(20 days)
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).
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 provided document is a 510(k) summary for the Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads (K171388). This document describes the device's substantial equivalence to a predicate device and includes information on verification and validation testing, but it does not contain the level of detail typically found in a study report for an AI/ML device. Therefore, I cannot fully answer all aspects of your request as it pertains to AI/ML device study criteria.
However, I can extract information related to acceptance criteria, testing performed, and ground truth as described in the summary for this medical device.
Manufacturer: Intuitive Surgical, Inc.
Device Name: EndoWrist Stapler 45 System and Stapler 45 Reloads
Predicate Device: EndoWrist Stapler 45 System and Stapler 45 Reloads (K113706)
Here's the breakdown of available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, which are common for AI/ML devices. Instead, it describes general acceptance based on meeting design verification and validation specifications, and achieving substantial equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification (Physical, Mechanical, etc.) | - Distal subject device subassemblies built with the new cam material were subjected to 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.- Reported Performance: "Subject device and subject device sub-assemblies met design verification specifications." |
| Design Verification (Sub-Assembly Specific) | - Evaluated "environmental assisted cracking susceptibility and requirements that have been affected by the design change."- Reported Performance: "Subject device sub-assemblies met design verification specifications." |
| Reliability/Life Testing | - Subject devices were fired, clamped, and reprocessed for the estimated life of the product.- Reported Performance: "Subject device met reliability/life specifications." |
| Design Validation (Clinical Setting / User Needs) | - Evaluated "general, functional, and interaction (compatibility) requirements for the subject device."- Animal model testing evaluated "performance based on comparative tissue approximation, hemostasis, and staple formation in accordance with its intended use."- Reported Performance: "Design Validation results confirm the design modifications to the Stapler 45 Instrument do not raise any new questions of safety and effectiveness." |
| Overall Substantial Equivalence Determination (FDA's) | - Reported Performance: Declared substantially equivalent to the predicate device (K113706), meaning it has the "same intended use, indications for use, technological characteristics, performance data, and utilize the same disposable accessories and instrument accessories," and the "results of the design verification and validation tests do not raise new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the numerical sample sizes for any of the tests (e.g., number of devices, number of sub-assemblies, number of animal models). It uses general terms like "Subject device sub-assemblies," "Subject devices," and "Tests with an animal model."
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of device testing, it would generally be prospective testing conducted in a laboratory or controlled setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The testing described (mechanical, functional, animal model) does not rely on expert interpretation of data in the way an AI/ML diagnostic device might.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for expert agreement in ground truth establishment for AI/ML models, which is not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied. This type of study is specific to AI/ML devices where human readers (e.g., radiologists) use the AI for assistance. The EndoWrist Stapler 45 System is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the device described. The EndoWrist Stapler 45 System is a surgical instrument used by a human surgeon with the da Vinci Si Surgical System. It is not an algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document describes several forms of "ground truth" or reference points for testing the device:
- Design Specifications: For verification testing, the ground truth is the predefined design specifications (e.g., maximum calculated load, expected clamp/fire/electrical connectivity).
- Predicate Device Performance: For validation, the critical "ground truth" is the performance of the legally marketed predicate device (K113706), against which the subject device is compared to demonstrate substantial equivalence.
- Physiological/Biological Response: In the animal model, the ground truth relates to expected outcomes like "comparative tissue approximation, hemostasis, and staple formation." This implicitly relies on established surgical and physiological standards for successful stapling.
- Absence of New Safety/Effectiveness Concerns: The ultimate "ground truth" for FDA clearance in this context is the determination that the device is as safe and effective as the predicate and raises no new concerns.
8. The sample size for the training set
This information is not applicable/not provided. The EndoWrist Stapler 45 System is a mechanical surgical instrument, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, there is no "training set" for this type of device.
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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
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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.
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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
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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) |
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K171388
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact: | Doreen Nakamura, R.A.C.Sr. Regulatory Affairs SpecialistPhone Number: 408-523-0595Fax Number: 408-523-8907Email: 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 II21 CFR 876.1500, Endoscope and Accessories21 CRF 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)GDW (Implantable Staple) |
| Classification AdvisoryCommittee: | General and Plastic Surgery |
| Predicate Devices: | K113706– EndoWrist Stapler 45 System and Stapler 45Reloads |
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).
