Verification
Sub-Assembly | Appropriate verification testing was performed on the subject
device sub-assembly to evaluate design specifications such as
environmental assisted cracking susceptibility and requirements
that have been affected by the design change.
Subject device sub-assemblies met design verification
specifications. |
| Reliability/Life
Testing | Verification testing was performed to evaluate requirements that
may be affected by the design change. Subject devices were fired,
clamped and reprocessed for the estimated life of the product.
Subject device met reliability/life specifications. |
| Table 2: Design Verification Performed | |||
|---|---|---|---|
| -- | -- | ---------------------------------------- | -- |
Design Validation:
Design Validation testing was performed on subject and predicate devices to confirm the subject device meets the user needs and intended use in a clinical setting. The testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model evaluated performance based on comparative tissue approximation, hemostasis, and staple formation in accordance with its intended use. Design Validation results confirm the design modifications to the Stapler 45 Instrument do not raise any new questions of safety and effectiveness.
8
Summary:
The subject EndoWrist Stapler 45 System and Stapler 45 Reloads and the predicate EndoWrist Stapler 45 System and Stapler 45 Reloads (K113706) have the same intended use, indications for use, technological characteristics, performance data, and utilize the same disposable accessories and instrument accessories. The results of the design verification and validation tests do not raise new issues of safety and effectiveness.
In conclusion, the EndoWrist Stapler 45 System and Stapler 45 Reloads described in this submission is substantially equivalent to the predicate device.
Image /page/8/Picture/5 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 in a smaller font and also in light gray, with the registered trademark symbol next to it. There is a yellow dot above the "I" in "INTUITIVE".