(58 days)
No
The summary describes a handheld camera for endoscopic viewing and its compatibility with a surgical system. There is no mention of AI, ML, or any advanced image processing beyond basic viewing. The performance studies focus on animal validation, bench verification, cybersecurity, software interface, and human factors, none of which indicate the presence of AI/ML.
No
The device is described as a camera for endoscopic viewing of internal surgery sites, designed for use with surgical systems. Its function is to provide visualization, not to directly treat or diagnose a disease or condition.
No
Justification: The device is described as an "endoscopic viewing" camera for "internal surgery sites." Its purpose is to provide images for surgeons, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a "lightweight handheld 2D Camera" and includes physical components like a camera head, light guide, and light guide adapter. It also mentions connecting to a third-party laparoscope and a da Vinci Surgical System Vision Cart. This indicates it is a hardware device with potential software components, not a software-only device.
Based on the provided information, the da Vinci Handheld Camera is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "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 used with a laparoscope to view images on a vision cart. This is consistent with a surgical imaging device used during surgery.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The da Vinci Handheld Camera does not perform this function. It is a tool for direct visualization during surgery.
Therefore, the da Vinci Handheld Camera is a surgical imaging device, not an IVD.
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
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 compatible da Vinci System Vision cart. The da Vinci Handheld Camera consists of the camera head, the light guide, and the light guide adapter. The da Vinci Handheld Camera Light Guide is a detachable device that connects to the third party laparoscope via a Handheld Camera Light Guide Adapter and to the da Camera connector prior to connecting it to the Endoscope controlle da Vinci Surgical System. The camera is reusable and is not provided sterile to the users.
The da Vinci Handheld Camera connects to a compatible da Vinci Surgical System Vision Cartroller. The da Vinci Handheld Camera. Light Guide and Light Guide Adapter are designed first entry and laparoscopic tasks during robotic procedures, prior to docking the compatible da Vinci Surgical System patient cart. It is intended to be used by surgeons, circulating nurses (non-sterile user) and scrub nurses (sterile user), in a hospital operating room (OR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal surgery sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, circulating nurses (non-sterile user) and scrub nurses (sterile user), in a hospital operating room (OR).
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)
Animal Validation: In-vivo testing with a live porcine model was used to evaluate the safety and efficacy of the subject Handheld Camera when used with SP Access Port Kit (cleared via K202571) in a representative simulated clinical setting. Live porcine models are appropriate for vision assessments as it is representative with respect to the tissue appearance and behavior. Testing was performed to evaluate various vision parameters of the subject device when used with the SP Access Port Kit during a series of simulated surgical tasks. Design validation activities demonstrated that the design outputs fulfill the user needs and that the intended use have been met.
Bench Verification: The design input, mechanical components, and device features are identical between the subject and predicate Handheld Camera K191043. Therefore, design and Reliability verification was not performed, and test results provided in the predicate submission K191043 remains valid and applies to the subject device.
Cybersecurity Verification: The cybersecurity requirements for the Handheld Camera was modified to include compatibility with the da Vinci SP1098 Surgical System. Delta Cyberseurity verification was performed using SP1098 System software version B70 P5 (cleared via K232773) to confirm the subject device meet Cybersecurity requirements. There were no modifications to the system software related to Cybersecurity in the scope of this submission. Testing confirmed the subject device meets Cyberseurity requirements and identified no issues of safety or effectiveness and no new risks.
Software User interface verification: SP1098 System software user interface verify compatibility with the subject da Vinci Handheld Camera when installed on the da Vinci SP Surgical system. Testing was performed on SP1098 System P5 software version (B70 P5) which was cleared in K232773. Testing confirmed that the test article met design inputs as documented in the user interface specification of the da Vinci SP Surgical System.
Human Factors: Human Factors Engineering process conducted for the subject devices included the following activities:
- o Known use-related issues for predicate devices and devices similar to the subject devices were analyzed using post-market data and the MAUDE database. All identified use-related issues that are relevant to the use of the subject devices were documented in the risk analysis.
- o A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user-device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
- o A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for each user task identified as New or Modified from the predicate in the CTA.
- o Formative usability evaluations were conducted during the design development process to modify or identify use-related hazards, develop risk mitigation strategies and refine the device user interface design.
