(23 days)
Not Found
No
The summary describes a mechanical surgical stapler accessory and its intended use with a robotic surgical system. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an obturator, used to facilitate placement of a cannula during surgery, and is not directly used to treat or cure a disease or condition. It is a surgical tool.
No
Explanation: The device is described as a surgical stapler and obturator used for resection and creation of anastomoses, which are surgical procedures, not diagnostic ones. Its purpose is to facilitate physical intervention during surgery.
No
The device description explicitly details physical components made of Radel R-550 and stainless steel, and the performance studies describe bench testing of mechanical properties and animal model testing, indicating 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, Thoracic, Gynecologic, and Urologic surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a surgical instrument (a bladeless obturator used with a cannula and seal) designed to facilitate the placement of other surgical tools. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to perform tests on samples taken from the body to diagnose diseases or conditions.
Therefore, the information provided strongly indicates this is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci 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, GCJ
Device Description
The subject 12 mm & Stapler Bladeless Obturator (Bladeless Obturator) is used with the 12 mm & Stapler Cannula (Cannula) and 12 mm & Stapler Cannula Seal (Cannula Seal) to facilitate placement of the Cannula in the body wall. The Bladeless Obturator consists of three components - a shaft, a handle, and two latches that allow it to latch onto the Cannula Seal. The handle is made of Radel R-550 while the shaft and the two latches are made of stainless steel. The subject device is a reusable device and is offered in two lengths (standard and long) to match the Cannula lengths and meet users' needs.
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
Not Found
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)
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.
Design Verification: The bench testing summarized in this submission verifies dimensional, mechanical and labeling requirements for the subject device. Drop test, axial load bearing capacity of the connection between the Obturator and Cannula Seal, maximum diametrical clearance when the Obturator is used with the Cannula, and maximum length of the Obturator shaft past the distal end of the Cannula were tested along with adequacy of labeling required to communicate compatibility of the subject device.
Design Validation: The testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model were performed to assess the subject device's latching mechanism and verify that the obturator does not catch on tissue. The subject device's compatibility with Cannula Seals were tested to ensure they maintain insufflation when used together.
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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2014
Intuitive Surgical Incorporated Manish Patel Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K143217
Trade/Device Name: 12 mm and Stapler Bladeless Obturators Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: November 7, 2014 Received: November 10, 2014
Dear Patel:
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
1
device-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/Resourcesfor You/Industry/default.htm. 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/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 yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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) K143217
Device Name
12 mm & Stapler Bladeless Obturators
Indications for Use (Describe)
The Intuitive Surgical EndoWrist Stapler 45. Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
Image /page/2/Picture/22 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a small yellow dot above the "U". Below that, in a smaller font, is the word "SURGICAL" with a trademark symbol.
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Contact: | Manish Patel |
| Regulatory Engineer | |
| Phone Number: 408-523-2185 | |
| Fax Number: 408-523-8907 | |
| Email: manish.patel@intusurg.com | |
| Date Summary Prepared: | November 07, 2014 |
| Trade Name: | 12 mm & Stapler Bladeless Obturators |
| Common Name: | Endoscope and accessories |
| Classification: | Class II |
| 21 CFR 876.1500, Endoscope and Accessories | |
| Product Codes: | NAY, GCJ |
| Classification Advisory | |
| Committee: | General and Plastic Surgery |
| Predicate Device: | K140553 - EndoWrist® Stapler 45, Stapler 45 Reloads and |
| Accessories |
Device Description
The subject 12 mm & Stapler Bladeless Obturator (Bladeless Obturator) is used with the 12 mm & Stapler Cannula (Cannula) and 12 mm & Stapler Cannula Seal (Cannula Seal) to facilitate placement of the Cannula in the body wall. The Bladeless Obturator consists of three components - a shaft, a handle, and two latches that allow it to latch onto the Cannula Seal. The handle is made of Radel R-550 while the shaft and the two latches are made of stainless steel. The subject device is a reusable device and is offered in two lengths (standard and long) to match the Cannula lengths and meet users' needs.
Intended Use/Indications for Use:
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci 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).
Image /page/3/Picture/8 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a small yellow dot above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller, lighter sans-serif font, followed by the registered trademark symbol.
4
Technological Characteristics:
The subject 12 mm & Stapler Bladeless Obturator is very similar to its predicate device (12 mm & Stapler Blunt Obturators cleared in K140553). It has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device. Modifications consist of a change in tip design from blunt to bladeless and change in material of the shaft from Radel to 17-4 stainless steel.
Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate impact of 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.
Design Verification:
The bench testing summarized in this submission verifies dimensional, mechanical and labeling requirements for the subject device. Drop test, axial load bearing capacity of the connection between the Obturator and Cannula Seal, maximum diametrical clearance when the Obturator is used with the Cannula, and maximum length of the Obturator shaft past the distal end of the Cannula were tested along with adequacy of labeling required to communicate compatibility of the subject device.
Design Validation:
The testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model were performed to assess the subject device's latching mechanism and verify that the obturator does not catch on tissue. The subject device's compatibility with Cannula Seals were tested to ensure they maintain insufflation when used together.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the subject 12 mm & Stapler Bladeless Obturator is substantially equivalent to the predicate 12 mm & Stapler Blunt Obturators cleared in K140553.
Image /page/4/Picture/12 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 a light gray color, with the registered trademark symbol to the right.