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510(k) Data Aggregation
(37 days)
The Senhance™ Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
The Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter are intended as additions to the suite of monopolar hook instruments and adapters previously cleared for use with the TransEnterix Senhance™ Surgical System. Three monopolar electrodes and one monopolar electrode adapter are being added. The instruments and adapter are modifications of the predicate TransEnterix® Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapters FDA cleared through K181517 (October 9, 2018). Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use.
This document describes the 510(k) summary for the Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter, which are additions to the TransEnterix Senhance™ Surgical System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K181517).
Based on the provided information, the device is an accessory to a surgical system and thus the acceptance criteria relate to its physical and functional performance, rather than diagnostic accuracy.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for tissue contact (<24 hours) | Patient-contacting portions are non-toxic, non-irritating, and do not result in an unacceptable adverse biological response. |
| Reprocessing Effectiveness | Cleaning Effectiveness for reusable instruments | Demonstrated effective cleaning according to processing instructions. |
| Performance Testing (Mechanical) | Mechanical integrity under simulated use conditions | Devices perform as intended after tests of mechanical integrity. |
| Performance Testing (System Compatibility) | Compatibility with the Senhance Surgical System | The Senhance system performs as intended when used with the subject devices. |
| Electrical Safety and Compatibility | Compliance with IEC 60601-2-2 and IEC 60601-2-18 | Instruments fulfill all applicable requirements with current electrical safety standards. |
| ESU Compatibility | Compatibility with third-party ESUs | All third-party ESUs compatible with the Senhance system are also compatible with the subject devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of instruments or adapters) used for each test. The studies were conducted by TransEnterix Inc. to support their 510(k) submission, implying they are likely prospective tests performed on newly manufactured devices or prototypes of the new instruments and adapters. The country of origin of the data is not explicitly stated, but given the company's US address, it's likely the testing was conducted in the US or in a facility that meets international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an accessory to a surgical system. The "ground truth" here relates to engineering and safety standards, and functional performance, not medical diagnosis or interpretation of medical images by experts. Compliance with standards and satisfactory performance are typically assessed by engineers and technicians.
4. Adjudication method for the test set
Not applicable. As noted above, this device focuses on engineering and functional performance, not diagnostic accuracy requiring expert adjudication.
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
Not applicable. This is not an AI-assisted diagnostic device. It is a surgical instrument. An MRMC study would not be relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. It is a surgical instrument.
7. The type of ground truth used
The "ground truth" for this submission is established by:
- International Standards: e.g., ISO 10993-1 for biocompatibility, IEC 60601-2-2 and IEC 60601-2-18 for electrical safety.
- Established Test Protocols: Procedures for cleaning effectiveness, mechanical verification, and ESU compatibility are consistent with previously cleared devices.
- Functional Performance Requirements: The expectation that the instruments perform as intended and that the surgical system remains compatible with the new accessories.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device submission.
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