(115 days)
Not Found
No
The description focuses on remote system information retrieval and configuration updates for diagnostic and maintenance purposes, with no mention of AI/ML terms or functionalities.
No
The device is described as an accessory for obtaining system information and remotely enabling/disabling features of a surgical system, not for direct therapeutic use on a patient.
Yes.
The device's intended use explicitly states "obtain system information for the purpose of diagnosing faults." This indicates its primary function is diagnostic in nature, specifically for identifying issues within the da Vinci Surgical Systems.
Yes
The device is explicitly described as a "software accessory" and its function is to remotely interact with a separate hardware system (da Vinci Surgical System) for diagnostic and configuration purposes. The description focuses solely on software functionalities and connectivity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being for trained Intuitive Surgical Field Service personnel to diagnose faults and manage system configurations of the da Vinci Surgical System. This is a technical support and maintenance function, not a diagnostic test performed on biological samples.
- Device Description: The device description reinforces the intended use, focusing on obtaining system information and enabling/disable features of the surgical system itself.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with or analyzing any biological samples (blood, tissue, urine, etc.), which is a fundamental characteristic of IVD devices.
- Intended User: The intended users are technical personnel (Field Service personnel), not healthcare professionals performing diagnostic tests on patients.
- No Diagnostic Metrics: The "Key Metrics" section is "Not Found," and the performance studies focus on software verification and in vitro validation of the device's functionality with the surgical system, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
In summary, the OnSite device is a software accessory for maintaining and troubleshooting a surgical system. It does not perform any diagnostic tests on biological samples, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Intuitive Surgical Field Service personnel / Hospital
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)
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.
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.
0
/21/21
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 Road | |
| Sunnyvale, CA 94086 | |
| Contact | Cherece L. Jones |
| Sr. Regulatory Affairs Specialist | |
| Telephone: (408) 523 - 6925 | |
| Fax: (408) 523 - 1390 | |
| e-mail: cherece.jones@intusurg.com | |
| Subject | |
| Device | Trade Name: Intuitive Surgical® OnSite™ for da Vinci® Surgical |
| Systems | |
| 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 IS2000 |
| with da Vinci OnSite™ and da Vinci Connect™ (legally marketed | |
| under K081207). | |
| Intuitive Surgical® da Vinci® S™ Surgical System, Model IS2000 | |
| with Connect™ OnSite™ and Wireless Connectivity Option | |
| (legally marketed under K101581). | |
| Device | |
| Description | 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: |
p. 1/2
1
| 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. |
| Technological | |
| Characteristics | The technological characteristics of the subject device are identical to the predicate devices. |
| Performance | |
| Data | 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. |
P. 2/2
2
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
3
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
4
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