(23 days)
Not Found
No
The summary describes a mechanical reducer for surgical instruments and does not mention any AI/ML components or functionalities.
No
The device, a reducer, is designed to support the use of surgical instruments and maintain pneumoperitoneum during da Vinci Xi procedures, but it does not directly treat a disease or condition itself.
No
The device description indicates it is a sterile, single-use hollow cylinder which is used to support da Vinci Xi 8mm instruments and endoscopes by ensuring they can be used with a 12mm & Stapler Cannula while maintaining pneumoperitoneum during surgical procedures. It is an accessory for surgical intervention, not for diagnosing.
No
The device description clearly outlines physical components (tube, handle, integrated seal) and mentions design verification and validation testing related to mechanical properties and physical interactions, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical stapling device used for resection, transection, and creation of anastomoses within the body during surgical procedures. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device description details a surgical instrument and an accessory (reducer) used in conjunction with a surgical system. It does not describe a device used to examine specimens from the human body for diagnostic purposes.
- No Mention of Diagnostic Testing: There is no mention of analyzing samples (blood, tissue, urine, etc.) or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories 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).
Product codes
NAY
Device Description
The da Vinci Xi 12 - 8 mm Reducer is a sterile, single use hollow cylinder with an integrated seal that is inserted into the da Vinci Xi 12 mm & Stapler Cannula/Cannula Seal assembly to support the use of da Vinci Xi 8 mm instruments and endoscopes.
The Reducer consists of three components - a tube, handle, and an integrated seal to allow a da Vinci Xi 8 mm instrument or endoscope to be used with a 12 mm & Stapler Cannula while maintaining pneumoperitoneum. The latch on the Reducer snaps onto the da Vinci Xi Stapler Cannula Seal by a molded-in latch flexure on the device.
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
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 of the subject device. Insertion force, retraction force, insertion friction, latch disengagement force, insertion axis range of motion, and internal seal leak rate were some of the requirements that were tested in addition to 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 confirm that the subject device functions in accordance with its intended use. The subject devices' compatibility with the cannulas, cannula seals, and sizecompatible endoscopes and instruments was tested to ensure they maintain insufflation when used together.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The profiles are rendered in black and have a flowing, almost wave-like quality. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Intuitive Surgical, Inc. Mr. Vishal Kanani Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K162411
Trade/Device Name: Da Vinci Xi 12-8 mm Reducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: August 26, 2016 Received: August 29, 2016
Dear Mr. Kanani:
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 Part 803); good manufacturing practice requirements as set forth
1
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 Parts 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.
Christopher J. Ronk -S
Fox 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
2
INDICATIONS FOR USE STATEMENT 6.0
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) K162411
Device Name da Vinci Xi 12 - 8 mm Reducer
Indications for Use (Describe)
The Intuitive Surgical Endo Wrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories 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)
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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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Image /page/2/Picture/21 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 the word "INTUITIVE" is the word "SURGICAL" in smaller, all-caps letters. The logo is simple and modern, and the use of the color yellow adds a touch of brightness.
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Contact: | Vishal Kanani |
| Sr. Regulatory Affairs Specialist | |
| Phone Number: 408-523-2035 | |
| Fax Number: 408-523-8907 | |
| Email: vishal.kanani@intusurg.com) | |
| Date Summary Prepared: | August 26, 2016 |
| Trade Name: | da Vinci Xi 12 – 8 mm Reducer |
| Common Name: | Endoscope and accessories |
| Classification: | Class II |
| 21 CFR 876.1500, Endoscope and Accessories | |
| Product Codes: | NAY |
| Classification Advisory | |
| Committee: | General and Plastic Surgery |
| Predicate Device: | K140553 – EndoWrist® Stapler 45 and Stapler 45 Reloads |
Device Description
The da Vinci Xi 12 - 8 mm Reducer is a sterile, single use hollow cylinder with an integrated seal that is inserted into the da Vinci Xi 12 mm & Stapler Cannula/Cannula Seal assembly to support the use of da Vinci Xi 8 mm instruments and endoscopes.
The Reducer consists of three components - a tube, handle, and an integrated seal to allow a da Vinci Xi 8 mm instrument or endoscope to be used with a 12 mm & Stapler Cannula while maintaining pneumoperitoneum. The latch on the Reducer snaps onto the da Vinci Xi Stapler Cannula Seal by a molded-in latch flexure on the device.
Intended Use/Indications for Use:
The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci® Surgical System (Model 1S4000) 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/9 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 to the right.
4
Technological Characteristics:
The modification to the design of the current 12 - 8 mm Reducer is the addition of a 303 Stainless Steel ring at 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.
Design Verification:
The bench testing summarized in this submission verifies dimensional, mechanical, and labeling requirements of the subject device. Insertion force, retraction force, insertion friction, latch disengagement force, insertion axis range of motion, and internal seal leak rate were some of the requirements that were tested in addition to 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 confirm that the subject device functions in accordance with its intended use. The subject devices' compatibility with the cannulas, cannula seals, and sizecompatible endoscopes and instruments was tested to ensure they maintain insufflation when used together.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the modified device (subject), 12 - 8 mm Reducer is substantially equivalent to the current device in the market (predicate).
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 also in a light gray color, with the registered trademark symbol to the right of the word.