Results from the performance data indicate that the subject da Vinci Handheld Camera is substantially equivale da Vinci Handheld Camera (K191043).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 28, 2024
Intuitive Surgical Operations, Inc. Heena Khandelwal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K241913
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: June 28, 2024 Received: July 1, 2024
Dear Heena Khandelwal:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.08.28 Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
1. Submitter
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------------------|-------------------------------------------------------------------------------------------|
| Official Contact: | Heena Khandelwal
Regulatory Affairs Specialist
Email: heena.khandelwal@intusurg.com |
| Date Summary Prepared: | June 28, 2024 |
2. Subject Device Information
| Manufacturer Name: | Intuitive Surgical, Inc. |
|---|---|
| Trade Name: | da Vinci Handheld Camera |
| Common Name: | Endoscope and accessories |
| Classification: | Class II |
| 21 CFR 876.1500, Endoscope and Accessories | |
| Product Code: | GCJ |
| Review Panel: | General and Plastic Surgery |
INTUITIVE
5
3. Predicate Device Information
| Manufacturer Name: | Intuitive Surgical, Inc. |
|---|---|
| 510k Number: | K191043, last cleared on June 6, 2019 |
| Trade Name: | da Vinci Handheld Camera |
| Common Name: | Endoscope and accessories |
| Classification: | Class II |
| 21 CFR 876.1500, Endoscope and Accessories | |
| Product Code: | GCJ |
| Review Panel: | General and Plastic Surgery |
4. 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 compatible da Vinci System Vision cart. The da Vinci Handheld Camera consists of the camera head, the light guide, and the light guide adapter. The da Vinci Handheld Camera Light Guide is a detachable device that connects to the third party laparoscope via a Handheld Camera Light Guide Adapter and to the da Camera comector prior to connecting it to the Endoscope controlle da Vinci Surgical System. The camera is reusable and is not provided sterile to the users.
The da Vinci Handheld Camera connects to a compatible da Vinci Surgical System Vision Cartroller. The da Vinci Handheld Camera. Light Guide and Light Guide Adapter are designed first entry and laparoscopic tasks during
INTUITIVE
6
Intuitive Surgical, Inc.
robotic procedures, prior to docking the compatible da Vinci Surgical System patient cart. It is intended to be used by surgeons, circulating nurses (non-sterile user) and scrub nurses (sterile user), in a hospital operating room (OR).
5. Indications for Use/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 da Vinci Surgical Systems.
6. Indication for use Comparison:
The indication for use is identical between the predicate and subject device.
7. Technological Comparison with the Predicate Device
The subject da Vinci Handheld Camera device is technologically identical to the predicate, however, only changes are being made to the labeling and da Vinci SP1098 System software to enable compatibility with the subject Handheld camera. There are no changes to the subject device design, material, and fundamental technology.
7. Non-Clinical and/or Clinical Test Summary
Verification and validation testing of design validation, software user interface verification, cybersecurity verification and human factors evaluation, on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified. The subject device met the same acceptance criteria as the predicate device. The successful completion of testing demonstrates that the subject device is substantially equivalent to its predicate device.
7
Intuitive Surgical, Inc.
Animal Validation
In-vivo testing with a live porcine model was used to evaluate the safety and efficacy of the subject Handheld Camera when used with SP Access Port Kit (cleared via K202571) in a representative simulated clinical setting. Live porcine models are appropriate for vision assessments as it is representative with respect to the tissue appearance and behavior. Testing was performed to evaluate various vision parameters of the subject device when used with the SP Access Port Kit during a series of simulated surgical tasks. Design validation activities demonstrated that the design outputs fulfill the user needs and that the intended use have been met.
Bench Verification
The design input, mechanical components, and device features are identical between the subject and predicate Handheld Camera K191043. Therefore, design and Reliability verification was not performed, and test results provided in the predicate submission K191043 remains valid and applies to the subject device.
Cybersecurity Verification
The cybersecurity requirements for the Handheld Camera was modified to include compatibility with the da Vinci SP1098 Surgical System. Delta Cyberseurity verification was performed using SP1098 System software version B70 P5 (cleared via K232773) to confirm the subject device meet Cybersecurity requirements. There were no modifications to the system software related to Cybersecurity in the scope of this submission. Testing confirmed the subject device meets Cyberseurity requirements and identified no issues of safety or effectiveness and no new risks.
Software User interface verification
SP1098 System software user interface verify compatibility with the subject da Vinci Handheld Camera when installed on the da Vinci SP Surgical system. Testing was performed on SP1098 System P5 software version (B70 P5) which was cleared in K232773. Testing confirmed that the test article met design inputs as documented in the user interface specification of the da Vinci SP Surgical System.
8
Intuitive Surgical, Inc.
Human Factors
Human Factors Engineering process conducted for the subject devices included the following activities:
- o Known use-related issues for predicate devices and devices similar to the subject devices were analyzed using post-market data and the MAUDE database. All identified use-related issues that are relevant to the use of the subject devices were documented in the risk analysis.
- o A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user-device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
- o A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for each user task identified as New or Modified from the predicate in the CTA.
- o Formative usability evaluations were conducted during the design development process to modify or identify use-related hazards, develop risk mitigation strategies and refine the device user interface design.
Results from the performance data indicate that the subject da Vinci Handheld Camera is substantially equivale da Vinci Handheld Camera (K191043).
8. Conclusion
Based on the intended use, indications for use, operating principles, technological characteristics and performance data, the subject da Vinci Handheld Camera is substantially equivalent to the predicate device (K191043).