(29 days)
No
The document describes a surgical system and imaging system with standard endoscopic and near-infrared fluorescence capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is a surgical system and imaging system that assists in surgical procedures by providing visualization and instrument control, not directly treating a disease or condition.
No
The da Vinci Surgical System is described as a system to assist in the accurate control of surgical instruments for manipulation of tissue during various surgical procedures. The Firefly Imaging System provides real-time endoscopic visible and near-infrared fluorescence imaging to assist surgeons with visual assessment during surgery, but it is not intended for standalone use for diagnosis.
No
The device description explicitly mentions hardware components like the da Vinci Xi 8 mm Endoscope and the da Vinci Surgical System, Model IS4000, and the performance studies include bench testing for mechanical, optical, electrical, and hardware/software compatibility requirements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The da Vinci Surgical System and the Firefly Imaging System are surgical tools used during surgical procedures to assist the surgeon in manipulating tissues, providing visualization (visible light and near-infrared fluorescence), and performing various surgical tasks. They are not used to analyze samples outside the body.
- Intended Use: The intended use clearly describes surgical procedures and visualization during those procedures, not the analysis of biological samples.
Therefore, the device described is a surgical system and imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The da Vinci® Firefly™ Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GCJ
Device Description
The da Vinci Xi 8 mm Endoscope was originally cleared under K131861 on March 28, 2014, for use with the da Vinci® Surgical System, Model IS4000. Additional features and indications were cleared under K141077 on August 12, 2014, to add the da Vinci® Firefly™ Imaging System. The Intuitive Surgical da Vinci® Firefly™ Imaging System uses the endoscope submitted in the original 510(k) K131861 for high definition (HD) visible light imaging and near-infrared fluorescence imaging during minimally invasive surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Real-time endoscopic visible and near-infrared fluorescence imaging
Anatomical Site
vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct)
Indicated Patient Age Range
Adult and pediatric use
Intended User / Care Setting
Trained physicians in an operating room environment
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)
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 the mechanical and labeling requirements for the subject device, including:
- optical;
- illumination;
- mechanical;
- temperature;
- electrical;
- hardware/software compatibility;
- functional;
- reliability/life;
- labeling.
Design Validation:
Validation Testing was performed to confirm that the subject device met the image characteristic requirements, endoscope mechanics requirements, intended use, and user needs of the subject device. Design Validation Testing was performed to confirm that the design modifications to the predicate device do not raise new questions of safety and effectiveness.
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.
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 & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are connected by a flowing line that resembles a ribbon or banner. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2017
Intuitive Surgical, Inc. Ms. Brittany Cunningham Sr. Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, CA 94086
Re: K171426
Trade/Device Name: da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY. GCJ Dated: May 12, 2017 Received: May 15, 2017
Dear Ms. Cunningham:
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,
Jennifer R. Stevenson -S3
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
2
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brittany Cunningham, M.S., R.A.C.
Sr. Regulatory Affairs Engineer
Phone Number: 408-523-0602
Fax Number: 408-523-8907
Email: BrittanyAnn.Cunningham@intusurg.com |
| Date Summary Prepared: | May 12, 2017 |
| Trade Names: | da Vinci Xi 8 mm Endoscope, 0°
da Vinci Xi 8 mm Endoscope, 30° |
| Common Name: | Endoscopic instruments and accessories |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY, GCJ |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Devices: | Main Predicate: K131861 – da Vinci Surgical System,
Model IS4000
Reference Predicate: K141077 – da Vinci Firefly Imaging
System |
Device Description
The da Vinci Xi 8 mm Endoscope was originally cleared under K131861 on March 28, 2014, for use with the da Vinci® Surgical System, Model IS4000. Additional features and indications were cleared under K141077 on August 12, 2014, to add the da Vincio Firefly" Imaging System. The Intuitive Surgical da Vinci® Firefly™ Imaging System uses the endoscope submitted in the original 510(k) K131861 for high definition (HD) visible light imaging and near-infrared fluorescence imaging during minimally invasive surgery.
Image /page/2/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that is the word "SURGICAL" in a smaller font and also in light gray with the registered trademark symbol.
3
Indications for Use:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Intended Use:
da Vincio Xi Surgical System, Model IS4000, EndoWrist® Instruments, and Accessories
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
da Vinci® Firefly™ Imaging System
The da Vinci® Firefly™ Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue
NIUITIVE SURGICAL®
4
perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Technological Characteristics:
In terms of intended use, indications for use, and technological characteristics the da Vinci Xi 8 mm Endoscope is substantially equivalent to the currently marketed da Vinci Xi 8 mm Endoscope, cleared originally under K131861, with additional features and indications cleared under the da Vinci Firefly Imaging System (K141077). The minor updates to the optical assembly and the geometry of the distal tip do not substantively change the function of the subject device relative to the function of the predicate device.
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 the mechanical and labeling requirements for the subject device, including:
- . optical:
- illumination; .
- mechanical;
- temperature; ●
- electrical; ●
- hardware/software compatibility; ●
- functional: ●
- reliability/life; ●
- labeling. .
Design Validation:
Validation Testing was performed to confirm that the subject device met the image characteristic requirements, endoscope mechanics requirements, intended use, and user needs of the subject device. Design Validation Testing was performed to confirm that the design modifications to the predicate device do not raise new questions of safety and effectiveness.
Image /page/4/Picture/21 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font and is in all caps. Below that, the word "SURGICAL" is also in a sans-serif font and is in all caps, with a registered trademark symbol next to it. Above the word "INTUITIVE" is a yellow dot.
5
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the modified device (subject), the da Vinci Xi 8 mm Endoscope is substantially equivalent to the currently marketed device da Vinci Xi 8 mm Endoscope (predicate), cleared under K131861, with additional features and indications cleared under K141077.
6
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) K171426
Device Name
da Vinci Xi 8 mm Endoscope, 0 degree da Vinci Xi 8mm Endoscope, 30 degree
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model 154000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
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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