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510(k) Data Aggregation
(15 days)
The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions.
Laparoscopic surgical manual instruments (containing a Laparoscopic Handle with PEEK Insulation and manual instrument insert) are intended for cutting, holding, grasping and manipulation of tissue, organ areas, and surgical auxiliaries such as suturing material. Some instruments have radiofrequency (RF) ports which allow them to be used for electrosurgery. The Laparoscopic Handles with PEEK Insulation (herein referred to as 'proposed device') can be used in combination with the predicate 5 mm inserts cleared in K973259. The proposed devices are designed to be sterilized by the end user using either the US or EU standard pre-vacuum sterilization cycles.
This document is a 510(k) premarket notification for a medical device (Laparoscopic Handles with PEEK Insulation). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or AI model performance evaluation. Therefore, most of the information requested in your prompt is not available in these documents.
Here's the information that can be extracted, and an explanation of why other requested information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Biocompatibility | - Criteria: Adherence to FDA Blue Book Memorandum #G95-1, ISO 10993-1:2009, ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Irritation and skin sensitization), ISO 10993-11 (Systemic toxicity). Device considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (<24 hours). |
| - Performance: Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity testing was performed on finished devices that had undergone simulated use and reprocessing. All biocompatibility testing had passing results. | |
| Sterilization Validation | - Criteria: Compliance with ISO 17665-1:2006 "Sterilization of Health Care Products Moist Heat Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices". Requirement for a Sterility Assurance Level (SAL) of $10^{-6}$. |
| - Performance: Sterilization has been validated to ensure a Sterility Assurance Level of 10-6. | |
| Electrical Safety | - Criteria: Compliance with ANSI/AAMI ES60601-1:2005 + A2 (R2012) +A1 "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance" and IEC 60601-2-2:2009 "Medical Electrical Equipment -Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories'. |
| - Performance: The proposed devices comply with the specified electrical safety standards. | |
| Mechanical Testing | - Criteria: Evaluation of Shaft deflection and Monopolar cycling (Reliability of electrical insulation through repeated firing of monopolar energy). Specific quantitative criteria are not listed in the provided text. |
| - Performance: Mechanical testing was conducted for Shaft deflection and Monopolar cycling. Specific quantitative results or passing values are not detailed in this summary. |
The following information is NOT available in the provided document:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document describes engineering and biocompatibility testing, not a clinical study with a "test set" in the context of an AI model or diagnostic device. Therefore, this information is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not a diagnostic device or AI model study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the physical tests (biocompatibility, sterilization, electrical, mechanical), the "ground truth" is defined by the specific requirements and methods of the referenced international standards (e.g., ISO, ANSI/AAMI). Passing these established and standardized tests serves as the "ground truth" for compliance.
8. The sample size for the training set
- Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
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