(109 days)
Not Found
No
The summary describes a fluorescence imaging system that uses existing hardware and a fluorescence imaging kit. There is no mention of AI, ML, or advanced image processing beyond standard endoscopic imaging. The performance studies focus on hardware functionality and usability, not algorithmic performance.
No.
The device is described as an "Imaging System" that provides real-time endoscopic visible and near-infrared fluorescence imaging for visual assessment. Its purpose is for visualization and assessment, not for direct treatment or therapy.
Yes
The device provides "real-time endoscopic visible and near-infrared fluorescence imaging" and enables "visual assessment of vessels, blood flow and related tissue perfusion" and "fluorescence imaging of biliary ducts." All of these are diagnostic functions.
No
The device description explicitly states that the system utilizes existing hardware components of the da Vinci Xi Surgical System, including endoscopes and an endoscope controller, and also requires a Fluorescence Imaging Kit. This indicates it is a system with both hardware and software components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The da Vinci Firefly Imaging System is an imaging system used during surgery to visualize anatomical structures (vessels, bile ducts) in real-time using visible and near-infrared light. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly describes real-time endoscopic imaging during surgery for visual assessment of vessels, blood flow, tissue perfusion, and bile ducts. This is an in vivo (within the living body) application, not in vitro (in glass/outside the body).
- Components: While it uses an imaging agent (ICG), this agent is administered to the patient and then visualized within the patient's body, not used to test a sample outside the body.
Therefore, the da Vinci Firefly Imaging System is a surgical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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, IZI
Device Description
The Intuitive Surgical da Vinci® Firefly™ Imaging System uses the existing endoscopic imaging system as submitted in K131861 (cleared March 28, 2014) for high definition (HD) visible light and near-infrared fluorescence imaging during minimally invasive surgery. The da Vincie Firefly™ Imaging System utilizes the following existing components of the da Vinci Xi Surgical System:
- 8 mm 0° and 30° endoscopes (PNs 470026 and 470027) .
- Endoscope Controller (PN 372601) .
For near-infrared fluorescence imaging, the Fluorescence Imaging Kit is also required. The kits will be provided to the end user in an identical manner to the current supply and distribution chain for the predicate device. The kit is unchanged from K101077 (February 4, 2011)/K124031 (September 13, 2013).
- Fluorescence Imaging Kit (PN 950156) [Includes IndoCyanine Green (ICG) fluorescence . imaging agent, aqueous solvent, and syringe trays]
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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
Not Found
Intended User / Care Setting
surgeons, minimally invasive surgery
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)
Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements for fluorescence imaging. The testing conducted consisted of bench and animal testing, and a human factors assessment.
Bench Testing:
Study Type: Design Verification
Sample Size: up to 5 units
Key Results: All final tests PASSED. Verified that the endoscopes met the dimensional, mechanical, functional, and electrical requirements and specifications. Tests performed: Optical, Illumination, Mechanical, Environmental, Labeling.
Animal Testing:
Study Type: Design Validation
Sample Size: One canine and one porcine
Key Results: All final tests PASSED. Confirmed that the da Vinci Firefly Imaging System meets the user needs and intended use as documented in the Product Requirements document.
Study Type: Device Comparison
Sample Size: Two porcines
Key Results: All final tests PASSED. Side-by-side comparison of fluorescence image quality between the da Vinci Firefly Imaging System and the predicate device (IS3000 Firefly mode).
Study Type: Surgeon Evaluation
Sample Size: Not explicitly stated, but involved four independent, external surgeons utilizing canines or porcines across four labs.
Key Results: All final tests PASSED. Confirmed that the da Vinci Firefly Imaging System has clinically acceptable performance and allows for safe and effective surgical use.
Human Factors and Usability Testing:
Study Type: Summative usability validation study
Sample Size: 16 teams of users (surgeons and operating room staff)
Key Results: Results of the validation studies and the other elements of the human factors engineering program provided evidence that the da Vinci® Firefly™ Imaging System is safe and effective when used by the intended users in the intended use environment.
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 shows the 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 depicts a stylized caduceus, with a double helix intertwined with a staff, representing health and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2014
Intuitive Surgical Incorporated Ms. Melissa S. Gonzalez Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K141077
Trade/Device Name: daVinci Firefly Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ, IZI Dated: July 15, 2014 Received: July 16, 2014
Dear Ms. Gonzalez:
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
1
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) K141077
Device Name
da Vinci Firefly Imaging System
Indications for Use (Describe)
The da Vincil Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeous to perform minimally invasive suggedy 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 duct. common bile duct or common hepatic duct), wing near infrared imaging.
