(185 days)
Generator: The E-100 is an electrosurgical generator for use with a compatible da Vinci Surgical System. It is an electrosurgical unit intended to deliver high-frequency energy (HF) for cutting, coagulation and vessel sealing of tissues.
Instrument: SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Generator: The E-100 Electrosurgical Generator is an electrosurgical generator intended to deliver High Frequency (HF) energy for cutting/transection, coagulation and vessel sealing of tissues when used with compatible "Intuitive Surgical Advanced Energy" bipolar instruments - "SynchroSeal" and "Vessel Sealer Extend". The generator provides a single HF output port into which one of these compatible surgical instruments mav be plugged.
Instrument: SynchroSeal is a single-use, disposable, 8 mm instrument with an integrated cord that connects to the E-100 Electrosurgical Generator. An electrode sealing surface and a protruding cut electrode within the jaws enable sealing and cutting/transection functionality. SynchroSeal is an advanced, wristed, bipolar instrument that provides a unique energy mode to enable sealing and transection of vessels and tissue bundles with a single pedal press. In addition to this functionality, SynchroSeal has the ability to grasp, dissect and spot coagulate tissue, and to independently seal vessels.
The provided text describes a 510(k) premarket notification for the Intuitive Surgical E-100 Electrosurgical Generator and SynchroSeal instrument. A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing performed to demonstrate this substantial equivalence.
Here's an analysis of the provided text to extract the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner as one might find in a clinical trial report. Instead, it describes various tests and states that the device "meets the design input requirements" or "did not negatively impact the safety or effectiveness." The overall "acceptance criterion" for a 510(k) is substantial equivalence to the predicate device in terms of safety and effectiveness.
Here's a breakdown of the performance evaluations:
| Test Type | Description of Acceptance / Performance Demonstrated |
|---|---|
| Generator (E-100 Electrosurgical Generator) | |
| Design Verification (Bench Testing) | Demonstrated that the device meets: |
- Hardware Requirements (physical measurements, general functionality, electrical components, reliability)
- EMC and Safety requirements
- Software requirements (power on/self-test, communications monitoring, instrument detection/compatibility, energy delivery/control, user interface, hardware health monitoring, system communication) |
| Design Validation (Animal/Cadaver) | Demonstrated that "design outputs fulfill the user needs and that the intended use, including indicated vessel sizes, have been met." |
| Chronic Animal Study (In-vivo) | Evaluated "clinical performance (long-term seal quality)" and "vascular healing response in a live animal model." The sealing performance of the VSE with the Erbe VIO dV (predicate) was used as the benchmark. |
| Instrument (SynchroSeal) | |
| Human Factors Testing | Performed (no specific quantitative outcome stated, but implies positive outcome). |
| Biocompatibility Testing | Demonstrated that the instrument is "nonhemolytic, does not cause intracutaneous irritation, skin sensitization, acute systemic toxicity, and is non-pyrogenic." "No issues of safety or effectiveness and no new risks" identified. |
| Sterilization Testing | Performed (implies positive outcome). |
| Packaging and Transit Testing | Performed (implies positive outcome). |
| Design Verification (Bench Testing) | Demonstrated that the device meets: - Physical Specifications (critical dimensions, mass, material, jaw to failure)
- Mechanical Requirements (range of motion, grip force, transection/cut distance, alignment, reliability)
- Electrical Requirements (leakage, creepage & clearance, electrostatic discharge, isolation)
- User Interface Requirements
- Equipment Interface Requirements (data verification, instrument recognition, guided tool change, gravity compensation) |
| Design Validation (Animal/Cadaver) | Demonstrated that "design outputs fulfill the user needs and that the intended use, including indicated vessel sizes, have been met." |
| Chronic Animal Study (In-vivo) | Evaluated "clinical performance (long-term seal quality)" and "vascular healing response in a live animal model." Compared to predicate device (ERBE VIO generator and EndoWrist Vessel Sealer Extend). |
| Overall Conclusion | "The E-100 Electrosurgical Generator and SynchroSeal instrument raise no new questions of safety or effectiveness. Based on their intended use, technical characteristics, and performance data, the E-100 Electrosurgical Generator and SynchroSeal instrument are equivalent to their respective predicate devices in terms of safety, effectiveness, and performance." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Sizes: The document does not specify exact sample sizes for any of the tests (bench, animal, cadaver studies). It refers to "series of tests" and "porcine models."
- Data Provenance:
- Country of Origin: Not explicitly stated, but given the FDA submission, the studies would likely be conducted in the US or in a manner compliant with US regulatory requirements.
- Retrospective or Prospective: The studies described (design verification, design validation, chronic animal study) are inherently prospective as they are designed experiments to test the device's performance against pre-defined criteria.
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. The text describes engineering and animal model testing, but not expert-driven ground truth establishment in a diagnostic context (e.g., radiologists interpreting images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not relevant or provided for the type of testing described (bench and animal studies for a surgical instrument). Adjudication methods like 2+1 or 3+1 are typical for human-read evaluations of diagnostic AI, where opinions need to be reconciled.
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
An MRMC study was not conducted as this is a surgical instrument and generator, not a diagnostic AI system that assists human readers. Therefore, there's no mention of human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "standalone" performance in this context would be the performance of the E-100 Generator and SynchroSeal instrument as objectively measured in the bench tests and animal studies, independent of human interaction beyond operating the device. The text details extensive standalone (device-only) performance testing. For example:
- "The subject device, E-100 Electrosurgical Generator, was subjected to series of tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements."
- "The subject device, SynchroSeal, was subjected to series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements."
- The chronic animal study measured "long-term seal quality" and "vascular healing response," which are objective, device-dependent outcomes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance assessment appears to be a combination of:
- Engineering Specifications/Benchmarking: For hardware, electrical, mechanical, and software requirements, the "ground truth" is adherence to pre-defined specifications and expected performance characteristics.
- Physiological/Pathological Outcomes in Animal Models: For vessel sealing efficiency, hemostatic transection, and tissue healing, the "ground truth" is based on observed clinical performance in porcine models (in vivo and ex vivo) and cadavers, using the predicate device's performance as a benchmark for comparison. This likely involves assessment of seal integrity, burst pressure, and histological evaluation of tissue healing, although specific methods are not detailed.
8. The sample size for the training set
This question is not applicable as the device is not an AI/ML algorithm that requires a "training set" in the traditional sense. It's an electrosurgical device. The "training" here would refer to the engineering and design iterations, which are not based on a 'data set' for model learning.
9. How the ground truth for the training set was established
Not applicable, as it's not an AI/ML algorithm with a training set.
§ 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.