(265 days)
The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.
The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.
This document describes the premarket notification (510(k)) for the GRI-Alleset Veress Needle, a disposable, single-use, sterile device intended for establishing pneumoperitoneum in minimally invasive abdominal procedures. The submission aims to demonstrate substantial equivalence to a predicate device, the Ethicon Endopath Ultra Veress Needle (K983925).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a separate table as "acceptance criteria." Instead, the document outlines performance tests that were conducted and states that the "results show acceptable results and demonstrate that the GRI-Alleset Veress Needle meets its specifications." The direct comparisons are made against the predicate device.
| Test / Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | ISO 10993 standards compliance | Biocompatible |
| Cytotoxicity | ISO 10993-5:2009 compliance | Acceptable |
| Irritation | ISO 10993-10:2010 compliance | Acceptable |
| Sensitization | ISO 10993-10:2010 compliance | Acceptable |
| Sterilization | ISO 11135-1:2014 compliance | Validated |
| ETO Residuals | ISO 10993-7:2008 compliance | Acceptable |
| Mechanical Bench Testing | Performance equivalent or superior to predicate | Acceptable, met specifications |
| Gas flow | Comparable to predicate | Acceptable |
| Leakage | Comparable to predicate | Acceptable |
| Max Puncture Force | Comparable to predicate | Acceptable |
| Rotational Valve Operation | Comparable to predicate | Acceptable |
| Stylet Alignment | Comparable to predicate | Acceptable |
| Stylet Strength | Comparable to predicate | Acceptable |
| Connector Fitting | Comparable to predicate | Acceptable |
| Audible Rate | Comparable to predicate | Acceptable |
| Shelf Life | Maintain functional performance and sterility | Maintains over proposed shelf life |
| Functional Performance | Maintained throughout shelf life | Acceptable |
| Packaging Sterility | Maintained throughout shelf life | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the test sets used in the biocompatibility, sterilization, mechanical bench testing, or shelf-life studies. It only mentions that these tests were "conducted in comparison with the predicate." The data provenance is not specified, but typically such testing would be performed in a controlled laboratory environment. The studies are prospective in the sense that the new device was evaluated against established standards and a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For medical devices like a Veress needle, "ground truth" is typically established through adherence to engineering standards, validated test methods, and comparison data from a legally marketed predicate, rather than expert consensus on a test set in the way AI algorithms are evaluated (e.g., image interpretation). The "experts" would be the engineers, quality specialists, and toxicologists conducting and interpreting the tests according to relevant ISO standards.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and the tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic accuracy assessments where there might be disagreement among human readers or interpreters. For device performance testing against engineering standards, results are typically objective and measurable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human interpretation is involved. The GRI-Alleset Veress Needle is a surgical instrument, and its effectiveness is assessed through physical and mechanical performance tests, not through reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The GRI-Alleset Veress Needle is a physical surgical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Established ISO Standards: For biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).
- Performance Specifications: The device must meet its own design specifications and perform comparably to the legally marketed predicate device (Ethicon Endopath Ultra Veress Needle).
- Predicate Device Performance: The predicate device itself serves as a benchmark for acceptable performance.
8. The Sample Size for the Training Set
This question is not applicable. Training sets are used for machine learning models. The GRI-Alleset Veress Needle is a hardware medical device, and its development does not involve machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for a hardware medical device.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.