(140 days)
Not Found
No
The summary describes a system for real-time endoscopic imaging using visible and near-infrared light with an imaging agent. It mentions "supporting software functions" but does not describe any AI/ML capabilities, image processing beyond basic display, or mention training/test sets related to AI/ML model development. The focus is on the hardware and the imaging modality itself.
No
The device is described as an "adjunct imaging system" intended to provide "real-time endoscopic visible and near-infrared fluorescence imaging" to aid surgeons in visualizing vessels, blood flow, and tissue perfusion. Its primary function is imaging and visualization, not direct treatment or therapy.
Yes
The device aids surgeons in the visual assessment of vessels, blood flow, and related tissue perfusion, which directly supports diagnosis by providing critical information about the physiological state of the tissue during surgery.
No
The device description explicitly states that the system consists of enhanced existing hardware components (endoscope controller, endoscope) and supporting software functions. It is not solely software.
Based on the provided information, the da Vinci SP Firefly Imaging System 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. They are used outside of the living organism.
- Device Function: The da Vinci SP Firefly Imaging System is used during surgery (in vivo) to provide real-time imaging of tissues and blood flow within the patient's body. It uses an intravenously injected imaging agent (ICG) and near-infrared light to visualize structures inside the patient.
- Intended Use: The intended use is to assist surgeons during minimally invasive surgery by providing enhanced visualization of vessels and tissue perfusion. This is a surgical tool, not a diagnostic test performed on a sample.
Therefore, the da Vinci SP Firefly Imaging System falls under the category of a surgical imaging system used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP 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, using near-infrared imaging.
Product codes (comma separated list FDA assigned to the subject device)
NAY, IZI
Device Description
The da Vinci SP Firefly Imaging System is a fully-integrated, adjunct imaging system for the da Vinci SP Surgical System. The da Vinci SP Firefly Imaging System consists of enhanced existing components of the da Vinci SP Surgical System: the endoscope controller, the endoscope, and supporting software functions. The endoscope controller provides a light source, either visible light or a near-infrared (NIR) excitation laser. The endoscope transmits visible light from the endoscope controller to illuminate the surgical site. The near-infrared light is used to fluoresce an intravenously-injected imaging agent, indocyanine green (ICG), which is imaged by the endoscope and displayed at the Surgeon Console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visible light, near-infrared imaging
Anatomical Site
Not Found
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)
The da Vinci SP Firefly Imaging System underwent a series of bench tests to verify requirements and risk mittigations. Based on the subject device impact on the parent da Vinci SP Surgical System, bench testing was limited to endoscope design verification, illumination reliability testing, and a human factors evaluation. The da Vinci SP Firefly Imaging System underwent validation testing using an animal model (porcine) to evaluate its safety and effectiveness for use in surgery.
Bench testing and clinical validation testing on the subject device confirmed that no issues of safety or effectiveness, analogous to the results of the predicate device verification testing. Therefore, the test results demonstrate that the subject device is substantially equivalent to its predicate device.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.
Intuitive Surgical, Inc. Connor Mccarty Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K212101
Trade/Device Name: da Vinci SP Firefly Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, IZI Dated: October 22, 2021 Received: October 25, 2021
Dear Connor Mccarty:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark W. Trumbore Ph.D., GWCPM Acting Assistant Director THT4A1: Robotically-Assisted Surgical Device Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
da Vinci SP Firefly Imaging System
Indications for Use (Describe)
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP 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, using near-infrared imaging.
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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510(k) Summary
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Intuitive Surgical, Inc. |
| Applicant Address | 1266 Kifer Road Sunnyvale CA 94086 United States |
| Applicant Contact Telephone | 805-798-4205 |
| Applicant Contact | Mr. Connor McCarty |
| Applicant Contact Email | connor.mccarty@intusurg.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | da Vinci SP Firefly Imaging System |
| Common Name | Endoscope and accessories |
| Classification Name | System, Surgical, Computer Controlled Instrument |
| Regulation Number | 876.1500 |
| Product Code | NAY |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K210918 | da Vinci Firefly Imaging System | NAY |
Device Description Summary
The da Vinci SP Firefly Imaging System is a fully-integrated, adjunct imaging system for the da Vinci SP Surgical System. The da Vinci SP Firefly Imaging System consists of enhanced existing components of the da Vinci SP Surgical System: the endoscope controller, the endoscope, and supporting software functions. The endoscope controller provides a light source, either visible light or a near-infrared (NIR) excitation laser. The endoscope transmits visible light from the endoscope controller to illuminate the surgical site. The near-infrared light is used to fluoresce an intravenously-injected imaging agent, indocyanine green (ICG), which is imaged by the endoscope and displayed at the Surgeon Console.
Intended Use/Indications for Use
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP 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, using near-infrared imaging.
Indications for Use Comparison
The indications for use of the subject device are a subset of the predicate device. The indications for use differ between the subject and predicate device based on the parent device indications for use. The parent da Vinci SP Surgical System indications for use do not include surgical procedures utilizing bile duct imaging, and so this indication for the subject device is not included. The intended use is identical between the predicate and subject devices are intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(4)
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Technological Comparison
The technological characteristics of the endoscope controller component of the predicate and subject devices are identical. The parent system software and endoscope components differ between the predicate and subject devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The da Vinci SP Firefly Imaging System underwent a series of bench tests to verify requirements and risk mittigations. Based on the subject device impact on the parent da Vinci SP Surgical System, bench testing was limited to endoscope design verification, illumination reliability testing, and a human factors evaluation. The da Vinci SP Firefly Imaging System underwent validation testing using an animal model (porcine) to evaluate its safety and effectiveness for use in surgery.
Bench testing and clinical validation testing on the subject device confirmed that no issues of safety or effectiveness, analogous to the results of the predicate device verification testing. Therefore, the test results demonstrate that the subject device is substantially equivalent to its predicate device.