Fluorescence imaging of billiary ducts with the da Vinci Firefly Imaging System is intended of care white light and when indicated intraoperady. The device is not intended for standalone use for bliany duct visualization
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Melissa S. Gonzalez
Regulatory Affairs
Phone Number: 408-523-8684
Fax Number: 408-523-8907
Email: melissa.gonzalez@intusurg.com |
| Date Summary Prepared: | April 24, 2014 |
| Trade Name: | da Vinci® Firefly™ Imaging System |
| Common Name: | Endoscopic instrument control system,
endoscopic instruments and accessories |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | da Vinci® Xi Surgical System device, K131861
da Vinci® Fluorescence Imaging Vision System, K101077
da Vinci® Fluorescence Imaging Vision System, K124031 |
Device Description
The Intuitive Surgical da Vinci® Firefly™ Imaging System uses the existing endoscopic imaging system as submitted in K131861 (cleared March 28, 2014) for high definition (HD) visible light and near-infrared fluorescence imaging during minimally invasive surgery. The da Vincie Firefly™ Imaging System utilizes the following existing components of the da Vinci Xi Surgical System:
- 8 mm 0° and 30° endoscopes (PNs 470026 and 470027) .
- Endoscope Controller (PN 372601) .
4
For near-infrared fluorescence imaging, the Fluorescence Imaging Kit is also required. The kits will be provided to the end user in an identical manner to the current supply and distribution chain for the predicate device. The kit is unchanged from K101077 (February 4, 2011)/K124031 (September 13, 2013).
- Fluorescence Imaging Kit (PN 950156) [Includes IndoCyanine Green (ICG) fluorescence . imaging agent, aqueous solvent, and syringe trays]
Intended Use/Indications 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.
Technological Characteristics:
In terms of intended use, indications for use, and technological characteristics, the da Vinci. Firefly™ Imaging System is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861, and the da Vinci Fluorescence Imaging Vision System (K101077) with modified indications cleared under K124031. There is one minor change to the internal glue used within the endoscope (non-patient-contacting) which does not substantively change the function of the subject device to the function of the predicate device.
Performance Data:
Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements for fluorescence imaging. The testing conducted consisted of bench and animal testing, and a human factors assessment.
5
Bench Testing
The testing provided in this submission consisted of dimensional measurements, mechanical, and functional verification.
| Test | Summary |
|---|---|
| Design Verification – All final tests PASSED | The purpose of this test was to verify that the endoscopes met the dimensional, mechanical, functional, and electrical requirements and specifications. Test methods were based on pre-defined test procedures, and objective pass/fail criteria were defined in the protocol and used. Sample sizes up to 5 units were used. The following design verification tests were performed: - Optical - Illumination - Mechanical - Environmental - Labeling |
Animal Testing
The testing provided in this submission was performed using simulated clinical models (animal) to evaluate the performance of the da Vinci Firefly Imaging System (endoscopes and endoscope controller). This included design validation to confirm the device meets the user needs and intended use, comparison testing against the predicate device (IS3000 Firefly), and surgeon evaluations.
| Test | Summary |
|---|---|
| Design Validation – All final tests PASSED | The purpose of this testing was to confirm that the da Vinci Firefly Imaging System meets the user needs and intended use as documented in the Product Requirements document. Testing was completed across two labs conducted with one canine and one porcine. A variety of surgical tasks were completed to evaluate the Firefly mode performance characteristics. Test methods were based on pre-defined test procedures and objective pass/fail criteria were defined in the protocol and used. |
| Device Comparison – All final tests PASSED | This testing compared the basic clinical function of the da Vinci Firefly Imaging System with respect to the predicate device (IS3000 Firefly mode). The study was a side- |
6
| Test | Summary |
|---|---|
| by-side comparison of fluorescence image quality between the two systems. Two porcines were both used in a nephrectomy setup and an upper GI setup to complete various visualization tasks for each system. | |
| Surgeon Evaluation – All final tests PASSED | The purpose of this testing was to confirm that the da Vinci Firefly Imaging System has clinically acceptable performance and allows for safe and effective surgical use as assessed by independent, external surgeon evaluators. Testing was completed across four labs, utilizing canines or porcines. Four independent, external surgeons served as evaluators to complete the vision assessments. All evaluators completed at least one Firefly application to assess the various Firefly vision parameters. |
Human Factors and Usability Testing
A comprehensive Human Factors Engineering (HFE) process for the development of the IS4000 Firefly was conducted in accordance with the following FDA guidelines:
- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk . Management, 2000
- Draft Guidance for Industry and Food and Drug Administration Staff Applying . Human Factors and Usability Engineering to Optimize Medical Device Design, 2011
The human factors development process focused primarily on identifying critical tasks and ensuring the safe and effective use of the product. User experience with the predicate device, the IS3000 da Vinci Surgical System Firefly (IS3000 Firefly), helped identify and assess use-related risks for the IS4000 Firefly.
A Summative usability validation study was conducted with 16 teams of users (surgeons and operating room staff) for the da Vincio Firefly™ Imaging System. The study was conducted in a simulated operating room and involved typical workflow scenarios, as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation studies and the other elements of the human factors engineering program provided evidence that the da Vincio Firefly™ Imaging System is safe and effective when used by the intended users in the intended use environment.
7
Summary:
Based on the intended use, indications for use, technological characteristics, and performance Dasod on the da Vinci® Firefly™ Imaging System is substantially equivalent to the currently ualla, the wa Vinci Xi Surgical System device, cleared under K131861, and the da Vinci marketed and Ther In Bargious (K101077) with modified indications cleared under K124031.