(143 days)
Not Found
Not Found
No
The summary describes a surgical stapler system and its accessories for use with a robotic surgical system. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on mechanical and functional aspects, not algorithmic performance.
Yes
The device is described as a surgical stapler system used for resection, transection, and creation of anastomoses in various surgeries, which are direct medical interventions to treat a condition. While the device does not provide a "therapy" like a drug, it has a therapeutic effect and is considered a therapeutic device.
No
The device is a surgical stapler system used for resection, transection, and creation of anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components including a reusable surgical stapler system, single-use staple cartridges, and accessories like cannulae and obturators. This indicates it is a hardware device with potential software control, not a software-only 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, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "reusable surgical stapler system" that places "implantable staples" and cuts tissue. This is a surgical instrument used during an operation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for physical manipulation of tissue during surgery.
N/A
Intended Use / Indications for Use
Intended Use:
To resect, transect and/or create anastomoses in surgery.
Indications for Use:
The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vincio 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).
Product codes (comma separated list FDA assigned to the subject device)
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 Vincio Surgical System (Model IS4000). It is intended for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic 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 implantable staples, trade name Stapler 45 Reloads, are provided in a separate single use cartridge and are available in the following three configurations to accommodate tissues of various thickness:
- 2.5 mm staple size single use reload (White Reload) .
- . 3.5 mm staple size single use reload (Blue Reload)
- 4.3 mm staple size single use reload (Green Reload)
Accessories, including cannulae, obturators, a cannula seal, and a cannula reducer, are provided to support the interface of the EndoWrist Stapler 45 with the da Vinci Surgical System (Model IS4000).
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
surgeons and operating room staff
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 (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. Bench testing included dimensional measurements, mechanical and functional verification, as well as electrical safety and electromagnetic compatibility assessment per IEC standards. In addition, staple formation, staple line integrity, and transection performance were evaluated in animal cadaver models with various reloads and buttress materials.
| Testing | IS4000 Stapler | IS3000 Stapler |
|---|---|---|
| Animal Survival Studies with side-by-side comparison between subject and predicate devices | ||
| • Small bowel anastomoses (14-day follow-up) | X | X |
| • Gastrectomy (14-day follow up) | X | X |
| • Lung Resection (7-day follow up) | X | X |
| • Pneumonectomy (28-day follow up) | X | * |
| Staple formation and transection testing | X | X |
| Buttress material compatibility testing | X | X |
| Burst pressure testing | X | X |
Human Factors and Usability Testing:
Summative usability validation studies were conducted with users (surgeons and operating room staff) for the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories. These studies were conducted in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation studies and the other elements of the human factors engineering program provide evidence that the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are safe and effective when used by the intended users in the intended use environment.
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.
Intuitive Surgical EndoWrist ® Stapler 45 System and Stapler 45 Reloads (for use with da Vinci ® IS3000 System)
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
510(k) Summary
JUL 2 5 2014
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Chang
Sr. Regulatory Affairs Specialist
Phone Number: 408-523-2347
Fax Number: 408-523-8907
Email: dawn.chang@intusurg.com |
| Date Summary Prepared: | July 24, 2014 |
| Trade Name: | EndoWrist ® Stapler 45 and Stapler 45 Reloads |
| Common Name: | Endoscope and accessories; Surgical Stapler and
implantable staples |
| 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 Device: | Intuitive Surgical EndoWrist ® Stapler 45 System and
Stapler 45 Reloads (for use with da Vinci ® IS3000 System)
and ENDOPATH® ETS Reload (White) |
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 Vincio Surgical System (Model IS4000). It is intended for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic 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).
1
The implantable staples, trade name Stapler 45 Reloads, are provided in a separate single use cartridge and are available in the following three configurations to accommodate tissues of various thickness:
- 2.5 mm staple size single use reload (White Reload) .
- . 3.5 mm staple size single use reload (Blue Reload)
- 4.3 mm staple size single use reload (Green Reload)
Accessories, including cannulae, obturators, a cannula seal, and a cannula reducer, are provided to support the interface of the EndoWrist Stapler 45 with the da Vinci Surgical System (Model IS4000).
Intended Use:
To resect, transect and/or create anastomoses in surgery.
Indications for Use:
The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vincio 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).
Technological Characteristics:
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (subject devices) are equivalent to the predicate device. EndoWrist Stapler 45 System, Stapler 45 Reloads, and Accessories (for use with the da Vinci IS3000 System) in terms of technological characteristics and intended use. Modifications to the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories include: (1) an update of the instrument design for compatibility with the da Vinci Surgical System (Model IS4000), (2) inclusion of a thoracic surgery indication with the addition of the Stapler 45 White Reload, and (3) a set of modified accessories to support use with the da Vinci Surgical System (Model IS4000).
Note that the subject devices, the EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories are not compatible with the da Vinci IS3000 System. Similarly, the predicate devices, EndoWrist Stapler 45 System, Stapler 45 Reloads, and Accessories, are not compatible with the da Vinci IS4000 System.
INTUITIVE
SURGICAL
Page 5-2
2
Performance Data:
Performance test data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. Bench testing included dimensional measurements, mechanical and functional verification, as well as electrical safety and electromagnetic compatibility assessment per IEC standards. In addition, staple formation, staple line integrity, and transection performance were evaluated in animal cadaver models with various reloads and buttress materials. The following table provides a quick summary:
| Testing | IS4000
Stapler | IS3000
Stapler |
|-----------------------------------------------------------------------------------------------|-------------------|-------------------|
| Animal Survival Studies with side-by-side comparison between
subject and predicate devices | | |
| • Small bowel anastomoses (14-day follow-up) | X | X |
| • Gastrectomy (14-day follow up) | X | X |
| • Lung Resection (7-day follow up) | X | X |
| • Pneumonectomy (28-day follow up) | X | * |
| Staple formation and transection testing | X | X |
| Buttress material compatibility testing | X | X |
| Burst pressure testing | X | X |
*IS3000 Stapler does not have thoracic (lung) indications
Human Factors and Usability Testing:
Summative usability validation studies were conducted with users (surgeons and operating room staff) for the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories. These studies were conducted in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation studies and the other elements of the human factors engineering program provide evidence that the EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are safe and effective when used by the intended users in the intended use environment.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are substantially equivalent to the predicate device, the Intuitive Surgical EndoWrist Stapler 45 System, Stapler 45 Reloads, and Accessories.
INTUITIVE SURGICAL"
Page 5-3
3
SERVICES. USA
HEALTH &
OF
HUMAN
DEPARTMENT
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
Intuitive Surgical, Inc. Ms. Dawn Chang Senior Regulatory Specialist 1266 Kifer Rd Sunnyvale, California 94086
K140553 Re: Trade/Device Name: Endowrist stapler 45 and stapler 45 reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories; Surgical Stapler And Implantable Staples Regulatory Class: Class II Product Code: NAY, GDW Dated: June 26, 2014 Received: June 27, 2014
Dear Ms. Chang,
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 devicerelated 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David | David Se -S
for Binita 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
5
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 on last page.
510(k) Number (if known) K140553
Device Name
EndoWrist® Stapler 45, Stapler 45 Reloads, and Accessories
Indications for Use (Describe)
The Intuitive Surgical EndoWrist® Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci System (Model 154000) 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)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
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