(115 days)
OnSite for da Vinci Surgical Systems is an accessory indicated for use by trained Intuitive Surgical Field Service personnel to: (1) obtain system information for the purpose of diagnosing faults, (2) remotely enable/disable features including configuration updates through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.
OnSite is a software accessory compatible with da Vinci Surgical Systems and allows Intuitive Surgical, Inc. (ISI) personnel to remotely, through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure:
• Obtain system information for the purpose of diagnosing faults
• Enable/disable features including configuration updates
The provided text describes a 510(k) summary for the "Intuitive Surgical® OnSite™ for da Vinci® Surgical Systems," which is a software accessory. However, it does not include information typically found in a study demonstrating device performance against specific acceptance criteria for diagnostic accuracy or clinical effectiveness in the way an AI/ML device would.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on its intended use, design, technological characteristics, and software verification/validation.
Here's an analysis based on the provided text for each requested item, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or clinical outcomes. The "Performance Data" section states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| New OnSite device performs as intended. | All test cases successfully passed. |
| Proposed software changes have no adverse impact on functionality. | All test cases successfully passed. |
| Substantially equivalent to predicate devices (K081207, K101581). | Demonstrating that the subject device is substantially equivalent to the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Software Verification Testing and In Vitro Validation Testing." It states "All test cases successfully passed." However, it does not specify the sample size for the test set (number of devices, scenarios, or test cases), nor does it provide information on data provenance (country of origin, retrospective/prospective). Given the nature of the device (software accessory for system troubleshooting and servicing), the "test set" likely refers to a set of software test cases rather than clinical data.
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)
This information is not provided in the document. For a software accessory focused on system functionality, ground truth establishment would typically involve engineering specifications and expected system behavior rather than expert clinical judgment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the type of testing (software verification and in vitro validation), adjudication methods like 2+1 or 3+1 (common in image analysis for clinical ground truth) are not applicable or 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
There is no indication that an MRMC comparative effectiveness study was conducted. The device is a software accessory for remote servicing and troubleshooting, not an AI/ML diagnostic interpretation tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Performance Data" section refers to software and in vitro validation testing. This inherently describes a standalone evaluation of the software's functionality against its specifications. The entire premise of the device is for trained Intuitive Surgical Field Service personnel to use it, implying human interaction, but the "performance data" focuses on the software's ability to execute its functions correctly. So, while it's not a "standalone performance" in the sense of a clinical diagnostic algorithm, the verification and validation tests evaluate the software itself. There is no separate human-in-the-loop performance study described in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "Software Verification Testing and In Vitro Validation Testing," the ground truth would most likely be defined by engineering specifications and expected functional behavior of the da Vinci Surgical System and the OnSite software. It would not typically involve expert clinical consensus, pathology, or outcomes data.
8. The sample size for the training set
The document does not mention a training set. This device is described as a software accessory with expanded capabilities, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Since there is no mention of a training set, this information is not applicable/provided.
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510(K) SUMMARY
OCT 25 2012
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
510(k) Number:
| Date | June 29, 2012 |
|---|---|
| Submitter | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
| Contact | Cherece L. JonesSr. Regulatory Affairs SpecialistTelephone: (408) 523 - 6925Fax: (408) 523 - 1390e-mail: cherece.jones@intusurg.com |
| SubjectDevice | Trade Name: Intuitive Surgical® OnSite™ for da Vinci® SurgicalSystems |
| Common Name: Endoscopic Instrument Control System,Endoscopic Instruments, and Accessories | |
| Classification Name: General and Plastic Surgery | |
| Predicate Devices | Intuitive Surgical® da Vinci® S™ Surgical System, Model IS2000with da Vinci OnSite™ and da Vinci Connect™ (legally marketedunder K081207). |
| Intuitive Surgical® da Vinci® S™ Surgical System, Model IS2000with Connect™ OnSite™ and Wireless Connectivity Option(legally marketed under K101581). | |
| DeviceDescription | OnSite is a software accessory compatible with da Vinci SurgicalSystems and allows Intuitive Surgical, Inc. (ISI) personnel toremotely, through either a wired or wireless Ethernet connectionbetween the da Vinci Surgical System and the hospital's InternetProtocol (IP) infrastructure: |
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| Protocol (IP) infrastructure: | |
|---|---|
| • Obtain system information for the purpose of diagnosing faults | |
| • Enable/disable features including configuration updates | |
| Intended Use | OnSite for da Vinci Surgical Systems is an accessory intended for use by trained Intuitive Surgical Field Service personnel for troubleshooting and servicing da Vinci Surgical Systems through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure. |
| TechnologicalCharacteristics | The technological characteristics of the subject device are identical to the predicate devices. |
| PerformanceData | Software Verification Testing and In Vitro Validation Testing were conducted to confirm that the new OnSite device performed as intended and that the proposed software changes had no adverse impact on the functionality of the da Vinci Surgical System. All test cases successfully passed demonstrating that the subject device is substantially equivalent to the predicate devices. |
| Conclusion | The modified OnSite software has the same Intended Use, device design and technological characteristics as the predicate devices (K081207 and K101581).Performance data supports that the OnSite software, with expanded capabilities, is substantially equivalent to the predicate devices in terms of safety and effectiveness. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized depiction of an eagle, which is a common symbol of the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 25 2012
Intuituve Surgical, Incorporated % Ms. Cherece L. Jones Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086 .
Re: K121921
Trade/Device Name: Intuitive Surgical® OnSite™ for da Vincio Surgical Systems Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: October 11, 2012 Received: October 12, 2012
Dear Ms. Jones:
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
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Page 2 - Ms. Cherece L. Jones
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/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 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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INDICATIONS FOR USE
长121921 510(k) Number if known:
Device Name: Intuitive Surgical® OnSite™ for da Vincia Surgical Systems
OnSite for da Vinci Surgical Systems is an accessory indicated for use by trained Intuitive Surgical Field Service personnel to: (1) obtain system information for the purpose of diagnosing faults, (2) remotely enable/disable features including configuration updates through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.
Prescription Use X (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)
Nikke for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121921
§ 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.