(306 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, 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 System 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 45 System is a reusable device and the Stapler 45 Reloads (available in various sizes) are single-use/disposable devices.
The provided document is a 510(k) summary for the Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads, a surgical stapler. It describes the device, its intended use, and states that performance data (bench and animal tests) demonstrate substantial equivalence to a predicate device. However, it does not contain the specific details required to answer the questions about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth methods.
The document states: "Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." This statement indicates that studies were performed, but the specifics of those studies are not included in this summary.
Therefore, I cannot provide the requested information from the given text.
Here's what the document does tell us, and why the other information is missing:
- Acceptance Criteria & Reported Performance: The document only states that "design output meets the design input requirements" and that the device is "substantially equivalent" to the predicate. It does not provide a table of specific acceptance criteria or detailed performance metrics.
- Sample Size (Test Set) & Data Provenance: Not mentioned. The studies are referred to generally as "bench and animal tests."
- Number of Experts & Qualifications: Not applicable for bench/animal tests of a surgical stapler's mechanical performance.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable to a surgical stapler's performance. This type of study is typically for evaluating diagnostic imaging or AI systems where human reader performance is a key metric.
- Standalone Performance: The performance data would inherently be "standalone" for the device itself, but specific metrics are not provided.
- Type of Ground Truth: For a surgical stapler, "ground truth" would likely involve objective measurements of staple formation, tissue integrity, leak pressure, etc., established during bench and animal testing. However, the exact methods are not detailed.
- Sample Size (Training Set): Not applicable for this type of device. "Training set" refers to data used to train AI/machine learning models, which is not relevant here.
- How Ground Truth for Training Set was Established: Not applicable.
{0}------------------------------------------------
510(k) Summary
| 510(k) Summary | OCT 17 2012 | |
|---|---|---|
| 510(k) Owner: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 | |
| Contact: | Crystal OngSr. Regulatory Affairs SpecialistPh: 408-523-8636; Fax: 408-523-1390crystal.ong@intusurg.com | |
| Date Summary Prepared: | August 3, 2012 | |
| Trade Name: | EndoWrist® Stapler 45 System and Stapler 45 Reloads | |
| Common Name: | Endoscope and accessoriesSurgical stapler and implantable staples | |
| Classification: | Endoscope and accessories (21 CFR 876.1500, Product CodeNAY)Surgical Devices, Implantable Staples (21 CFR 878.4750, ProductCode GDW) | |
| Predicate Device: | Ethicon ETS Flex-45 Endoscopic Articulating Linear Cutter(K002398)EndoWrist® Instruments (cleared for use with da Vinci Si SurgicalSystem, K081137) |
Device Description:
The Intuitive Surgical EndoWrist Stapler 45 System 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 45 System is a reusable device and the Stapler 45 Reloads (available in various sizes) are single-use/disposable devices.
Intended 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, 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).
{1}------------------------------------------------
Technological Characteristics:
The Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads are substantially equivalent to the predicate device in terms of technological characteristics and intended use.
Performance Data:
Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements.
Summary:
Based on the Indications for Use, technological characteristics and performance data, the Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads are substantially equivalent to the predicate device.
$\beta_{0}$ 2/2
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intuitive Surgical, Incorporated % Ms. Meghna Sridharan Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
OCT 17 2012
Re: K113706
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 Dated: October 5, 2012 Received: October 9, 2012
Dear Ms. Sridharan:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Ms. Meghna Sridharan
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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.
Mark N. Malkerson
Mark N. Melkersof Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number if known: K113706
Device Name: EndoWrist® Stapler 45 System and Stapler 45 Reloads
INDICATION 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, transection to be about with of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _ (Per 21 CFR 807 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division ¨çn-Off) (Division - Angical, Orthopedic, and Restorative Devices
K1/3/06
510(k) Number
§ 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.