(291 days)
The da Vinci® Fluorescence Imaging Vision System is intended to provide realtime endoscopic visible and near-infrared fluorescence imaging. The da Vinci® Fluorescence Imaging Vision 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 infra-red imaging.
The Intultive Surgical da Vinci® Fluorescence Imaging Vision System is an endoscopic imaging system for high definition (HD) visible ilght and near-Infrared fluorescence Imaging during minimally invasive surgery. The Intuittve Surgical da Vincl® Fluorescence Imaging Vision System is a variation of the Intultive Surgical da Vincle SI Surgical System: Model IS3000 (K081137) with the following modified/additional components:
- 12mm endoscopes (0 degree or 30 degree) optimized for NIR . fluorescence Imaging In addition to VIS Imaging,
- A 3D High Definition stereoscopic camera head optimized for NIR . fluorescence imaging In addition to VIS Imaging,
- A new illuminator for use with the existing video processor unit, and ◆
- A Fluorescence Imaging Klt (IndoCyanine Green (ICG) fluorescence ● Imaging agent, aqueous solvent, and syringe trays)
The provided text describes the Intuitive Surgical da Vinci® Fluorescence Imaging Vision System, its intended use, and its equivalence to predicate devices, but it does not contain specific acceptance criteria or detailed study results beyond a general statement of verification and validation. Therefore, most of the requested information cannot be extracted directly from the given document snippets.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "The results of verification and validation tests demonstrate that the da Vinci® Fluorescence Imaging Vision System components met their design and performance criteria and are substantially equivalent to the predicate devices." However, it does not specify what those criteria were nor does it report specific performance metrics (e.g., sensitivity, specificity, accuracy, or any quantitative measurements related to image quality or vessel visualization).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "verification and validation tests" but does not provide any details about the sample sizes, data provenance, or whether the tests were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. The document does not describe any studies involving human experts to establish ground truth for a test set. The validation seems to be focused on meeting technical design and performance specifications rather than clinical performance evaluated by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. As no studies involving human experts or ground truth establishment are detailed, no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The document describes a medical device, not an AI or deep learning system that provides assistance to human readers in the traditional sense. It's a fluorescence imaging system. There is no mention of an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided clearly. The device itself is an imaging system used by surgeons. Its "performance" would inherently involve a human surgeon viewing the images. The document states "The da Vinci® Fluorescence Imaging Vision 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 infra-red imaging." This implies human interpretation is part of its intended use. There's no mention of an "algorithm only" performance evaluation as typically understood for AI-driven diagnostic tools.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. There is no information about the type of ground truth used for performance evaluation, as detailed clinical validation studies are not described in the provided text. The "ground truth" for this device's validation appears to be its stated design and performance criteria, verified through technical tests, rather than a clinical ground truth like pathology for diagnostic accuracy.
8. The sample size for the training set
- Cannot be provided. The document describes a hardware and imaging system, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- Cannot be provided. As there is no mention of a training set, this question is not applicable.
Summary of what the document does provide:
- Device Name: Intuitive Surgical da Vinci® Fluorescence Imaging Vision System
- Intended Use/Indications for Use: To provide real-time endoscopic visible and near-infrared fluorescence imaging. It 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 infra-red imaging.
- Performance Data Statement: "The results of verification and validation tests demonstrate that the da Vinci® Fluorescence Imaging Vision System components met their design and performance criteria and are substantially equivalent to the predicate devices."
- Predicate Devices: Intuitive Surgical da Vinci® SI Surgical System: Model IS3000 (K081137) and Novadaq Spy Scope Intra-operative Operating System (KO91515).
- Conclusion: The device is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.
The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices based on design, technological characteristics, and a high-level summary of verification and validation that confirm the device meets its own design requirements and specifications. It does not usually include detailed clinical study protocols, acceptance criteria, or performance metrics in the way these questions are posed, especially for a device that is an imaging system and not an AI diagnostic algorithm.
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KI017 page (1) of (2)
FEB - 4 2011 INTUITIVE
falling surgery beyond the limits of the numan hund "
SURGICAL
510(k) Summary (As Required by 21 CFR 807.92(c))
April 16, 2010
Submitter: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086
- Official Contact: Karen Uyesuai Vice President, Clinical and Regulatory Affalrs Ph: 408-523-8918 Fax: 408-523-1390 karen.uyesugl@Intusurg.com
Trade Name: Intuitive Surgical da Vinci® Fluorescence Imaging Vislon System
Common Name: system, surgical, computer controlled Instrument
Product Code: NAY (GCJ/IZI)
Classification: endoscope and accessories, 21 CFR 876. 1500
Predicate Devices: Intuitive Surgical da Vinci� SI Surgical System: Model IS3000 (K081137) Novadaq Spy Scope Intra-operative Operating System (KO91515)
Device Description: The Intultive Surgical da Vinci® Fluorescence Imaging Vision System is an endoscopic imaging system for high definition (HD) visible ilght and near-Infrared fluorescence Imaging during minimally invasive surgery. The Intuittve Surgical da Vincl® Fluorescence Imaging Vision System is a variation of the Intultive Surgical da Vincle SI Surgical System: Model IS3000 (K081137) with the following modified/additional components:
- 12mm endoscopes (0 degree or 30 degree) optimized for NIR . fluorescence Imaging In addition to VIS Imaging,
- A 3D High Definition stereoscopic camera head optimized for NIR . fluorescence imaging In addition to VIS Imaging,
- A new illuminator for use with the existing video processor unit, and ◆
- A Fluorescence Imaging Klt (IndoCyanine Green (ICG) fluorescence ● Imaging agent, aqueous solvent, and syringe trays)
Intuitive Surgical, Inc.
Confidential
page 5-2 of 55
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ge (2) of (2)
falling surgery be rand the lines of the human hand "
N T II I T I V F SURGICAL
Intended Use/Indications for Use: The da Vincle Fiuorescence Imaging Vision System is Intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vincl® Fluorescence Imaging Vision 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 infra-red imaging.
Technological Characteristics: The da Vinci® Fluorescence Imaging Vision System is equivalent to the predicate devices in terms of its indications for use, design, technology and performance specifications.
Performance Data: Verification and validation were performed on the da Vincle Fluorescence Imaging Vision System to evaluate the device requirements/specifications and to demonstrate that they are substantially equivalent to the predicate devices (da Vinct®Si Surgical System: Model IS3000 and SPY Scope Intra-operative Imaging System).
The results of verification and validation tests demonstrate that the da Vincle Fluorescence imaging Vision System components met their design and performance criteria and are substantlally equivalent to the predicate devices.
Summary: Based on the Indications for use, design, technological characteristics and performance data the da Vincl® Fluorescence Imaging Vision System Is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.
Confidential
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intuitive Surgical, Inc. % Ms. Karen Uyesugi Vice President, Clinical and Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
FEB - 4 201
Re: K101077
Trade/Device Name: da Vinci® Fluorescence Imaging Vision System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, NAY, IZI Dated: January 10, 2011 Received: January 11, 2011
Dear Ms. Uyesugi:
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
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Page 2 - Ms. Karen Uyesugi
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number if known: K101077
Device Name: da Vinci® Fluorescence Imaging Vision System
INDICATION FOR USE:
The da Vinci® Fluorescence Imaging Vision System is intended to provide realtime endoscopic visible and near-infrared fluorescence imaging. The da Vinci® Fluorescence Imaging Vision 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 infra-red imaging.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-the-Counter Use (Per 21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Niel R. Dyke
Signature
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101077
Confidential
§ 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.