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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.

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.

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The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of highfrequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilization procedures.

The LAPARETTE is a hybrid device consisting of three reusable (Handle, Electrode-Cannula, and Insulated Sleeve) and two single use components (Cartridge and Sheath). All LAPARETTE components are supplied non-sterile, requiring sterilization by the health care facility before use. The LAPARETTE is sold both as a set and as individual products.

The provided text is a 510(k) summary for the LAPARETTE device and does not contain detailed information about acceptance criteria or a specific study proving the device meets them. The summary focuses on establishing substantial equivalence to predicate devices based on intended use, design, and general operating characteristics, rather than presenting a performance study against predefined acceptance criteria.

The document mentions "Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE," but it does not elaborate on the specific tests, their results, or the acceptance criteria for those tests.

Therefore, I cannot populate the requested tables or answer all questions as the necessary information is not present in the provided text.

Here is what can be inferred or stated based on the available text:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary (K971146) for the LAPARETTE device does not explicitly state specific acceptance criteria in a quantitative manner, nor does it detail a comprehensive study that proves the device meets such criteria in the way a clinical trial report would.

The basis for substantial equivalence is primarily founded on comparison to predicate devices regarding:

• Intended use
• Design considerations
• General operating characteristics

The document states, "Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE." However, it does not provide details on the methodology, results, or specific acceptance thresholds for these tests.

Given the information, a table of acceptance criteria and reported device performance cannot be generated as requested. Similarly, detailed answers to questions concerning sample size, expert involvement, adjudication methods, or specific study types (MRMC, standalone) are not available.

Below is a partial response based on the limited inferences possible from the text:

1. Table of Acceptance Criteria and Reported Device Performance

• Electrocautery (cutting and bleeding control)
• Irrigation
• Suction | LAPARETTE performs electrocautery, irrigation, and suction. |
  | Operating Characteristics:
• Monopolar use | LAPARETTE is designated for monopolar use only. |
  | Dimensions:
• Usable shaft length: ~30-35mm
• Shaft O.D.: ~5.0-5.4mm | LAPARETTE usable shaft length: 30.5 mm
  LAPARETTE shaft O.D. within range. |
  | Material Compatibility:
• Use of polymers common to medical devices | LAPARETTE uses polymers common to various medical devices. |
  | Tip Rotation Feature (for comparison with D&G Multi-Function) | LAPARETTE features tip rotation. |
  | Tip Shielding during insertion (for comparison with Ethicon Probe Plus) | LAPARETTE features the ability to shield the tip during insertion. |
  | Sterilization: (implicit requirement for reusable components) | Reusable components require steam sterilization; protective sheath requires ethylene oxide. |

2. Sample size and Data Provenance

The document mentions "Bench and animal testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts and Qualifications

Not specified in the provided text. Ground truth for the performance tests is not explicitly defined with expert involvement.

4. Adjudication method

Not specified for any testing done.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study

No MRMC study is mentioned. The primary method for establishing equivalence is comparison to predicate devices, not improvement over human readers.

6. Standalone performance (algorithm only without human-in-the-loop performance)

While "Bench and animal testing" were performed, the details are not provided. It is likely these were standalone performance tests of the device's physical and functional capabilities, but this is not definitively stated or elaborated upon for an "algorithm only" context, as this is a surgical instrument and not an AI/software device.

7. Type of ground truth used

For the "Bench and animal testing," the specific type of ground truth is not elaborated. Given the nature of a surgical electrosurgical instrument, "ground truth" would likely relate to objective measurements of cutting efficacy, coagulative properties, irrigation flow rates, suction effectiveness, mechanical integrity, and biocompatibility, as determined by standard engineering and biological testing rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

Not applicable. This device is a physical surgical instrument, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable (as above).

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