(60 days)
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.
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.
This document focuses on the da Vinci E-200 Electrosurgical Generator, which is an electrosurgical unit (ESU). The information provided is a 510(k) summary, which inherently focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo study with strict acceptance criteria and performance metrics for a novel technology.
Therefore, the requested information elements related to standalone performance, MRMC studies, specific acceptance criteria values, sample sizes for test and training sets, and expert details for ground truth establishment are not explicitly described in the provided text in the manner typically found for AI/ML device studies. The document describes a traditional medical device (electrosurgical generator) and its safety and efficacy testing, not an AI/ML diagnostic or predictive system.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that "Verfication and validation activities were successfully completed that the subject device performs as intended and is substantially equivalent to its predicate."
The "acceptance criteria" are implied by the successful completion of the following testing types:
| Test Type | Implied Acceptance Criteria / Performance Demonstrated |
|---|---|
| Design Verification (Bench Testing) | Functional design outputs were met. Specifically: Software requirements (including cybersecurity) were met.EMC (Electromagnetic Compatibility) and Electrical Safety requirements were met.System interface requirements were met.Instrument compatibility requirements were met.Packaging and Labeling requirements were met. |
| Design Validation (Simulated Clinical Use) | Product specifications continued to meet the users' needs and intended use in a simulated clinical environment. (Performed with a porcine model, implying demonstration of cutting, coagulation, and vessel sealing efficacy and safety in tissue.) |
| Human Factor Evaluation | The device was determined to be safe and effective for its intended uses by the intended users in the intended use environment. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. For bench testing, this would refer to the number of test cases or iterations. For simulated clinical use, it refers to the number of porcine models or procedures performed.
- Data Provenance:
- Bench Testing: Likely internal laboratory testing at Intuitive Surgical.
- Simulated Clinical Use: Performed with a porcine model, indicating animal tissue (non-human, in vivo or ex vivo animal studies).
- Retrospective or Prospective: These tests are inherently prospective, as they are conducted specifically for the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This concept of "ground truth" established by experts, as typically applied to image-based AI diagnostics, is not directly applicable here. The device is an electrosurgical generator, and its performance (e.g., cutting efficacy, coagulation, vessel sealing) is assessed through objective measurements (bench testing) and direct observation/clinical evaluation (simulated clinical use).
For the Human Factor Evaluation, experts (likely human factors engineers and potentially medical professionals) would assess usability and safety, but they are evaluating the device's interaction with users, not establishing a "ground truth" for a diagnostic output.
4. Adjudication Method for the Test Set:
Not applicable in the context of electrosurgical generator testing as described. Adjudication methods (like 2+1 or 3+1) are typically used to resolve disagreements among multiple expert readers establishing ground truth for diagnostic decisions, which is not the primary output of this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study is not mentioned. Such studies are generally performed for diagnostic devices, especially those incorporating AI, to compare human performance with and without AI assistance. This device is a surgical tool, not a diagnostic one.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
The "standalone" performance for this device refers to its ability to function as an electrosurgical generator without being integrated into a da Vinci robotic system. The device description explicitly states: "The da Vinci E-200 Electrosurgical Generator... also operate as a standalone electrosurgical generator." The testing described (bench testing, simulated clinical use, human factor evaluation) would have covered this standalone operation, ensuring its basic electrosurgical functions (cutting, coagulation, sealing) are performed as intended. However, "standalone" in the context of an algorithm's diagnostic performance (without human interpretation) is not relevant here.
7. The Type of Ground Truth Used:
- Bench Testing: Engineering specifications, electrical safety standards, EMC standards, software requirements, measured physical parameters (e.g., power output, frequency).
- Simulated Clinical Use (Porcine Model): Direct observation of tissue effects (e.g., cut quality, coagulation adequacy, seal strength) by qualified personnel, possibly confirmed by gross and/or histopathological examination. Performance against a "gold standard" of expected surgical outcomes for electrosurgery.
- Human Factor Evaluation: Usability metrics, error rates, user feedback, adherence to human factors engineering principles.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set of data. The "training set" concept is relevant for machine learning algorithms, which "learn" from data. This device is a traditional electrosurgical generator engineered to specific design parameters.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
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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).
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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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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).
§ 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.