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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".
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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 DeviceEndoWrist Stapler 45 System andStapler 45 Reloads | Predicate DeviceEndoWrist Stapler45 System andStapler 45Reloads(K113706) |
|---|---|---|
| Devices, Trade Name | EndoWrist® Stapler 45 System andStapler 45 Reloads | IDENTICAL |
| Product Code | NAY | IDENTICAL |
| Regulation Numberand Name | 21 CFR 876.1500, Endoscope andAccessories | IDENTICAL |
| Classification AdvisoryCommittee | General and Plastic Surgery | IDENTICAL |
| Classification | II | IDENTICAL |
| Intended Use | To resect, transect and/or createanastomoses in surgery. | IDENTICAL |
| Indications for Use | The EndoWrist Stapler 45 System andEndoWrist Stapler 45 Reloads areintended to be used with the da Vinci SiSurgical System (Model IS3000) forresection, transection and/or creation ofanastomoses in General, Gynecologicand Urologic surgery. The device canbe used with staple line or tissuebuttressing material (natural orsynthetic). | IDENTICAL |
| Prescription Use | Physician use only | IDENTICAL |
| Where used (hospital,home ambulance, etc.) | Hospital | IDENTICAL |
| Mechanism of action | The stapler instrument achieves itsintended function by placing multiplestaggered rows of implantable staplesin the target tissue followed by cuttingof the target tissue along the middle ofthe staple line. | IDENTICAL |
| Table 1: Device Comparison | ||
|---|---|---|
| Item | Subject DeviceEndoWrist Stapler 45 System andStapler 45 Reloads | Predicate DeviceEndoWrist Stapler45 System andStapler 45Reloads |
| Stapler Motor Pack andcable | Stapler Motor Pack 372300Cable 372032 | (K113706)IDENTICAL |
| Stapler ReloadsSterilization Method | Blue 41645BGreen 41445GEO | IDENTICALIDENTICAL |
| Manual Unclamp Tool(EndoWrist StaplerRelease Kit) | EndoWrist Stapler Release Kit 381181 | IDENTICAL |
| Stapler Cannula Kit | EndoWrist Stapler Cannula Kit 420378 | IDENTICAL |
| Stapler Sheath | Stapler Sheath 410370 | IDENTICAL |
| Stapler 45 InstrumentType of UseSterilization Method | Stapler 45 Instrument 410298Reusable●Steam● | IDENTICAL |
| Stapler 45 InstrumentLabeling Change | Labeling divided into two documentsand added Wall ChartStapler Instrument and●Accessories ManualReprocessing Instructions●Wall Chart (derivative of●Reprocessing Instructions) | StaplerInstrument andAccessoriesManualcontainingReprocessingInstructions.Section 4 |
| Stapler 45 InstrumentCam Change | Stainless steel with better corrosionresistant properties and carbon coatingon all surfaces | Stainless steel, nocoating |
| Stapler 45 InstrumentAnvil Change | Carbon coating removed from anvilsurfaces interfacing with cam | Carbon coatingpresent on allsurfaces, exceptfor cosmetic topsurface |
| Stapler 45 InstrumentMarking Change | "Autoclave" added to instrumenthousing | Not present |
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EndoWrist Stapler 45 System and Stapler 45 Reloads
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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 |
|---|---|
| DesignVerification | Appropriate verification testing was performed on the subjectdevice to evaluate design specifications such as physical,mechanical, and any requirements that may be affected by thedesign change.Distal subject device subassemblies built with the new cam materialwere subjected to a 3X the maximum calculated load.Subject devices were cleaned and sterilized and then tested forclamp, fire, electrical connectivity of reload and Stapler MotorPack.Subject device and subject device sub-assemblies met designverification specifications. |
| DesignVerificationSub-Assembly | Appropriate verification testing was performed on the subjectdevice sub-assembly to evaluate design specifications such asenvironmental assisted cracking susceptibility and requirementsthat have been affected by the design change.Subject device sub-assemblies met design verificationspecifications. |
| Reliability/LifeTesting | Verification testing was performed to evaluate requirements thatmay 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.
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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".
§ 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.