(60 days)
No
The summary describes a standard electrosurgical generator and its functions, with no mention of AI or ML capabilities. The focus is on delivering high-frequency energy and compatibility with surgical systems and instruments.
Yes
The device is described as an electrosurgical unit that delivers high-frequency energy for cutting, coagulation, and vessel sealing of tissues during surgical procedures, which are direct interventions meant to treat or correct a medical condition.
No
The device is an electrosurgical generator designed to deliver high-frequency energy for cutting, coagulation, and vessel sealing of tissues during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is an "electrosurgical unit (ESU)" and describes physical components like an LCD display, LED indicators, and connections for instruments and footswitches, indicating it is a hardware device with integrated software.
Based on the provided information, the da Vinci E-200 Electrosurgical Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures." This describes a device used during surgical procedures on living tissue, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description details an electrosurgical unit that provides energy for surgical actions like cutting, coagulation, and vessel sealing. This aligns with surgical tools, not diagnostic tests performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The da Vinci E-200 Electrosurgical Generator is a surgical tool used for therapeutic purposes during procedures.
N/A
Intended Use / Indications for Use
The da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.
Product codes
GEI
Device Description
The da Vinci E-200 Electrosurgical Generator is an electrosurgical unit (ESU) designed to provide high-frequency (HF) traditional monopolar, bipolar, and advanced bipolar outputs intended for cutting, coagulation and/or vessel sealing of tissues. The da Vinci E-200 Electrosurgical Generator is intended to be used with the da Vinci Xi, and da Vinci 5 surgical systems, and also operate as a standalone electrosurgical generator. When connected to the E-200 provides HF output to da Vinci instruments. Control and status messages are passed between the E-200 and the da Vinci system through an Ethernet communication cable. The E-200 is also compatible with open and laparoscopic third-party handheld monopolar and bipolar instruments, fingerswitch equipped instruments (where applicable) and Intuitive provided auxiliary footswitches. The primary function of the E-200 Electrosurgical Generator is to allow a surgeon to deliver HF out, seal, or coagulate tissue during surgery. The user interface includes audible indicator tones, LED indicators on the front of the generator, and status messages provided on its LCD display.
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
Not Found
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
Verfication and validation activities were successfully completed that the subject device performs as intended and is substantially equivalent to its predicate, da Vinci E-200 Electrosurgical Generator. Testing included the following: Design Verification (Bench Testing)
Bench testing was performed to verify functional design outputs met the functional design verification in this section addressed the following:
- · Software requirements, including cybersecurity
- · EMC and Electrical Safety requirements
- · System interface requirements
- · Instrument compatibility requirements
- · Packaging and Labeling
Design Validation
Simulated clinical use testing was performed with a porcine model to validate that the product specifications continued to meet the users' needs and intended use.
Human Factor Evaluation testing:
The Human factor evaluation determined that the subject da Vinci E-200 Electrosurgical Generators are safe and effective for their intended uses by the intended users, in the intended use environment.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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August 5, 2024
Intuitive Surgical Medha Sateesh Bharadwaj Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K241635
Trade/Device Name: da Vinci E-200 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 6, 2024 Received: June 6, 2024
Dear Medha Sateesh Bharadwaj:
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" (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).
1
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 Date: 2024.08.05 09:04:13
-04'00' Trumbore -S Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
da Vinci E-200 Electrosurgical Generator
Indications for Use (Describe)
The da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.
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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3
510(k) Summary
Prepared on: 2024-06-06
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Intuitive Surgical |
|---|---|
| Applicant Address | 1266 Kifer Road Sunnyvale CA 94086 United States |
| Applicant Contact Telephone | 631-532-7229 |
| Applicant Contact | Ms. Medha Sateesh Bharadwaj |
| Applicant Contact Email | medha.sateeshbharadwaj@intusurg.com |
21 CFR 807.92(a)(2)
| Device Name | |
|---|---|
| Device Trade Name | da Vinci E-200 Electrosurgical Generator |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number | 878.4400 |
| Product Code(s) | GEI |
21 CFR 807.92(a)(3)
| Legally Marketed Predicate Devices | |
|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) |
| K231212 | da Vinci E-200 Electrosurgical Generator |
| Product Code | |
| GEI |
21 CFR 807.92(a)(4)
| Device Description Summary | |
|---|---|
| ---------------------------- | -- |
The da Vinci E-200 Electrosurgical Generator is an electrosurgical unit (ESU) designed to provide high-frequency (HF) traditional monopolar, bipolar, and advanced bipolar outputs intended for cutting, coagulation and/or vessel sealing of tissues. The da Vinci E-200 Electrosurgical Generator is intended to be used with the da Vinci Xi, and da Vinci 5 surgical systems, and also operate as a standalone electrosurgical generator. When connected to the E-200 provides HF output to da Vinci instruments. Control and status messages are passed between the E-200 and the da Vinci system through an Ethernet communication cable. The E-200 is also compatible with open and laparoscopic third-party handheld monopolar and bipolar instruments, fingerswitch equipped instruments (where applicable) and Intuitive provided auxiliary footswitches. The primary function of the E-200 Electrosurgical Generator is to allow a surgeon to deliver HF out, seal, or coagulate tissue during surgery. The user interface includes audible indicator tones, LED indicators on the front of the generator, and status messages provided on its LCD display.
Intended Use/Indications for Use
The da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.
Indications for Use Comparison
Indications for use are the same as the predicate device.
Technological Comparison
gulation and vessel sealing of
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
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The technological characteristics of the subject da Vinci E-200 Electrosurgical Generator are the predicate device cleared under K231212. The subject device has the same indication for use, same fundamental scientific technology, and similar technological characteristics as the predicate device. Results from performance data indicate that the subject da Vinci E-200 Electrosurgical Generator is substantially equivalent to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Verfication and validation activities were successfully completed that the subject device performs as intended and is substantially equivalent to its predicate, da Vinci E-200 Electrosurgical Generator. Testing included the following: Design Verification (Bench Testing)
Bench testing was performed to verify functional design outputs met the functional design verification in this section addressed the following:
- · Software requirements, including cybersecurity
- · EMC and Electrical Safety requirements
- · System interface requirements
- · Instrument compatibility requirements
- · Packaging and Labeling
Design Validation
Simulated clinical use testing was performed with a porcine model to validate that the product specifications continued to meet the users' needs and intended use.
Human Factor Evaluation testing:
The Human factor evaluation determined that the subject da Vinci E-200 Electrosurgical Generators are safe and effective for their intended uses by the intended users, in the intended use environment.
Based on the indications for use, technological characteristics, and performance data, the subject da Vinci E-200 Electrosurgical Generator is substantially equivalent to the predicate device (K231212).