(128 days)
The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.
The Senhance Ultrasonic System is an energized instrument system which delivers ultrasonic energy to the tissue of interest for soft tissue incisions. It is designed to be used with the Senhance Surgical System which precisely manipulates laparoscopically based instruments in surgery. The Senhance Ultrasonic System is composed of five components: 1. The Dissector which interfaces with the tissue of interest 2. The Transducer which converts electrical energy into ultrasonic energy 3. The Senhance Adapter which physically attaches the instrument to the Senhance Surgical Robotic System manipulator arm 4. The Ultrasonic Generator which controls the energy settings to be delivered to the tissue 5. The Footswitch
This document describes the Senhance Ultrasonic System, a surgical device designed for soft tissue incisions. The system is intended for use with the Senhance Surgical System, a robotic platform. The 510(k) summary provided outlines the device's characteristics, comparison to a predicate device, and the performance data used to support its substantial equivalence.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly present a table of "acceptance criteria" against which specific numerical performance metrics are then stated. Instead, the performance testing described aims to demonstrate the safety and effectiveness of the device by showing its compatibility and comparable performance to a predicate and reference device across various characteristics. The ultimate "acceptance criterion" for this submission appears to be demonstrating substantial equivalence, meaning the technological differences do not raise any different questions of safety or effectiveness.
| Category of Performance Test | Implied Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 | All patient-contacting devices assessed; results support biocompatibility. |
| Cleaning, Disinfection (Reprocessing) & Sterilization | Validation through AAMI TIR12, TIR30, ANSI/AAMI/ISO 17665-1, ISO 14937, and EN ISO 11135-1:2014, EN ISO 10993-7:2008 with a SAL of 10-6. | Reusable components validated; disposable dissector provided sterile with SAL of 10-6. |
| Bench Testing | System compatibility, comparable ultrasonic energy delivery, and tissue effects to the reference system. | Confirmed compatibility; ultrasonic energy delivery to tissue comparable to the reference system; tests included cantilever bend stiffness, force feedback, fulcrum accuracy, jaw output force, mechanical reliability, thermal spread, and tissue effects (vessel sealing burst pressure & lesion size). |
| Electrical Safety and Compatibility | Compliance with IEC 60601-1, -1-2, -2-2, and -2-18 for non-interference with vision systems. | Complies with current versions of these IEC standards; verified no interference with the vision system signal when used concurrently. |
| Software Verification and Validation | Conformity to FDA's Guidance for Premarket Submissions for Software in Medical Devices ("major" level of concern). | Verification conducted for Senhance Surgical System software modification and Ultrasonic Generator; documentation provided. |
| Pre-Clinical Design Validation | System conformity to defined user needs and intended uses in a simulated environment; all pre-determined acceptance criteria met. | All pre-determined acceptance criteria were met by four teams (surgeon + assistant) performing various surgical tasks on a live porcine model. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Pre-Clinical Design Validation: Four teams (one surgeon and one surgical assistant per team), totaling 8 individuals. These teams performed surgical tasks on a live porcine model.
- Biological Testing, Cleaning/Sterilization, Bench Testing, Electrical Safety, Software V&V: Specific number of units/samples for these tests are not explicitly stated. The description indicates "testing" was conducted.
- Data Provenance: The pre-clinical design validation was conducted in a "single-center" environment.
- The "live porcine model" implies prospective data collection using animal subjects for performance evaluation.
- Other tests (biocompatibility, cleaning, bench, electrical safety, software) would typically involve lab-based prospective testing of the device components.
- The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Pre-Clinical Design Validation: Four surgeons and four surgical assistants were involved as users in the simulated use validation. These individuals "represented the intended primary user population" and were "trained subjects." Their specific years of experience or formal qualifications (e.g., board-certified) are not explicitly detailed, but their participation in surgery and assistance roles implies relevant medical expertise in gynecological and general surgery. They essentially served as experts evaluating the device's performance against user needs.
- For other tests (e.g., biocompatibility guidance, sterilization standards), the "ground truth" is established by adherence to recognized international standards and FDA guidance, meaning the experts implicit are those who draft and approve such standards and the specialists performing the tests according to those standards.
4. Adjudication Method for the Test Set
- For the pre-clinical design validation, the summary states that "All pre-determined acceptance criteria were met." This suggests a direct evaluation against predefined performance benchmarks. It does not describe an explicit "adjudication method" in the sense of multiple experts independently scoring and then resolving discrepancies (like 2+1 or 3+1). The "trained subjects" (surgeons and assistants) in this simulated environment were likely the evaluators of the system's performance and their assessment contributed to meeting the acceptance criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided 510(k) summary. The study described is a pre-clinical design validation with simulated use, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- The Senhance Ultrasonic System is an instrument system for robotic surgery, not an AI-driven diagnostic or image analysis algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply to this type of device. The system requires human intervention for its operation via the Senhance Surgical System by a surgeon and surgical assistant.
7. The Type of Ground Truth Used
- Pre-Clinical Design Validation: The ground truth for this phase was established by observing and evaluating the device's performance during surgical tasks on a live porcine model. The "pre-determined acceptance criteria" serve as the standard against which performance was measured. In this context, the "ground truth" is based on observed functional performance in a simulated biological environment, representing what is expected of the device in actual surgical use (e.g., effective soft tissue incisions, hemostasis, minimal thermal injury).
- Other Tests (Biocompatibility, Sterilization, Bench Testing, Electrical Safety, Software V&V): The ground truth is adherence to established scientific principles, international standards (ISO, AAMI, IEC), and FDA guidance documents.
8. The Sample Size for the Training Set
- The provided 510(k) summary does not describe a "training set" in the context of machine learning. The device is a surgical instrument and robotic system, not a machine learning algorithm that requires a data training set.
9. How the Ground Truth for the Training Set Was Established
- As the device is not a machine learning algorithm, there is no "training set" or corresponding ground truth establishment process for a training set described in this submission.
§ 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.