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510(k) Data Aggregation
(120 days)
Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.
Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.
The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.
This document describes the Ergonomic Handle (K173272), which is an accessory to laparoscopic surgical manual instruments. The device allows for adjustable grip angles to improve surgeon comfort. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 (for External Communicating Devices: Tissue/Bone/Dentin with limited contact duration <24 hours) | Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity tested. All acceptance criteria of the standards were met through testing or justified through risk assessment. |
| Sterilization Validation | ISO 17665-1 (for Pre-vacuum steam sterilization cycles of 132°C for 4 minutes and 134°C for 3 minutes) | Testing was done to validate common cycles to achieve a Sterility Assurance Level of 10⁻⁶. |
| Electrical Safety | ANSI/AAMI ES60601-1 (General Requirements for Basic Safety and Essential Performance) and IEC 60601-2-2 (Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories) | The proposed devices comply with these standards for safety. |
| Mechanical Testing | Not explicitly stated, but included testing for shaft deflection and electrical safety after simulated use. | Reliability testing was conducted, including shaft deflection and electrical safety after simulated use. (Implied to have met performance needs for substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify sample sizes for any of the testing conducted (biocompatibility, sterilization, electrical safety, mechanical testing).
The data provenance is not explicitly stated beyond the testing being performed in support of the substantial equivalence determination for the device. Given the context of a 510(k) submission, this typically refers to testing conducted by the manufacturer or a contracted lab under their direction, likely within the US, but this is an inference. It is retrospective in the sense that the testing was performed on completed device designs to demonstrate compliance, rather than in a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes pre-market testing for a medical device (laparoscopic handle). These types of tests (biocompatibility, sterilization, electrical safety, mechanical) do not typically involve human experts establishing "ground truth" in the way it's understood for AI/diagnostic studies. The "ground truth" here is defined by compliance with established scientific standards and regulatory requirements. The experts involved would be the testers and engineers conducting the studies, and potentially external auditors or consultants specializing in those regulatory standards. Their qualifications would be in their respective fields (e.g., microbiology for sterilization, toxicology for biocompatibility, electrical engineering for safety, mechanical engineering for mechanical testing). No specific number or qualifications of such experts are provided in this document.
4. Adjudication Method for the Test Set
As mentioned above, the tests are primarily objective measurements against established standards, not subjective assessments requiring adjudication. Therefore, no adjudication method like 2+1 or 3+1 is applicable or mentioned for the described testing. The assessments are based on whether predefined metrics (e.g., bacterial kill rate, material toxicity, electrical leakage) meet specified limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or is mentioned. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI. This device is a surgical instrument handle, not an interpretive medical device.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
N/A. This device is a manual surgical instrument handle, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance assessment of this ergonomic handle is defined by:
- Compliance with recognized international and national standards: ISO 10993 series (biocompatibility), ISO 17665-1 (sterilization), ANSI/AAMI ES60601-1 and IEC 60601-2-2 (electrical safety).
- Engineering specifications and test protocols: for mechanical reliability (shaft deflection, electrical safety after simulated use).
- Demonstration of substantial equivalence to a predicate device (K150127) through comparing technological characteristics and ensuring no new issues of safety or effectiveness are raised.
8. The Sample Size for the Training Set
N/A. This device is a physical surgical instrument, not an AI/machine learning system, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. Since there is no training set, this question is not applicable.
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