(48 days)
Not Found
No
The document describes a standard endoscopic camera system and does not mention any AI or ML capabilities.
No.
The da Vinci Handheld Camera is intended for endoscopic viewing during minimally invasive surgery; it does not directly perform any therapeutic action.
No
Explanation: The device is intended for endoscopic viewing during surgery, providing visualization rather than diagnosing conditions or diseases.
No
The device description explicitly details hardware components such as the camera head, light guide, camera connector, light guide adaptor, endocoupler, and cable assembly. It also mentions a sterilization tray for the camera head. The performance studies include bench testing of physical, mechanical, and electrical requirements, as well as animal and human factors evaluations, all of which are indicative of a hardware device.
Based on the provided information, the da Vinci Handheld Camera is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "endoscopic viewing of internal surgery sites during minimally invasive surgery." This describes a device used in vivo (within a living organism) for visualization during a surgical procedure.
- Device Description: The description details a camera system for viewing internal anatomy during surgery, connecting to a laparoscope and a surgical system. This aligns with surgical imaging, not in vitro testing.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The da Vinci Handheld Camera does not perform any such analysis of specimens.
Therefore, the da Vinci Handheld Camera is a surgical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The da Vinci Handheld Camera is a lightweight handheld 2D Camera which can be connected to any third party 5 mm to 10 mm laparoscope to view images on the da Vinci Xi Vision cart. The da Vinci Handheld Camera consists of the camera head, the light guide, camera connector and the light guide adaptor.
The da Vinci Handheld Camera leverages the illuminator, video processor, monitor and video outputs on the do Vinci Xi Vision Cart to provide common functions of a laparoscopic video tower. The da Vinci Xi Handheld Camera connects to the vision cart in the same way an endoscope does through the endoscope controller. The da Vinci Handheld Camera consists of the camera head, endocoupler, cable assembly, light guide, and an adapter. The da Vinci Handheld Camera Head Sterilization Tray is intended for use to encase and protect da Vinci Handheld Camera Head during sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Endoscopic viewing
Anatomical Site
internal surgery sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design outputs meet the design requirements. The testing includes dimensional measurements, mechanical and functional verification, simulated use in animal model (porcine), and human factors evaluation.
Bench Testing:
The subject device, da Vinci Handheld Camera, was subjected to a series of bench tests to evaluate the performance and to demonstrate that the design outputs meet the input requirements. The design verification testing assessed the following:
- Physical Specifications
- Mechanical Requirements
- Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements
Animal Validations:
A series of tests were performed using simulated clinical models (animal) to evaluate the performance of the subject device, da Vinci Handheld Camera.
Human Factors Evaluation:
As part of the Usability Engineering Process for the da Vinci Handheld Camera, the Usability Risk Analysis was updated to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. Human factors evaluation was conducted on the da Vinci Handheld Camera. Based on the results of those studies, the da Vinci Handheld Camera is found to be safe and effective for the intended users, uses, and use environments.
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.
Intuitive Surgical Stereo View Endoscopic System (K080155)
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 shows 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 letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 6, 2019
Intuitive Surgical, Inc. Mr. Manjunath Bisalehalli Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K191043
Trade/Device Name: da Vinci Handheld Camera Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 17, 2019 Received: April 19, 2019
Dear Mr. Bisalehalli:
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.
1
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 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-reporting-
combination-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 mediation-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,
for
Jennifer R. Stevenson Acting Division Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191043
Device Name da Vinci Handheld Camera
Indications for Use (Describe)
The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.
| 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 7
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Manjunath Bisalehalli
Regulatory Affairs Engineer
Phone Number: 408-523-7089
Fax Number: 408-523-8907
Email: Manjun.Bisalehalli@intusurg.com |
| Date Summary Prepared: | April 17, 2019 |
| Trade Name: | da Vinci Handheld Camera |
| Common Name: | Endoscope and accessories |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | GCJ (Endoscope and accessories) |
| Classification Advisory
Committee: | |
| Committee: | General and Plastic Surgery |
| Predicate Device: | Intuitive Surgical Stereo View Endoscopic System
(K080155) |
Device Description
The da Vinci Handheld Camera is a lightweight handheld 2D Camera which can be connected to any third party 5 mm to 10 mm laparoscope to view images on the da Vinci Xi Vision cart. The da Vinci Handheld Camera consists of the camera head, the light guide, camera connector and the light guide adaptor.
The da Vinci Handheld Camera leverages the illuminator, video processor, monitor and video outputs on the do Vinci Xi Vision Cart to provide common functions of a laparoscopic video tower. The da Vinci Xi Handheld Camera connects to the vision cart in the same way an endoscope does through the endoscope controller. The da Vinci Handheld Camera consists of the camera head, endocoupler, cable assembly, light guide, and an adapter. The da Vinci Handheld Camera Head Sterilization Tray is intended for use to encase and protect da Vinci Handheld Camera Head during sterilization.
Image /page/3/Picture/8 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color, with the registered trademark symbol to the right of it.
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Intended Use
The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible do Vinci Surgical Systems.
Technological Characteristics
The subject device, do Vinci Handheld Camera, is technologically very similar to the predicate device, Intuitive Surgical Stereo View Endoscopic System (cleared under K080155). The subject device has the same architecture design, as the predicate except it is a handheld camera.
Performance Data
Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design outputs meet the design requirements. The testing includes dimensional measurements, mechanical and functional verification, simulated use in animal model (porcine), and human factors evaluation.
Bench Testing
The subject device, da Vinci Handheld Camera, was subjected to a series of bench tests to evaluate the performance and to demonstrate that the design outputs meet the input requirements. The design verification testing assessed the following:
- . Physical Specifications
- Mechanical Requirements
- Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements
Animal Validations
A series of tests were performed using simulated clinical models (animal) to evaluate the performance of the subject device, da Vinci Handheld Camera.
Human Factors Evaluation
As part of the Usability Engineering Process for the da Vinci Handheld Camera, the Usability Risk Analysis was updated to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. Human factors
Image /page/4/Picture/19 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 in a smaller font and also in a light gray color, with the registered trademark symbol to the right of it.
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evaluation was conducted on the da Vinci Handheld Camera. Based on the results of those studies, the da Vinci Handheld Camera is found to be safe and effective for the intended users, uses, and use environments.
Summary
Based on the intended use, indications for use, technological characteristics, and performance data, the subject device, da Vinci Handheld Camera is substantially equivalent to the predicate device, Intuitive Surgical Stereo View Endoscopic System.
Image /page/5/Picture/6 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, and is placed above the word "SURGICAL", which is in a smaller font. There is a yellow dot above the "I" in "INTUITIVE".