Endo Wrist Stapler 45 and Stapler 45 Reloads: The Intuitive Surgical Endo Wrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System 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).
EndoWrist Stapler 30 and Stapler 30 Reloads: The Intuitive Surgical Endo Wrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and or creation of anastomoses in General. Thoracic. Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
EndoWrist Stapler 45 and Stapler 45 Reloads: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection 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).
EndoWrist Stapler 30 and Stapler 30 Reloads: The Intuitive Surgical EndoWrist Stapler 30 and Stapler 30 Reloads are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use 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).
This document is a 510(k) summary for the Intuitive Surgical EndoWrist Stapler 45 and 30, and their respective reloads. It primarily discusses updates to the Indications for Use statements due to changes in compatible da Vinci Surgical Systems.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table. Instead, it makes a general statement about substantial equivalence.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not explicitly stated | Not explicitly stated |
| Device is found substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "Design verification and design validation testing were not required since design inputs were not changed." This indicates that no new testing (and therefore no new test set or data provenance) was performed to support this 510(k) submission, as the changes were limited to labeling/indications for use and not the fundamental design or performance of the device.
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)
Since no new verification or validation testing was conducted, there are no experts mentioned for establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Since no new verification or validation testing was conducted, there is no adjudication method mentioned.
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
No MRMC comparative effectiveness study was mentioned or performed. This device is a surgical stapler, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical stapler, not an algorithm, so standalone performance in that context is not relevant. The device operates with a human surgeon in the loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As no new performance testing was conducted, no specific ground truth type is mentioned or implied for this submission. The basis of the submission is the substantial equivalence to predicate devices whose performance was previously established.
8. The sample size for the training set
The document does not mention a training set because the submission is about updating indications for use for an existing physical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning algorithm is discussed.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
Intuitive Surgical, Inc. Ms. Cheryl Wu Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K170508
Trade/Device Name: Endowrist Stapler 45 Instrument, Endowrist Stapler 45 Reloads, Endowrist Stapler 30 Instrument, Endowrist Stapler 30 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: February 17, 2017 Received: February 21, 2017
Dear Ms. Wu:
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
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Part 807); labeling (21 CFR Part 801); medical device 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 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.
Sincerely,
Jennifer R. Stevenson -S
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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6.0 INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) к170508
Device Name
EndoWrist Stapler 45 and Stapler 45 Reloads EndoWrist Stapler 30 and Stapler 30 Reloads
Indications for Use (Describe)
Endo Wrist Stapler 45 and Stapler 45 Reloads
The Intuitive Surgical Endo Wrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System 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).
EndoWrist Stapler 30 and Stapler 30 Reloads
The Intuitive Surgical Endo Wrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and or creation of anastomoses in General. Thoracic. Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
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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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Image /page/2/Picture/26 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in all caps, with a small yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in smaller, all-caps letters, with the trademark symbol to the right.
CONFIDENTIAL
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510(k) Summary
| 510(k) Submitter: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact: | Cheryl WuRegulatory Affairs EngineerPhone: 408-523-6401Fax: 408-523-1390Email: cheryl.wu@intusurg.com |
| Date Summary Prepared: | February 17, 2016 |
| Trade Name: | EndoWrist Stapler 45 and Stapler 45 ReloadsEndoWrist Stapler 30 and Stapler 30 Reloads |
| Common Name: | Endoscope and accessories;Surgical stapler and implantable staples |
| Classification: | Class II21 CFR 876.1500, Endoscope and Accessories21 CFR 878.4750, Implantable Staple |
| Product Codes: | NAYGDW |
| Classification AdvisoryCommittee: | General and Plastic Surgery |
| Predicate Device: | K140553 – EndoWrist Stapler 45 and Stapler 45 ReloadsK152421 - Endowrist Stapler 30 Instrument and Stapler 30Reloads |
Intended Use (EndoWrist Stapler 45 and Stapler 45 Reloads):
To resect, transect and/or create anastomoses in surgery.
Indications for Use (EndoWrist Stapler 45 and Stapler 45 Reloads):
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System 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).
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Device Description (EndoWrist Stapler 45 and Stapler 45 Reloads):
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection 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 EndoWrise Stapler 45 with a compatible da Vinci Surgical System.
Intended Use (EndoWrist Stapler 30 and Stapler 30 Reloads):
The EndoWrist Stapler 30 and Stapler 30 Reloads are intended to resect, transect and/or create anastomoses in surgery.
Indications for Use (EndoWrist Stapler 30 and Stapler 30 Reloads):
The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
Device Description (EndoWrist Stapler 30 and Stapler 30 Reloads):
The Intuitive Surgical EndoWrist Stapler 30 and Stapler 30 Reloads are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use 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 offered in two configurations, a straight tip and a curvedtip. The Stapler 30 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The reloads are available in four configurations (Gray, White, Blue and Green) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).
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 smaller font size, also in light gray, with a trademark symbol next to it.
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Indications for Use:
Technological Characteristics:
The EndoWrist Stapler 45 and Stapler 45 Reloads (hereinafter referred to as "Stapler 45 System") and EndoWrist Stapler 30 and Stapler 30 Reloads (hereinafter referred to as "Stapler 30 System") are identical to their predicate devices in terms of design, technology, and performance specifications.
The purpose of this submission is to change the Indications for Use for both the Stapler 45 and Stapler 30 Systems' Indications for Use statements. Specific references to compatible systems (i.e. "Xi", "Model IS4000") have been removed from both the Stapler 30 Systems' Indications for Use statements. The reference to "compatible da Vinci Surgical Systems" in the subject Indications for Use coupled with identification of specific systems in the Compatibility Information section of the User Manual for the subject devices is essentially equivalent to the reference to "Model IS4000" in the predicate Indications for Use statements.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of labeling modifications on the predicate devices. Design verification and design validation testing were not required since design inputs were not changed.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the subject devices EndoWrist Stapler 30 and 45 Systems are substantially equivalent to currently marketed predicate devices.
Image /page/5/Picture/10 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.
§ 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.