(100 days)
The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of high-frequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilisation procedures.
The LAPARETTE is a hybrid device consisting of three reusable component (Protective sheath, Electrode-Cannula, and Insulated Sleeve) and one single use component(Cartridge and Handle all together). All LAPARETTE components are supplied non sterile, requiring sterilization by health care facility before first use and reuse of the reusable components. The LAPARETTE is sold as a set. The only option possible for the customer is the form of the cautery tip.
This document describes a 510(k) premarket notification for the "LAPARETTE" device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Laparette K971146) based on intended use, design considerations, and operating characteristics. The key point of the submission is that the new LAPARETTE is "exactly the same because the patent and ownership has been transfer from RD CHUS inc. to Instruments Médicaux G.B. Inc." and it will now be sold as a nine-time reusable device, whereas the predicate was sold non-sterile and without explicit reusability claims.
Since the submission claims the device is "exactly the same" and the changes relate to reusability and commercial aspects (e.g., selling as a set), the document does not contain information about specific performance acceptance criteria or a study proving that the device meets those criteria in the way a clinical trial or performance study for a novel device would. Instead, the "proof" is the substantial equivalence to the previously cleared device, assuming the reusability doesn't compromise its performance, which would typically be addressed through cleaning, disinfection, and sterilization validation, and possibly biocompatibility for repeated use.
Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness are not present in this type of 510(k) submission.
Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific performance metrics for cutting tissue, controlling bleeding, irrigation, or suction) or corresponding reported device performance values. The basis for substantial equivalence is primarily design, intended use, and general operating characteristics being identical or highly similar to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate K971146) | Reported Device Performance (Implied by Substantial Equivalence to Predicate K971146) |
|---|---|
| Ability to cut tissue using high-frequency electrical current | Equivalent to Laparette (K971146) |
| Ability to control bleeding using high-frequency electrical current | Equivalent to Laparette (K971146) |
| Ability to irrigate tissue and cavities | Equivalent to Laparette (K971146) |
| Ability to suction fluids from the wound | Equivalent to Laparette (K971146) |
| Suitable for use in minimally invasive surgery (e.g., laparoscopy) | Equivalent to Laparette (K971146) |
| Not intended for use in tubal sterilization procedures | Equivalent to Laparette (K971146) |
| Monopolar use only | Equivalent to Laparette (K971146) |
| Reusability for nine times (after sterilization) | Claimed for the new device; predicate was sold non-sterile. Revalidation of reusability (cleaning/sterilization) would be part of engineering testing, not typically presented as clinical performance in this context. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission is a claim of substantial equivalence based on the device being "exactly the same" as a previously cleared predicate and a change in reusability (from non-sterile, no reusability claim to nine-time reusable). It does not describe a performance study with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No performance study with ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No performance study with a test set is described.
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 device is not an AI/imaging diagnostic device. It is an electrosurgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable. No performance study with ground truth is described.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device that uses a training set.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).